Amicus Curiae Brief — Thompson v. Western States Medical Center

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No. 01-344 FILED

JAN 14 2OZ

IN THE

Supreme Court of the Anited States

TOMMY G. THOMPSON,

SECRETARY OF HEALTH AND HUMAN SERVICES, ef al..

Petitioners.

Vv.

WESTERN STATES MEDICAL CENTER, ef ai/..

Respondents.

On Writ of Certiorari to the

United States Court of Appeals

for the Ninth Circuit

AMICI CURIAE BRIEF OF

JULIAN M. WHITAKER, M.D.; AMERICAN

ASSOCIATION FOR HEALTH FREEDOM;

DURK PEARSON; SANDY SHAW; PURE

ENCAPSULATIONS, INC.; WELLNESS LIFESTYLES,

INC. D/B/A AMERICAN LONGEVITY; HERO

NUTRITIONALS, INC.; LIFE SERVICES

SUPPLEMENTS, INC.; LIFE ENHANCEMENT

PRODUCTS, INC.; AND LIFE EXTENSION

FOUNDATION, SUPPORTING RESPONDENTS

JONATHAN W. EMORD *

CLAUDIA A. LEWIS-ENG

ANDREA G. FERRENZ

EMORD & ASSOCIATES, P.C.

~ 5282 Lyngate Court

Burke, VA 22015

* Counsel of Record (202) 466-6937

January | 1, 2002 Attorney for Amici Curiae

WILSON-EPES PRINTING Co-, INC. — (202) 789-0096 — WASHINGTON, D.C. 20001

TABLE OF CONTENTS

TABLE OF AUTHORITIES .........::s-ssssssssrserseeeneneenesrens

INTEREST OF THE AMICI CURIAE ......0+-000000s0e000000"

SUMMARY OF ARGUMENT ......::-+sssseseesesersnensnsneness

I. HEALTH AND SAFETY REGULATION OF

Il.

COMPOUNDING HAS LONG BEEN A

STATE PROVINCE ........-ssssesserseeessnnsnensensensenes

A. The Historic and Indispensable Role of

Compounding..........s-sesesssrereeneneenensnsnsnnenensess

B. Modern State Regulation of Compounding..

CONGRESSIONAL AND FDA RECOGNI-

TION AND ACCEPTANCE OF STATE

COMPOUNDING REGULATION ..........0-+20++

COMPOUNDING IS BUT ONE OF

SEVERAL EXEMPTIONS FROM THE

FDCA’S DRUG APPROVAL PROCESS.........

A. The Statutory and Regulatory Exemptions

from New Drug Approval.........--+-:sssssssseee

1. Personal Use Importation of Unap-

2. Unapproved Uses of Approved Drugs...

3. Investigational Use of Drugs ........-....---.

B. FDA’s pre-FDAMA Limits on Substances

Used in Compounding and on Interstate

Distribution of Compounded Drugs..........---

TABLE OF CONTENTS—Continued

C. The Non-Speech Provisions of the

FDCA, Left Unchallenged in This Litiga-

tion, Have Been Construed to Permit

Regulation of the Amount of Compound-

ing and, To a Large Extent, the Avail-

ability of Substances for Compounding ...

IV. THE POWER TO REGULATE COM-

POUNDING DOES NOT INCLUDE THE

POWER TO REGULATE TRUTHFUL AND

NONMISLEADING ADVERTISING ..............

V. THE GOVERNMENT’S JUSTIFICATION

FOR BANNING ADVERTISING OF

SPECIFIC COMPOUNDED DRUGS AND

PRICES, BUT NOT OF THE AVAIL-

ABILITY OF COMPOUNDING SERVICES,

LACKS RATIONALITY AND FAILS THE

DIRECT AND MATERIAL ADVANCE-

DEEN T1G0 © scccceccccccnscsovenovoseesonessssonapnosenbenseanedens

VI. THERE ARE NUMEROUS AND OBVIOUS

LESS RESTRICTIVE NON-SPEECH REG-

ULATORY ALTERNATIVES TO THE

GOVERNMENT’S SPEECH BAN..............0000

Vil. SEVERAL LOWER FEDERAL COURT

CASES REVEAL THE FDAMA SPEECH

BAN TO BE PART OF A GENERAL

FDA PATTERN OF SPEECH SUPPRES-

SIVE ACTIONS, ALL DIRECTLY IN-

FLUENCED BY THE COURT’S RESOLU-

TION OF THE FIRST AMENDMENT ISSUE

TN THES CASS, ..cccccccccccossnnsssnssonsosonsoonenenssscnsonets

CONCLUSION .....ccccsssrccccescenscessossnonessnsnensasssonabssssnesbeopen

Page

iii

TABLE OF AUTHORITIES

CASES Page

44 Liquormart v. Rhode Island, 517 U.S. 484

ee 4,21, 22, 26

Central Hudson Gas & Electric Corporation v.

Public Service Commission of New York, 447

TT ernrernepnannngnssesesnensnsccenenseel 6, 7, 26

Chaney v. Heckler, 718 F.2d 1174 (D.C. Cir.

iri tenacieaaiadinbeiteeenmpecenenamnenenenenneesnsunsctonseeeeets 3,17

Cowan v. United States, 5 F. Supp. 2d 1235

III, SII icsctintrncesnnsnenetneceusnsennncensnsense 16, 17, 19

Edenfield v. Fane, 507 U.S. 761 (1993) .......c00000 6, 26

Frost & Frost Trucking Company v. Railroad

Commission of California, 271 U.S. 583

i acetitiiehineiniennsnttiidnemenesmnccnnnsnececesencncboncanss 22

Ibanez v. Florida Department of Business and

Professional Regulation, 521 U.S. 136 (1994).. 6

In re RMJ, 455 U.S. 191 (1982)........ccccccccceeeseeesees 26

Pearson v. Shalala, 164 F.3d 650 (D.C. Cir.

1999); reh’g denied en banc, 172 F.3d 72

TC SET 2, 7, 26, 27

Pearson v. Shalala, 130 F. Supp. 2d 105 (D.D.C.

ee 2, 7, 26, 27

Pearson v. Thompson, 141 F. Supp. 2d 105

TT niitteennsipenernrncennesnesnnssedveneceece 2, 7, 26, 27

Peel v. Attorney Registration & Disciplinary

Comm'n of Illinois, 496 U.S. 91 (1990)............. 26

Perry v. Sindermann, 408 U.S. 593 (1972).........+. 22

Professionals & Patients for Customized Care v.

Shalala, 487 F. Supp. 1359 (S.D. Tex. 1994)... 8

Rubin v. Coors Brewing Company, 514 U.S. 476

Ee 5, 6, 24, 25

TABLE OF AUTHORITIES—C ontinued

Page

United States of America v. Algon Chemical,

Incorporated, 879 F.2d 1154 (3rd Cir. 1989).... 17, 19

United States v. Evers, 643 F.2d 1043 (Sth Cir.

SUDEP censunssscenenssannatensemmunepenenstnannaeinenssninnanetes 19

Virginia State Board of Pharmacy v. Virginia

Citizens Consumer Council, 425 U.S. 748

ee EI 2, 13, 22, 23

Washington Legal Foundation v. Henney,

56 F. Supp.2d 81 (D.D.C. 1999) rev'd 202

Ao fe 26, 27

Zauderer v. Office of Disciplinary Counsel of

Supreme Court of Ohio, 471 U.S. 626 (1985) ... 6

CONSTITUTION, STATUTES, AND

REGULATIONS

FDA Modernization Act of 1997, Pub. L. No.

105-115, 111 Stat. 2296 (1997) occ ceccceeeeees passim

Food, Drug and Cosmetic Act (FDCA) § 501, 21

ies Ae ie Ci ncartcerenepinristcinennemesnnitiantaie a

FDCA § 502, 21 U.S.C. § 352 (2001) ................... 18

FDCA § 503, 21 U.S.C. § 353 (2001) ...............00.. 16, 20

FDCA § 505, 21 U.S.C. § 355 (2001) ............0... 4, 18, 20

FDCA § 510, 21 U.S.C. § 360 (2001) ................... passim

FDCA § 704, 21 U.S.C. § 374 (2001) .............000 3, 18

All 50 States Medical Practice Acts Cited............. 5, 16

All 50 States Pharmacy Practice Acts Cited........... 13, 14

Md. Code Ann. Health Occupations § 12-101

| eee ne 15

Be Gi © Fee ee crennrnitinimntiainin 18, 20

TABLE OF AUTHORITIES—Continued

Legal Status of Approved Labeling for Pre-

scription Drugs; Prescribing for Uses Unap-

proved by the Food and Drug Administration,

37 Fed. Reg. 16,503 (1972) ........ccseseseesseeeeeeees

MISCELLANEOUS

Allen, Jr., Ph.D., Loyd V., Allen’s Compounded

Formulations: The U.S. Pharmacist Collec-

OW ee

Allen, Jr., Ph.D., Loyd V., The Art, Science, and

Technology of Pharmaceutical Compounding

(BG) ccccccccscssncessssscnsessssseseussnessnssscsssssssssases 8, 10,

American Academy of Pediatrics, Few Pre-

scription Drugs Labeled for Pediatric Use,

4 1, 3 (visited Dec. 20, 2001) <http://www.

babybag.com/articles/aap_drug.htm>................

fon | tnustend Soum of Plame

Compounding for Hospice and Cancer Patients,

4 International Journal of Pharmaceutical

Compounding 4 (2000) .............cssssseerseeeeeseenes

Compounding for Pain Management, 2 Inter-

national Journal of Pharmaceutical Com-

pounding 2 (1996)..........cc.cccccsccsescccsccscsecsscseceenes

Compounding for Pain Management, 4 Inter-

national Journal of Pharmaceutical Com-

Compounding for Pediatric Patients, 5 Inter-

national Journal of Pharmaceutical Com-

pounding | (2001).............sserssersenensereneenenees

Page

11, 13

11,12

TABLE OF AUTHORITIES—Continued

Page

Compounding Parenteral Nutrition Solutions, 2

International Journal of Pharmaceutical Com-

I D Gor i eccccrenattntinasesttinemesease 11

Duffy, John, From Humors to Medical Science:

A History of American Medicine (1993)............ 10

I TE eocesncesniqnesesinininisindininidenadcasnienipmesens 8

Exploring Compounding Options for Geriatric

Patients, | International Journal of Pharma-

ceutical Compounding 3 (1997) .................cce0ee 12

FDA, Compliance Policy Guides, § 460.200

(CPG 7132.16)(1992); Rescinded, 64 Fed.

a a passim

FDA, Compliance Policy Guides, 7125.40 Chap.

gee 17

FDA, Regulation Procedures Manual, “Coverage

of Personal Importation,” Chapter 9, (August

Ue carennnieninencnnitsmseeanneessmapemennmeneatenniemeneson 18

Gill, Jr., Harold B., The Apothecary in Colonial

gE NET 9, 10

H.R. Rep. No. 74-2755 (1936)..........c.ccccsceeseeeseeees 19

Kremers, E. and Urdang,. G., History of

Pharmacy: A Guide and a Survey (1947).......... 8, 10

Kurland, Posadas de Puerto Rico v. Tourism

Company: “‘Twas Strange, ‘Twas Passing

Strange; ‘Twas Pitiful, ‘Twas Wondrous

Pitiful,” 1986 S.Ct.Rev. 1, 12-15 ..........ccccecceees 21

LaWall, Charles, The Curious Lore of Drugs and

GT GYD cerncsceguisienmennnmtiemeean 8, 10

Nightingale, M.D., Stuart L., Use of Drugs for

Unlabeled Indications, FDA Perspective 269

vii

TABLE OF AUTHORITIES—Continued

Page

Nightingale, M.D., Stuart L., Unlabeled Uses of

Approved Drugs, 26 Drug Information Journal

See 18, 19

S. Rep. No. 105-43 (1997).......cccccccececseerserseereenenees 7, 27

S. Rep. No. 87-1744 (1962).........ccccccseeseeseeseeeeeeeenes 19

S. Rep. No. 74-361 (1935)......cccccsecseereerseereereeneeees 19

S. Rep. No. 74-646 (1935).......ccccccsecseereereeneeneenennes 19

Troy, Daniel, The FDA and Off-Label Uses of

Drugs and Devices, 4 3 (visited Dec. 20,

2001) <http://www.mediainst.org/digest/97 fall/

ID eecccncceneemeneenessssenssemmcemeqenseenmenase 19

United States Pharmacopoeial Convention, Inc.,

United States Pharmacopoeia XXV/ National

Formulary XX. (2002)........scssssessseseesereeeeneneenes 13

INTEREST OF THE AMICI CURIAE '

Julian M. Whitaker, M.D. is a physician licensed to prac-

tice medicine in California and Washington. Dr. Whitaker

prescribes compounded drugs for special needs patients. The

petitioners prohibit advertising of compounded drug avail-

ability and price. Dr. Whitaker relies on that information to

obtain for those patients competitively priced compounded

drugs as efficiently as possible. He is therefore adversely

affected, as are his patients, by the petitioners’ adver-

tising ban.

American Association for Health Freedom (“AAHF”) is

a Virginia non-profit corporation with over 500 physician,

pharmacist, chiropractor and other health care practitioner

members. AAHF endeavors to protect consumer access to

preventive therapies and the right of health care providers to

offer those therapies. AAHF’s 240 physician members, in-

cluding its nine physician board members, rely on the

compounding services of pharmacists from across the nation.

The drug price advertising the petitioners prohibit is precisely

the advertising those members need most to provide their

special needs patients competitively priced compounded

drugs as efficiently as possible. Thus, AAHF’s physician

board members and physician members are adversely

affected, as are their patients, by the petitioners’ adver-

tising ban.

Durk Pearson; Sandy Shaw; Pure Encapsulations, Inc.;

Wellness Lifestyles, Inc. d/b/a American Longevity; Hero

Nutritionals, Inc.; Life Enhancement Products, Inc.; Life

' Counsel of record for the amici curiae authored this brief in whole.

The amici curiae paid all costs associated with the preparation and

submission of the brief with the exception of a monetary contribution

made by Coastal Georgia Health Institute, Inc., 158 ScrantotConnector

Bivd., Brunswick, GA 31525. The amici have received the written

consent for the filing of this brief from counsel to the petitioners and the

respondents. Those letters have been filed with the Clerk of the Court.

Extension Foundation; and Life Services Supplements, Inc.

design, license and sell dictary supplements. As such, they

are regulatees of the Food and Drug Administration (FDA).

Their products labeling and advertising is directly (in the case

of labeling) and indirectly (in the case of advertising)

regulated by the FDA. The blanket speech ban here in issue,

administered by the FDA, is substantively indistinguishable

from the blanket bans imposed on these amici by FDA to

prevent the communication of truthful dietary supplement

health claims. See Pearson v. Shalala, 164 F.3d 650 (D.C.

Cir. 1999); reh’g denied en banc, 172 F.3d 72 (D.C.Cir.

1999)(hereinafter “Pearson I”); Pearson v. Shalala, 130

F. Supp.2d 105 (D.D.C. 2001) (hereinafter “Pearson IY’);

Pearson v. Thompson, 141 F. Supp.2d 105 (D.D.C. 2001)

(hereinafter “Pearson III’) (declaring such bans unconsti-

titional under the First Amendment). The legal validity of

FDA blanket speech bans will likely be affected by this

Court’s First Amendment determination on the blanket ban

here in issue. These amici thus have a keen interest in the

outcome of the case. |

SUMMARY OF ARGUMENT

Upholding the decision below protects the First Amend-

ment presumption favoring disclosure of truthful, nonmis-

leading health information over its suppression. It reaffirms

the principles first articulated in Virginia State Board of

Pharmacy v. Virginia Citizens Consumer Council, 425

U.S. 748 (1976), that weigh heavily against blanket bans on

drug advertising.

In Virginia State Board of Pharmacy this Court held drug

price information protected from a blanket advertising ban,

reasoning that communication on the availability of the X

prescription drug at the Y price was indispensable to

consumers (indeed, was potentially more important to them

than the day’s most urgent political debate). /d. at 763.

Here again the Court confronts a blanket ban on drug

advertising. That ban deprives physicians, including those

among the amici, of information they need to locate

competitively priced compounded drugs efficiently.

Drug compounding (the state regulated and licensed

practice of manipulating drug content, delivery method, and

dose to treat special needs patients) occurs on a case by case

basis and is performed under state law either by individual

physicians directly or by pharmacists pursuant to an indi-

vidual physician’s prescription. By contrast, drug manu-

facturing (the federally regulated production of standardized

and FDA pre-approved drugs) occurs in mass, pre-set

quantities and delivery forms for distribution to licensed drug

retailers and licensed practitioners nationwide. Drug com-

pounding when performed under state law is thus part of a

physician’s practice of medicine, a practice heavily regulated

by the states. When a drug is prescribed by physicians for an

unapproved use (i.e., for a use not evaluated by the FDA for

safety or efficacy)—a practice especially common among

oncologists and pediatricians—or is manipulated by or at the

behest of a physician to satisfy the treatment needs of a

specific patient, that is a “practice of medicine” regulated by

the states. The “practice of medicine” is expressly exempt

from federal regulation under the Food Drug and Cosmetic

Act (FDCA). See 21 U.S.C. § 360(g)(2) (exempting

“practitioners licensed by law to prescribe or administer drugs

or devices and who manufacture, prepare, propagate, or

compound, or process drugs or devices solely for use in the

course of their professional practice” from the FDCA drug

registration and inspection provisions); see also 21 U.S.C. §

374(a)(2)(A);(B); Chaney v. Heckler, 718 F.2d 1174, 1180

(D.C. Cir. 1983). The petitioners thus err when they argue to

the Court that prior to the adoption of the FDA Modernization

Act, Pub. L. No. 105-115, 111 Stat. 2296 (1997) (FDAMA),

there existed no statutory basis for exempting compounded

drugs from the FDCA’s pre-market approval provisions.

But even were the drug pre-market approval provisions

deemed applicable to patient specific compounded drugs (as

the petitioners presume they are), it is not true that the FDA,

pre-FDAMA, deemed itself incapable of regulating interstate

traffic in compounded drugs. To the contrary, FDA has

previously assumed that the FDCA’s drug manufacturing and

distribution provisions, 21 U.S.C. § 351; 355 (2001), left un-

challenged in this litigation, grant FDA authority to limit the

amount of compounded drugs entering interstate commerce.

FDA has also assumed that those sections of the FDCA grant

it authority to limit the kinds of substances that may be

shipped interstate for use in compounding. See e.g., FDA,

Compliance Policy Guides (hereinafter, “CPG”) 7132.16

Chap. 4 § 460.200 (1992) (revoked by FDA following

passage of FDAMA). Thus, without the FDAMA sections

here in issue (and without need for resort to speech

restrictions), the petitioners have limited the mass interstate

distribution of compounded drugs and substances for use in

compounded drugs.

To be sure, it is possible to limit the amount and kind of

compounded drugs in interstate commerce without imposing a

blanket ban on advertising of specific compounded drugs and

drug prices. The petitioners presume, however, that the power

to regulate commercial activity carries with it a “lesser”

included power to regulate speech concerning that activity.

That underlying premise of the petitioners’ argument is

substantively indistinguishable from a false syllogism rejected

by this Court in 1996. The view that the power to regulate a

commercial activity includes within it the power to regulate

speech concerning that activity, the so-called “greater-

includes-the-lesser” syllogism, is, post 44 Liguormart v. Rhode

Island, 517 U.S. 484, 510-513 (1996), not good law.

The petitioners insist that they must ban compounded drug

advertising to protect patient health and safety, but that

argument too is lacking in persuasive force because health

and safety regulation of pharmacy and physician com-

pounding has long been a province of the states. For decades

hospitals, physicians, and pharmacists have engaged in

compounding under extensive state regulation. Contrary to

the petitioners’ argument, that state system has had an

yutstanding safety record. It has been patients’ first line of

protection since the advent of modern pharmacy com-

pounding in the late 1960’s. There is no basis, and certainly

no record evidence, to question the adequacy or effectiveness

of state health and safety regulation of pharmacy and

physician compounding.

The Congress of the United States and the FDA have

recognized that regulation of compounding, like regulation of

medical and pharmacy practice, is a matter of state concern.

The FDAMA exemption afforded compounded drugs from

the new drug approval provisions of the FDCA is but one of

several statutory and regulatory exceptions to the general rule

requiring federal pre-market drug approval. Those exceptions

(such as for the practice of medicine and pharmacy, including

compounding; for unapproved uses of FDA approved drugs;

for personal use importation of unapproved drugs from

outside the United States; and for experimental _use of

unapproved drugs) provide physicians the flexibility they

must have to treat patients for whom approved drugs are

either inappropriate, ineffective, or dangerous.

Here, as in Rubin v. Coors Brewing Company, 514 U.S.

476 (1995), the Government's justification for its speech ban

rests on an irrational regulatory scheme. On the one hand, the

Government permits pharmacy advertising of the existence of

compounding services, arguing that it can allow that

advertising without fear of increased demand for com-

pounded drugs. On the other, the Government forbids

pharmacy advertising of the existence of specific com-

pounded drugs at specific prices, arguing that it cannot allow

that advertising without fear of moe ee

compounded . The argument apparently presumes

physicians 0 a ch drugs will be less apt to find

those drugs if they are only informed of the places that sell

them rather than of the availability, classes, types, and prices

of compounded drugs sold. That argument is counterintuitive

and wholly speculative backed by not one shred of record

evidence despite its illogic. This Court has repeatedly

rejected such speculative argument as insufficient to satisfy

the Government’s high First Amendment burden. See Coors

514 U.S. at 487-489; Edenfield v. Fane, 507 U.S. 761 770-

771 (1993); Ibanez v. Florida Department of Business and

Professional Regulation, 521 U.S. 136, 143 (1994); Zauderer

v. Office of Disciplinary Counsel of Supreme Court of Ohio,

471 U.S. 626, 648-649 (1985). Logically, while less

information may make the cost of obtaining a compounded

drug higher than would otherwise be the case, it will likely

not dissuade a physician intent on obtaining a compounded

drug for a patient in need if that physician receives

information on the existence and location of compounding

pharmacies. Thus, the Government’s position, dependent on

speech suppression, provides at best only remote, indirect,

and ineffective support, if any, for the Government’s goal of

keeping the demand for compounded drugs at some

unarticulated lower than free market level.

In the present case the petitioners have not established that

the FDAMA speech ban on compounded drug advertising

(reaching even the phrase, “I will sell you the X compounded

prescription drug at the Y price”) directly and materially

advances their goal of reducing to some unspecified below

market level the amount of compounded drugs. They have

not established the rationality of a regulatory scheme that

allows advertising of compounding services but not of

specific compounded drugs. They have not established the

absence of numerous and obvious less restrictive alternatives

(such as limits on the drugs available for compounding and

on the amount of compounded drugs distributed interstate).

Thus, having failed the direct advancement and means-ends

tailoring prongs of Central Hudson Gas & Electric v. Public

Service Commission of New York, 447 U.S. 557 (1980) (as

modified by its progeny), the Government’s speech ban is

unconstitutional. This Court should therefore uphold the

decision of the United States Court of Appeals for the Ninth

Circuit invalidating the speech ban.

This case is not unique. The lower federal courts have

repeatedly condemned FDA blanket speech bans on truthful

health information to no avail; FDA’s acts of suppression

continue largely unabated. See Pearson I, 164 F.3d 650;

Pearson II, 130 F. Supp.2d 105; Pearson III, 141 F. Supp.2d

105; see also S.Rep. No. 105-43, at 50 (1997). The FDAMA

blanket ban is thus part of a common, redundant approach

favored by petitioners, an approach they employ undeterred

by constitutional mandates in specific cases to the contrary.

The precedential impoft and impact of the present case is thus

profound and will necessarily be viewed as expressing the

Court’s willingness to condone similar FDA violations in

future. The amici therefore urge the Court when resolving

the current controversy to make clear that would-be health

information speech police must abide by the same high First

Amendment standard this Court expects of other would-be

regulators of commercial speech, emphasizing that FDA

regulators cannot shirk their constitutional duty to satisfy the

First Amendment standard and must, consistent with that

standard, favor disclosure of health information as the rule

(relegating suppression to the status of a rare exception).

ARGUMENT

I. HEALTH AND SAFETY REGULATION OF

COMPOUNDING HAS LONG BEEN A STATE

PROVINCE

The preparation of patient-specific formulations by phar-

macies and physicians (compounding *) has been a part of

2 Compounding has been succinctly defined as a process by which a

pharmacist “combines, mixes, or alters ingredients to create a certain

medical and pharmacy practice for thousands of years. In

modern times, compounded preparations are essential for

special needs patients, such as children and the elderly who

may have difficulty swallowing patented drugs in their

commercially available dosage forms; hospitalized patients

who need parenteral nutrition for extended recuperative stays;

and cancer patients who need compounded chemotherapy

cocktails. It is thus no exaggeration to say that longevity and

pain relief are in no small measure due to the ability of

physicians, pharmacists, and veterinarians to compound

medications expeditiously for their special needs patients.

A. The Historic and Indispensable Role of

Compounding

Compounding is a practice as old as the first preparers of

remedies for the first recorded civilizations.” Ancient

Babylonian-Assyrian medicine included a class of “Preparers

of remedies” whose functions included compounding.‘

Compounding was practiced by apothecaries in ancient Egypt

as recorded in the Ebers Papyrus circa 1500 B.C.° The

scriptures refer to the art of the apothecary and to

compounding: “And thou shalt make it an oil of holy

ointment, an ointment compound after the art of the

apothecary: It shall be an holy anointing oil.” Exodus 30:25.

See also Loyd V. Allen, Jr., Ph.D., The Art, Science, and

Technology of Pharmaceutical Compounding xi (1998).

medication for a patient.” Professionals & Patients for Customized Care

v. Shalala, 847 F. Supp. 1359, 1361 (S.D. Tex. 1994), aff'd, 56 F.3d 592

(Sth Cir. 1995).

* Loyd V. Allen, Jr, Ph.D., The Art, Science, ad Technology of

Pharmaceutical Compounding xi (1998)

* Edward Kremers and George Urdang, History of Pharmacy: A Guide

and a Survey 4-7 (1947).

* See id. at 387; see also Charles H. LaWall, The Curious Lore of

Drugs and Medicines 11 (1927).

a ee ws

During the Norman period in England, the word

“apothecary . . . designated anyone who kept a shop or store

of such nonperishable commodities as spices, drugs, combits,

and preserves.” Harold B. Gill, Jr., The Apothecary in

Colonial Virginia 1 (1972). From approximately 1300 to

1500, “the term [apothecary] was restricted to those who

prepared and sold drugs,” /d. at 1.° Until the late 1700's

apothecaries who learned their skills through apprenticeship

performed roles commonly associated with physicians. See

id. On the eve of the nineteenth century, there first arose a

professional distinction between druggists and apothecaries,

on the one hand, and physicians, on the other. See id. Before

that time, it was common for apothecaries to diagnose disease

and dispense drugs. See id. at 8.

In June 1632, Parliament passed a law making it unlawful

for apothecaries to sell drugs without a physician’s

prescription, but the law was honored more in the breach.

See id. Parliament’s passage of the Apothecaries’ Act of

1815 caused a true separation between the medical and

pharmaceutical professions in England. See id. at 15. From

the 17th century until at least 1851, apothecaries in America

performed the dual role of druggist and physician.’ Modern

® Even at this early date, concern arose among professionals for quality

apothecaries and drugs, as evidenced by the words of English physician

William Bulleyn who died in 1576:

His of dwelling must be cleanly, to please the senses withal.

Si taicaenantttied oth harp eftahen, conhs, and sot

He must have his mortars, stills, pots, filters, glasses, boxes, clean

and sweete. He must have two places in his shop, one must be clean

for physic, and [the other a }] base place for chirurgic stuff. He is

neither to [increase nor] diminish the physician's prescriptions. He

is neither to buy nor sell rotten drugs . .. .

Id. at 14,

” During his 1788 travels in America, Frenchman Jacques P. Brissot de

Warville observed: “The greatest part of these physicians [at Philadelphia}

are, at the same time, apothecaries. They continue to unite these two

professional pharmacies first appeared in the United States in

1851.* It was not until the second World War, however, that

consumers came to rely primarily on physicians, rather than

apothecaries, for medical advice.’ Moreover, patent medi-

cines were quite scaice in America before the end of World

War II. Consequeutly, local plants, such as Indian hemp,

papoose root, Indian mallow, and snake root were commonly

compounded by apothecaries. Gill, supra, at 40.

Modern regulation of pharmacy as a distinct profession

began with model state laws initially introduced at the

Chicago meeting of the American Pharmaceutical Associa-

tion in 1869. See Kremers, supra, at 199. By 1909 all then

extant states of the United States had adopted the model laws

for the regulation of pharmacy. See id.

Despite the rise of mass manufactured drugs, compounding

has remained an indispensable tool in modern medical and

pharmaceutical practice.' In modern times, compounding

permits physicians and veterinarians to respond to a wide

variety of patient specific needs that cannot be accom-

modated, or cannot be accommodated adequately, with mass

sciences out of respect to the people, who wish that the man who orders

the medicine should likewise prepare it.” Gill, supra,. at 28.

* Kremers et al, supra, at 293.

*“. . {AJt least until World War Il, apothecaries, or druggists, were

often the first to be called upon for medical advice.” John Duffy, From

Humors to Medical Science: A History of American Medicine 7-8 (1993).

See also LaWall, supra, at 11.

® Loyd V. Jr., Ph.D. has explained the basic distinction between

ceutical Compounding, supra, at |.

manufactured drugs.'' Compounding occurs routinely in

hospitals, physicians’ offices, veterinary clinics, and phar-

macies. In 1995, compounded prescriptions represented

approximately 11% of all prescriptions dispensed.“ Anyone

hospitalized for more than a day is almost always the

beneficial recipient of compounded drugs. “In hospitals,

compounding has always been a part of pharmacy practice,

intravenous admixture programs were brought into hospital

pharmacy departments in the 1960s and 1970s and many ©

pediatric formulations are prepared routinely.” Loyd V.

Allen, Jr., Ph.D., Allen’s Compounded Formulations: The

U.S. Pharmacist Collection, 1995-1998 vil (1997). The

ubiquitous “TV” is usually a compounded solution prepared to

satisfy the particular needs of the hospitalized patient.

Examples of compounded products dispensed every day by

health care professionals include total parenteral nutrition

solutions; intrathecal solutions for pain management (such as

morphine solutions); most intravenous pen ere a

antibiotic preparations for ambulatory care; most oncol-

ogy preparations. See generally, Compounding Parenteral

Nutrition Solutions, 2 International Journal “whee aang

ompounding 5 (1998); Compounding for Pain anagement,

> neeaeee Journal of Pharmaceutical Compounding 2

(1998); Compounding for Pain Management, 4 Interna-

tional Journal of Pharmaceutical Compounding | (2000);

Compounding for a Diverse Ambulatory Patient Base,

1 International Journal of Pharmaceutical Compounding

6 (1997); Compounding for Hospice and Cancer Patients,

'! See The Art, Science, and Technology of Pharmaceutical Ccmpound-

ing, supra, at 1: “Compounding is . . . essential to the provision of health

care. Compounding can be as simple as the addition of a liquid to a

manufactured drug powder, or as complex as the preparation of a

multicomponent parenteral nutrition solution.”

'2 The Art, Science, and Technology of Pharmaceutical Compounding,

supra, at xii.

4 Intersational Journal of Pharmaceutical Compounding 4

(2000). Pediatric medications are not generally avail-

able ir an easy-to-swallow form; consequently pharma-

cists frequently make liquids for oral consumption from

commercially available tablets/capsules. See generally,

Compounding for Pediatric Patients, 5 International Journal

of Pharmaceutical Compounding | (2001). Because those

drugs often have relatively short shelf lives when put into

solution, they must be compounded by the pharmacist.

Geriatric medications for the elderly who have difficulty

swallowing are also frequently compounded. See generally,

Exploring Compounding Options for Geriatric Patients, |

International Journal of Pharmaceutical Compounding 3

(1997). The need to vary dosage forms and to eliminate

preservatives or allergy-producing excipients may lead a

physician or pharmacist to cause a pharmaceutical product to

undergo compounding before it is ingested or administered

to a patient.'?

Through compounding, pharmacists, physicians, and vet-

erinarians prepare solutions, suspensions, topicals, and sup-

positories that provide alternative routes of administration

sometimes necessary in the treatment of particular patients.

They are also able to prepare select dosage forms from bulk

drug ingredients. Compounding is required to prepare

radioactive isotopes and cassettes, syringes, and other de-

vices for drug administration in the home setting. See id.

at XV-xvi.

There is now near universal scientific recognition of the

need for compounding in the provision of patient care. In

" See The Art, Science, and Technology of Pharmaceutical Com-

pounding, supra, at xii: “Complete pharmaceutical care must involve the

dosage form, which might necessitate compounding a patient-specific

form not available commercially; possibly the preparation of a product

without a preservative or a specific allergy-producing excipient that must

1990, the U.S. Pharmacopoeial Convention appointed a

Pharmacy Compounding Practices Expert Advisory Panel to

prepare a chapter on compounding for the USP and to prepare

monographs on compounded products. The chapter on

“Pharmacy Compounding Practices” appeared in 1996 and

the first compounding monographs appeared in 1998. See,

Allen's Compounded Formulations, supra, at 2; see generally

United States Pharmacopoeial Convention, Inc., United States

Pharmacopoeia XXV/ National Formulary XX (2002).

Far from constituting a health threat, compounding under

state regulation is an indispensable tool in the treatment of

disease and the alleviation of pain. Its modern yse is a

professional practice under the ever-watchful eye of state

boards of medicine and pharmacy."

B. Modern State Regulation of Compounding

Every state extensively regulates pharmacy practice, in-

cluding compounding. '® Compounding is not regulated

'* In its first decision concerning price advertising by pharmacists, this

Court recognized the high degree of professionalism associated with a

state licensed pharmacy practice, writing:

[T]he practice is subject to extensive regulation aimed at p-eserving

high professional standards. . . . . The Board is broadly charged by

statute with various responsibilities, including the “[m]aintenance of

the quality, quantity, integrity, safety and efficacy of drugs or

devices distributed, dispensed or administered.” . . . It also is to

concern itself with “{maljintaining the integrity of, and public

confidence in, the profession and improving the delivery of quality

, nt cendeneen@nelt of Virginia.”

Virginia State Board of Pharmacy, 425 U.S. at 750-751.

'S See Ala. Code § 34-23-1 et seq. (2001); Alaska Stat. § 08.80.003 er

seq. (2001); Ariz. Rev. Stat. § 32-1901 et seq. (2001); Ark. code ann.

§ 17-92-101 et seq. (2001); Cal. Business and Professions Code § 4000 er

seq. (West 2001); Colo. Rev. Stat. Ann. § 12-22-101 et seq. (West 2001);

Conn. Gen. Stat. Ann. § 20-570 et seg. (West 2001); Del. Code Ann. tit.

24 § 2501 et seq. (2001); D.C. Code Ann. § 3-1201.01 et seq. (2001); Fla.

Stat. ch. 465.001 et seq. (2001); Ga. Code Ann. § 26-4-1 ef seq. (2001);

separate from pharmacy but is accepted as an integral part of

it. Consider, for example, Maryland’s rather typical statutory

definition of pharmacy practice:

[To] “practice pharmacy” means to engage in any of the

following activities:

(i) Providing pharmaceutical care;

(ii) Compounding, dispensing, or distributing pre-

scription drugs or devices;

(iii) Compounding or dispensing nonprescripti

drugs or devices; : oe

(iv) Monitoring prescriptions for prescription and

nonprescription drugs or devices;

Haw. Rev. Stat. Ann. § 461-1 ef seq. (2001); Idaho Code § 54-1701 er

seq. (2001); 225 Ill. Comp. Stat. Ann. 85/1 et seg. (West 2001); Ind.

Code. Ann. § 25-26-13-1 et seq. (2001); lowa Code Ann. § 155A.1 ef seq.

(West 2001); Kan. Stat. Ann. § 1625 et seq. (2000); Ky. Rev. Stat. Ann.

§ 315.002 et seq. (Michie 2001); La. Rev. Stat. Ann. § 1161 ef seg. (West

2001); Me. Rev. Stat. Ann. tit. 32, § 13701 et seg. (West 2000}; Md. Code

Ann. Health Occupations § 12-101 et seg. (2001); Mass. Gen. Laws Ann.

112 § 24 et seq. (2001); Mich. Comp. Laws § 333.17701 et seq. (2001);

Minn. Stat. § 151.01 ef seq. (2001); Miss. Code Ann. § 73-21-69 et seq.

(2001); Mo. Ann. Stat. § 338.010 et seg. (West 2001); Mont. Code Ann.

§ 37-7-101 et seq. (2001); Neb. Rev. Stat. § 71-1,142 et seg. (2001); Nev.

Rev. Stat. Ann. § 639.001 et seq. (2001); N.H. Rev. Stat. Ann. § 318:1 ef

seq. (2001); N.J. Stat. Ann. § 45:14-11:11 et seq. (2001); N.M. Stat. Ann.

§ 61-11-2 et seq. (Michie 2001); N.Y. Educ. Law § 6800 et seg. (2001);

N.C. Gen. stat. § 90-85.2 et seg. (2000); N.D. Cent. Code § 43-15-01 ef

seq. (2001); Ohio Rev. Code Ann. § 4729.01 et seq. (Anderson 2000);

Okla. Stet. tit. 59, § 353 et seq. (2000); Or. Rev. Stat. § 689.005 er seq.

(2000); Pa. Stat. Ann. tit. 63, § 390-1 ef seq. (West 2001); R.1. Gen. Laws

§ 5-19-1 et seq. (2001); S.C. Code Ann. § 40-43-10 et seg. (West 2000);

S.D. Codified Laws § 36-11-1 (Michie 2001); Tenn. Code Ann. § 63-10-

301 et seq. (2001); Tex. Occ. Code Ann. § 551.001 et seg. (West 2001);

Utah Code Ann. § 58-17a-101 ef seg. (2001); Vt. Stat. Ann. tit. 26 § 2021

et seq. (2001); Va. Code Ann. § 54.1-3300 (Michie 2001); Wash. Rev.

Code Ann. § 18.64.001 ef seq. (2001); W. Va. Code § 30-5-1 ef seq.

(2001); Wis. Stat. Ann. § 450.01 ef seq. (West 2001); Wyo. Stat. Ann.

§ 33-24-10! ef seg. (2001).

(v) Providing information, explanation, or recom-

mendations to patients and health care practitioners

about the safe and effective use of prescription or

nonprescription drugs or devices; or

(vi) Identifying and appraising problems concern-

ing the use or monitoring of therapy with drugs

or devices.

Md. Code Ann. Health Occupations § 12-101.

Pharmacists and physicians who compound and physicians

who prescribe compounded drugs must adhere to generally

recognized standards of care enforced by state boards of

pharmacy and medicine. '°

'© See (Pharmacists) Ala. Code § 34-23-2; Alaska Stat. §§ 08.80.003-

08.80.005; Ariz. Rev. Stat. § 32-1904; Ark. code ann. § 17-92-205(a);

Cal. Business and Professions Code § 4005; Colo. Rev. Stat. Aan. § 12-

22-101; Conn. Gen. Stat. Ann. § 20-576; Del. Code Ann. tit. 24 § 2501;

D.C. Code Ann. § 3-1204.08; Fla. Stat. ch. 465.002; Ga. Code Ann.

§ 26-4-3; Haw. Rev. Stat. Ann. § 461-1; Idaho Code § 54-1702; 225 Ill.

Comp. Stat. Ann. 85/1; Ind. Code. Ann. § 25-26-13-1; lowa Code Ann.

§ 155A.2; Kan. Stat. Ann. § 65-1627; Ky. Rev. Stat. Ann. § 315.002; La.

Rev. Stat. Ann. § 1162; Me. Rev. Stat. Ann. tit. 32, §§ 1371!, 13721,

13723; Md. Code Ann. Health Occupations § 12-205; Mass. Gen. Laws

Ann. 112 § 24; Mich. Comp. Laws § 333.17722; Minn. Stat. § 151.01;

Miss. Code Ann. § 73-21-83; Mo. Ann. Stat. § 338.140; Mont. Code Ann.

§§ 37-7-101, 37-7-201; Neb. Rev. Stat. § 71-1,142.09; Nev. Rev. Stat.

Ann. § 639.070; N.H. Rev. Stat. Ann. § 318:5-a; N.J. Stat. Ann. § 45:14-

14:1,45:14-3; N.M. Stat. Ann. § 61-11-6; N.Y. Educ. Law § 6804; N.C.

Gen. stat. §§ 90-85.2, 90-85.6; N.D. Cent. Code § 43-15-10; Ohio Rev.

Code Ann. §§ 4729.02, 4729.04; Okla. Stat. tit. 59, §§ 353, 353.7; Or.

Rev. Stat. §§ 689.025, 689.135; Pa. Stat. Ann. tit. 63, § 390-6; R.1. Gen.

Laws § 5-19-6; S.C. Code Ann. § 40-43-60; S.D. Codified Laws

§§ 36-11-1, 36-11-11; Tenn. Code Ann. § 63-10-501; Tex. Occ. Code

Ann. § 554.002; Utah Code Ann. § 58-17a-201; Vt. Stat. Ann. tit. 26

§ 2032; Va. Code Ann. § 54.1-3305; Wash. Rev. Code Ann. § 18.64.005;

W. Va. Code § 30-5-2; Wis. Stat. Ann. § 450.02; Wyo. Stat. Ann.

§ 33-24-102. See also (Physicians) Ala. Code § 34-24-53; Alaska Stat.

§§ 08.64.100, 08.64.101; Ariz. Rev. Stat. § 32-1403; Ark. code ann.

§ 17-95-303; Cal. Business and Professions Code § 2220; Colo. Rev. Stat.

Il. CONGRESSIONAL AND FDA RECOGNITION

AND ACCEPTANCE OF STATE COMPOUND-

ING REGULATION

Almost sixty years before adoption of FDAMA, Congress

chose to exempt from FDA drug registration and inspection

pharmacies and physicians whose compounding practices

complied with state laws governing those practices.'’

Congress also chose to exempt from FDCA misbranding

provisions any drug dispensed by filling. or refilling a valid

prescription from a licensed physician. '*

Before FDAMA, federal courts understood 21 U.S.C.

§ 360(g)(2) to create a “practice of medicine” exemption to

the FDCA. See Cowan v. United States, 5 F. Supp.2d 1235,

Ann. §§ 12-36-102, 12-36-104; Conn. Gen. Stat. Ann. § 20-8a; Del. Code

Ann. tit. 24 §§ 1701, 1730; D.C. Code Ann. § 3-1202.03, 3-1204.08; Fla.

Stat. ch. 458.307; Ga. Code Ann. § 43-34-21; Haw. Rev. Stat. Ann.

§ 453-5.1; Idaho Code § 54-1806; 225 Ill. Comp. Stat. Ann. §§ 60/8, 60/9;

Ind. Code. Ann. § 25-22.5-2-7; lowa Code Ann. § 148.2A; Kan. Stat.

Ann. § 65-2812; Ky. Rev. Stat. Ann. § 311.565; La. Rev. Stat. Ann.

§ 1261; Me. Rev. Stat. Ann. tit. 32, § 3269; Md. Code Ann. Health

Occupations § 12-101; Mass. Gen. Laws Ann. 112 § 2; Mich. Comp.

Laws § 333.17021; Minn. Stat. § 147.001; Miss. Code Ann. §§ 73-25-3,

73-25-30; Mo. Ann. Stat. § 334.120; Mont. Code Ann. §§ 37-3-203, 37-3-

101; Neb. Rev. Stat. § 71-111,71-1,104.06; Nev. Rev. Stat. Ann.

§§ 630.003, 630.130; N.H. Rev. Stat. Ann. § 329:2; N.J. Stat. Ann.

§§ 45:9-22.1, 45:9-22:18; N.M. Stat. Ann. §§ 61-6-10.8, 61-6-10.9; N.Y.

Educ. Law §§ 6508, 6509; N.C. Gen. stat. § 90-2; N.D. Cent. Code

§ 43-17-07.1; Ohio Rev. Code Ann. § 4731.20; Okla. Stat. tit. 59, §§ 481,

509; Or. Rev. Stat. §§ 677.015, 677.265; Pa. Stat. Ann. tit. 63, §§ 422.3,

422.8; R.l. Gen. Laws § 5-37-1.3; S.C. Code Ann. § 40-47-20; S.D.

Codified Laws § 36-4-29; Tenn. Code Ann. § 63-6-101; Tex. Occ. Code

Ann. § 153.001; Utah Code Ann. § 58-67-201; Vt. Stat. Ann. tit. 26

§ 1353; Va. Code Ann. § 54.1-2911; Wash. Rev. Code Ann. § 18.71.015;

W. Va. Code §§ 30-3-1, 30-3-7; Wis. Stat. Ann. § 448.02; Wyo. Stat.

Ann. § 33-26-202.

'7 21 U.S.C. §§ 360(g)(1);(2); 374(aX2)A);(B).

21 U.S.C. § 353(b\(2).

1240-1241 (N.D. Okla. 1998); United States v. Algon

Chemical, Inc., 879 F.2d 1154 (3rd Cir. 1989); Chaney, 718

F.2d 1174. In Chaney, the D.C. Circuit explained the purpose

of the exemption as follows:

The better explanation for the practice-of-medicine

exemption is that Congress did not want to interfere with

physicians’ treatment of their patients. New uses for

drugs are often discovered after FDA approves the

package inserts that explain a drug’s approved uses.

Congress would have created havoc in the practice of

medicine had it required physicians to follow the

expensive and time-consuming procedure of obtaining

FDA approval before putting drugs to new uses. Thus

Congress exempted the practice of medicine from the

Act so as not to limit a physician’s ability to treat his

patients.

718 F.2d at 1180.

Prior to FDAMA, FDA had generally exercised enforce-

ment discretion to avoid the prosecution of physicians and

pharmacists whose compounding practices with unapproved

drug substances did not introduce into interstate commerce

harmful drug products. See e.g., CPG 7132.16. FDA did so

recognizing that drug compounding, as opposed to drug

manufacturing, was a legitimate practice when performed by

licensed professionals under state law. In 1992 FDA adopted

its CPG 7132.16 (rescinded in January of 1999 to implement

the compounding provisions of FDAMA (see 64 Fed.

Reg.1,207)). Another FDA CPG allows within certain limits

the compounding of veterinary drugs. See CPG 7125.40

Chap. 6 § 608.400 (2001). -

Ill. COMPOUNDING IS BUT ONE OF SEVERAL

EXEMPTIONS FROM THE FDCA’S DRUG

APPROVAL PROCESS

The “practice-of-medicine” exemption, 21 U.S.C. § 360(g)(2)

(exempting “practitioners licensed to prescribe or administer

drugs or devices and who manufacture, prepare, propagate,

compound, or process drugs or devices” from the FDCA’s

registration and inspection requirements) (see also 21 U.S.C.

§ 374(a)(2)(A);(B)), like the FDAMA exemptions for pharmacy

compounding, are not unique. By FDA policy, under certain

circumstances unapproved drugs may be imported into the

United States on the prescription of a physician. See FDA,

Regulation Procedures Manual (hereinafter “RPM’”), “Coverage

of Personal Importation,” Chapter 9, (August 1997). Moreover,

FDA has long allowed unapproved uses of approved drugs. See

Stuart L. Nightingale, M.D., Use of Drugs for Unlabeled

Indications, FDA Perspective, 269 (September 1986). Further,

unapproved drugs may be prepared for and administered by

physicians in clinical trials authorized by FDA. 21 U.S.C.A. §

355(1); 21 C.F.R. § 312 (2001). Those caveats to the general

rule have also been crafted in recognition of the professional

status of physicians and pharmacists and their independent

regulation by the states.

A. The Statutory and Regulatory Exemptions

from New Drug Approval

1. Personal Use Importation of Unapproved

Drugs

While it is generally illegal to import unapproved drugs, in

response to a market that demands medical treatments lawful

abroad but not domestically FDA has created a personal use

importation policy. That policy permits unapproved drugs to

be imported via personal baggage or mail shipment into the

United States in personal-use quantities. See generally, RPM,

supra, at Chap. 9.

2. Unapproved Uses of Approved Drugs

Under 21 U.S.C. § 352, the FDA has no authority to

regulate the practice of medicine or to restrict the manner in

which a physician may use an FDA approved drug. Indeed,

Congress did not intend FDA to regulate the practice of

medicine or to interfere with a physician’s ability to treat

patients. See S. Rep. No. 74-361, at 3 (1935); S. Rep. No. 74-

646, at 1 (1935) (explaining that the enactment of the FDCA

was not intended to permit FDA to interfere with medical

practice as between the physician and patient); H.R. Rep. No.

74-2755, at 5 (1936); S.Rep. No. 87-1744, pt. 1; at 56 (1962).

Case law also confirms that the FDCA does not grant FDA

authority to prohibit a doctor from prescribing a lawful drug

for a purpose not approved by FDA. See Cowan, 5 F. Supp.

2d at 1240-1241; Algon Chemical, 879 F. 2d at 1160-1163;

Chaney, 718 F.2d at 1180, rev'd on other grounds, 470 U.S.

821(1985); United States v. Evers, 643 F.2d 1043, 1048 (Sth

Cir. 1981).

Moreover, FDA recognizes that unapproved uses of

approved drugs may be appropriate and necessary, and may

even represent important therapeutic innovations by phys-

icians. See Use of Drugs for Unlabeled Indications, supra, at

269; Stuart L. Nightingale, M.D., Unlabeled Uses of

Approved Drugs, 26 Drug Information Journal 141 (1992).

FDA recognizes that accepted medical practice can include a

use for a drug that is not included in its approved uses and

that the unapproved use may be appropriate if based on

controlled clinical trials or reliable medical opinion. See

- Unlabeled Uses of Approved Drugs, supra, at 142, citing 37

Fed. Reg. 16,503 (1972). Prescriptions for unapproved uses

are common among pediatricians and oncologists. See Amer-

ican Academy of Pediatrics, Few Prescription Drugs Labeled

for Pediatric Use, § 1, 3 (visited Dec. 20, 2001) <http://

www.babybag.com/articles/aap_drug.htm>; Daniel Troy, The

FDA and Off-Label Uses of Drugs and Devices, § 3 (visited

Dec. 20, 206!) <http://www.mediainst.org/ digest/97fall/

wif.html>.

3. Investigational Use of Drugs

By statute and regulation, it has long been lawful for

qualified physicians to use unapproved new drugs in clinical

trials authorized by FDA. See 21 U.S.C.A. § 355(I); 21

C.F.R. § 312.

B. FDA’s Pre-FDAMA Limits on Substances Used

in Compounding and on Interstate Distribution

of Compounded Drugs

While the statutory exemption for the practice of medicine,

21 U.S.C. § 360(g)(2), would appear to entrust the states with

the authority to regulate compounding, pre-FDAMA, FDA

has construed its statutory authority to allow the imposition of

federal limits on the amount of interstate distribution of

compounded drugs and on the substances available for

compounding. See 21 U.S.C. § 353 A(B)(1)(A). While the

exercise of that pre-FDAMA authority ‘is not before this

Court, the petitioners lack credibility when they argue that

they depend upon FDAMA’s speech ban to limit the amount

of compounded drugs in interstate commerce.

C. The Non-Speech Provisions of the FDCA, Left

Unchallenged in This Litigation, Have Been

Construed to Permit Regulation of the Amount

of Compounding and, To a Large Extent, the

Availability of Substances for Compounding

Prior to FDAMA FDA issued a Compliance Policy Guide

(“CPG”), “Manufacture, Distribution, and Promotion of

Adulterated, Misbranded, or Unapproved New Drugs for

Human Use by State Licensed Pharmacies,” reflecting long-

standing FDA policy on drug compounding articulated in

related compliance policy guides, warning letters, and federal

court decisions. See CPG 7132.16 (rescinded when the

FDAMA provisions on drug compounding became effective,

64 Fed. Reg. 1,207). Under the CPG, FDA threatened

enforcement action against any pharmacy that compounded

“in inordinate amounts . . . drug products that [were] com-

mercially available in the marketplace” or were “essentially

generic copies of commercially available, FDA-approved

drug[s].” Moreover, FDA threatened enforcement action

against any pharmacy that received, stored, or used drug

substances not made in “FDA approved facility[ies]” or that

distributed “inordinate amounts of compounded products out

of state.” See CP6 7132.16. Thus, through pre-FDAMA

enforcement policy, FDA construed its statutory authority as

authorizing it to limit the amount and kind of compounded

drugs prepared and distributed in interstate commerce.

IV. THE POWER TO REGULATE COMPOUNDING

DOES NOT INCLUDE THE POWER TO

REGULATE TRUTHFUL AND NONMIS-

LEADING ADVERTISING

The petitioners’ argument rests on an unmistakably clear

premise that the power to regulate compounding, a com-

mercial activity, includes within it the power to regulate

advertising about that activity. In other words, the petitioners

essentially reassert that the power to regulate a commercial

activity is a power greater than that to regulate truthful and

nonmisleading advertising about that activity. Yet that very

“greater-includes-the-lesser” syllogism is a false one in our

constitutional system. It guts the First Amendment presump-

tion in favor of speech by rendering general regulatory power

over commercial activity superior to constitutional protection

for truthful speech. This Court has rejected the syllogism.

See, e.g., 44 Liquormart, 517 U.S. at 510-513 (“Further

consideration persuades us that the ‘greater-includes-the-

lesser’ argument should be rejected for the . . . reason that it is

inconsistent with both logic and well-settled doctrine”); see

also Kurland, Posadas de Puerto Rico v. Tourism Company:

“‘Twas Strange, ‘Twas Passing Strange; ‘Twas Pitiful, ‘Twas

Wondrous Pitiful,” 1986 S.Ct.Rev. 1, 12-15.

Furthermore, the fact that in FDAMA the Government

conditions receipt of a statutory exemption from the new drug

approval requirements on relinquishment of the right to speak

in no way lessens the First Amendment violation present. As

the Court explained in 44 Liqguormart:

Even though government is under no obligation to

provide a person, or the public, a particular benefit, it

does not follow that conferral of the benefit may be

conditioned on the surrender of a constitutional right.

See, e.g., Frost & Frost Trucking Co. v. Railroad

Comm'n of Cal., 271 U.S. 583, 594 (1926). In Perry v.

Sindermann, 408 U.S. 593 (1972), relying on a host of

cases applying that principle during the preceding

quarter century, the Court explained that government

“may not deny a benefit to a person on a basis that

infringes his constitutionally protected interests—

especially his interest in freedom of speech.” /d., at 597.

That teaching clearly applies to state attempts to regulate

commercial speech, as our cases striking down bans on

truthful, nonmisleading speech by licensed professionals

attest. See, e.g., Bates v. State Bar of Ariz., 433 U.S. at

355; Virginia Bd. of Pharmacy v. Virginia Citizens

Consumer Council, Inc., 425 U.S. 748 (1976).

Id. at 513.

It is thus the case that the Government cannot overcome

the strong First Amendment presumption in favor of truthful

and nonmisleading commercial speech on the basis that its

speech ban is limited to those who seek to engage in a

commercial activity that it could lawfully limit.

Could it be that truthful compounded drug advertising is

less deserving of First Amendment protection than other

commercial speech? If there was any doubt about the

intrinsic First Amendment value of truthful drug advertising,

that doubt should have been put to rest in Virginia State -

Board of Pharmacy, 425 U.S. 748. The advertising ban at

issue in Virginia State Board is in no respect materially

—

me ee + ee eee

different from the advertising ban at issue here. Both forbid

drug advertising, including communication of the following:

“I will sell you the X prescription drug at the Y price.” The

Virginia State Board decision includes recognition that drug

advertising carries with it profound importance for the price

conscious consumer. That consumer could be a patient, as in

Virginia State Board, or, as here, a physician searching for

competitively priced compounded drugs for his special needs

patient(s). The Court explained that drug advertising includes

information essential for “the alleviation of physical pain or

the enjoyment of basic necessities.” /d. at 763-764. The free

flow of that information is indispensable to the efficient and

effective rendering of numerous private economic decisions

whether made by patients directly or by physicians who must

purchase compounded drugs expeditiously. See id. at 765.

As in Virginia State Board, so too here, the advertising ban

“does not directly affect” the alleged government interest

“one way or the other.” /d. at 769. Rather, “it affects” those

interests “only through the reactions it is assumed people will

have to the free flow of drug price information.” /d. Yet, as

this Court has stated repeatedly, governmental assumptions

are not enough to overcome the First Amendment

presumption in favor of disclosure over suppression. Indeed,

the First Amendment has made disclosure the rule and

suppression the exception, limited to circumstances of

compelling justification, not to ones involving sheer

speculation as to market reaction. See id at 770.

V. THE GOVERNMENT’S JUSTIFICATION FOR

BANNING ADVERTISING OF SPECIFIC COM-

POUNDED DRUGS AND PRICES, BUT NOT OF

THE AVAILABILITY OF COMPOUNDING

SERVICES, LACKS RATIONALITY AND FAILS

THE DIRECT AND MATERIAL ADVANCE-

MENT TEST

The petitioners argue that they must prohibit the adver-

tising of specific compounded drugs and prices to encourage

a reduction in the amount of compounded drugs and thereby

reduce the risk that pharmacies will overstep a line they leave

undefined between permitted “compounding” and prohibited

“manufacturing.” Nevertheless, the petitioners do allow

advertising of the availability of compounding services

by pharmacists.

The Government’s position is self-defeating and irrational.

It rests on the counterintuitive assumption that physicians

intent on compounding will be dissuaded from doing so if

their contacts with compounding pharmacies are based on

general advertisements of the availability of pharmacy

compounding services rather than on specific advertisements

of the availability and price of pharmacy compounded drugs.

In short, the Government asks the Court to accept on faith

_ that allowance of the one kind of advertising and disal-

lowance of the other will result in a reduction in overall

compounding activity such that the undefined and thus

elusive point at which drug “manufacturing” takes place

will not be reached. But the Government’s scheme is wholly

illogicai. Backed by nothing but counterintuitive supposition,

it is irrational and, thus, incapable of justifying a blanket

speech ban. \

The Court rejected a similar irrational scheme in Coors,

514 U.S. 476. In Coors, the Government argued that a

statutory prohibition on placement of alcohol content on beer

labels and in beer advertising lessened “strength wars” by

reducing competition among brands based on the potency of

beer. But the law in question allowed alcohol content

labeling in states that required such labeling and limited its

~ ban on alcohol content advertising to those states that

affirmatively prohibited such advertising. The regulatory

scheme thus failed to advance directly and materially the

Government’s interest due to the “overall irrationality of the

Government’s regulatory scheme.” Coors, 514 U.S. at 488.

Likewise, here, if the Government’s true aim is to prevent

compounding from becoming “drug manufacturing,” it makes

no rational sense to prohibit pharmacies from advertising

specific compounded drugs and prices but permit them to

advertise the availability of compounding services. The

regulatory scheme is self-defeating and irrational. Like the

scheme in Coors, the one here cannot directly and materially

advance the Government’s asserted interest.

VI. THERE ARE NUMEROUS AND OBVIOUS LESS

RESTRICTIVE NON-SPEECH REGULATORY

ALTERNATIVES TO THE GOVERNMENT’S

SPEECH BAN |

The petitioners lack credibility when they argue they need

the FDAMA provisions stricken by the Ninth Circuit to

reduce the amount of compounding to some unidentified

below market level when prior to FDAMA FDA assumed

power to limit the amount of compounded drugs in interstate

commerce (and the substances available for compounding)

based on its interpretation of the unamended FDCA. See

CPG 7132.16. It is of course within the power of Congress to

enact statutory provisions that limit the amount of com-

pounded drugs in interstate commerce or that grant FDA

authority to identify substances that may not be used in

compounding, all without resort to a blanket ban on com-

pounded drug advertising. Furthermore, the Government’s

concern that physicians may regard compounded drugs as

FDA approved if advertising is permitted can be resolved in

the first instance by mandating use of a reasonable disclaimer

to that effect. This Court has repeatedly held use of

reasonable disclaimers constitutionally preferable to outright .

speech suppression. See 44 Liquormart, 517 U.S. at 499-500;

Ibanez, 512 U.S. at 144-46; Peel v. Attorney Registration &

Disciplinary Comm'n of Illinois, 496 U.S. 91, 110 (1990); Jn

re RMJ, 455 U.S. 191, 203 (1982); Central Hudson, 447 U.S.

at 571; Bates, 433 U.S. at 383-384. The lower courts have

repeatedly ordered FDA to accept disclaimers as a less

restrictive alternative to outright suppression of vital health

information. See Pearson I, 164 F.3d 650; Pearson Il, 130

F. Supp.2d 105; Pearson Ill, 141 F. Supp.2d 105; see also

Washington Legal Foundation v. Henney, 56 F. Supp.2d 81,

87 (D.D.C. 1999) rev'd on other grounds 202 F.3d 331

(D.C.Cir. 2000). Finally, it is indeed true (albeit effectuation

of this option would be harmful to Americans) that Congress

could prohibit compounding altogether, again without

violating the First Amendment (unless it could be shown that

congressional action was motivated by a desire to suppress

protected speech). The Court has regularly accepted the

existence of numerous and obvious less restrictive alter-

natives to speech bans as evidence of an inadequate fit

between the regulatory means chosen and the ends. That

inadequate fit warrants invalidation of the FDAMA speech

ban under the final prong of the Central Hudson test. See

Central Hudson, 447 U.S. at 566; see also 44 Liquormart,

517 U.S. at 507-508; Ibanez, 512 U.S. at 143; Edenfield, 507

U.S. at 771-772.

Vil. SEVERAL LOWER FEDERAL COURT

CASES REVEAL THE FDAMA SPEECH BAN

TO BE PART OF A GENERAL FDA

PATTERN OF SPEECH SUPPRESSIVE

ACTIONS, ALL DIRECTLY INFLUENCED

BY THE COURT’S RESOLUTION OF THE

FIRST AMENDMENT ISSUE IN THIS CASE

The published cases in the lower federal courts concerning

FDA regulation of speech reveal that the agency has

repeatedly relied on blanket speech bans and has refused to

abide by the requirements of the First Amendment. See

Pearson |, 164 F.3d 650; Pearson Il, 130 F. Supp.2d 105;

Pearson Ill, 141 F. Supp.2d 105; Washington Legal Foun-

dation, 56 F. Supp.2d 81. Indeed, the amici here include

plaintiffs in litigation against the agency in three of those four

First Amendment cases. Repeatedly, those decisions have

faulted the FDA for suppressing vital health information on

labels and in labeling. In one such case, the FDA suppressed

a folic acid/neural tube defect claim that daily consumption of

folic acid by women of childbearing age could reduce the

incidence of neural tube defect births and deaths by as much

as 50 percent. Congress found FDA’s suppression of that

claim contributed to many preventable neural tube defects.

See S.Rep. No. 105-43, at 50 (1997) (“Undoubtedly, many

children suffered from preventable neural tube defects as a

result of FDA’s delay in authorizing health claims”). Thus,

there is an urgent need for this Court to make clear once again

that adherence to the First Amendment is imperative and that

neither Congress nor the FDA enjoy an exception from the

Constitution’s strictures when either presumes to regulate the

communication of health information.

CONCLUSION

For the foregoing reasons, the decision of the United States

Court of Appeals for the Ninth Circuit should be affirmed.

Respectfully submitted,

JONATHAN W. EMORD *

CLAUDIA A. LEWIS-ENG

ANDREA G. FERRENZ

EMORD & ASSOCIATES, P.C.

5282 Lyngate Court

: Burke, VA 22015

* Counsel of Record (202) 466-6937

January 11, 2002 Attorney for Amici Curiae

Dr. Julian M. Whitaker; Durk

Pearson; Sandy Shaw; Pure

Encapsulations, Inc.;

American Association for

Health Freedom; Wellness

Lifestyles, Inc. d/b/a American

Longevity; Hero Nutritionals,

Inc.; Life Enhancement

Foundation; Life Services

Supplements, Inc.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.