# Amicus Curiae Brief — Thompson v. Western States Medical Center

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URL: https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385014_0499%3A08

## Record

- **Collection:** Supreme Court brief
- **Document type:** Amicus Curiae Brief
- **Published:** January 1, 2002
- **Citation:** 534 U.S. 1077

## Text

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.

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..........---

13

16

17

18

18
18
20

20

ii
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

20

21

J4

25

27
28

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

iv
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

v
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) ................

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

19

11, 13

11,12

vi
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) 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.

12

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

13

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);

14
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).

15

(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.

16

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).

17

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

18

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,

19

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) ; Daniel Troy, The
FDA and Off-Label Uses of Drugs and Devices, § 3 (visited
Dec. 20, 206!) .

20

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

21

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.

22

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

23

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.

24

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

25

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

26

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.

27

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.

28
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.

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/brief%3Amicro_IA40385014_0499%3A08. Public record. Not legal advice.