Amicus Curiae Brief — Gonzales v. Oregon

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| Supreme Court, ULS

| FILED

2 MAY 9 - 2005

No. alae OFFICE OF THE CLERK

IN THE

Supreme Court of the Gnited States

ALBERTO GONZALES, ATTORNEY GENERAL, ef ai.,

Petitiouers,

STATE OF OREGON, et al.,

Respondents.

ON WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

PRO-LIFE LEGAL DEFENSE FUND,

LEGAL CENTER FOR DEFENSE OF LIFE, AND

UNIVERSITY FACULTY FOR LIFE

IN SUPPORT OF PETITIONERS

RICHARD F. COLLIER, JR. DWIGHT G. DUNCAN

Collier & Basil, P.C. Counsel of Record

100 Thanet, P.O. Box 3720 333 Faunce Comer Road

Princeton, NJ 08543 North Dartmouth, MA 92747

(609) 924-2213 (508) 998-9600

COLBE MAZZARELLA THOMAS M. HARVEY

265 Essex Street, Suite 202 One Constitution Center

Salem, MA 01970 Boston, MA 02129

(617) 569-5971 (617) 886-0364

BATEMAN & SLADE, INC. BOSTON, MASSACHUSETTS

TABLE OF CONTENTS

TABLE OF AUTHORITIES

. THE NINTH CIRCUIT’S HOLDING RESTED ON

4" | vp | THE ERRONEOUS PREMISE THAT DRUG

nee be 4 REGULATIONS ARE A “STATE ISSUE”

A. The Federal Government Has Extensively

Regulated the Prescription, Distribution, and

Utilization of Controlled Substances and

Other Drugs For Over One Hundred Years

nites ee | By: : | a. 1. The Import Drugs Act (1848), Pure

eae, S ; r Food and Drugs Act (1906), and Early

Federal Regulations

. The Federal Food, Drug, and Cosmetic

Act (1938) and New Deal Regulations

: . The Harrison Narcotics Act (1914) and

q Controlled Substances Act (1970)

. Durham-Humphrey Amendment (1951),

Kefauver-Harris Amendments (1962),

and Medical Device Amendments (1976)

. Federal Regulations under Ford, Carter,

Reagan, Bush, Clinton, and Bush

. The Pervasive Federal Regulation of Controlled

Substances and Other Dangerous Drugs Belies

Any Claim That This is “State Issue”

CONCLUSION

TABLE OF AUTHORITIES

CASES:

American Home Prods. Corp. v. Johnson & Johnson,

672 F. Supp. 135 (S.D.N.Y. 1987).....cccccscssssscessessseees 3,15

F.D.A. v. Brown & Williamson Tobacco Corp.,

S29 U.S. 130 CAGGG) ..cccccoscessrcnsessvionssenniesnenmuaamaiaanae 8

Grand Labs., Inc. v. Harris, 644 F.2d 729

(8th Cir. 1981)..........00. sececesssosenennsaneiensniddeniieiananiaall 6

In re Grand Jury Proceedings, 801 F.2d 1164

(Sa Cae, 1SBG) .cccccccecssscesccosessneesinsnnmsennmnsianne 16

Linder v. United States, 268 U.S. 5 (1925) ......cccsccceeeeees 16-17

Minneapolis & St. L.R. Co. v. Bombolis,

B41 U.S. 201 CIDEE) .ccccccscnsescnsisnescsnsesiniienismneainianna 19

Minor v. United States, 396 U.S. 87 (1969)........cccccceceee 15,17

Norfolk S. Ry. Co. v. Kirby, 125 S. Ct. 385 (2004).............. 18

Oregon v. Ashcroft, 368 F.3d 1118 (9th Cir. 2004)......passim

Reina v. United States, 364 U.S. 507 (1960) ........... 15-16, 17

Romero v. International Terminal Operating Co.,

3SB U.S. 3546 (1GGP) .nccocescossnssessnsetenenmmenemaiaaaa 19

Solid Waste Agency v. U.S. Army Corps of Eng’rs,

S31 U.S. 15D (ABBE ) ..ccccccsscsssntesnssinencestsenieaiiane 18

Testa v. Katt, 330 U.S. 386 (1947).........cccssrsssscssrcssesseeeseees 19

United States v. Alveri, 715 F. Supp. 1508

(OED. Als. 19GD) ..cccccsossssscosssssteiesenmmesmmmaaaae 15

United States v. Articles of Drug (Lannett),

SOS F.26 STS (36 Cie. BG FED. .ccccrcsntensicentininemana 6

United States v. Darby, 312 U.S. 100 (1941)......ccccceeceseeeee 17

United States v. Freed, 401 U.S. 601 (1971) w....cccccccccesseeeee 15

United States v. Gel Spice Co., 601 F. Supp. 1214

(B.D.N.Y.. 39GS) nccccccssscosssccessennssnseensnuneniiaanee 3

United States v. Kaplan, 895 F.2d 618 (9th Cir. 1990)........ 10

United States v. Kim, 94 F.3d 1247 (9th Cir. 1996)............. 16

United States v. Kirk, 70 F.3d 791 (Sth Cir. 1995) ............. 19

United States v. Lerebours, 87 F.3d 582 (1st Cir. 1996) .....16

United States v. McCoy, 323 F.3d 1114 (9th Cir. 2003) .....17

United States v. Moore, 423 U.S. 122 (1975) cocccccccccccoceccooes 10

United States v. New England Grocers Supply Co.,

488 F. Supp. 230 (D. Mass. 1980) ........cccccccccccccecceees 3,15

United States v. Oakland Cannabis Buyers’ Coop.,

EE 17, 18

United States v. Rutherford, 442 U.S. 544 (1979)........... 8, 18

United States v. Rybar, 103 F.3d 273 (3d Cir. 1996)............ 19

United States v. Tisor, 96 F.3d 370 (9th Cir. 1996)............. 16

Washington v. Glucksberg, 521 U.S. 702 (1997) ...cccccccccccooee. l

Webb v. United States, 249 U.S. 96 (1919) ...cccccccccccecccecseeeeees )

Weinberger v. Hynson, Westcott & Dunning, Inc.,

cs 8

FEDERAL STATUTES AND REGULATIONS:

Import Drugs Act of 1848,

30 Cong. Ch. 70, 9 Stat. 237 (1848) oo.coccccccccccceeeeees 3,4

Biologics Control Act of 1902,

Pub. L. No. 57-244, 32 Stat. 328 (1902) oo...cccccccccccce. 4,6

Pure Food and Drugs Act of 1906,

Pub. L. No. 59-384, 34 Stat. 768 (1906).......... 3, 4, 5, 6,7

Virus, Serum & Toxin Act of 1913,

Pub. L. No. 66-430, 31 Stat. 828 (1912)

(codified at 21 U.S.C. § 151 (2000))

Harrison Narcotics Act of 1914,

Pub. L. No. 63-223, 38 Stat. 785 (1914)

(superceded by Controlled Substances Act of 1970) .9, 10

Federal Food, Drug, and Cosmetic Act of 1938,

Pub. L. No. 75-717, 52 Stat. 1040 (1938)

(codified at 21 U.S.C. §§ 301-392 (2000)) .....2, 3, 7-8, 11

Durham-Humphrey Amendment of 1951,

82 Cong. Ch. 578, 65 Stat. 648 (1951)

(codified at 21 U.S.C. § 353 (2000))......cccccccccccccccceeeeeee 11

Kefauver-Harris Amendments of 1962,

Pub. L. No. 87-781, 76 Stat. 780 (1962)

(codified in sections of 21 U.S.C. (2000))............... 11,12

Comprehensive Drug Abuse Prevention and Control

Act of 1970, Pub. L. No. 9-513, 84 Stat. 236 (1970)

(codified at 21 U.S.C. §§ 801-971 (2000)) ..........c-se0e0+ 10

Controlled Substances Act of 1970,

Pub. L. No. 91-513, 84 Stat. 1242 (1970)

(codified at 21 U.S.C. §§ 801-904 (2000)) ............. passim

Medical Device Amendments ~* 1976,

Pub. L. No. 94-295, 90 Stat 579 (1976)

(codified at 21 U.S.C. §§ 360(c)-(k) (2000)) ........... 11, 13

Toxic Substances Control Act of 1976,

Pub. L. No. 94-469, 90 Stat. 2003 (1976)

(codified at 15 U.S.C. §§ 2601-2692 (2000)) ..........-.-++. 13

Psychotropic Substances Act of 1978,

Pub. L. No. 95-633, 92 Stat. 3768 (1978)

(codified at 21 U.S.C. § 881 (1994))..........ccceseeseseeeneees 13

Federal Anti-Tampering Act of 1983,

Pub. L. No. 98-127, 97 Stat. 838 (1983)

(codified at 18 U.S.C. § 1365 (1992))..........ceseeseserseees 14

Dangerous Drug Diversion Control Act of 1984,

Pub. L. No. 98-473, 98 Stat. 2070 (1984)

(codified at 18 U.S.C. § 1203 (2000))............eceeseeeeeerees 14

Narcotics Penalties and Enforcement Act of 1986,

Pub. L. No. 99-570, 100 Stat. 3207-2 (1986)

(codified in sections 18, 21, and 28 U.S.C. (2000))....... 14

Drug Export Amendments Act of 1986,

Pub. L. No. 99-660, 100 Stat. 3743 (1986)

(codified at 42 U.S.C. § 262(h)(1)(B){D) (1994))........... 14

Controlled Substances Analogue Enforcement Act of

1986, Pub. L. No. 99-570, 100 Stat. 3207-16 (1986)

(codified at 21 U.S.C. $960 (1994))..........ccseeseeenennes 14

Prescription Drug Marketing Act of 1987,

Pub. L. No. 100-293, 102 Stat. 95 (1987)

(codified at 21 U.S.C. §381(d) (2000)) ..........-.cceeeeeeeees 14

Chemical Diversion and Trafficking Act of 1988,

Pub. L. No. 100-690, 102 Stat. 4312 (1988)

(codified in scattered sections of 21 U.S.C. (1988))...... 14

Safe Medical Devices Act of 1990,

Pub. L. No. 101-629, 104 Stat. 4511 (1990)

(codified in sections 21 and 42 U.S.C.) ..........ccccccceeeeees 13

Mammography Quality Standards Act of 1992,

Pub. L. No. 102-539, 106 Stat. 3547 (1992)

(codified at 42 U.S.C. §§ 201, 263(b) (1994) ................ 13

Food and Drug Modernization Act of 1997,

Pub. L. No. 105-115, 111 Stat. 2310 (1997)

(codified at 21 U.S.C. § 355(d) (1997)) ........ccccccceeseeeeeee 14

Public Health Security and Bioterrorism Preparedness

Act of 2002, Pub. L. No. 107-188, 116 Stat. 594

(2002) (codified in sections of 42 U.S.C.). ............... 14-15

en 10, 18

ARTICLES, BOOKS, AND TREATISES:

25 American Jurisprudence 2d Drugs and Controlled

OEE 15

Berger, Mitchell & Berger, Barry, FDA Overview,

available at eMedicine.com (2003) .......... 5, 6,8, 12,14

Charting a New Mission (1999).........ccc0eeeseeeeeees 9,11

Heath, Wesley J., America’s First Drug Regulation

Regime: The Rise and Fall of the Import Drug Act

of 1848, 59 Food & Drug L.J. 169 (2004) ................ 4,5

Hull, Richard T., “Medical Ethics and Society,”

available at http://www.richard-t-hull.com/

publications/medical_ethics.pdf (1987) ..............-.-00++ 5

Hutt, Peter, Philosophy of Regulation Under the

Federal Food, Drug and Cosmetic Act, 50 Food

On 18

Jackson, Charles O., Food and Drug Legislation in

Ce 7

Klein, Daniel B. & Tabarrok, Alexander, History of

www .fdareview.org/history (2001)............-00+ passim

Korwek, Edward L., Human Biological Drug

Regulation, 50 Food & Drug L.J. 123 (1995)............... 7

Law, Marc T., History of Food and Drug Regulation

in the United States, EH.Net Encyclopedia

(Whaples, Robert ed.) (2004) ............cccccceeeeees 4,5, 6,12

Merrill, Richard A. & Hutt, Peter Barton, Food and

BURN Et CD ccensccssccssensnsnsssessscsscecsssssmsssssssssenesesss 11

Walsh, Charles J. & Pyrich, Alissa, Rationalizing the

Regulation of Prescription Drugs and Medical

Devices, 48 Rutgers L. Rev. 883 (1996) ....5-6, 7, 11, 13

INTEREST OF AMICI CURIAE '

The Pro-Life Legal Defense Fund, Inc. (PLLDF), a

Massachusetts not-for-profit corporation, and the Legal

Center for Defense of Life, Inc. (the “Legal Center”), a New

Jersey not-for-profit corporation, both provide pro bono

legal services for the protection of human life. University

Faculty for Life (UFL) is a multidisciplinary association of

scholars founded in 1989 to promote research, dialogue, and

scholarship among faculty members on various topics in

medical ethics including euthanasia. The PLLDF, Legal

Center, and UFL strongly oppose the use of federally-

regulated controlled substances to facilitate physician-

assisted suicide, euthanasia, or eugenics. Amici respectfully

submit this brief in support of the Petitioners and urge the

Court to reverse the Ninth Circuit.

The PLLDF and Legal Center filed a joint brief, as

friends of this Court, in Washington v. Glucksberg, 521 U.S.

702 (1997). See 1996 WL 656314. Here, as in Glucksberg,

amici’s purpose in filing is to correct the historical errors of

the Ninth Circuit’s majority opinion. In Glucksberg, amici

respectfully pointed out that the Ninth Circuit’s “majority

opinion distort{ed] the historical record in an apparent

attempt to justify its creation of a new fundamental

constitutional right.” Jd at *5. Similarly, amici now

respectfully point out that the Ninth Circuit’s majority

opinion has distorted the historical record of federal

regulation of medicine and controlled substances in an

apparent attempt to characterize this case as involving an

exclusively “state issue.” Because the Ninth Circuit based

its holding on this erroneous premise, that court should once

again be reversed.

' Counsel for all four parties have consented to the filing of this amicus

brief. Their consent letters are on file with the Clerk of the Court. No

counsel for a party authored this brief in whole or in part.

SUMMARY OF ARGUMENT

The federal government has extensively regulated the

practice of medicine and the distribution of controlled

substances for over one hundred years. This longstanding

and pervasive federal regulation belies any claim that this

case involves an exclusively “state issue.” As a result, the

Ninth Circuit, which based its holding on the erroneous

premise that controlled substances constitute “an area of law

traditionally reserved for state authority,” should be reversed.

An examination of the history of federal drug regulation

demonstrates the Ninth Circuit’s error. Interest in federal

drug regulation arose contemporaneously with the interest in

state regulation during the late nineteenth century. Congress

provided the first comprehensive drug regulations in the

Pure Food and Drugs Act of 1906 and delegated even

greater authority to federal regulators under the Federal

Food, Drug, and Cosmetic Act of 1938 (FFDCA). The

FFDCA also established the precursor to the FDA, which

now regulates one-quarter of the gross national product.

Moreover, Congress has regulated highly dangerous

drugs extensively since the Harrison Narcotics Act of 1914.

To provide even greater federal oversight, Congress passed

the Controlled Substances Act of 1970 (CSA). The CSA is

just one of over fifty pieces of legislation since 1914

pursuant to which federal agencies have enacted regulations

governing controlled substances.

Federal regulations thus provide comprehensive and

uniform standards for prescribing, dispensing, and using

controlled substances and other dangerous drugs. Against

this extensive regulatory background, a state cannot

unilaterally decide to “opt out” of federal regulations.

Allowing such an unprecedented circumvention of federal

law for every state that disagrees with a federal policy would

not only be antithetical to the Congressional objective of

protecting public health and safety in this case, but also

create an impracticable system of administrative law by

establishing a precedent for future opt-outs.

ARGUMENT

I. THE NINTH CIRCUIT’S HOLDING RESTED

ON THE ERRONEOUS PREMISE THAT DRUG

REGULATIONS ARE A “STATE ISSUE.”

The decision of the Ninth Circuit should be reversed

because the majority’s opinion failed to recognize that the

federal government has regulated the practice of medicine

and distribution of drugs extensively. The premise of the

Ninth Circuit’s opinion—that drug regulations involve “an

area of law traditionally reserved for state authority’—is

incorrect as a matter of both historical and current practice.

For over one hundred years the federal government has

regulated the prescription, distribution, and utilization of

controlled substances and other dangerous drugs. The

extensive federal regulation of this area of law thus belies

any claim that this case involves an exclusively “state issue.”

A. The Federal Government Has Extensively

Regulated the Prescription, Distribution, and

Utilization of Controlled Substances and Other

Drugs For Over One Hundred Years.

Federal regulations have governed this area of medicine

for over one hundred years and continue to do so today.’

The Jmport Drugs Act (1848), Pure Food and Drugs Act

(1906), Harrison Narcotics Act (1914), Federai Food, Drug,

and Cosmetic Act (1938), and Controlled Substances Act

(1970) are just a few of the many statutes under which

? See American Home Prods. Corp. v. Johnson & Johnson, 672 F. Supp.

135, 145 (S.D.N.Y. 1987) (“Federal regulation of drug safety and

efficacy is pervasive and complete.”); United States v. Gel Spice Co., 601

F. Supp. 1214, 1229 (E.D.N.Y. 1985) (noting the “pervasive nature of the

federal regulation of the food and drug industry”); United States v. New

England Grocers Supply Co., 488 F. Supp. 230, 238 (D. Mass. 1980)

(basing its holding on the “pervasive nature and long history of federal

regulation of the food and drug industry”).

executive agencies have established myriad regulations. The

comprehensiveness of this federal regulatory system

demonstrates the federal government’s substantial and

longstanding interest in protecting public health and

maintaining public safety with regard to controlled

substances and other dangerous drugs.

1. The Import Drugs Act (1848), Pure

Food and Drugs Act (1906), and Early

Federal Regulations

The “interest in federal regulation [of food and drugs]

arose contemporaneously with interest in state regulation”

during the late nineteenth century. Marc T. Law, History of

Food and Drug Regulation in the United States, at 4 (2004).

During the Reconstruction years, Congress established the

U.S. Department of /.:grieulture Bureau of Chemistry, the

predecessor to the Food and Drug Administration (FDA).

Early federal regulations regarding the prescription,

distribution, and utilization of drugs targeted specific issues

of national importance such as importation and biologics.

See, e.g., Import Drugs Act of 1848, 30 Cong. Ch. 70, 9 Stat.

237 (1848) (curbing the import of adulterated medicines);

Piologics Control Act of 1902, Pub. L. No. 57-244, 32 Stat.

328 (1902) (requiring the federal government to grant pre-

market approval for every biological drug and for the process

and facility producing such drugs).

> See also Wesley J. Heath, America’s First Drug Regulation Regime:

The Rise and Fall of the Import Drug Act of 1848, 59 Food & Drug L.J.

169, 199 (2004) (“Defeating critics who had argued that the federal

government should not interfere with freedom of commerce, the [/mport

Drugs Act of 1848] had proven not only that regulation of some markets

could be extremely beneficial but also that the federal government was a

highly competent drug regulator. The 1848 law undoubtedly contributed

greatly to Congress’ confidence in the federal government’s ability to

regulate drugs.”).

Before the emergence of a comprehensive federal

regulatory system in 1906, most “[d]rugs could be bought

and sold like any other consumer good.” Mitchell S. Berger

& Barry A. Berger, FDA Overview, Introduction: History of

Food and Drug Regulation, at *1 (2003); see also Richard T.

Hull, “Medical Ethics and Society,” at *4 (1987) (“[T]here

was virtually no regulation of medicines and remedies.

Medicines containing narcotics, such as morphine and

cocaine, were sold without restriction. Quack remedies—

some claiming to cure cancer—and contaminated drugs were

largely uncontrolled by the federal government.”’).

As a result, in the late nineteenth century, national

interest grew in establishing a general and comprehensive

system for regulating food and drugs. See Heath, supra, at

170 (“As continued industrialization and social change swept

the nation throughout the later half of the nineteenth century,

the federal government had no choice but to deconstruct its

ad hoc governmental system and replace it with broad

institutional structures.”). By 1906, America was “ready for

comprehensive drug regulation.” Jd. at 199.

Thus, following a long legislative battle,’ Congress

passed the Pure Food and Drugs Act of 1906, Pub. L. No.

59-384, 34 Stat. 768 (1906). The 1906 Act provided the

Statutory authorization necessary for a comprehensive

system of food and drug regulation at the federal level. See

Law, supra, at *1 (“Federal regulation of the industry began

on a large scale |.: the early twentieth century when Congress

enacted the Pure Food and Drugs Act of 1906.”’).

The 1906 Act “banned the manufacture and distribution

of adulterated and misbranded food and drugs” and

prohibited “false and misleading advertising of food and

drugs.” Charles J. Walsh & Alissa Pyrich, Rationalizing the

Regulation of Prescription Drugs and Medical Devices, 48

* See Law, supra, at *4 (noting that “conflict among competing interest

groups regarding the provisions of a federal law made it difficult to build

an effective political constituency”).

Rutgers L. Rev. 883, 891 (1996). Violation of the Act could

result in “seizure of non-conforming goods or criminal

penalties against those responsible for the violation.” /d.

The Act also recognized both the U.S. Pharmacopoeia,

(established in 1820) and National Formulary (originally

published in 1888) as “official standards for the strength,

quality, and purity of drugs and for the tests to make such

determinations.” Daniel B. Klein & Alexander Tabarrrok,

History of Federal Regulation: 1902-Present, at *2 (2001).

As a result, the 1906 Act established the first comprehensive

system of drug regulations and set the stage for future federal

regulations. See United States v. Articles of Drug (Lannett),

585 F.2d 575, 577 (3d Cir. 1978) (“Federal regulation of the

drug industry may be traced to the passage of the Pure Food

and Drug Act of 1906.”).°

At the same time, Congress also turned its attention to

establishing federal regulations for biological drugs. Federal

regulation of human biologics began in 1902 when Congress

enacted the Biologics Control Act, Pub. L. No. 57-244, 32

Stat. 328 (1902). The Act required that the federal

government grant premarket approval for every biological

drug and for every process and facility producing such drugs.

See Grand Labs., Inc. v. Harris, 644 F.2d 729, 732 (8th Cir.

1981) (stating that the Act “prohibit{ed] the importation or

interstate shipment of any virus, serum, toxin, antitoxin, or

analogous products unless licensed by the Treasury

* Responsibility for enforcing the Pure Food and Drugs Act of 1906 fell

to the Bureau of Chemistry, a division of the United States Department of

Agriculture (USDA), which conducted some of earliest studies regarding

food and drugs in the United States. The USDA’s Division of Chemistry

was established by President Abraham Lincoln in 1862. In 1901 the

Division became the Bureau of Chemistry, which in 1927 became the

Food, Drug and Insectic: ’ Administration, which subsequently became

the FDA in 1931. See Law, supra, at *5. The FDA currently regulates

products accounting for approximately twenty-five percent of the United

States gross national product, has over nine thousand employees, and has

a total budget of over $1.4 billion. See Berger & Berger, supra, at *1, 6.

Department and properly labeled.”). In 1913, Congress

amended the 1902 Act by passing the Virus, Serum & Toxin

Act of 1913, Pub. L. No. 66-430, 31 Stat. 828 (1912). Asa

result, the federal regulation of biological drugs, like the

regulation of other drugs under the Pure Food and Drugs Act

of 1906, was well-established even prior to the First World

War. See Edward L. Korwek, Human Biological Drug

Regulation, 50 Food & Drug L.J. 123, 124 (1995) (pointing

out the “long history of biologics regulation, beginning in

1902 with the Virus, Serum, and Antitoxin Act” and noting

that “such a ninety-year history, even with an emphasis on

the last fifty years, cannot be easily reduced to a few pages

of text”).

2. The Federal Food, Drug, and Cosmetic

Act (1938) and New Deal Regulations

The federal regulation of food and drugs continued to

increase significantly during the New Deal. See generally

Charles O. Jackson, Food and Drug Legislation in the New

Deal (1970). During the early 1930s, Congress “weighed

and rejected several bills aimed at improving existing federal

regulation of drugs.” Walsh & Pyrich, supra, at 893. In

1937, however, over one hundred people (mostly children)

died as the result of ingesting a drug known as Elixir

Sulfanilamide. The public outcry over the incident “spurred

Congress to undertake the necessary process of reforming

federal drug law.” Jd.; see also Klein & Tabarrok, supra, at

*3 (noting that the Elixir Sulfanilamide tragedy

demonstrated to Congress that “unfettered markets cause

reckless injury and that public safety called for additional

laws’’).

As a result, in 1938 Congress strengthened the federal

government’s power to protect the public from dangerous

drugs by enacting the Federal Food, Drug, and Cosmetic Act

of 1938, Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified

at 21 U.S.C. §§ 301-392 (2000)). This Cow has described

the 1938 Act’s pervasive reach and severe pezialties:

The 1938 Act, which established a system of

premarketing clearance of drugs, prohibited the

introduction into commerce of any “new drug” unless

a new drug application (NDA) filed with the Food

and Drug Administration (FDA) was effective with

respect to that drug. . . . The Government could sue to

enjoin violations, prosecute criminally, and seize and

condemn the articles.

Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S.

609, 612-613 (1973); see also F.D.A. v. Brown &

Williamson Tobacco Corp., 529 U.S. 120, 134 (2000)

(“(T]he Act generally requires the FDA to prevent the

marketing of any drug or device where the ‘potential for

inflicting death or physical injury is not offset by the

possibility of therapeutic benefit.””) (quoting United States v.

Rutherford, 442 U.S. 544, 556 (1979)).°

Thus, under the Federal Food, Drug, and Cosmetic Act

of 1938, the federal government was “given considerably

greater authority over the food and drug industry.” Law,

supra, at *6; see also Klein & Tabarrok, supra. at *4

(pointing out that because of the broad construction the

courts have given to the interstate commerce clause, “in

practice the [Act] regulates every drug”). The

® See also Berger & Berger, supra, at *2 (“Among other things, the 1938

Act did the following: compelled manufacturers to demonstrate to the

FDA the safety of new drugs prior to marketing; allowed the FDA to

inspect manufacturing facilities; set tolerances for certain substances

such as pesticides; extended FDA regulation to color additives and

cosmetics; allowed the FDA to seek injunctions from courts; and

provided detailed legal definitions of drug, devices, cosmetics, and

labeling.”’).

“developments of this early period set a precedent for federal

government activism in medicine.” /d. at 3.

3. The Harrison Narcotics Act (1914) and

Controlled Substances Act (1970)

The comprehensive federal regulation of narcotics,

controlled substances, and other highly dangerous drugs

began (but certainly did not end) with the Harrison

Narcotics Act of 1914, Pub. L. No. 63-223, 38 Stat. 785

(1914). Indeed, according to a 1970 Congressional report:

“Since 1914 the Congress has enacted more than fifty pieces

of legislation relating to. control and diversion, from

legitimate channels, of those drugs referred to as narcotic

and dangerous drugs.” H.R. Rep. No. 91-1444 (1970),

reprinted in 1971 U.S.C.C.A.N. 4566, 4601. The provisions

of the Harrison Act and subsequent legislation were

consolidated in the Controlled Substances Act of 1970.

Congress enacted the Harrison Narcotics Act of 1914 to

limit the distribution of cocaine and heroin to health care

professionals and to regulate the free use that had been in

effect prior to the statute. See Klein & Tabarrrok, supra, at

*3 (“The Harrison Narcotics Act of 1914 placed a tax on the

production, sale, and use of opium and required prescriptions

for products exceeding the allowable limit of narcotics. This

act also mandated increased record keeping for physicians

and pharmacists who dispense narcotics.”). In 1919, the

Supreme Court expansively interpreted the Harrison Act to

prohibit any distribution of these drugs and held that such

distribution was criminal. See Webb v. United States, 249

U.S. 96, 99-100 (1919).

The Harrison Narcotics Act of 1914 became the

foundation for the federal regulation of controlled substances

and dangerous drugs. See Martin Alan Greenberg,

Prohibition Enforcement 6 (1999) (“For more than 50 years,

this federal statute was the main basis of narcotics regulation

in the U.S. as interpreted by the Supreme Court.”).

Congress, however, continued to enact legislation—over

fifty statutes between 1914 and 1970—to provide even more

federal oversight of narcotics and controlled substances. See

H.R. Rep. No. 91-1444 (1970), reprinted in 1971

U.S.C.C.A.N. 4566, 4601.

The laws and various amendments related to the

Harrison Narc ‘ics Act were consolidated and reinforced in

the Comprehensive Drug Abuse Prevention and Control Act

of 1970, Pub. L. No. 9-513, 84 Stat. 236 (1970). As Title II

of this Act, Congress enacted the Controlled Substances Act

(CSA), 1970, Pub. L. No. 91-513, 84 Stat. 1242 (1970)

(codified at 21 U.S.C. §§ 801-904 (2000), under which it is

“unlawful to prescribe or dispense controlled substances

without a federal registration.” Oregon v. Ashcroft, 368 F.3d

1118, 1121 (9th Cir. 2004) (citing 21 U.S.C. § 841(a)(1)).

The CSA prohibits physicians from dispensing and

prescribing controlled substances except for legitimate

medical purposes. See 21 C.F.R. § 1306.04(a) (“A

prescription for a controlled substance to be effective must

be issued for a legitimate medical purpose.”); United States

v. Moore, 423 U.S. 122, 124 (1975) (holding that physicians

violate the CSA “when their activities fall outside the usual

course of professional practice”); United States v. Kaplan,

895 F.2d 618, 619 (9th Cir. 1990) (stating that the CSA

prohibits “prescribing controlled substances for reasons other

than legitimate medical purposes”).

Moreover, as the Ninth Circuit’s majority admits, “[i]n

1984, Congress amended the CSA to give broader authority

to the Attorney General” in a provision that “gives the

Attorney General new discretion over the registration of

health care practitioners.” Ashcroft, 368 F.3d at 1122. “The

Attorney General is now authorized to revoke a physician’s

prescription privileges upon his determination that the

physician has ‘committed such acts as would render his

registration . . . inconsistent with the public interest[.]’” Jd.

(citing 21 U.S.C. § 824(a)(4)). Overall, the Controlled

Substances Act significantly enhanced federal regulatory

power because it reflected a “fundamental change in

interpretation of the [C]ommerce [C]lause of the

Constitution, thus eliminating the need to portray a police

function as a revenue measure.” Greenberg, supra, at 6.

4. Durham-Humphrey Amendment (1951),

Kefauver-Harris Amendments (1962),

and Medical Device Amendments (1976)

Meanwhile, federal regulation of those drugs regulated

under the Federal Food, Drugs, and Cosmetic Act of 1938

continued during the post-World War II years.’ Indeed,

since its enactment, “the 1938 Act has been amended more

than twenty times.” Walsh & Pyrich, supra, at 896. The

general trend in amendments to the Act has been to “increase

the coverage of the Act or to increase the substantive

authority granted to the FDA over products already within its

jurisdiction.” Jd. at 896 n.35 (citing Richard A. Merrill &

Peter Barton Hutt, Food and Drug Law 5 (1980)). Among

the most significant reforms were the Durham-Humphrey

Amendment of 1951, the Kefauver-Harris Amendments of

1962, and the Medical Device Amendments of 1976. See id.

(“These revisions laid the final building blocks for the

comprehensive system of drug and medical device regulation

that exists today.”’).

Disagreements over whether certain drugs required a

physician’s prescription led to the Durham-Humphrey

Amendment of 1951, 82 Cong. Ch. 578, 65 Stat. 648 (1951).

The Durham-Humphrey Amendment permitted a drug to be

sold directly to patients “unless, because of its toxicity or

other potential for harmful effect or because the method of

” See Klein & Tabarrok, supra, at *5 (“In the post-World War II era, the

field of pharmacology entered a new age. People with bacterial illnesses

could now be treated with a host of new antibiotics, and diabetics were

likewise given the life-saving invention of insulin. In the 1950s in

particular, many new drugs were called ‘magic bullets’ because of their

potency and swift defeat of disease. The very success of the new drugs,

however, spurred new regulations.”).

collateral measures necessary to its use, it may be sold and

used only under the supervision of a practitioner.” Law,

supra, at *6-7. The 1951 Act thus delineated a clearer

distinction between prescription and over-the-counter drugs,

and, under federal law, “[m]any important drugs could be

sold only by prescription from a licensed practitioner.”

Klein & Tabarrok, supra, at *5.

The “most significant expansion” in FDA authority over

drugs in this period, however, occurred when Congress

enacted the Kefauver-Harris Amendments of 1962, Pub. L.

No. 87-781, 76 Stat. 780 (1962). Law, supra, at *7. In

response to the thalidomide birth-defect tragedy,® Congress

passed the Kefauver-Harris Amendments, which “require{d]

drug companies to conduct and submit tests determining

safety and efficacy.” Klein & Tabarrok, supra, at *6. In

addition, federal regulators now had to ‘ lear all human

trials, drug advertising, and labeling.” /d.

In the post-World War II era, the federal regulation of

medical devices also became a prominent issue. See Klein &

Tabarrok, supra, at *7 (“As with drugs, the field of medical

devices entered a new era after World War II.”). As medical

devices became “more common and more complex,” it

* See Klein & Tabarrok, supra, at *6 (describing how the West German

pharmaceutical thalidomide, which by 1962 had been sold in forty-six

countries (although not the United States), caused severe birth defects,

including truncated limbs, in thousands of newborn babies).

* See also Berger & Berger, supra, at *3 (“Among other things, the

amendment requires drug manufacturers to show the effectiveness of

their products as well as their safety, to report adverse events to the FDA,

and to ensure that their advertisements to physicians disclose the risks as

well as the benefits of their products. Informed consent was required

from participants in clinical studies. The FDA also was given

jurisdiction over prescription drug advertising. In addition, the agency

was required to approve a regulatory submission known as a new drug

application before a company could market a new drug and be allowed to

issue good manufacturing practice guidelines governing how drugs were

to be manufactured. Inspection of drug manufacturers was mandated

every 2 years.”).

‘

a te Sa = ~

became apparent “that some sort of federal safety regulation

was necessary.” Walsh & Pyrich, supra, at 902. In

response, Congress passed the Medical Device Amendments

of 1976, Pub. L. No. 94-295, 90 Stat. 579 (1976) to provide a

comprehensive and uniform system of federal regulation

over medical devices. With the passage of the Medical

Device Amendments, federal regulators “achieved

jurisdiction over nearly every commercial implement or

substance used in the treatment or diagnosis of disease.”

Walsh & Pyrich, supra, at 903. The federal government has

continued to regulate medical devices extensively to ensure

public health and safety. See, e.g., Safe Medical Devices Act

of 1990, Pub. L. No. 101-629, 104 Stat. 4511 (1990)

(substantially increasing reporting requirements for medical

devices); Mammography Quality Standards Act of 1992,

Pub. L. No. 102-539, 106 Stat. 3547 (1992) (ensuring that

mammography facilities are certified and inspected).

5. Federal Regulations Under Ford, Carter,

Reagan, Bush, Clinton, and Bush

Following the Controlled Substances Act of 1970,

Congress continued to regulate controlled substances and

other dangerous drugs under both the Ford and Carter

administrations. See, e.g., Toxic Substances Control Act of

1976, Pub. L. No. 94-469, 90 Stat. 2003 (1976) (requiring

premarket notification for chemical substances);

Psychotropic Substances Act of 1978, Pub. L. No. 95-633,

92 Stat. 3768 (1978) (controlling illicit trafficking of

psychotropic substances across national borders); see also

Medical Device Amendments of 1976, Pub. L. No. 94-295,

90 Stat. 579 (1976). However, it was under the Reagan

administration (despite its proclivity for deregulation) that

Congress enacted a number of new statutes that further

extended the already pervasive federal oversight of

controlled substances and other drugs.'°

Likewise, under President Clinton, Congress attempted

to modernize drug regulation through the Food and Drug

Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat.

2310, § 115(a) (1997). The Food and Drug Modernization

Act established “fast-track approval for certain new drugs

and accelerated approval for innovative devices by

exempting certain devices from premarket notification

requirements.” Berger & Berger, supra, at 5. The Act also

allowed federal regulators “to use expert panels in the drug

approval process, regulated health claims in _ food,

reauthorized [a previous prescription drug statute], and

provided additional marketing exclusivity time to companies

that conducted pediatric studies.” Jd. at 5-6.

As the United States entered the twenty-first century, the

importance of federal regulation over controlled substances

and other drugs was made frighteningly clear. In response to

the attacks of September 11, 2001 and the subsequent

anthrax scares, Congress enacted the Public Health Security

and Bioterrorism Preparedness Act of 2002, Pub. L. No.

107-188, 116 Stat. 594 (2002). The Bioterrorism Act

provides federal regulators with “significant new authority”

for regulating the nation’s food and drug supply. Berger &

Berger, supra, at *61.

Overall, the comprehensive federal regulation of

controlled substances and other drugs from the Food and

Drug Act of 1906 to the Public Health Security and

'° See, e.g., Federal Anti-Tampering Act of 1983, Pub. L. No. 98-127, 97

Stat. 838 (1983); Dangerous Drug Diversion Control Act of 1984, Pub.

L. No. 98-473, 98 Stat. 2070 (1984); Narcotics Penalties and

Enforcement Act of 1986, Pub. L. No. 99-570, 100 Stat. 3207-2 (1986);

Controlled Substances Analogue Enforcement Act of 1986, Pub. L. No.

99-570, 100 Stat. 3207-16 (1986); Drug Export Amendments Act of

1986, Pub. L. No. 99-660, 100 Stat. 3743, §351(h)(I(B)i) (1986);

Prescription Drug Marketing Act of 1987, Pub. L. No. 100-293, 102 Stat.

95 (1987); Chemical Diversion and Trafficking Act of 1988, Pub. L. No:

100-690, 102 Stat. 4312 (1988).

Bioterrorism Preparedness Act of 2002 demonstrates not

only the extent but also the importance of uniform federal

regulations in protecting public health and safety. Indeed,

the “pervasive nature and long history of federal regulation

of the food and drug industry” are undeniable. New England

Grocers Supply Co., 488 F. Supp. at 238; see also American

Home Prods. Corp., 672 F. Supp. at 145 (“Federal regulation

of drug safety and efficacy is pervasive and complete.”).

B. The Pervasive Federal Regulation of Controlled

Substances and Other Dangerous Drugs Belies

Any Claim That This is a “State Issue.”

The comprehensive federal regulations described above

belie any claim that this case involves “an area of law

traditionally reserved for state authority.” Ashcroft, 368 F.3d

at 1125. Indeed, federal drug regulations provide uniform

standards for prescribing, dispensing, and using controlled

substances. As a result, a State cannot “opt out” of federal

drug regulations. Allowing such a circumvention of federal

law would set a dangerous precedent for future opt-outs.

It is black-letter law that “[w]ith regard to federal

regulation, Congress undoubtedly pc ssesses the authority to

proscribe drugs it considers dangerous to the public welfare.”

25 Am. Jur. 2d Drugs and Controlled Substances § 19

(2004); see also United States v. Alveri, 715 F. Supp. 1508,

1511 (M.D. Ala. 1989) (“To paraphrase Justice Douglas’s

rationale in Freed, one would hardly be surprised to learn

that dispensation of drugs is an act involving substantial

governmental concerns. . . . [T]his is Congress’s legitimate

prerogative.”) (citing United States v. Freed, 401 U.S. 601,

609 (1971)).

This Court has repeatedly upheld federal regulation of

the distribution of controlled substances as within Congress’s

Commerce Clause authority. See Minor v. United States,

396 U.S. 87, 98 n.13 (1969) (ban on sale of narcotics is

within Congress’s constitutional power); Reina v. United

States, 364 U.S. 507, 511 (1960) (Congress had “undoubted

power to enact the narcotics laws”); see also United States v.

Tisor, 96 F.3d 370, 375 (9th Cir. 1996), (“Controlled

Substances Act does not exceed Congressional authority

under Commerce Clause.”); United States v. Kim, 94 F.3d

1247, 1250 (9th Cir. 1996) (“[E]very circuit that has

considered a Commerce Clause challenge to § 841(a)(1)

after Lopez has upheld the provision’s constituiionality.”).

Moreover, it is also black-letter law that Congress does

“not abridge the reservation of police powers to the states

under the Tenth Amendment by passing statutes prohibiting

the possession and distribution of drugs.” 25 Am. Jur. 2d

Drugs and Controlled Substances § 19 (2004). See Reina,

364 U.S. at 511 (rejecting argument that state narcotic laws

are “a subject that has traditionally been within the police

power of the state” because “[t]he relevant inquiry here” is

simply whether the federal action is “necessary and proper to

the more effective enforcement of the undoubted power to

enact the narcotics laws”).''

As Judge Wallace’s dissent makes clear, the majority’s

“argument that ‘direct control of medical practice in the

states is beyond the power of the federal government’ misses

the point.” Ashcroft, 368 F.3d at 1143 (quoting Linder v.

United States, 268 U.S. 5 (1925)).'* Both the Supreme Court

'' See also United States v. Lerebours, 87 F.3d 582, 585 (1st Cir. 1996)

(rejecting defendant’s Tenth Amendment police powers argument

because “courts will not strike down a statute under the Tenth

Amendment where Congress was within its powers under the Commerce

Clause to enact the statute”); Jn re Grand Jury Proceedings, 801 F.2d

1164, 1169 (9th Cir. 1986) (per curiam) (rejecting Tenth Amendment

argument that the “control of medical practice is beyond the power of the

federal government” because “the Commerce Clause empowers the

federal government to regulate prescription drugs” and thus “physician

may not defend a federal prosecution for improper drug prescription

practices on Tenth Amendment grounds”).

' The Ninth Circuit’s reliance on Lochner-era cases to justify an

unprecedented regulatory “opt out” right for individual states is entirely

misplaced. The majority cited Linder as establishing a constitutional

and Ninth Circuit’s “binding precedent compel the

conclusion that Congress acts comfortably within its

Commerce Clause power when it regulates the prescription

and dispensation of controlled substances.” /d. at 1143

(citing Minor, 396 U.S. 87, and Reina, 364 U.S. 507).

Because “Congress’ Commerce Clause power to prohibit

physicians from prescribing controlled substances to assist

suicide is not open to serious question[,] [t]hat ends the

matter in this circuit and, of course, for this case.” Jd. at

1142 (citing United States v. McCoy, 323 F.3d 1114 (9th Cir.

2003)).

Indeed, respondents do not (and cannot) cite to a single

currently-applicable case that would suggest there is a

constitutional limitation on Congress’s ability to exercise the

full scope of its enumerated powers simply because it may

have some effect on the practice of medicine. In fact,

directly contrary to the respondents’ assertions, this Court

has applied the Controlled Substances Act in cases where its

impact on the practice of medicine and state law was obvious

without intimating the existence of any such constitutional

limitation. See United States v. Oakland Cannabis Buyers’

Coop., 532 U.S. 483, 494-495 (2001) (Controlled Substances

Act precludes recognition of a “medical necessity” defense

for marijuana use despite California’s determination that

marijuana has medical utility); Moore, 423 U.S. at 139

(upholding Controlled Substances Act conviction of

physician for illegally dispensing controlled substances from

his medical practice).

Thus, because controlled substances are not “an area of

law traditionally reserved for state authority” (see supra Part

prohibition against Congress's legislating in a way that affects “control

of medical practice in the states.” Ashcroft, 368 F.3d at 1124. However,

Linder’s reliance on the Lochner-era doctrine that Congress could not

employ its enumerated powers to accomplish general goals relating to

health and welfare was expressly disavowed in United States v. Darby,

312 U.S. 100, 115-117 (1941) and has not been revived since.

1.A.1-I1.A.5) and because the Attorney General’s

interpretation of 21 C.F.R. § 1306.04(a) does not “invoke[]

the outer limits of Congress’ power” or “push the limit of

congressional authority” under the Commerce Clause, Solid

Waste Agency v. U.S. Army Corps of Eng’rs, 531 U.S. 159,

172-173 (2001), the “clear statement rule does not apply”

and this Court should evaluate the Attorney General’s

Directive “according to ordinary standards of deference.”

Ashcroft, 368 F.3d at 1143 (Wallace, J., dissenting).

United States v. Rutherford, 442 U.S. 544 (1979), also

offers an instructive comparison. In holding that terminally

ill cancer patients could not enjoin the United States from

interfering with the interstate shipment and sale of Laetrile,

Justice Marshall, writing for the Court, stated that “the

construction of a statute by those charged with its

administration is entitled to substantial deference.” Jd. at

553; see id. at 559 (Whether, as a policy matter, an

exemption should be created is a question for legislative

judgment, not judicial inference.”).'°

The Court pointed out that “[s]Juch deference is

particularly appropriate where, as here, an agency’s

interpretation involves an issue of considerable public

controversy, and Congress has not acted to correct any

misperception of its statutory objectives.” Jd. at 554

(citations omitted). Justice Marshall concluded that

“historical experience does suggest why Congress could

reasonably have determined to protect the terminally ill, no

less than other patients, from the vast range of self-styled

panaceas that inventive minds can devise.” /d. at 558.

'> See also Oakland Cannabis Buyers’ Coop., 532 U.S. at 491 n.4 (noting

that “[ejlimination of medical-necessity defense under Controlled

Substances Act . . . does not require an explicit statement in the Act, as

the Supreme Court will decline to set the bar so high, considering that . . .

such a defense would entail a social balancing that is better left to

Congress”); cf Peter Hutt, Philosophy of Regulation Under the Federal

Food, Drug and Cosmetic Act, 50 Food & Drug L.J. 101, 103 (1995)

(“Administration of the Act is and always has been largely a matter of

judgment and discretion.”).

Similarly, under the Controlled Substance Act, Congress

has established comprehensive and uniform standards for the

distribution of controlled substances and other dangerous

drugs. These comprehensive and uniform standards are

essential for the effective regulation of drugs in all fifty

states. See United States v. Rybar, 103 F.3d 273, 284 (3d

Cir. 1996) (“({FJederal regulation of controlled substances

[is] ‘essential to effective control of the interstate incidents’

of traffic in particular commodities.”) (quoting United States

v. Kirk, 70 F.3d 791, 796-797 (Sth Cir. 1995)); cf Norfolk S.

Ry. Co. v. Kirby, 125 S. Ct. 385, 396 (2004) (O’Connor, J.)

(citing Romero v. International Terminal Operating Co., 358

U.S. 354, 373 (1959) (“[S]tate law must yield to the needs of

a uniform federal maritime law when this Court finds inroads

on a harmonious system[,] [b]ut this limitation still leaves

the States a wide scope.”).'*

It is clear, however, that neither Oregon, nor any other

state, may decide unilaterally to “opt out” of comprehensive

and uniform federal regulations. Cf Testa v. Katt, 330 U.S.

386, 393 (1947) (concluding that a state cannot “refuse to

enforce the right arising from the law of the United States

because of conceptions of impolicy or want of wisdom on

the part of Congress in having called into play its lawful

powers”) (quoting Minneapolis & St. L.R. Co. v. Bombolis,

241 U.S. 211, 222 (1916)); id. at 391 (“[T]he Constitution

and the laws passed pursuant to it are the supreme laws of

the land, binding alike upon states, courts, and the people,

‘anything in the Constitution or Laws of any State to the

contrary notwithstanding.’”) (quoting U.S. Const. Art. VI, §

2). Allowing such an unprecedented circumvention of

federal law for any state that disagrees with a federal policy

' Indeed, in this case, as Judge Wallace has pointed out, “([s]tate

legislators may supplement the [Attorney General’s] sanctions, and they

may authorize alternative methods for assisting suicide that do not

involve the prescription of controlled substances.” Ashcroft, 368 F.3d at

1148.

would not only be antithetical to the Congressional objective

of protecting public health and safety in this case, but also

create an impracticable system of administrative law by

establishing a dangerous precedent for future opt-outs.

CONCLUSION

For the foregoing reasons, the decision of the Ninth

Circuit should be reversed.

Respectfully submitted,