Fwd: Jason Vale's Conviction-Laetrile sales & Alternative Medicine Pt 1

[Guest guest]

There is no problem with tons of dangerous chemicals in our food, water, or air

as long as it is done by major players in industry who hold hands with the

politicians..

 

The majority of pharmacuetical chemicals foisted off on the public are dangerous

and damaging and don't cure anything. They pretty much put anything on the

market that they want, even if it just makes you sicker, and the public be

damned. All that counts is the bottom line of profits. All with the help of

government and political power.

 

While all of this is going on they are taking away the rights to buy vitamins,

herbs, even an apricot seed, a B vitamin, or a nontoxic amino acid found in most

foods. What kind of freedom is that?

 

If things continue, I think that it is only a matter of time when it will be

against the law to sell or possess vitamins or herbs of any usable strength.

They are slowly but surely criminalizing the natural substances which they view

as competition and attack with underhanded methods.

 

If natural methods do not work but are non toxic and do no damage, why are they

so determined to do away with them? Because if the truth were known, almost

evryone would prefer the natural healing to the unnatural toxic chemicals which

are only designed to suppress the symptoms and then cause serious side effects

in their own right.

 

In the face of all this, do you really believe that the system is designed with

your health in mind?

 

Frank

 

 

arnoldgore

Wed, 27 Aug 2003 14:19:44 EDT

Jason Vale's Conviction-Laetrile sales & Alternative Medicine Pt 1

 

 

I received a perceptive email from Tony Martinez, a health lawyer and lobbyist

for health freedom. He pointed out that the current legal position that Jason

Vale faces after conviction for violating the consent order he had signed

previously not to distribute Laetrile was predictable based on the US Supreme

Court Decision below.Since it is very long, the decision is continued in a 3nd

Email. But the sentencing hearing may offer some hope.

The conviction of Jason Vale for advertising the benefits of and selling

laetrile.Laetrile has repeatedly demonstrated ability to reverse some cancers.

It has caused considerable concern and eventual " manipulation " of experimental

data and proponents to publicize some public relations statements discounting

the efficacy of this therapy. A penalty should reflect the danger posed by Jason

to the community at large. His sincere good faith effort to help people should

be utilized to perform community service. It may be necessary to take the

position that he was not aware of the seriousness of the consent order.

 

In the meantime the Access to Medical Treatment Act, which might give a

statutoty right to advertise and sell Alternative non FDA approved therapies.

 

 

U.S. Supreme Court Decision

 

UNITED STATES v. RUTHERFORD, 442 U.S. 544 (1979)

 

442 U.S. 544 UNITED STATES ET AL. v. RUTHERFORD ET AL.CERTIORARI TO THE UNITED

STATES COURT OF APPEALS FOR THE TENTH CIRCUIT.No. 78-605. Argued April 25,

1979.Decided June 18, 1979. Terminally ill cancer patients and their spouses

brought this action to enjoin the Government from interfering with the

interstate shipment and sale of Laetrile, a drug not approved for distribution

under the Federal Food, Drug, and Cosmetic Act (Act). Section 505 of the Act

prohibits interstate distribution of any " new drug " unless the Secretary of

Health, Education, and Welfare approves an application supported by substantial

evidence of the drug's safety and effectiveness. Section 201 (p) (1) of the Act

defines a " new drug " to include " any drug . . . not generally recognized . . .

as safe and effective for use under the conditions prescribed, recommended, or

suggested in the labeling. " Finding that Laetrile, in proper dosages, was

nontoxic and effective, the District Court ordered the Government to

permit limited purchases of the drug by one of the named plaintiffs. While not

disturbing the injunction, the Court of Appeals instructed the District Court to

remand the case to the Food and Drug Administration (FDA) for determination

whether Laetrile was a " new drug " under 201 (p) (1), and, if so, whether it was

exempt from premarketing approval under either of the Act's two grandfather

clauses. After completion of administrative hearings, the Commissioner of the

FDA found that Laetrile constituted a " new drug " as defined in 201 (p) (1) and

fell within neither grandfather provision. On review of the Commissioner's

decision, the District Court concluded that Laetrile was entitled to an

exemption from premarketing approval under the Act's 1962 grandfather clause

and, alternatively, that the Commissioner had infringed constitutionally

protected privacy interests by denying cancer patients access to Laetrile. The

Court of Appeals, without addressing either the statutory or

constitutional rulings of the District Court, held that the Act's " safety " and

" effectiveness " standards have " no reasonable application " to terminally ill

cancer patients and approved intravenous injections of Laetrile for such

individuals. Held:

 

The Act makes no express exception for drugs used by the terminally ill and no

implied exemption is necessary to attain congressional objectives or to avert an

unreasonable reading of the terms " safe " and " effective " in 201 (p) (1). Pp.

551-559. [442 U.S. 544, 545](a) Nothing in the legislative history suggests

that Congress intended protection only for persons suffering from curable

diseases. Moreover, in implementing the statutory scheme, the FDA has never

exempted drugs used by the terminally ill. The construction of a statute by

those charged with its administration is entitled to substantial deference

particularly where, as here, an agency's interpretation involves issues of

considerable public controversy, and Congress has not acted to correct any

misperception of its statutory objectives. Pp. 552-554.(b) The Court of Appeals

erred in concluding that the safety and effectiveness standards of 201 (p) (1)

could have " no reasonable application " to terminal patients. For purposes

of 201 (p) (1), the effectiveness of a drug does not necessarily denote

capacity to cure; in the treatment of any illness, terminal or otherwise, a drug

is effective if it fulfills, by objective indices, its sponsor's claims of

prolonged life, improved physical condition, or reduced pain. Nor is the concept

of safety under 201 (p) (1) without meaning for terminal patients; a drug is

unsafe for the terminally ill, as for anyone else, if its potential for

inflicting death or physical injury is not offset by the possibility of

therapeutic benefit. Finally, construing 201 (p) (1) to encompass treatments for

terminal diseases does not foreclose all resort to experimental cancer drugs by

patients for whom conventional therapy is unavailing. That 505 (i) of the Act

makes explicit provision for carefully regulated use of certain drugs not yet

demonstrated to be safe and effective reinforces the conclusion that no

exception for terminal patients may be judicially implied. Pp. 554-559.582

F.2d 1234, reversed and remanded. MARSHALL, J., delivered the opinion for a

unanimous Court.Solicitor General McCree argued the cause for the United States

et al. With him on the briefs were Assistant Attorney General Shenefield, Deputy

Solicitor General Barnett, Elinor Hadley Stillman, Barry Grossman, and Richard

M. Cooper.Kenneth Ray Coe argued the cause for respondents. With him on the

brief were Kirkpatrick W. Dilling and Dennis M. Gronek.* [Footnote *] Briefs of

amici curiae urging reversal were filed by Francis X. Bellotti, Attorney

General, and Jonathan Brant, Assistant Attorney General, [442 U.S. 544, 546]

for the Commonwealth of Massachusetts et al.; and by Grace Powers Monaco for the

American Cancer Society, Inc. Briefs of amici curiae urging affirmance were

filed by David H. Gill II for the Committee for Freedom of Choice in Cancer

Therapy; by Stephen Tornay for the McNaughton Foundation of California; by

Kirkpatrick W. Dilling and Dennis M. Gronek for the National

Health Federation; and by Daniel H. Smith for the Northwest Academy of

Preventive Medicine.

 

Briefs of amici curiae were filed by George Deukmejian, Attorney General, Robert

Philibosian, Chief Assistant Attorney General, Daniel J. Kremer, Assistant

Attorney General, and Harley D. Mayfield and Robert M. Foster, Deputy Attorneys

General, for the State of California; by Dennis S. Avery for the American

Academy of Medical Preventics; by David Laufer for the Cancer Control Society;

and by David S. King for the Save the United States Movement, Improving Public

Health and Physical Fitness of the United States Citizens. [442 U.S. 544, 546]

MR. JUSTICE MARSHALL delivered the opinion of the Court.The question presented

in this case is whether the Federal Food, Drug, and Cosmetic Act precludes

terminally ill cancer patients from obtaining Laetrile, a drug not recognized as

" safe and effective " within the meaning of 201 (p) (1) of the Act, 52 Stat.

1041, as amended, 21 U.S.C. 321 (p) (1).I

 

Section 505 of the Federal Food, Drug, and Cosmetic Act, 52 Stat. 1052, as

amended, 21 U.S.C. 355, prohibits interstate distribution of any " new drug "

unless the Secretary of Health, Education, and Welfare approves an application

supported by substantial evidence of the drug's safety and effectiveness.1 As

defined in 201 (p) (1) of the Act, 21 U.S.C. 321 (p) (1), the term " new drug "

includes " [a]ny drug . . . not generally recognized, among experts [442 U.S.

544, 547] qualified by scientific training and experience to evaluate the

safety and effectiveness of drugs, as safe and effective for use under the

conditions prescribed, recommended, or suggested in the labeling . . . . " [442

U.S. 544, 548]Exemptions from premarketing approval procedures are available for

drugs intended solely for investigative use2 and drugs qualifying under either

of the Act's two grandfather provisions.3In 1975, terminally ill cancer patients

and their spouses brought this action to enjoin the Government

from interfering with the interstate shipment and sale of Laetrile, a drug not

approved for distribution under the Act.4 Finding that Laetrile, in proper

dosages, was nontoxic and effective, the District Court ordered the Government

to permit limited purchases of the drug by one of the named plaintiffs. 399 F.

[442 U.S. 544, 549] Supp. 1208, 1215 (WD Okla. 1975).5 On appeal by the

Government, the Court of Appeals for the Tenth Circuit did not disturb the

injunction. However, it instructed the District Court to remand the case to the

Food and Drug Administration for determination whether Laetrile was a " new drug "

under 201 (p) (1), and, if so, whether it was exempt from premarketing approval

under either of the Act's grandfather clauses. 542 F.2d 1137 (1976).

 

After completion of administrative hearings,6 the Commissioner issued his

opinion on July 29, 1977. 42 Fed. Reg. 39768 (1977). He determined first that no

uniform definition of Laetrile exists; rather, the term has been used

generically for chemical compounds similar to, or consisting at least in part

of, amygdalin, a glucoside present in the kernels or seeds of most fruits. Id.,

at 39770-39772. The Commissioner further found that Laetrile in its various

forms constituted a " new drug " as defined in 201 (p) (1) of the Act because it

was not generally recognized among experts as safe and effective for its

prescribed use. See 42 Fed. Reg. 39775-39787 (1977). In so ruling, the

Commissioner applied the statutory criteria delineated in Weinberger v. Hynson,

Westcott & Dunning, Inc., 412 U.S. 609, 629-630 (1973), and concluded that

there were no adequate well-controlled scientific studies of Laetrile's safety

or effectiveness. 42 Fed. Reg. 39775-39787 (1977).7 [442 U.S. 544, 550] Having

determined that Laetrile was a new drug, the Commissioner proceeded to consider

whether it was exempt from premarketing approval under the 1938 or 1962

grandfather provisions. On the facts presented, the Commissioner found that

Laetrile qualified under neither clause. See id., at 39787-39795. First, there

was no showing that the drug currently known as Laetrile was identical in

composition or labeling to any drug distributed before 1938. See 21 U.S.C. 321

(p) (1); n. 3, supra. Nor could the Commissioner conclude from the evidence

submitted that, as of October 9, 1962, Laetrile in its present chemical

composition was commercially used or sold in the United States, was generally

recognized by experts as safe, and was labeled for the same recommended uses as

the currently marketed drug. See 107 © (4), 76 Stat. 789; n. 3, supra.On

review of the Commissioner's decision, the District Court sustained his

determination that Laetrile, because not generally regarded as safe or

effective,

constituted a new drug under 201 (p) (1). 438 F. Supp. 1287, 1293-1294 (WD

Okla. 1977). The court also approved the Commissioner's denial of an exemption

under the 1938 grandfather clause. However, concluding that the record did not

support the Commissioner's findings as to the 1962 grandfather provision, the

District Court ruled that Laetrile was entitled to an exemption from

premarketing approval requirements. Id., at 1294-1298. Alternatively, the court

held that, by denying cancer patients the right to use a nontoxic substance in

connection with their personal health, the Commissioner had infringed

constitutionally protected privacy interests. Id., at 1298-1300.

 

The Court of Appeals addressed neither the statutory nor the constitutional

rulings of the District Court. Rather, the [442 U.S. 544, 551] Tenth Circuit

held that " the `safety' and `effectiveness' terms used in the statute have no

reasonable application to terminally ill cancer patients. " 582 F.2d 1234, 1236

(1978). Since those patients, by definition, would " die of cancer regardless of

what may be done, " the court concluded that there were no realistic standards

against which to measure the safety and effectiveness of a drug for that class

of individuals. Id., at 1237. The Court of Appeals therefore approved the

District Court's injunction permitting use of Laetrile by cancer patients

certified as terminally ill. However, presumably because the Commissioner had

found some evidence that Laetrile was toxic when orally administered, see 42

Fed. Reg. 39786-39787 (1977), the Court of Appeals limited relief to intravenous

injections for patients under a doctor's supervision. 582 F.2d, at

1237. In addition, the court directed the FDA to promulgate regulations " as if "

the drug had been found " `safe' and `effective' " for terminally ill cancer

patients. Ibid.We granted certiorari, 439 U.S. 1127 (1979), and now reverse.II

 

The Federal Food, Drug, and Cosmetic Act makes no special provision for drugs

used to treat terminally ill patients. By its terms, 505 of the Act requires

premarketing approval for " any new drug " unless it is intended solely for

investigative use or is exempt under one of the Act's grandfather provisions.

See nn. 2, 3, supra. And 201 (p) (1) defines " new drug " to encompass " [a]ny drug

.. . . not generally recognized . . . as safe and effective for use under the

conditions prescribed, recommended, or suggested in the labeling. " See supra, at

546-547.When construing a statute so explicit in scope, a court must act within

certain well-defined constraints. If a legislative purpose is expressed in

" plain and unambiguous language, . . . the . . . duty of the courts is to give

it effect according to its terms. " United States v. Lexington Mill & Elevator

Co., 232 U.S. 399, 409 (1914). See Andrus v. Sierra Club, ante, p. 347. [442

U.S. 544, 552] Exceptions to clearly delineated statutes will

be implied only where essential to prevent " absurd results " or consequences

obviously at variance with the policy of the enactment as a whole. Helvering v.

Hammell, 311 U.S. 504, 510-511 (1941). See TVA v. Hill, 437 U.S. 153, 187-188

(1978); United States v. Key, 397 U.S. 322, 324-325 (1970); United States v.

American Trucking Assns., 310 U.S. 534, 543-544 (1940). In the instant case, we

are persuaded by the legislative history and consistent administrative

interpretation of the Act that no implicit exemption for drugs used by the

terminally ill is necessary to attain congressional objectives or to avert an

unreasonable reading of the terms " safe " and " effective " in 201 (p) (1).A

 

 

 

Nothing in the history of the 1938 Food, Drug, and Cosmetic Act, which first

established procedures for review of drug safety, or of the 1962 Amendments,

which added the current safety and effectiveness standards in 201 (p) (1),8

suggests that Congress intended protection only for persons suffering from

curable diseases. To the contrary, in deliberations preceding the 1938 Act,

Congress expressed concern that individuals with fatal illnesses, such as

cancer, should be shielded from fraudulent cures. See, e. g., 79 Cong. Rec. 5023

(1935) (remarks of Sen. Copeland, sponsor of the Act); 83 Cong. Rec. 7786-7787,

7789 (1938) (remarks of Reps. Phillips and Lea). Similarly, proponents of the

1962 Amendments to the Act, including Senator Kefauver, one of the bill's

sponsors, [442 U.S. 544, 553] indicated an understanding that experimental

drugs used to treat cancer " in its last stages " were within the ambit of the

statute. See, e. g., 108 Cong. Rec. 17399 (1962) (remarks of Sen. Kefauver);

id., at 17401 (comments of Sen. Eastland). That same understanding is reflected

in the Committee Reports on the 1962 Amendments. Both Reports note with approval

the FDA's policy of considering effectiveness when passing on the safety of

drugs prescribed for " life-threatening disease. " 9In implementing the statutory

scheme, the FDA has never made exception for drugs used by the terminally ill.

As this Court has often recognized, the construction of a statute by those

charged with its administration is entitled to substantial deference. Board of

Governors of FRS v. First Lincolnwood [442 U.S. 544, 554] Corp., 439 U.S. 234,

248 (1978); Bayside Enterprises, Inc. v. NLRB, 429 U.S. 298, 304 (1977); Udall

v. Tallman, 380 U.S. 1, 16 (1965). Such deference is particularly appropriate

where, as here, an agency's interpretation involves issues of considerable

public controversy, and Congress has not acted to correct any misperception of

its statutory objectives. See Red Lion Broadcasting

Co. v. FCC, 395 U.S. 367, 381 (1969); Zemel v. Rusk, 381 U.S. 1, 11-12

(1965).10 Unless and until Congress does so, we are reluctant to disturb a

longstanding administrative policy that comports with the plain language,

history, and prophylactic purpose of the Act.B

 

In the Court of Appeals' view, an implied exemption from the Act was justified

because the safety and effectiveness [442 U.S. 544, 555] standards set forth in

201 (p) (1) could have " no reasonable application " to terminally ill patients.

582 F.2d, at 1236. We disagree. Under our constitutional framework, federal

courts do not sit as councils of revision, empowered to rewrite legislation in

accord with their own conceptions of prudent public policy. See Anderson v.

Wilson, 289 U.S. 20, 27 (1933). Only when a literal construction of a statute

yields results so manifestly unreasonable that they could not fairly be

attributed to congressional design will an exception to statutory language be

judicially implied. See TVA v. Hill, 437 U.S., at 187-188. Here, however, we

have no license to depart from the plain language of the Act, for Congress could

reasonably have intended to shield terminal patients from ineffectual or unsafe

drugs.A drug is effective within the meaning of 201 (p) (1)

if there is general recognition among experts, founded on substantial evidence,

that the drug in fact produces the results claimed for it under prescribed

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

629-634; n. 7, supra. Contrary to the Court of Appeals' apparent assumption, see

582 F.2d, at 1236, effectiveness does not necessarily denote capacity to cure.

In the treatment of any illness, terminal or otherwise, a drug is effective if

it fulfills, by objective indices, its sponsor's claims of prolonged life,

improved physical condition, or reduced pain. See 42 Fed. Reg. 39776-39786

(1977).

 

So too, the concept of safety under 201 (p) (1) is not without meaning for

terminal patients. Few if any drugs are completely safe in the sense that they

may be taken by all persons in all circumstances without risk.11 Thus, the

Commissioner generally considers a drug safe when the expected therapeutic gain

justifies the risk entailed by its use.12 For [442 U.S. 544, 556] the

terminally ill, as for anyone else, a drug is unsafe if its potential for

inflicting death or physical injury is not offset by the possibility of

therapeutic benefit. Indeed, the Court of Appeals implicitly acknowledged that

safety considerations have relevance for terminal cancer patients by restricting

authorized use of Laetrile to intravenous injections for persons under a

doctor's supervision. See 582 F.2d, at 1237; supra, at 551.Moreover, there is a

special sense in which the relationship between drug effectiveness and safety

has meaning in the context of incurable illnesses. An otherwise harmless drug

can

be dangerous to any patient if it does not produce its purported therapeutic

effect. See 107 Cong. Rec. 5640 (1961) (comments of Sen. Kefauver). But if an

individual suffering from a potentially fatal disease rejects conventional

therapy in favor of a drug with no demonstrable curative properties, the

consequences can be irreversible.13 For this reason, even before the 1962

Amendments incorporated an efficacy standard into new drug application

procedures, the FDA considered effectiveness when reviewing the safety of drugs

used to treat terminal illness. See nn. 8, 9, supra. The FDA's practice also

reflects the recognition, amply supported by expert medical testimony in this

case, that with diseases such as cancer it is often impossible to identify a

patient as terminally ill except in retrospect.14 Cancers vary considerably in

behavior [442 U.S. 544, 557] and in responsiveness to different forms of

therapy. See 42 Fed. Reg. 39777 (1977).15 Even critically ill individuals may

have

unexpected remissions and may respond to conventional treatment. Id., at 39777,

39805. Thus, as the Commissioner concluded, to exempt from the Act drugs with no

proved effectiveness in the treatment of cancer " would lead to needless deaths

and suffering among . . . patients characterized as `terminal' who could

actually be helped by legitimate therapy. " Id., at 39805.

 

It bears emphasis that although the Court of Appeals' ruling was limited to

Laetrile, its reasoning cannot be so readily confined. To accept the proposition

that the safety and efficacy standards of the Act have no relevance for terminal

patients is to deny the Commissioner's authority over all drugs, however [442

U.S. 544, 558] toxic or ineffectual, for such individuals. If history is any

guide, this new market would not be long overlooked. Since the turn of the

century, resourceful entrepreneurs have advertised a wide variety of purportedly

simple and painless cures for cancer, including liniments of turpentine,

mustard, oil, eggs, and ammonia; peat moss; arrangements of colored floodlamps;

pastes made from glycerin and limburger cheese; mineral tablets; and " Fountain

of Youth " mixtures of spices, oil, and suet.16 In citing these examples, we do

not, of course, intend to deprecate the sincerity of Laetrile's current

proponents, or to imply any opinion on whether that drug may

ultimately prove safe and effective for cancer treatment. But this 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. We note finally that

construing 201 (p) (1) to encompass treatments for terminal diseases does not

foreclose all resort to experimental cancer drugs by patients for whom

conventional therapy is unavailing. Section 505 (i) of the Act, 21 U.S.C. 355

(i), exempts from premarketing approval drugs intended solely for investigative

use if they satisfy certain preclinical testing and other criteria.17 An

application for clinical testing of Laetrile by the National Cancer Institute is

now pending before the Commissioner. Brief for United States [442 U.S. 544,

559] 35 n. 23. That the Act makes explicit provision for carefully regulated use

of certain drugs not yet demonstrated safe and effective reinforces our

conclusion that no exception for terminal patients may be judicially implied.

Whether, as a policy matter, an exemption should be created is a question for

legislative judgment, not judicial inference. The judgment of the Court of

Appeals is reversed, and the case is remanded for further proceedings consistent

with this opinion.18So ordered. Footnotes

 

[Footnote 1] Section 505, as set forth in 21 U.S.C. 355, provides in part: " (a) .

.. . No person shall introduce or deliver for introduction into interstate

commerce any new drug, unless an approval of an application filed pursuant to

subsection (b) of this section is effective with respect to such drug. " (b) . . .

Any person may file with the Secretary an application with [442 U.S. 544, 547]

respect to any drug subject to the provisions of subsection (a) of this section.

Such person shall submit to the Secretary as a part of the application (1) full

reports of investigations which have been made to show whether or not such drug

is safe for use and whether such drug is effective in use . . . .. . . . .

 

" (d) . . . If the Secretary finds . . . that (1) the investigations . . .

required to be submitted to the Secretary . . . do not include adequate tests by

all methods reasonably applicable to show whether or not such drug is safe for

use under the conditions prescribed, recommended, or suggested in the proposed

labeling thereof; (2) the results of such tests show that such drug is unsafe

for use under such conditions or do not show that such drug is safe for use

under such conditions; . . . (4) . . . he has insufficient information to

determine whether such drug is safe for use under such conditions; or (5) . . .

there is a lack of substantial evidence that the drug will have the effect it

purports or is represented to have under the conditions of use prescribed,

recommended, or suggested in the proposed labeling thereof; or (6) based on a

fair evaluation of all material facts, such labeling is false or misleading in

any particular; he shall issue an order refusing to approve the

application. . . . As used in this subsection . . ., the term `substantial

evidence' means evidence consisting of adequate and well-controlled

investigations, including clinical investigations, by experts qualified by

scientific training and experience to evaluate the effectiveness of the drug

involved, on the basis of which it could fairly and responsibly be concluded by

such experts that the drug will have the effect it purports or is represented to

have under the conditions of use prescribed, recommended, or suggested in the

labeling or proposed labeling thereof.. . . . . " (i) . . . The Secretary

shall promulgate regulations for exempting from the operation of the foregoing

subsections of this section drugs intended solely for investigational use by

experts qualified by scientific training and experience to investigate the

safety and effectiveness of drugs. . . . " The Secretary has delegated his

approval authority to the Commissioner of the Food and Drug Administration. See

21 CFR 5.1 (a) (1) (1978).[Footnote 2] The requirements for investigative use

are set forth in 505 (i) of the Act, 21 U.S.C. 355 (i). See n. 1,

supra.[Footnote 3] In the Federal Food, Drug, and Cosmetic Act of 1938, 52 Stat.

1041, Congress exempted from the definition of " new drug " any drug that was

subject to the Pure Food and Drug Act of 1906, ch. 3915, 34 Stat. 768, if its

labeling retained the same representations concerning conditions of use made

prior to 1938. This exemption is currently contained in 201 (p) (1) of the Act,

as codified in 21 U.S.C. 321 (p) (1). The Drug Amendments of 1962 added a second

grandfather clause, which provides: " In the case of any drug which, on the day

immediately preceding the enactment date [October 10, 1962], (A) was

commercially used or sold in the United States, (B) was not a new drug as

defined by section 201 (p) of the basic Act as then in force, and © was not

covered by an effective [new drug] application under section 505 of that Act,

the

amendments to section 201 (p) made by this Act shall not apply to such drug

when intended solely for use under conditions prescribed, recommended, or

suggested in labeling with respect to such drug on that day. " 107 © (4), 76

Stat. 789.[Footnote 4] The suit was originally instituted by a cancer patient,

Juanita Stowe, and her husband, Jimmie Stowe. After Ms. Stowe's death, two other

patients, Glen L. Rutherford and Phyllis S. Schneider, and Ms. Schneider's

husband, filed an amended complaint on behalf of a class composed of all cancer

patients and spouses responsible for the costs of treatment. By order entered

April 8, 1977, the District Court certified a class consisting of terminally ill

cancer patients. 429 F. Supp. 506 (WD Okla.). The Government did not seek review

of that order.

 

[Footnote 5] The District Court subsequently entered similar orders for other

individuals who submitted affidavits averring their membership in the certified

class of terminally ill cancer patients. See App. 1-6.[Footnote 6] The

Commissioner initiated proceedings with an announcement in the Federal Register

seeking public comment. 42 Fed. Reg. 10066-10069 (1977). Notice was also

afforded to certain known proponents of Laetrile. See id., at

39785-39786.[Footnote 7] The Act does not define what constitutes general

recognition of a drug's safety and effectiveness under 201 (p) (1). However,

based on the structure and purpose of the statutory scheme, this Court in

Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S., at 629-634, [442

U.S. 544, 550] interpreted 201 (p) (1) to require an " expert consensus " on

safety and effectiveness founded upon " substantial evidence " as defined in 505

(d) of the Act, 21 U.S.C. 355 (d). See n. 1, supra.[Footnote 8] Under the 1938

Act, a " new drug "

was one not generally recognized by qualified experts as safe for its

recommended use. 201 (p) (1), 52 Stat. 1041. The Drug Amendments of 1962, Pub.

L. 87-781, 76 Stat. 789, redefined the term to include drugs not generally

recognized as effective or safe for their intended use. 201 (p) (1), 21 U.S.C.

321 (p) (1). See supra, at 546-547, 551. In addition, the Amendments provided

that no new drug application may be approved absent substantial evidence that

the drug is effective as well as safe under prescribed conditions. 505 (d), 21

U.S.C. 355 (d). See n. 1, supra.[Footnote 9] The Senate Report states: " The Food

and Drug Administration now requires, in determining whether a `new drug' is

safe, a showing as to the drug's effectiveness where the drug is offered for use

in the treatment of a life-threatening disease, or where it appears that the

`new drug' will occasionally produce serious toxic or even lethal effects so

that only its usefulness would justify the risks involved in its

use. In such cases, the determination of safety is, in the light of the

purposes of the new drug provisions, considered by the Food and Drug

Administration to be inseparable from consideration of the drug's effectiveness.

The provisions of the bill are in no way intended to affect any existing

authority of the Department of Health, Education, and Welfare to consider and

evaluate the effectiveness of a new drug in the context of passing upon its

safety. " S. Rep. No. 1744, 87th Cong., 2d Sess., pt. 1, p. 15 (1962).See also H.

R. Rep. No. 2464, 87th Cong., 2d Sess., 3 (1962).The FDA's practice was further

amplified by HEW Secretary Ribicoff in testimony on the bill that ultimately

became the 1962 Amendments: " If the drug is offered for treatment of progressive

or life-threatening diseases, such as cancer, . . . we now consider its

effectiveness. In such cases the determination of safety is, in the light of the

purpose of the new drug provisions, inseparable from consideration of the

drug'seffectiveness. " Hearings on S. 1552 before the Subcommittee on Antitrust

and Monopoly of the Senate Committee on the Judiciary, 87th Cong., 1st Sess.,

2588 (1961)