PRINTER'S NO. 324
No. 320 Session of 1979
INTRODUCED BY McKINNEY, LYNCH, HANKINS AND FUMO,
FEBRUARY 27, 1979
REFERRED TO PUBLIC HEALTH AND WELFARE, FEBRUARY 27, 1979
AN ACT
1 Relating to amygdalin (laetrile).
2 The General Assembly of the Commonwealth of Pennsylvania
3 hereby enacts as follows:
4 Section 1. Notwithstanding the provisions of any other laws
5 or regulations adopted pursuant thereto, the manufacture, sale,
6 possession or distribution of amygdalin (laetrile) pursuant to
7 this act shall not be unlawful.
8 Section 2. A hospital or other health care facility shall
9 not interfere with the physician-patient relationship by
10 restricting or forbidding the use of amygdalin (laetrile) as an
11 adjunct to recognized, customary or accepted modes of therapy in
12 the treatment of any malignancy, disease, illness or physical
13 condition when it is prescribed or administered by a physician
14 and the patient has signed the "written informed request."
15 Section 3. A physician may not be subjected to disciplinary
16 action by the State Board of Medical Education and Licensure or
17 the State Board of Osteopathic Examiners in the Department of
1 State for prescribing or administering amygdalin (laetrile) to a
2 patient under his care as an adjunct to recognized, customary or
3 accepted modes of therapy in the treatment of any malignancy,
4 disease, illness or physical condition if and when the patient
5 has signed the "written informed request" as set forth in
6 section 4.
7 Section 4. The "written informed request" referred to in
8 this act shall be on a form prepared by, and obtained from, the
9 Department of Health, shall be subject to the department's
10 continuing jurisdiction and control concerning any changes in
11 the "written informed request" pursuant to law and shall be in
12 substance as follows:
13 WRITTEN INFORMED REQUEST FOR PRESCRIPTION
14 OF AMYGDALIN (LAETRILE) FOR MEDICAL TREATMENT
15 Patient's name:
16 Address:
17 Age: Sex:
18 Name and address of prescribing physician:
19 Malignancy, disease, illness or physical condition
20 diagnosed for medical treatment by amygdalin (laetrile):
21
22
23 My physician has explained to me:
24 (1) That the Federal Food and Drug Administration has
25 determined amygdalin (laetrile) to be an "unapproved
26 new drug" and that Federal law prohibits the
27 interstate distribution of an "unapproved new drug."
28 (2) That neither the American Cancer Society nor the
29 Pennsylvania Medical Society recommends the use of
30 amygdalin (laetrile) in the treatment of any
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1 malignancy, disease, illness or physical
2 condition.
3 (3) That there are alternative recognized treatments for
4 the malignancy, disease, illness or physical condition
5 from which I suffer which he has offered to provide for
6 me including: (Here describe)
7
8
9 That notwithstanding the foregoing, I hereby request
10 prescription and use of amygdalin (laetrile) in the medical
11 treatment of the malignancy, disease, illness or physical
12 condition from which I suffer.
13
14 Signature of Patient
15 ATTEST:
16
17 Prescribing Physician
18 A copy of such "written informed request" shall be forwarded
19 forthwith after execution thereof to the hospital or related
20 institution and the Department of Health for appropriate filing.
21 Section 5. Nothing in this act shall be construed as
22 constituting an endorsement of amygdalin (laetrile) for the
23 treatment of any malignancy, disease, illness or physical
24 condition, and nothing in this act shall be construed as
25 preventing a physician from prescribing amygdalin (laetrile) as
26 a dietary supplement to a patient not suffering from any known
27 malignancy, disease, illness, or physical condition.
28 Section 6. Nothing in this act requires any physician, any
29 pharmacist, any pharmacy, any manufacturer or distributor to
30 manufacture, sell or distribute amygdalin (laetrile), and
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1 nothing requires any physician to prescribe amygdalin (laetrile)
2 for any patient.
3 Section 7. (a) The Department of Health shall establish
4 standards for the manufacture and preparation within this State
5 of amygdalin (laetrile). The Department of Health shall adopt
6 rules and regulations governing the production, processing,
7 labeling, storing, handling, selling and administering of such
8 drug. The department shall establish said standards and
9 promulgate said rules and regulations within 90 days of the
10 effective date of this act.
11 (b) If either the House of Representatives or the Senate,
12 within 30 days of the date any standards, rules or regulations
13 are promulgated pursuant to subsection (a), disapprove the
14 adoption of any of the said standards, rules or regulations,
15 such standard, rule or regulation shall not take effect.
16 (c) The Department of Health may set reasonable fees, to be
17 collected from the manufacturer, for establishing and
18 administrating standards.
19 Section 8. Any person who manufactures or prepares a new
20 drug which fails to comply with the standards in this State for
21 the manufacture of amygdalin (laetrile) shall upon conviction
22 thereof be guilty of a misdemeanor and be sentenced to pay a
23 fine not in excess of $5,000 or undergo imprisonment of one year
24 or both. Each day of violation shall constitute a separate
25 offense.
26 Section 9. Three years after the date of enactment of this
27 act the Secretary of the Department of Health shall make a
28 determination of the effectiveness of amygdalin (laetrile) in
29 the treatment of cancer, and, if amygdalin (laetrile) is found
30 to have no beneficial effect in the treatment of cancer, this
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1 act shall expire.
2 Section 10. This act shall take effect immediately.
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