Bill Text: PA SB421 | 2009-2010 | Regular Session | Introduced

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Bill Title: Providing for the definitions of "clinical trial" and "pharmaceutical drug" and for drug manufacturer clinical trials reporting; and further providing for prohibited acts and penalties.

Spectrum: Bipartisan Bill

Status: (Introduced - Dead) 2009-02-20 - Referred to PUBLIC HEALTH AND WELFARE [SB421 Detail]

Download: Pennsylvania-2009-SB421-Introduced.html

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PRINTER'S NO. 422
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No. 421 Session of2009
INTRODUCED BY BROWNE, WASHINGTON, BOSCOLA, ERICKSON, O'PAKE, COSTA, VANCE, RAFFERTY AND FERLO, FEBRUARY 20, 2009
REFERRED TO PUBLIC HEALTH AND WELFARE, FEBRUARY 20, 2009
AN ACT
Amending the act of April 14, 1972 (P.L.233, No.64), entitled
"An act relating to the manufacture, sale and possession of
controlled substances, other drugs, devices and cosmetics;
conferring powers on the courts and the secretary and
Department of Health, and a newly created Pennsylvania Drug,
Device and Cosmetic Board; establishing schedules of
controlled substances; providing penalties; requiring
registration of persons engaged in the drug trade and for the
revocation or suspension of certain licenses and
registrations; and repealing an act," providing for the
definitions of "clinical trial" and "pharmaceutical drug" and
for drug manufacturer clinical trials reporting; and further
providing for prohibited acts and penalties.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Section 2(b) of the act of April 14, 1972 (P.L.
233, No.64), known as The Controlled Substance, Drug, Device and
Cosmetic Act, is amended by adding definitions to read:
Section 2. Definitions.--* * *
(b) As used in this act:
* * *
"Clinical trial" means a clinical investigation as defined by
the United States Food and Drug Administration that involves any
experiment to test the safety or efficacy of a drug or
biological product with one or more human subjects.
* * *
"Pharmaceutical drug" means any drug which is approved by the
United States Food and Drug Administration and commercially
available for dispensing with a prescription.
* * *
Section 2. The act is amended by adding a section to read:
Section 6.1. Drug Manufacturer Clinical Trials Reporting.--
(a) A manufacturer of a pharmaceutical drug that sells,
delivers, offers for sale or gives away any pharmaceutical drug
for use within this Commonwealth shall post on a publicly
accessible clinical trials registry, including the clinical
trials data bank established pursuant to section 402(i) of the
Social Security Act (49 Stat. 620, 42 U.S.C. § 282(i)) and
developed by the National Library of Medicine, the following
information regarding all clinical trials that the manufacturer
has conducted or sponsored on each pharmaceutical drug that it
sells, delivers, offers for sale or gives away for use within
this Commonwealth:
(1) The name of the entity that conducted or is conducting
the clinical trial.
(2) A summary of the purposes of the clinical trial.
(3) The dates during which the trial has taken place.
(4) Information concerning the results of the clinical
trial, including potential or actual diverse effects of the
drug.
(b) A manufacturer of a pharmaceutical drug that sells,
delivers, offers for sale or gives away any pharmaceutical drug
for use within this Commonwealth that conducts or sponsors a
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clinical trial shall register the clinical trial at or before
the onset of patient enrollment by providing information
necessary for publication in the clinical trials data bank
established pursuant to 42 U.S.C. § 282(i) and in a manner as
required by regulations or other guidance established by the
United States National Library of Medicine or the United States
Secretary of Health and Human Services.
(c) Upon annual registration or filing with the secretary
under section 6, each manufacturer subject to this section shall
submit a report to the secretary certifying that it is in
compliance with this section, together with a filing fee of one
thousand dollars ($1,000). Fees collected under this subsection
shall be used to cover the cost of overseeing the implementation
of this section, including maintaining links to publicly
accessible Internet websites to which manufacturers are posting
clinical trial information under this section and other relevant
sites.
(d) The department may adopt rules or regulations to
implement this section.
Section 3. Section 13(a) of the act is amended by adding a
clause and the section is amended by adding a subsection to
read:
Section 13. Prohibited Acts; Penalties.--(a) The following
acts and the causing thereof within the Commonwealth are hereby
prohibited:
* * *
(39) The failure by a manufacturer of a pharmaceutical drug
to submit the results of all clinical trials that have been
conducted on each pharmaceutical drug that it sells, delivers,
offers for sale or gives away for use within this Commonwealth.
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* * *
(q) (1) The Attorney General may bring a civil action to
enforce the requirements of section 6.1.
(2) A manufacturer that violates subsection (a)(39) shall be
liable for civil penalties of not more than twenty-five thousand
dollars ($25,000) per violation.
Section 4. This act shall take effect in 180 days.
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