I 
109TH CONGRESS 
1ST SESSION 
H. R. 870
To amend the Federal Food, Drug, and Cosmetic Act to provide enhanced 
criminal penalties for certain violations of the Act involving knowing 
concealment of evidence of a serious adverse drug experience, and for 
other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
FEBRUARY 16, 2005
Mr. STARK (for himself and Mr. BERRY) introduced the following bill; which 
was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
provide enhanced criminal penalties for certain violations 
of the Act involving knowing concealment of evidence 
of a serious adverse drug experience, and for other pur-
poses.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Pharmaceutical Re-
search and Manufacturers Accountability Act of 2005’’ or 
the ‘‘PhRMA Act of 2005’’.
SEC. 2. CONCEALMENT OF SERIOUS ADVERSE DRUG EXPE-
RIENCE. 
(a) PENALTY FOR KNOWING CONCEALMENT OF SE-
RIOUS ADVERSE DRUG EXPERIENCE.—Section 303 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) 
is amended by adding at the end the following: 
‘‘(h) An individual who violates a provision of section 
301 shall be imprisoned for a term of a minimum of 20 
years and a maximum of life, fined not more than 
$2,000,000, or both, if—
‘‘(1) the individual is employed as the chief ex-
ecutive officer or a member of the senior executive 
management group of the manufacturer of a drug; 
and 
‘‘(2) the violation involves, with respect to such 
drug, knowing concealment by the individual of evi-
dence of a serious adverse drug experience (as that 
term is defined in section 505(o)).’’. 
(b) ANNUAL ATTESTATION BY CEO REGARDING ANY 
SERIOUS ADVERSE DRUG EXPERIENCE.—The Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) 
is amended—
(1) in section 505 (21 U.S.C. 355), by adding 
at the end the following: 
‘‘(o) ANNUAL ATTESTATION BY CEO REGARDING 
ANY SERIOUS ADVERSE DRUG EXPERIENCE.—
‘‘(1) REQUIREMENT.—For each drug for which 
an approval of an application filed under subsection 
(b) or (j) is in effect, the Secretary shall require the 
chief executive officer of the manufacturer of the 
drug to submit a separate, written attestation on an 
annual basis—
‘‘(A) stating that the manufacturer has 
disclosed to the Secretary all evidence of any se-
rious adverse drug experience related to the 
drug; and 
‘‘(B) describing the process by which the 
manufacturer ensures that such disclosure has 
occurred. 
‘‘(2) DEFINITIONS.—For purposes of this sub-
section: 
‘‘(A) The term ‘evidence of any serious ad-
verse drug experience’ includes any evidence of 
a serious adverse drug experience that—
‘‘(i) is obtained by the manufacturer 
involved from any source of information, 
foreign or domestic, including any informa-
tion obtained from a clinical trial con-
ducted before or after approval of the 
drug, from postmarketing surveillance of
the drug, or from a postmarketing report 
by a physician; or 
‘‘(ii) is required by any provision of 
this Act to be reported by the manufac-
turer to the Secretary. 
‘‘(B) The term ‘serious adverse drug expe-
rience’ means an adverse drug experience occur-
ring at any dose that results in—
‘‘(i) death, a life-threatening adverse 
drug experience, inpatient hospitalization, 
prolongation of existing hospitalization, a 
persistent or significant disability or inca-
pacity, or a congenital anomaly or birth 
defect; or 
‘‘(ii) a medical event that, based on 
appropriate medical judgment, may jeop-
ardize the patient or subject and may re-
quire medical or surgical intervention to 
prevent one of the outcomes listed in 
clause (i). 
‘‘(3) INITIAL
ATTESTATION.—The Secretary 
shall require that the first attestation under this 
subsection for a drug be submitted—
‘‘(A) in the case of a drug for which ap-
proval of an application filed under subsection
(b) or (j) is in effect on the date of the enact-
ment of this subsection, not later than 1 year 
after such date; and 
‘‘(B) in the case of any other drug, not 
later than 1 year after the the date of such ap-
proval for the drug. 
‘‘(4) FAILURE TO SUBMIT.—If the chief execu-
tive officer of a manufacturer of a drug for which 
an approval of an application filed under subsection 
(b) or (j) is in effect fails to submit a timely attesta-
tion for the drug as required by paragraph (1), the 
Secretary—
‘‘(A) may issue an order withdrawing ap-
proval of the application; and 
‘‘(B) shall not revoke such an order, or 
otherwise approve or reinstate the application, 
unless—
‘‘(i) the Secretary conducts a review 
of the drug’s safety; 
‘‘(ii) the Secretary determines that 
the drug is safe for use; and 
‘‘(iii) the manufacturer reimburses the 
Secretary for the costs of such review and 
determination.