2245 112th CONGRESS
H. R. 2245
To amend the Federal Food, Drug, and Cosmetic
Act to provide the Food and Drug Administration with improved capacity to prevent
drug shortages.IN THE HOUSE OF REPRESENTATIVES
Ms. DEGETTE (for herself and Mr. ROONEY) introduced the
following bill; which was referred to the Committee on Energy and Commerce
To amend the Federal Food, Drug, and Cosmetic Act
to provide the Food and Drug Administration with improved capacity to prevent
Be it enacted by the Senate and House
of Representatives of the United States of America in Congress assembled,
1. SHORT TITLE.
This Act may be cited as the `Preserving Access
to Life-Saving Medications Act of 2011'.
SEC. 2. DISCONTINUANCE
OR INTERRUPTION OF THE MANUFACTURE OF A PRESCRIPTION DRUG.
In General- Section 506C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
356c) is amended to read as follows:
`SEC. 506C. DISCONTINUANCE
OR INTERRUPTION OF THE MANUFACTURE OF A PRESCRIPTION DRUG.
Definitions- In this section:
`(1) The term `average historic
demand' means the individual manufacturer's average monthly volume of sales of
the drug during the last calendar year.
`(2) The term
`discontinuance' means the permanent termination of the manufacture of a drug
by an individual manufacturer.
`(3) The term `interruption'
means a change that--
`(A) may result in the total
supply of a drug manufactured by the individual manufacturer not meeting average
historic demand; and
`(i) a change in the supply of one or more raw materials, including active pharmaceutical
`(ii) an unplanned interruption
in ability to produce the drug;
a business decision affecting the manufacture of the drug, such as a merger or
a change in production output; or
any other type change that could have the result described in subparagraph (A),
as determined by the Secretary.
`(1) IN GENERAL- A manufacturer of a drug
that is subject to section 503(b)(1) and marketed in interstate commerce shall
notify the Secretary of a discontinuance or interruption in the manufacture of
`(2) NOTIFICATION PERIOD- A notification pursuant
to paragraph (1) shall be submitted to the Secretary--
`(A) in the case of a planned discontinuance, at least 6 months prior to the date
of such discontinuance; and
`(B) in the case
of any other discontinuance or interruption--
`(i) at least 6 months prior to the date of such discontinuance or interruption;
`(ii) if the manufacturer cannot
provide 6 months advance notice, as soon as practicable after the manufacturer--
`(I) becomes aware of such discontinuance; or
`(II) becomes aware that such interruption may result in the total supply of the
drug manufactured by the individual manufacturer not meeting average historic
`(3) ADDITIONAL INFORMATION- A
manufacturer may, but is not required to, include in a notification submitted
pursuant to paragraph (1) information about an alternative source of the drug
or the availability of a drug with the same active ingredient.
`(4) REDUCTION IN NOTIFICATION PERIOD- The notification period required under
paragraph (2) for a manufacturer may be reduced if the manufacturer certifies
to the Secretary that good cause exists for the reduction, such as a situation
`(A) a public health problem may result
from continuation of the manufacturing for the 6-month period;
`(B) a biomaterials shortage prevents the continuation of the manufacturing for
the 6-month period;
`(C) a liability problem
may exist for the manufacturer if the manufacturing is continued for the 6-month
`(D) continuation of the manufacturing
for the 6-month period may cause substantial economic hardship for the manufacturer;
`(E) the manufacturer has filed for bankruptcy under chapter 7 or 11 of title
11, United States Code; or
`(F) the manufacturer
can continue the distribution of the drug involved for 6 months.
`(5) OTHER REDUCTIONS IN NOTIFICATION PERIOD- The Secretary may reduce the notification
period required under paragraph (2) based on--
the type of discontinuance or interruption at issue; and
`(B) any other factor, as determined by the Secretary.
`(6) CONFIDENTIALITY OF INFORMATION- Any information provided to the Secretary
under paragraph (1) shall be treated as trade secret or confidential information
subject to section 552(b)(4) of title 5 and section 1905 of title 18.
`(A) Any manufacturer that knowingly
fails to submit a notification in violation of paragraph (1) shall be subject
to a civil money penalty not to exceed $10,000 for each day on which the violation
continues, and not to exceed $1,800,000 for all such violations adjudicated in
a single proceeding.
`(B) Not later than 180
days after the date of the enactment of the Preserving Access to Life-Saving Medications
Act of 2011, the Secretary shall, subject to subparagraph (A), promulgate final
regulations establishing a schedule of civil monetary penalties for violations
of paragraph (1).
`(C) The provisions of paragraphs
(5), (6), and (7) of section 303(f) shall apply with respect to a civil penalty
under this paragraph to the same extent and in the same manner as such provisions
apply with respect to a civil penalty under paragraph (1), (2), (3), (4), or (9)
of section 303(f).
`(c) Notifications by Secretary-
`(1) DRUG SHORTAGE DEFINED- In this section, the term `drug shortage' means, with
respect to a drug, a period of time when the total supply of such drug available
at the user level will not meet the demand for such drug at the user level as
determined by the Secretary.
`(2) PUBLIC NOTIFICATION-
`(A) IN GENERAL- Subject to subsection (b)(6), the Secretary shall--
`(i) publish on the public Internet Web site of the Food and Drug Administration
`(I) the types
of discontinuances and interruptions for which a notification is required under
subsection (b)(1); and
actual drug shortages; and
to the maximum extent practicable, distribute such information to appropriate
health care providers and patient organizations.
`(B) DURATION- The Secretary shall include in any publication or distribution
under subparagraph (A), when possible, an estimate of the expected duration of
any discontinuance or interruption or actual drug shortage.
`(3) IDENTIFICATION AND NOTIFICATION OF DRUGS VULNERABLE TO DRUG SHORTAGE-
`(A) IN GENERAL- If the Secretary determines using the criteria under subparagraph
(B) that a drug may be vulnerable to a drug shortage, the Secretary shall notify
the manufacturer of the drug of--
`(ii) the Secretary's
duty to collaborate to improve continuity of supply plans under paragraph (4).
`(B) EVIDENCE-BASED CRITERIA- The Secretary shall implement evidence-based criteria
for identifying drugs that may be vulnerable to a drug shortage. Such criteria
shall be based on--
`(i) the number of manufacturers
of the drug;
`(ii) the sources of raw
material or active pharmaceutical ingredients;
`(iii) the supply chain characteristics, such as production complexities; and
`(iv) the availability of therapeutic alternatives.
`(4) CONTINUITY OF SUPPLY PLANS-
`(A) IN GENERAL-
With respect to drugs that are vulnerable to a drug shortage (as determined under
paragraph (3)), the Secretary shall collaborate with manufacturers and other stakeholders
(such as distributors and health care providers) to establish and improve continuity
of supply plans, so that such plans include a process for addressing drug shortages.
`(B) LIMITATION ON SECRETARY'S AUTHORITY- The Secretary may not in any case require
`(i) to manufacture a drug
in the event of a discontinuance or interruption; or
`(ii) to delay or alter a discontinuance or interruption.
`(C) ALLOCATION BY MANUFACTURER- No provision of Federal law shall be construed
to prohibit a manufacturer from, or penalize a manufacturer for, allocating distribution
of its products in order to manage an actual or potential drug shortage.
`(d) Rulemaking- The Secretary shall carry out this section pursuant to regulations
promulgated after providing notice and an opportunity for comment.'.
(b) Applicability; Transitional Period- Section 506C of the Federal Food, Drug,
and Cosmetic Act, as amended by subsection (a), applies with respect to discontinuances,
interruptions, and drug shortages (as such terms are used in such section 506C)
that occur on or after the day that is 1 year after the date of the enactment
of this Act. Until such day, the provisions of section 506C of the Federal Food,
Drug, and Cosmetic Act, as in effect on the day before the enactment of this Act,
shall continue to apply.
SEC. 3. REPORTS TO CONGRESS.
The Secretary of Health and Human Services shall submit to the Congress--
(1) not later than the date that is 1 year after the date of the enactment of
this Act, a report describing the actions taken by the Secretary during the previous
1-year period to address drug shortages (as defined in section 506C of the Federal
Food, Drug, and Cosmetic Act, as amended by section 2) through all aspects of
the prescription drug supply chain; and
(2) every 5 years
thereafter, a report describing such actions taken by the Secretary during the
previous 5-year period.
SEC. 4. GAO STUDY.
(a) Study- The Comptroller General of the United States shall conduct a study--
(1) to examine how the Food and Drug Administration identifies and responds to
drug shortages (as defined in section 506C of the Federal Food, Drug, and Cosmetic
Act, as amended by section 2);
(2) to examine the possible
causes of such drug shortages, including manufacturing problems, breakdown in
the supply chain delivery system, changes in the supply of raw materials, stockpiling
at the wholesale or provider level, and restrictive regulatory requirements;
(3) to identify if there is adequate communication between industry, the Food
and Drug Administration, distributors, and end users;
(4) to analyze the effects of the enactment of this Act on the ability of the
Food and Drug Administration to identify and ameliorate such drug shortages; and
(5) to identify any additional measures that need to be taken to prevent or address
such drug shortages.
(b) Report- Not later than 1 year after
the date of the enactment of this Act, the Comptroller General shall submit a
report to the Congress on the results of the study under subsection (a).