The following are excerpts, highlighted in red, from the final legislation and/or conference report which contain references to and studies for The National Academies. (Pound signs [##] between passages denote the deletion of unrelated text.)
HR3580 Dingell (D-Mich.) 09/20/07
Enrolled (finally passed both houses)
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.
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SEC. 2. TABLE OF CONTENTS.
SUBTITLE B—OTHER PROVISIONS TO ENSURE DRUG SAFETY AND SURVEILLANCE
Sec. 911. Clinical trial guidance for antibiotic drugs.
Sec. 912. Prohibition against food to which drugs or biological products have been added.
Sec. 913. Assuring pharmaceutical safety.
Sec. 914. Citizen petitions and petitions for stay of agency action.
Sec. 915. Postmarket drug safety information for patients and providers.
Sec. 916. Action package for approval.
Sec. 917. Risk communication.
Sec. 918. Referral to advisory committee.
Sec. 919. Response to the institute of medicine.
Sec. 920. Database for authorized generic drugs.
Sec. 921. Adverse drug reaction reports and postmarket safety.
SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQUITY ACT.
(a) In General.—Section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) is amended to read as follows:
“SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL PRODUCTS.
“(l) Institute of Medicine Study.—
“(1) IN GENERAL.—Not later than three years after the date of the enactment of the Pediatric Research Equity Act of 2007, the Secretary shall contract with the Institute of Medicine to conduct a study and report to Congress regarding the pediatric studies conducted pursuant to this section or precursor regulations since 1997 and labeling changes made as a result of such studies.
“(2) CONTENT OF STUDY.—The study under paragraph (1) shall review and assess the use of extrapolation for pediatric subpopulations, the use of alternative endpoints for pediatric populations, neonatal assessment tools, the number and type of pediatric adverse events, and ethical issues in pediatric clinical trials.
“(3) REPRESENTATIVE SAMPLE.—The Institute of Medicine may devise an appropriate mechanism to review a representative sample of studies conducted pursuant to this section from each review division within the Center for Drug Evaluation and Research in order to make the requested assessment.
SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN ACT.
(a) Pediatric Studies of Drugs.—
(1) IN GENERAL.—Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended to read as follows:
“SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
“(p) Institute of Medicine Study.—Not later than 3 years after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the Secretary shall enter into a contract with the Institute of Medicine to conduct a study and report to Congress regarding the written requests made and the studies conducted pursuant to this section. The Institute of Medicine may devise an appropriate mechanism to review a representative sample of requests made and studies conducted pursuant to this section in order to conduct such study. Such study shall—
“(1) review such representative written requests issued by the Secretary since 1997 under subsections (b) and (c);
“(2) review and assess such representative pediatric studies conducted under subsections (b) and (c) since 1997 and labeling changes made as a result of such studies;
“(3) review the use of extrapolation for pediatric subpopulations, the use of alternative endpoints for pediatric populations, neonatal assessment tools, and ethical issues in pediatric clinical trials;
“(4) review and assess the pediatric studies of biological products as required under subsections (a) and (b) of section 505B; and
“(5) make recommendations regarding appropriate incentives for encouraging pediatric studies of biologics.
SEC. 601. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION.
(a) In General.—Chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end the following:
“SUBCHAPTER I—REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION
“SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION.
“(a) In General.—A nonprofit corporation to be known as the Reagan-Udall Foundation for the Food and Drug Administration (referred to in this subchapter as the ‘Foundation’) shall be established in accordance with this section. The Foundation shall be headed by an Executive Director, appointed by the members of the Board of Directors under subsection (e). The Foundation shall not be an agency or instrumentality of the United States Government.
“(C) APPOINTED MEMBERS.—
“(i) IN GENERAL.—The ex officio members of the Board under subparagraph (B) shall, by majority vote, appoint to the Board 14 individuals, of which 9 shall be from a list of candidates to be provided by the National Academy of Sciences and 5 shall be from lists of candidates provided by patient and consumer advocacy groups, professional scientific and medical societies, and industry trade organizations. Of such appointed members—
“(I) 4 shall be representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries;
“(II) 3 shall be representatives of academic research organizations;
“(III) 2 shall be representatives of patient or consumer advocacy organizations;
“(IV) 1 shall be a representative of health care providers; and
“(V) 4 shall be at-large members with expertise or experience relevant to the purpose of the Foundation.
“(I) EXPERTISE.—The ex officio members shall ensure the Board membership includes individuals with expertise in areas including the sciences of developing, manufacturing, and evaluating the safety and effectiveness of devices, including diagnostics, biologics, and drugs, and the safety of food, food ingredients, and cosmetics.
“(II) FEDERAL EMPLOYEES.—No employee of the Federal Government shall be appointed as a member of the Board under this subparagraph or under paragraph (3)(B).