110th Congress

The Food and Drug Administration Amendments Act of 2007

P.L. 110‑85 (H.R. 3580)

Impact of Public Law

P.L. 110‑85 primarily affects authorities of the Food and Drug Administration (FDA).  It contains provisions to revise and extend the FDA user‑fee programs for prescription drugs and medical devices and provisions to enhance the post‑market authorities of FDA with respect to drug safety.  The Act also contains several provisions of interest to the National Institutes of Health (NIH), including the following:

• Title III is aimed at enhancing research regarding pediatric medical devices.  It requires NIH to identify a point of contact to help innovators and physicians identify sources of funding for the development of such devices.  Title III also requires the Secretary of Health and Human Services, acting through FDA and NIH, to create a research plan to expand research on pediatric medical devices.
• Title V contains a reauthorization of the Best Pharmaceuticals Act, a bill originally passed in 2002 (P.L. 107‑109) aimed at expanding research regarding drugs and other therapies that are used in pediatric populations.  The Act, as amended, requires NIH to develop a list of those areas of medicine that require additional testing involving children.  Under the Act, NIH also conducts pediatric studies in cases in which a drug is no longer under patent or the manufacturer of a patented drug has declined to conduct a requested study and other funds are not available.
• Title VIII requires the expansion of ClinicalTrials.gov, a Web based data bank operated by the National Library of Medicine that informs the public about the conditions and interventions being investigated in clinical trials and provides the location of trial sites and contact information. Much of the impetus for this legislation can be traced to ongoing public interest in the transparency of information concerning clinical trials. As expanded by the Act, ClinicalTrials.gov will include information on a broader scope of trials and will ultimately include certain information regarding the results of those trials. Title VIII imposes stiff penalties, including civil monetary penalties, for failure to comply with its provisions.

Legislative History

P.L. 110‑85 represents a compromise regarding several legislative measures introduced during the 110th Congress that were aimed at enhancing FDA’s authorities regarding drug safety.  Because both the drug and medical device user-fee statutes required reauthorization before October 1, 2007, there was pressure on Congress to complete action on a comprehensive drug safety package.

S. 484, the Enhancing Drug Safety and Innovation Act of 2007, was introduced by Senator Michael B. Enzi (R‑WY) on February 1, 2007, and was referred to the Senate Committee on Health, Education, Labor and Pensions (HELP).  On March 14, the Committee held a hearing on the bill.  No further action has occurred on this legislation.

H.R. 1561, the Enhancing Drug Safety and Innovation Act of 2007, was introduced by Representative Henry A. Waxman (D‑CA) on March 19, 2007, and was referred to the House Committee on Energy and Commerce.  No further action has occurred on this legislation.
S. 1082, the Food and Drug Administration Revitalization Act, was introduced by Senator Edward M. Kennedy (D‑MA) on April 10, 2007, and was referred to the Senate HELP Committee.  On April 18, the Committee reported out S. 1082 favorably with an amendment in the nature of a substitute.  The bill, as amended, was passed by the Senate on May 9 by a vote of 93 to 1.  No further action has occurred on this legislation.

H.R. 2900, the Food and Drug Administration Amendments Act of 2007, was introduced by Representative John D. Dingell (D‑MI) on June 28, 2007, and was referred to the House Committee on Energy and Commerce.  On July 11, the bill was reported out favorably by the House Committee on Energy and Commerce.  H.R. 2900 was passed by the House under suspension of the rules on the same day by a vote of 403 to 16.  No further action has occurred on this legislation.

H.R. 3580, the Food and Drug Administration Amendments Act of 2007, was introduced by Representative Dingell on September 19, 2007, and was referred to the House Committee on Energy and Commerce.  On the same day, the bill was passed by the House under suspension of the rules by a vote of 405 to 7.  The bill represents the conference agreement for S. 1082, which was passed by the Senate on May 9, and H.R. 2900, which was passed by the House on July 11.  On September 20, H.R. 3580 was passed by the Senate by unanimous consent.  On September 27, President Bush signed H.R. 3580 into law as P.L. 110‑85.

May 2008