Health - Drug Safety

H.R. 1561
The Enhancing Drug Safety and Innovation Act of 2007

On March 19, 2007, Rep. Waxman (D-CA) joined Rep. Edward J. Markey (D-MA) to introduce H.R. 1561, The Enhancing Drug Safety and Innovation Act of 2007. H.R. 1561 is the House counterpart to the Enzi-Kennedy drug safety bill (S. 484).

S. 484 contains many important provisions that will: (1) strengthen FDA’s post-market drug safety system; (2) establish the Reagan-Udall Institute for Applied Biomedical Research, a new public-private partnership to advance FDA’s Critical Path Initiative; (3) establish mandatory clinical trials registry and results databases; and (4) reform procedures to manage conflicts of interest on FDA’s advisory Committees. H.R. 1561 builds upon those provisions to further increase FDA’s post-market drug safety authority, provide greater FDA transparency, and enhance the mandatory clinical trial registry and results databases. Specifically, H.R. 1561 will:

• Give the FDA enhanced tools to ensure post-market drug safety through the “Risk Evaluation and Mitigation Strategy” (REMS) process, including: (1) increasing the possible moratorium on direct-to-consumer advertising from two years to three years; (2) adopting the IOM recommendation that the FDA place a symbol on the packaging of a product to let consumers know that the drug is new to the marketplace; and (3) requiring a review of drug products after they have been on the market for 7 years (the average time it takes to detect most side effects);
• Increase the transparency of the REMS review process;
• Enhance FDA’s enforcement authority by giving the FDA the ability to impose civil monetary penalties if drug companies fail to comply with any requirements relating to drugs in the Federal Food, Drug, and Cosmetic Act and increasing the amount of those civil penalties;
• Provide for a balance between funding from user fees and federal dollars in FDA’s drug safety budget by authorizing $25 million for each of fiscal years 2008 through 2012 in addition to other funds available for carrying out Title I activities;
• Require the FDA to report to Congress on its efforts to integrate the expertise of the Office of Surveillance and Epidemiology (formerly Office of Drug Safety) into the Agency’s approval, labeling, and post-approval safety decisions; and
• Strengthen the clinical trials registry and results databases to include more information on more trials (including medical devices), and give the Secretary the added ability to impose civil monetary penalties for non-compliance.
  

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