Senate push for post-marketing
Senator Charles Grassley, a Republican of Iowa, and Senator Christopher Dodd, a Democrat from Connecticut, on April 27 joined in introducing a bill that would establish an independent center within the Food and Drug Administration (FDA) to focus on formal post-market reviews of drugs and biological products. The bill includes provisions empowering the agency to require manufacturers to conduct post-market safety studies and spelling out several corrective measures, including label changes, restricting product distribution, or even withdrawing a product's license in cases where agency officials conclude that a licensed product poses an “unreasonable risk.” In addition, the “Food and Drug Administration Safety Act of 2005 (FDASA)” would strengthen FDA in its ability to review advertising materials for new products or those under renewed scrutiny, add authority for new civil penalties, and authorize $500 million over 5 years to support these new safety efforts. Last February, Health and Human Services secretary Mike Leavitt and acting FDA Commissioner Lester Crawford announced plans to create a “Drug Safety Oversight Board” at FDA. Despite overlapping intent between these two approaches to enhancing product safety, the agency actions focus more on disseminating available information about product safety as it becomes available, whereas the FDASA would substantially broaden agency authority in this arena—for example, enabling officials to insist that new safety studies be conducted. JLF
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