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When the Democrats took control of Congress following last year’s elections, they promised to increase oversight of the Executive Branch and enforce stricter regulations. This has certainly been the case with the FDA. Members of Congress have become increasingly more involved in questioning the agency and finding ways to strengthen its activities. In the three months since the new congressional leadership was sworn in, committee chairmen have focused on the agency’s drug approval process and what could be influencing it. Both the House and the Senate are considering bills to strengthen the agency’s drug safety efforts. The FDA’s relationship with the pharmaceutical industry has been criticized with some questioning the agency’s reliance on user fees, with former employees testifying that the agency rushed drug approvals to appease companies. The FDA’s policies regarding conflicts of interest in advisory committee members has continued to come under fire, although the agency responded by creating stricter qualifications for serving on the committees. The Democrats are not the only players, as one senior Republican senator and long-term agency critic asked the FDA to explain its delays in updating product labels to reflect safety issues. This issue of The Food & Drug Letter looks at Congress’ efforts to oversee the agency’s activities, and the FDA’s response to the enhanced oversight.