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The FDA has sent Congress its final recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA),
including an increase in user fees to pay for drug safety reviews, as well as reviews of direct-to-consumer (DTC) advertising.
Sen. Chuck Grassley (R-Iowa) is asking FDA Commissioner Andrew von Eschenbach to account for the agency’s delays in taking action on updating acetaminophen product labeling to reflect safety issues.
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.
The FDA has sent Congress its final recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA), including an increase in user fees to pay for drug safety reviews as well as reviews of direct-to-consumer (DTC) advertising.
Sen. Chris Dodd (D-Conn.) reintroduced a bill to improve incentives for developing pediatric medical devices so children are not left with "one-size-fits-all" products, his office announced last week.
A bipartisan group of lawmakers is using a recent government report to pressure the Bush administration to increase funding for FDA oversight of direct-to-consumer (DTC) drug advertising and to institute a moratorium on ads for newly approved products.
The Democrats’ takeover of both houses of Congress will result in increased attention to the drug industry’s use of direct-to-consumer (DTC) advertising, but may not result in any real changes, industry observers say.
Sen. Chuck Grassley (R-Iowa) said comments from FDA Commissioner Andrew von Eschenbach discourage openness within the agency and raise questions about what problems the agency might be trying to conceal.
Rep. Henry Waxman (D-Calif.), chairman of the House Oversight and Government Reform Committee, last week sent letters to Boston Scientific and Johnson & Johnson (J&J) asking the firms for information on their drug-eluting stents.
Sens. Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) have asked FDA Commissioner Andrew von Eschenbach to respond to an independent review that called the agency’s postmarketing surveillance system “dysfunctional.”