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The FDA is attempting to place itself in the growing debate over the independence of its advisory committee members and head off potential legislative changes with its announcement of a slate of new guidances. Read More
The FDA's decision to grant conflict-of-interest waivers for two-thirds of the voting members of an advisory committee proves that the agency is not following Congress' or the Institute of Medicine's (IOM) directives to minimize such conflicts, sources say. Read More
Conflicts of interest in the drug community have come under increasing scrutiny, with lawmakers, activists and medical journals questioning financial relationships between manufacturers and the individuals who study, review and approve their products. Some have gone as far as saying the FDA's policies favor the drug industry at the expense of patient safety. The agency's advisory committees are particularly under fire, causing some in Congress to call for a total ban on conflict-of-interest waivers. Institutional
review boards also met with controversy over a report that some members approved protocols although they were in possible conflict-of-interest situations. Medical journals have clamped down as well, requiring detailed disclosures by authors and going to great lengths to admit when contributors do not properly reveal ties to the drug industry. Government officials who run afoul of their agencies' conflict-of-interest rules meet with more serious consequences. Federal prosecutors have charged a top NIH scientist with
accepting $285,000 in undisclosed consulting fees and travel expenses from a major drug company. Former FDA commissioner Lester Crawford, who left the agency two months after being confirmed, pled guilty to failing to disclose financial conflicts and making false statements. This issue of The Food & Drug Letter looks at the ongoing debate over conflict-of-interest policies.Read More
A top FDA official said the agency is confident it can get Andrew von Eschenbach confirmed as the FDA commissioner by the end of the week, due to a growing understanding on the Hill of the need for permanent leadership at the agency. Read More
Representing small and mid-sized device and diagnostics firms, the Medical Device Manufacturers Association (MDMA) in 2007 will lobby Congress to support reduced FDA user fees, expand small business provisions for MDMA members, reconsider Medicare gainsharing policies and repeal the Medicare anti-kickback safe harbor for hospital group purchasing organizations (GPOs), its top official said in a recent interview. Read More
Conservative and moderate House Democrats, known as "Blue Dog" Democrats, represent a pivotal voting bloc that will help decide what healthcare legislation makes it through the House and whether the White House and Democratic leadership can reach compromises, former lawmakers and Hill staffers say. Read More
The combination of a closely split Senate, a Republican president and a looming presidential election in 2008 will likely add up to gridlock in Washington, D.C., numerous experts say. Read More
The biotechnology industry is focusing its lobbying efforts in the 110th Congress on ensuring that the FDA has sufficient appropriations and user fees to perform timely reviews of new products, an industry official says. Read More
Presumptive Speaker of the House Rep. Nancy Pelosi (D-Calif.) is promising that the new Democratic leadership will provide the federal government with the authority to directly negotiate with drug companies for lower Medicare costs. Read More