We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Financial conflicts of interest are common in FDA drug advisory committee meetings, a report by a frequent critic of the FDA says,
necessitating a more aggressive effort to change this process. 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
The U.S. FDA's Center for Devices and Radiological Health (CDRH) should add new "cross-cutting collaborative groups" to its structure to help the agency deal with the total product life cycles of the devices it regulates, an advisory team has recommended. Read More
The FDA sent warning letters to five firms for compounding topical anesthetic creams, but the firms say their manufacturing practices are beyond the FDA’s jurisdiction. Read More
Outgoing Senate Majority Leader Bill Frist’s (R-Tenn.) last-minute effort to push through the Bush administration’s nominee to be the FDA commissioner could set a precedent that hampers congressional oversight throughout the next session, a congressional source says. Read More
The FDA is supporting a user fee program for direct-to-consumer (DTC) advertising, where companies are only required to pay when they have ads up for review, a high-ranking agency official told DID. Read More
Antidepressant use appears to raise the risk of suicidal thoughts and behavior for adults aged 18–30, but may lower it in adults over 30, according to an FDA staff briefing document. Read More
Lawmakers should not interfere with the current off-label prescribing system because doing so would limit patients’ access to the most innovative treatments, a high-ranking FDA official says. Read More