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A top-ranking House Democrat has accused the FDA of failing to enforce laws barring false and misleading advertising and demanded an explanation from agency Commissioner Mark McClellan.
Aventis will file a report with the FDA about the deaths of five Japanese patients participating in a postmarketing study of its rheumatoid arthritis drug Arava, although there is no clear evidence the drug caused the fatalities, Aventis told DID yesterday.
The Medicare prescription drug benefit enacted in December 2003 could increase government scrutiny of pharmaceutical sample distribution — especially if physicians start dispensing Rx drugs from their offices for home use and essentially act as pharmacies — according to an expert on healthcare fraud enforcement.
Despite a statement from four prominent medical associations warning about the risk of adverse side effects of some antipsychotics, Pfizer continues to resist FDA-requested labeling changes for its Geodon (ziprasidone HCl) product.
The position of industry representative on the Center for Drug Evaluation and Research’s (CDER’s) various advisory committees will soon become a permanent, albeit nonvoting, position in the coming year according to Igor Cerny, acting director of CDER’s advisory committee group.
The Center for Drug Evaluation and Research (CDER) approved 72 new drug applications (NDAs) during calendar year 2003, but less than 10 percent of those required convening an advisory panel meeting to mediate problems between the agency and the sponsor about data presented or other controversial issues.
FDA's Center for Drug Evaluation and Research (CDER) brought its advisory committees together on 44 occasions during 2003 for one- to two-day meetings to cover a wide range of topics including 33 specific drug products; and with the release of its scheduled advisory committee meetings for 2004, the center shows no sign of slowing down, tentatively scheduling more than 40 meetings for the current year (see sidebar).
While the majority of new drug applications never see the light of an FDA advisory committee, those that do certainly get their share of publicity and public scrutiny -- factors the agency's senior official in charge of advisory committees welcomes when the agency is faced with approving a controversial new drug.