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A health advocacy group is demanding that the FDA remove three members of its Psychopharmacologic Advisory Committee who had done research, consulting and other work for manufacturers of antidepressant drugs, even though the committee recently urged the agency to issue stronger warnings about increased suicide risk among children taking those drugs.
The FDA has shut down four websites it claims sold bogus transdermal contraceptive patches containing no active ingredients, as part of its ongoing enforcement efforts against drug counterfeiters, the agency said Thursday.
Drugmakers' anticounterfeiting efforts may be strengthened by new guidelines issued by the Health Industry Group Purchasing Association (HIGPA), a trade group representing 175 healthcare purchasing and supply chain organizations.
Faced with a barrage of international news stories, Aventis said last week it would 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 the company contends there is no clear evidence the drug caused the fatalities.
The FDA last week ramped up its efforts to convince U.S. cities that importing drugs from Canada is a bad idea, releasing details of a second import blitz showing that the only thing Canadian about many of the drugs seized was the postmark on the packages in which they were to be delivered.
The FDA hopes to release details today about a second import blitz that occurred in November 2003, following up on a report of a similar joint FDA/U.S. Customs and Border Protection enforcement effort conducted three months earlier, according to a top FDA official.
Even though HHS has stated that the Medicare Rx drug law does not give the secretary the power to approve pilot plans sponsored by state and local governments, and the FDA has repeatedly opposed the reimportation of prescription drugs, the agency continues to meet with state and local officials to clear up confusion over the practice.
The House Energy and Commerce Committee continued to expand its investigation into pharma distribution issues earlier in the month, concerned that the FDA is not being informed of adverse events relating to patients who get their Rx drugs online.
The House Energy and Commerce Committee continued to expand its investigation into pharma distribution issues late last week by asking a physician allegedly involved in writing internet prescriptions for information on his adverse event reporting procedures.
Although the FDA is opposed to the reimportation of prescription drugs and despite announcements from HHS that the Medicare Rx law does not give the secretary the power to approve pilot plans sponsored by municipal governments, the agency continues to meet with state and local officials to clear confusion over the practice.