Look for more Avandias. Regardless of the anti-diabetes drug’s medical merits, the recent furor surely opens an era of politico-medical soap operas that will ensnare other drugs.
The Purdue Frederick Co. and three of its officers entered a plea agreement with the FDA in which the company agreed to pay more than $600 million to resolve criminal charges and civil liabilities over illegal promotion of OxyContin between its 1995 approval and 2001.
While acknowledging improvements in the guidance they get from the FDA, the nation’s pharmaceutical, biotechnology, and medical device companies still want faster turnaround times and other improvements.
The FDA’s own little “Avandiagate,” complete with Nixonian “dirty tricks,” emerged in May’s mass media coverage of the editorial decision at the New England Journal of Medicine to rush online publication of preliminary safety data on this GlaxoSmithKline diabetes top-seller.
Family Research Council file suit to overturn Plan B decision
The Family Research Council and a coalition of medical and women’s groups have filed suit to overturn the FDA’s decision to approve Plan B for OTC sales. They say the FDA lacked authority to approve the application and did so in response to political pressure.
The FDA’s DDMAC says a retail sell sheet and sales aid for Alcon Laboratories’ Ciprodex omits material facts about the drug, including some risk information and limits to its indication.
BMS and Sanofi-Aventis issued civil investigative demands
The FTC has issued civil investigative demands, which act like subpoenas, to Bristol-Myers Squibb and Sanofi-Aventis for documents relating to efforts to delay Apotex and other competition for Plavix (clopidogrel bisulfate).
Prosecutors allege Wheat discussed handgun silencers with defendants
Federal prosecutors allege that Jared Wheat, Hi-Tech Pharmaceuticals’ founder and CEO, discussed with other defendants obtaining a handgun silencer to be used to “attack” an FDA criminal investigator. They were indicted last year on felony charges relating to a scheme to sell adulterated and unapproved new drugs over the Internet.
The FDA was petitioned to approve OTC switches for Allegra (fexofenadine), Allegra D 12-hour and 24-hour (fexofenadine with pseudophedrine), and Zyrtec (cetirizine) and Zyrtec D (cetirizine with pseudophedrine).
The FDA needs more resources and not more authority to help it manage drug safety, and if it gets the new authority that some legislative proposals are calling for, there could be “adverse impacts,” according to former FDA chief counsel Dan Troy, now a partner at Sidley Austin.