Reps. John Dingell (D-MI), Frank Pallone (D-NJ) and Bart Stupak (D-MI), have introduced the “Food and Drug Import Safety Act of 2007” (HR 3610), which they say will dramatically improve the nation’s system for ensuring the safety of imported food and drugs.
To help it implement new FDA reform legislation signed into law in September, the Bush administration has shaken up the leadership of the agency’s drug center, whose flounderings over product safety more than anything else provoked passage of the FDA Amendments Act.
The FDA’s formal public examination of a third class of drugs for the US, between Rx and OTC, sets the stage for a bruising battle between an industry that has always fought the concept and the pharmacy profession which has yearned for it as a professional enhancement long established elsewhere.
Supplemental NDA for stronger version of Advair deemed “not approvable”
A GlaxoSmithKline supplemental NDA for a stronger version of asthma drug Advair Diskus for use in treating patients with chronic obstructive pulmonary disease, recommended for approval by an FDA advisory committee, has been deemed “not approvable” in another apparent show of agency independence from its outside panels.
The FDA reports that Bristol-Myers Squibb has revised hepatitis B therapy Baraclude’s boxed warning labeling to caution against its use in HIV/hepatitis B virus co-infected patients who are not also receiving highly active antiretroviral therapy due to the potential for developing HIV resistance.
File card for Exelon makes unsubstantiated superiority claims
The FDA says a professional journal ad for Pfizer’s antipsychotic medication Geodon (ziprasidone mesylate) for injection omits important risk info and contains unsubstantiated superiority claims.
A 10-year review of DTC advertising by researchers from three major universities suggests that oversight of advertising by the FDA’s DDMAC has declined dramatically.
Abbott employees have edited over 1,000 online Wikipedia entries involving some of the company’s drug products in an attempt to change or remove unfavorable safety information, according to a patient advocacy group.
The Washington, DC Court of Appeals has ruled in the FDA’s favor that terminally ill patients have no “fundamental right ‘deeply rooted in this nation’s history and tradition'” to have access to experimental drugs.