Today’s (9/17/08) news headlines include reporting on FDA’s ban on the import of more than 30 generic drugs made by Ranbaxy at two manufacturing sites in India. The ban is based on FDA’s adverse inspection findings (the notorious Inspectional Observations (FDA-483 form)) at Ranbaxy’s Dewas and Sahib facilities..
FDA has a wide degree of power to exclude products from interstate commerce. However, it takes great care not to disrupt the supply of important medicines. In this case, FDA took major steps to assure the US public that the banned drugs currently in the US are safe and that the public should continue taking them. FDA created a web site to deal with this matter.
All of the banned drugs except one are multi-source, meaning that there are other suppliers of the generics. The exception is ganciclovir sodium (the active ingredient in an antiviral medication that treats retinitis, the inflammation of the retina in the eye). FDA is allowing this drug to continue to be imported under increased oversight.
Ranbaxy is engaged in a continuing criminal investigation of whether Ranbaxy submitted fraudulent data to the FDA. Apparently, it was surprised by the FDA action. In its press release, Ranbaxy stated “the company has just received the warning letters that FDA has issued and has not had the opportunity to review those concerns that FDA has determined are unresolved.” Those in our industry know that these matters are not a surprise.