Whether making or taking prescription heart drugs, don’t forget that FDA’s permission is needed


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You could be forgiven for thinking that there is no illegal activity taking place in the following scenario: You go to your physician with, say, chest pain; she diagnoses angina and writes you a prescription for nitroglycerin tablets; you go to your local pharmacy and fill your prescription, secure in the belief that the prescription medication you rely on for your heart condition is being produced with the blessing and oversight of the federal agency that regulates drug makers.

It’s that last step where an occasional--and potentially illegal--corner can get cut, as an FDA announcement released Tuesday reveals.


The FDA on Tuesday gave two generic drugmakers--Glenmark Generics of Mahwah, N.J., and Konec Inc. of Tucson -- 90 days to stop making and selling nitroglycerin tablets for use by heart patients and 180 days to stop shipping those they have made. In doing so, the agency made a point of reminding doctors and patients of something that may still surprise them: that ‘not all drugs on the market are backed by an FDA approval.’

The nitroglycerin tablets being made and marketed supposedly without FDA approval are only the latest to be highlighted as part of the FDA’s ‘Unapproved Drug Initiative.’ In the last 18 months, the FDA has exposed dozens of prescription-drug manufacturers--some of them household names--for failing to seek the agency’s permission (and submit the necessary paperwork to ensure their production standards and proposed formulations could pass muster) before they started punching out prescription medications. Most of these companies do large-scale business with pharmacies and pharmacy distributors, prompting little question about their credentials.

And we’re not just talking about aspirin here. Some of the companies nabbed by the FDA’s initiative have been making and distributing morphine, oxycodon, a migraine medicine called ergotamine that narrows the blood vessels in the brain, and colchicine, an allergy medicine. Here‘s a list of the drugs and companies the FDA has found so far.

-- Melissa Healy