Drug makers, beware: FDA is watching

WHAT IT MEANS AND WHY IT'S IMPORTANT Drug companies had better take a close look at their portfolios and make sure they aren’t marketing unapproved drugs. Any excuses they might have for making prescription drugs without regulatory approval will go unheeded by Food and Drug Administration officials.

(THE NEWS: FDA shuts down unapproved Glenmark, Konec drugs. For the full story, click here)

It seems simple enough, but a number of drugs on the market today entered the market long before the FDA adopted its current drug regulations, meaning that despite being commonly prescribed, they’re technically illegal.

The FDA started the unapproved drugs initiative in 2006 to bring these so-called “grandfathered” drugs into compliance with current policies. Most recently, it sent warning letters to Glenmark Generics and Konec to stop marketing nitroglycerine tablets. Last April, it warned nine companies to stop manufacturing unapproved narcotic drugs, including Boehringer Ingelheim, which had been marketing unapproved morphine and oxycodone products since 1983.

In the short term, the FDA’s actions don’t usually lead to shortages. The agency said Pfizer made nitroglycerin tablets in the same strengths as Glenmark and Konec, and the two companies would be given three months to stop manufacturing the tablets and six months to stop shipping them, rather than having to pull drugs from pharmacy shelves. In the cases when shortages do happen, the FDA has been known to temporarily suspend its warnings to drug makers; anticipating a shortage after its action against the nine companies last year, the FDA allowed the continued marketing and distribution of high-concentrate morphine sulfate oral solution on an interim basis.

And regardless, drug makers can still get approval: In January, the FDA approved Roxane’s morphine sulfate oral solution.

“An important goal of the unapproved drugs initiative is to make sure that marketed drugs meet current FDA standards,” FDA Center for Drug Evaluation and Research deputy director Douglas Throckmorton said at the time. “Our action today reflects a careful balance between ensuring patient access to necessary medicines, while making sure companies comply with the law.”


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