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Feds Threaten to Pull ProAmatine for Lack of Postmarket Data (Updated 8/18)

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FDA on Monday announced that it was looking to withdraw approval for the low-blood-pressure treatment midodrine hydrochloride because the companies manufacturing the drug failed to provide data from post-approval studies.

The kicker: The drug was approved 14 years ago.

FDA gave midodrine hydrochloride—branded by Shire as ProAmatine and produced by a half-dozen generics firms—the green light in 1996 as part of the fast-track approval program designed to speed to market drugs for diseases with no current treatments.

The catch is that FDA requires post-market clinical trials to ensure that the drug is meeting risk/benefit endpoints. In other words, the regulatory body wanted to make sure no hiccups occurred with the treatment when it hit the general population.

In response, Shire—who acquired the drug when it bought Roberts Pharma in 1999—chose to withdraw the drug as of September 30. The drug firm made it clear that the withdrawal had nothing to do with any safety concerns. In addition, Shire stated that it had conducted post-market trials in conjunction with Roberts, but FDA felt the results were “inconclusive.”

According to a release by FDA, none of the companies selling the drug have provided any data to prove that the treatment is beneficial. That said, some 100,000 people were treated with the midodrine hydrochloride last year alone.

“We’ve worked continuously with the drug companies to obtain additional data showing the drug’s clinical benefits to patients,” stated Norman Stockbridge, director of the Division of Cardiovascular and Renal Drugs in the FDA’s Center for Drug Evaluation and Research. “Since the companies have not been able to provide evidence to confirm the drug’s benefit, the FDA is pursuing a withdrawal of the product.”

FDA stated that patients currently on midodrine hydrochloride should not stop taking the medication. Shire now has 15 days to respond to FDA’s inquiry and provide some data supporting the drug. Shire did not respond to calls as of Monday afternoon. In addition, it’s unclear as to why FDA waited so long to ask for more data and whether any adverse reactions have been reported pertaining to the drug.

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One Comment

  1. Bill Cooney
    Posted August 19, 2010 at 9:39 am | Permalink

    If the FDA is going to require safety studies on drugs that have passed their patent expiry, it better come up with a new game plan. It’s unreasonable to expect Shire to exclusively underwite additional, expensive safety studies on a drug that’s now provided by several other generic manufacturers. The FDA’s only solution is to pull from the market a drug that appears to be beneficial to 100,000 patients. That would be a stunning disservice and run completely counter to the agency’s mission. The FDA is looking uncaring, ineffectual and petulant, like child who doesn’t like the way the game is going and so says, “It’s my ball and I’m taking it home!”

    There are some strong parallels between this case the the current fiasco surrounding REMS for long-acting opiods. In that case too, the FDA wants to impose expensive new regulatory burdens on a class of drugs that are provided by numerous companies, including many generic maunfacturers. For two years now the FDA has struggled to come up with a solution, and they don’t appear close to resolution for a drug class that the FDA itself has identified as the #1 priority for preventing unnecessary deaths.

    As the FDA expands its regulatory grasp far down into the lifetime of medical products, it had better get its head around a very simple concept: once a drug becomes generic, its “ownership” transitions from private hands to the public domain. So too, the responsibility for assessing and managing the safety of a drug transitions to the public domain. However painful it may be for the FDA, this means the agency or its bethren at NIH will have to live with, and fund, its own sprawling mandates.

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