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Did Emflaza’s DMD approval expose cracks at the FDA? Lawmakers want to know | FiercePharma

After lambasting Marathon Pharma for its pricing strategy on a decades-old med recently approved to treat Duchenne muscular dystrophy, Sen. Bernie Sanders and Rep. Elijah Cummings are turning their fire on the FDA.

The congressmen wrote FDA Acting Commissioner Stephen Ostroff to pose some “serious questions” about the agency’s review and approval for Emflaza. They asked whether the agency normally considers 20-year-old efficacy data—as they said the FDA did in this case—and whether any internal concerns about approving the medicine remained.

The Emflaza situation encapsulates several prominent issues in biopharma, including drugmakers’ pricing power, high prices on older meds, and potential problems with the United States’ orphan drug laws. Citing possible “misuse” of the Orphan Drug Act of 1983, Sen. Chuck Grassley recently committed to looking into that topic. For about a year and a half, lawmakers have dug into controversial price hikes throughout the drug industry, investigating moves by Martin Shkreli’s Turing Pharma, Valeant Pharmaceuticals, Mylan and others.

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Did Emflaza’s DMD approval expose cracks at the FDA? Lawmakers want to know | FiercePharma.