Does the FDA Have a High Enough Standard for Drug Approvals?

STAT News, September 28, 2016. Is the Food and Drug Administration’s approval process broken? At a HUBweek panel hosted by STAT, experts explored that question in light of the FDA’s decision last week to approve a controversial drug for Duchenne muscular dystrophy, a rare disease.

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Furor Over Drug Prices Puts Patient Advocacy Groups in Bind

The New York Times, September 27, 2016. Public anger over the cost of medical products has burned hot for a year, coursing through social media, popping up on the presidential campaign, and erupting in a series of congressional hearings, including one last week over the rising price of the allergy treatment EpiPen.

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FDA Approves Muscular Dystrophy Drug That Patients Lobbied For

The New York Times, September 19, 2016. The Food and Drug Administration approved the first drug to treat patients with the most common childhood form of muscular dystrophy. The agency’s approval went against the recommendation of FDA experts and the agency’s independent Advisory Committee. “The agency has set a dangerous precedent,” said Diana Zuckerman, president of the National Center for Health Research.

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FDA Grants Accelerated Approval for Sarepta Muscular Dystrophy Drug Eteplirsen

Tech Times, September 20, 2016. The U.S. Food and Drug Administration (FDA) has approved the first drug for treating patients with Duchenne muscular dystrophy. “The agency has set a dangerous precedent,” said National Center for Health Research president Diana Zuckerman. “To prove something works, you have to compare it to something else — a placebo or a treatment. They didn’t do that.”

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