FDA Policy/General

Gottlieb to Tackle Drug Prices at AEI

Outgoing FDA commissioner Scott Gottlieb, who was a resident fellow at the American Enterprise Institute (AEI) conservative think tank before being named to head FDA, is returning to AEI to focus on drug prices. In an interview with the Washington Post, Gottlieb said he is interested in trying to determine how to pay for innovative treatments, including gene therapies for diseases such as hemophilia and sickle-cell anemia, that will be administered to patients just once and could have lifelong benefits. Some such treatments are likely to cost several hundred thousand dollars or more.

“The question,” Gottlieb said, “is how we spread out these costs. That’s a whole different paradigm.”

He also said he wants to look into “market failures” that keep drug prices high. For example, he said, in some classes of drugs there are not enough products competing to constrain prices. While he acknowledged that some of it is due to innovator companies “gaming” the system to keep generics off the market, he said there also are new data showing it takes longer to bring a second drug in a particular category to market, especially for orphan drugs or those that are underdeveloped due to their limited potential for profitability. As a result, he said, the first drugs to market in such situations are “monopolies in perpetuity.”

Asked about his time at FDA, Gottlieb said he was most gratified by his efforts to change the agency’s perception of its role in big public health challenges, especially the opioid epidemic. He said it is now widely accepted within FDA that part of the agency’s mission is to try to decrease the rate of new addictions and to look at the potential for illicit use when considering new drugs.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome