Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Pilot Program Designed To Increase Transparency Around Drug Rejection Letters
The Washington Post: FDA To Release More Clinical Trial Information For Newly Approved Drugs
The Food and Drug Administration is taking steps to make it easier for doctors, patients and researchers to get access to clinical trial data amassed during the process of approving new drugs, Commissioner Scott Gottlieb said Tuesday. Gottlieb announced the actions just before a speech on FDA transparency at a Washington forum. The meeting, attended by researchers and academics, focused on 18 recommendations for making the agency's decision-making less opaque. The suggestions were part of a report called Blueprint for Transparency. (McGinley, 1/16)
Stat: Gottlieb Changes Course On FDA Publication Of Rejection Letters
Before Scott Gottlieb was in charge of the Food and Drug Administration, he called on the agency to publicly release its rejection letters to drug manufacturers. But now as commissioner, he is stopping short of actually making that change. “Releasing all the [complete response letters] would be administratively challenging, given the likelihood we would continue to redact certain proprietary information from these letters,” Gottlieb said Tuesday morning. He said that the agency is “evaluating whether there is a subset of complete response letters where there are especially important public health reasons to redact and release these letters.” (Swetlitz, 1/16)
The Hill: Pentagon, FDA To Speed Up Approval For Battlefield Medical Products
The Defense Department and the Food and Drug Administration (FDA) announced on Tuesday new steps aimed at expediting the approval of medical devices and drugs for use on the battlefield. The plan is being carried out in line with a law passed last year in the wake of a controversy over whether the Pentagon should be allowed to approve products for battlefield use. (Kheel, 1/16)
CQ: FDA And Pentagon Issue Plans For Battlefield Medical Products
Under the agencies’ work plan, officials will meet at least quarterly to discuss the Pentagon’s priorities for medical product development. Products that are considered a priority will get a faster approval similar to the FDA’s breakthrough designation, which means a review that takes closer to six months than the normal 10 months, as well as more frequent meetings and communications between FDA officials and the product’s developers. The FDA is also promising to offer advice on clinical development and product manufacturing. (Siddons, 1/16)
