FDA Policy/General

Trump Renews Call to Double Industry User Fees

The Trump Administration has renewed its call for Congress to double user fees paid by industry to help with the government’s budgetary activities. In a statement following House passage (see story) of a user fee reauthorization bill (HR 2430), the White House said that to “better support FDA’s lifesaving mission while carefully spending taxpayer dollars, the president’s budget asks companies that benefit directly from FDA’s premarket review of medical products to finance 100% of FDA’s premarket review. In its current form, HR 2430 would require significant investment of taxpayer resources in FDA’s medical product review programs. The Administration urges the Congress to provide for 100% user fee funding within the reauthorized programs. In an era of renewed fiscal restraint, industries that benefit directly from FDA’s work should pay for it.”

The Administration’s statement also said it was concerned with certain other provisions in the bill, “such as those providing additional market exclusivity to manufacturers, which could make exclusivity unpredictable and decrease competition. The Administration is committed to promoting the availability of generics in an efficient and effective manner that avoids unintended, adverse consequences. In addition, there are a number of important technical changes that the Administration seeks to make to the bill, including adjusting the foreign drug facility inspection fee.”

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