Drugs

User Fee Reauthorization Agreement Reached in Senate

Senate Health, Education, Labor and Pensions Committee leaders have reached a compromise to reauthorize FDA’s user fee programs for an additional five years. The reauthorization package, which is “practically clean” with few policy riders, will likely be attached to a continuing resolution that Congress is expected to take up next week, according to Roll Call. The user fee programs are set to expire 9/30 without the reauthorization, but FDA leaders said carryover balances could sustain the programs for several weeks thereafter if need be.

Committee ranking member Richard M. Burr (R-N.C) said one of his offers to chairwoman Patty Murray (D-WA) had been accepted, but he did not offer additional details on what policy riders were to be included, Roll Call reported. “I think one would call this practically clean,” he said, and a Murray aide described the measure in the same detail: “Sen. Murray has reached a deal on a practically clean reauthorization that ensures congressional inaction won’t force FDA to send out pink slips along with some additional policies. But even after we have addressed this immediate challenge before the looming deadline, she believes we can’t, and she won’t, stop pushing for the kind of reforms families need to see from the drug industry and this critical agency.”

While the House has already passed its version of the bill months back, Energy and Commerce Committee chairman Frank Pallone Jr. (D-NJ) would not confirm whether lawmakers have agreed to the deal, according to Roll Call. “Congressional leaders are still haggling over the stopgap spending bill that will serve as a vehicle for the user fee package,” it reported. “Republican leadership has been angling for a clean reauthorization in addition to a clean spending bill. The text is expected to eschew most of the varied policy riders that passed out of the Energy and Commerce and HELP committees. Those include overhauls of the diagnostic, dietary and cosmetic industries as well as provisions on medical device cybersecurity, diversity in clinical trials, regulation of infant formula and oversight of FDA accelerated drug approvals.”

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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