Drugs

Senate Passes User Fee Reauthorization Bill

The Senate has voted 94-1 vote to pass an FDA user fee reauthorization bill to fund agency product reviews and related activities for the next five years. Senator Bernie Sanders (I-VT) was the lone vote against the measure. The House passed a similar bill earlier this summer.

“The Senate has sent to the president’s desk legislation that will speed cures and treatments into patients’ medicine cabinets,” Senate Health, Labor, Education and Pensions Committee chair Lamar Alexander (R-TN) said after the vote. “The first step was last year's passage of 21st Century Cures to spur medical research, and this is the next step — ensuring patients see the benefits of those research advancements.”

Pharmaceutical Research and Manufacturers of America (PhRMA) president and CEO Stephen J. Ubl had this to say: “PhRMA applauds the Senate for passage of the Prescription Drug, Biosimilar and Generic Drug User Fee Acts. PDUFA VI better incorporates real-world evidence and patient perspectives into the drug development and approval process, while also providing the U.S. Food and Drug Administration (FDA) with new tools and resources to keep up with the latest scientific advances. By strengthening the FDA and improving efficiency in the drug review process, we can bring safe, innovative medicines to patients faster, which will enhance competition and lower costs. This is a major victory for medical innovation, the FDA and patients.”

Meanwhile, public advocacy group Public Citizen applauded lawmakers for rejecting an amendment that could have had a negative impact on certain drug prices. “The pharmaceutical industry had lobbied the U.S. Senate to include the pharma-backed Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2017 (OPEN) in its approval, which would have extended marketing exclusivities on all uses of medications that have been approved in part to treat rare diseases,” the group said. “A Public Citizen report found that the OPEN Act could cost taxpayers and consumers up to $11.6 billion over 10 years.”

Public Citizen said that the vote may “become a turning point in the fight for affordable medicine for all... The next step is to pass meaningful prescription price reform, such as the Affordable Meds Act (S. 771) and the Stop Price Gouging Act (S. 1369).”

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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