Drugs

Cut GDUFA Fees to Promote Competition: Analysis

Three Harvard University professors and two Zuckerman attorneys who used to work at HHS say FDA should use the GDUFA 3 reauthorization negotiations to “balance the need to ensure sustainability with the goal of providing a level playing field for competition among firms of all sizes.” Writing in Health Affairs, the five say the agency should impose fees on the market segments where they are least likely to discourage supply.

“Evidence suggests that at typical rates of participation found in small generic drug markets (those with an average of 2.5 products), adding a new entrant would reduce generic prices by 5% to 9%,” they write. “Our finding that introduction of GDUFA fees was associated with 20% fewer market entries by small manufacturers suggests that reducing these fees could lead more small firms to enter. This effect would be especially important in markets for injectable products. Therefore, the next step in refining GDUFA should be to redesign the user fee structure so that larger manufacturers pay more and fees for small manufacturers decline.”

The authors say the medical device user fee program provides a good model that could be used to change the GDUFA structure.

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