Drugs

FDA Hiring Freeze Lifted; Trump Wants Plan to Cut Costs

President Trump has lifted his January-ordered hiring freeze (see earlier story) affecting FDA and other agencies, and instead he has ordered agencies to take immediate actions to reduce staff and cut costs in line with his recent fiscal year (FY) 2018 Budget Blueprint. An Office of Management and Budget memo also calls for FDA and other agencies to develop individual plans to maximize employee performance by 6/30, and they must submit a reform plan in September as part of the agency’s FY 2019 budget submission that should include long-term workforce reductions.

Lifting the hiring freeze should be welcome news by FDA and its stakeholders. There have been concerns that the hiring freeze could set the agency back as it tries to implement the 21st Century Cures Act and staff additions called for under the user fee reauthorization bills that are moving through Congress.

The FY 2018 budget blueprint, which was released last month, was met with significant resistance (see earlier story) from FDA constituencies over a proposed doubling of FDA user fees on regulated industry’s medical product marketing applications, to about $2 billion annually. Such a jump “replaces the need for new budget authority to cover pre-market review costs,” the budget plan says. “To complement the increase in medical product user fees, the budget includes a package of administrative actions designed to achieve regulatory efficiency and speed the development of safe and effective medical products. In a constrained budget environment, industries that benefit from FDA’s approval can and should pay for their share.”

Congressional hearings on the user fee reauthorization plans have not welcomed any increase in fees above what was negotiated last year by FDA and industry. It remains to be seen how the agency will make expected cuts and which programs could be affected.

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