Drugs

House Bill Includes New FDA Responsibilities

A Democratic-introduced bill this week contains several provisions affecting FDA that, even though the bill is expected to stall, are likely to be under consideration in the next coronavirus package with which the House and Senate come to terms, according to the Alliance for a Stronger FDA. The Trump administration dismissed the legislation and signaled it “dead on arrival,” adding that Republicans will be coordinating the next coronavirus relief package. Writing in a 5/15 commentary, Alliance deputy executive director Steven Grossman says the “Health and Economic Recovery Omnibus Emergency Solutions Act,” (text here; summary here) highlighted five provisions in the measure that could be added to other pieces of legislation having a better chance of passing.

National Centers of Excellence in Continuous Pharmaceutical Manufacturing (pages 464 to 476 of the bill text): FDA would be directed to designate National Centers of Excellence in Continuous Pharmaceutical Manufacturing (NCEs). The NCEs will aim to craft a national framework for implementing continuous manufacturing of drugs, which would include supporting additional research and development of the technology, workforce development, standardization, and collaborating with manufacturers to support its adoption.
GAO Report on Diagnostic Tests (pages 499 to 502 of the bill text). The section requires a GAO report on the responses by laboratories, diagnostic test manufacturers, state, local, tribal, and territorial governments, and relevant federal agencies, on Covid-19 test development, regulatory evaluation, and deployment.
Research and Development (pages 533 to 535 of the bill text). The section requires FDA, CDC, and other agencies to support research and development on efficient and effective testing, contact tracing, and surveillance strategies.
Federal Modernization for Health Inequities Data (pages 558 to 559 of the bill text). The section authorizes funding for FDA and other agencies to modernize their data collection methods and infrastructure in order to increase data collection related to health inequities.
COVID-19 Emergency Medical Supplies Enhancement (pages 906 to 934 of the bill text). The section would expand the use and oversight of Defense Production Act authorities to: increase the production and supply of critical medical supplies and equipment, such as diagnostic tests and personal protection equipment; focus efforts on supply chain mobilization; decrease the disruption of critical deliveries to state and local governments; and require assessments for both immediate and longer term needs and plans to meet those needs, as well as requiring longer-term planning to ensure that the U.S. is better prepared for future emegencies.

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