FDA Policy/General

Collins Presses for Faster Generic Competition at Hearing

U.S. Sen. Susan Collins (R-ME) used a Senate hearing 4/16 to spotlight barriers to lower-cost drugs, pressing an expert witness on delays in bringing generics and biosimilars to market and promoting her own legislative proposals aimed at reducing prices.

During a Senate Health, Education, Labor, and Pensions Committee hearing, Collins questioned Brian Miller, an associate professor at Johns Hopkins University, about regulatory and competitive hurdles that can slow the availability of cheaper alternatives to brand-name medicines.

Collins pointed to bipartisan bills she has introduced, including the INSULIN Act and the Ensuring Timely Access to Generics Act, which she said are designed to streamline approvals and curb practices that delay competition.

The insulin-focused legislation would cap monthly costs at $35 for insured patients and establish a pilot program for uninsured individuals, while also creating an expedited regulatory pathway for biosimilar insulin products.

Miller told lawmakers that biosimilars can take roughly nine years and cost about $300 million to develop, compared with significantly lower costs and shorter timelines for traditional generic drugs. He argued that simplifying evidentiary requirements, such as focusing on pharmacokinetic data, could reduce development costs and boost competition.

“Old drugs should be cheap,” Miller said, emphasizing that longstanding therapies like insulin should not pose financial barriers to patients.

Collins also raised concerns about misuse of FDA’s citizen petition process, which allows stakeholders to request regulatory review but has been criticized as a tactic used by some manufacturers to delay approvals of competing products.

Miller agreed the process can be exploited, citing cases where companies filed numerous petitions to stall market entry of generics or biosimilars. He suggested FDA should have greater authority to dismiss such petitions and coordinate with antitrust regulators, including the Federal Trade Commission and the U.S. Department of Justice, to address anti-competitive behavior.

The hearing reflects ongoing bipartisan interest in tackling prescription drug affordability, particularly by increasing competition in markets for older therapies where high prices persist despite long-standing availability.

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