Drugs

Senators Seek FDA Fixes to Brand Companies Delaying Competition

Barely a week after he called for public input on the problem, a group of senators have urged FDA commissioner Scott Gottlieb to address prescription drug costs by curbing abuses by drug companies to delay competition. Senator Dianne Feinstein (D-CA) joined a bipartisan group of Senate Judiciary Committee members led by Senator Amy Klobuchar (D-MN) and wrote Gottlieb asking him to address abuses in the regulatory process that delay competition and increase prescription drug costs. The request aligns with objectives of legislation senators Feinstein, Klobuchar, Chuck Grassley (R-IA), Patrick Leahy (D-VT), Dick Durbin (D-IL), Sheldon Whitehouse (D-RI), Mike Lee (R-UT), and Richard Blumenthal (D-CT) introduced earlier this year, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act.

In their letter, the senators asked Gottlieb to detail the regulatory actions FDA can and cannot take to address strategies that prevent generics from obtaining samples needed for regulatory testing and abuses in the Risk Evaluation Mitigation Strategy (REMS) program. The letter also asked Gottlieb to determine whether FDA can approve a single REMS system for a generic product that meets the same, safety requirements as the branded company’s system “more readily” than it has in the past.

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