Drugs

House Hearing to Grill FDA on Foreign Inspections

The House Energy and Commerce Oversight and Investigations Subcommittee has planned a 12/10 hearing entitled “Securing the U.S. Drug Supply Chain: Oversight of FDA’s Foreign Inspection Program.” It will be held at 10 am in the John D. Dingell Hearing Room, 2123 Rayburn House Office Building.

“Over a decade ago, the Energy and Commerce Committee exposed vulnerabilities in the Food and Drug Administration’s foreign drug inspection program that led to stronger inspection authorities from Congress,” subcommittee leadership says. “Recent recalls and troubling news reports raise fresh concerns that FDA has still not resolved some of these issues, which could undermine the safety of some drugs. Next week, we will press FDA on its efforts to address longstanding foreign inspection challenges and its ability to ensure the safety of the United States’ drug supply.”

In October, CDER director Janet Woodcock testified before a House Energy and Commerce Subcommittee on Health hearing and sounded alarms over the increasing number of active pharmaceutical ingredient (API) manufacturing sites in China and other countries and the U.S.’s reliance on foreign-sourced APIs, which exposes patients to potential supply shortages. She told lawmakers that “advanced manufacturing technologies” could reduce U.S. drug maker reliance on foreign-sourced APIs and thus “enable U.S.-based pharmaceutical manufacturing to regain its competitiveness with China and other foreign countries.”

Woodcock also told the hearing that FDA has been “working diligently in collaboration with industry and other federal agencies to ensure our reliance of foreign manufacturing does not pose a national security risk. While FDA cannot tell industry where they can and cannot manufacture APIs, we can work with industry to utilize new technologies and new manufacturing methods to further incentivize domestic production of drugs and APIs.”

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