Drugs

Bipartisan Draft Bill to Cut Health Costs

The Lower Health Care Costs Act of 2019, bipartisan legislation released for comment by the Senate HELP Committee, includes more than 30 specific provisions, including some affecting FDA, to reduce the costs Americans pay for health care. Last year, the committee asked the American Enterprise Institute, Brookings Institution, governors, state insurance commissioners, doctors, hospitals, patients, and innovators for their recommendations about what Congress could do to help lower health care costs. The legislation is based on the responses received, according to a committee news release, and is to be marked up by the end of June.

Title II of the discussion draft addresses drug costs and calls for:

eliminating a loophole where the first generic drug to submit an application to FDA can block other generic drugs from being approved;
preventing abuse of the FDA citizen petition process to unnecessarily delay drug approvals;
ensuring that makers of branded drugs, including insulin, don’t game the system to prevent new, lower-cost generics or biosimilars from coming to market;
helping bring biosimilar drugs to market faster to ensure patients can better afford promising biologic medicines;
educating healthcare providers and patients on biological products and biosimilars; and
helping generic drug and biosimilar companies speed drug development and avoid patent infringement through transparent, modernized, and searchable patent databases.

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