Drugs

2 Bills Affecting FDA Signed Into Law

President Biden has signed into law two FDA-related bills that are intended to help lower drug/biologic prices. The Advancing Education on Biosimilars Act of 2021 (S 164) requires FDA to advance education and awareness programs for health care providers on biological/biosimilar products, including by developing or improving continuing education programs that address the prescribing of biological products and biosimilars. FDA is directed to maintain and operate a Web site to provide educational materials about biological products, including what products are interchangeable, as well as how to report any adverse events.

Additionally, the Ensuring Innovation Act (S 415) clarifies that the five-year new chemical entity exclusivity is only available for drugs containing no active component that has previously been approved in the U.S. Senator Bill Cassidy (R-LA), who co-sponsored the measure said the law will help reduce drug costs and improve access to more affordable generic drugs by ensuring that market exclusivity, which can delay generic drugs from entering the market, is only made available to truly innovative products.

The bill codifies FDA’s approach to granting five years of exclusivity to drugs with no previously approved “active moiety,” instead of “active ingredient.” The agency defines active moiety as the molecule responsible for the physiological or pharmacological action of the drug.

Cassidy said companies have found loopholes to claim new innovations on the same drug, that aren’t really innovations, to extend their exclusivity and prevent cheaper generics from coming to market. The new law is intended to close the loopholes to prevent the gaming of market exclusivity.

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