Drugs

Senate Bipartisan Agreement on FDA Reform Bills

Senate Health, Education, Labor, and Pensions (HELP) Committee chairman Bernie Sanders (I-VT) and ranking member Bill Cassidy (R-LA) announced 4/25 that a legislative bipartisan deal has been reached to expand the availability of low-cost generic drugs, clarify orphan drug exclusivity, and reform the pharmacy benefit managers (PBM) equation in drug pricing. The HELP Committee says in a 4/25 release that it plans to hold a markup 5/2 of the following four bills:

Ensuring Timely Access to Generics Act of 2023 was introduced by Jeanne Shaheen (D-NH) and Susan Collins (R-ME) and it aims to increase generic competition through improved oversight of citizen petition process. “Currently, the process is being exploited by bad actors who fill citizen petitions in order to delay the approval of generic competitors and extend their patent protections,” the lawmakers said in a release. “This legislation ensures the FDA has the ability to reject citizen petitions if they believe that the primary purpose of the petition is to delay the approval of an application, thereby increasing competition in the marketplace and lowering costs for patients.”

Expanding Access to Low-Cost Generics Act was introduced by Senators Tina Smith (D-MN) and Mike Braun (R-IN) to prevent pharmaceutical company actions to block generic drug competition through a practice called “parking.” The senators say that parking occurs when a brand company agrees not to sue the first company that submits an application to market a related generic (first filer) and enters into an agreement where this first filer agrees to delay bringing its generic drug to market. “No other company can bring a generic version of a brand name drug to market until 180 days after the first filer has done so,” they say, adding that such anti-competitive agreements allow fewer lower-cost generic products to come to market.

Additionally, the RARE Act (Retaining Access and Restoring Exclusivity Act) would address an appeals court decision suggesting FDA was wrong to base previous orphan drug exclusivity decisions on the uses or indications for which a drug is approved instead of all uses or indications within an orphan-designated disease or condition. Orphan drug exclusivity (ODE) has been in limbo since the 9/2021 11th Circuit Court of Appeals decision in Catalyst Pharms v. Becerra struck down the agency’s indication-specific interpretation of ODE (see earlier story). The bill would fully restore FDA’s approach to base exclusivity decisions on previous and long-standing rulings related to a drug’s approved uses/indications.

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