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The U.S. Chamber of Commerce and three other chambers have filed a motion for a preliminary injunction preventing implementation of the Drug Price Negotiation Program in the Inflation Reduction Act (IRA) because it violates the Fifth Amendment Due Process Clause. Read More
The FTC will continue its ongoing examination of the pharmacy benefit management (PBM) industry at an open meeting July 20 when it decides whether to issue a warning to PBMs to stop relying on older FTC advocacy materials that opposed mandatory PBM transparency and disclosure requirements. Read More
Over the past week, the FDA has issued draft guidances on inborn errors of metabolism, clinical trial postmarketing studies and human cellular and gene therapy products. Read More
In an effort to improve adherence with postmarketing requirements (PMR), the FDA has laid out the circumstances under which noncompliance with PMRs is justified in a new draft guidance. Read More
Acknowledging the complexity of human cellular and gene therapy (CGT) products, the FDA has written a draft guidance intended to help manufacturers manage and report changes in products, based on a lifecycle approach, and how to assess the effect of manufacturing changes on product quality. Read More
Merck has asked a federal judge to issue an order granting a summary judgment in its case against HHS over the Inflation Reduction Act (IRA) on the grounds that “no genuine issue as to any material fact exists.” Read More
A revised report from the Institute for Clinical Evaluation and Research (ICER) has reiterated that two experimental gene therapies for sickle cell disease (SCD) would likely be cost-effective if priced at $2 million. Read More
The U.S. Justice Department (DOJ) has provided errant manufacturers with a way to avoid prosecution if they confess their misconduct right away. Read More
After analyzing four additional years of data, the FDA has decided to reverse its 2019 judgment of the mortality risk of paclitaxel-coated devices, saying data do not support a finding of excess mortality risk. Read More
The FDA’s recent final guidance on clinical decision support software prevents physicians from fully disclosing critical health information and therefore violates the First Amendment, a Florida law professor has written in her citizen petition to the FDA. Read More
The European Medicines Agency (EMA) is conducting a safety review of GLP-1 receptor agonists such as Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide) following 150 reports from the Icelandic Medicines Agency of suicidal thoughts and self-injury in people using one of the drugs for weight loss or type 2 diabetes. Read More