Rx Drugs

House Energy & Commerce Democratic leaders Monday (Aug. 17) launched an investigation into whether the Trump administration’s changes to the U.S. Postal Service are delaying delivery of prescription drugs during the COVID-19 pandemic.

The administration says it will only use march-in rights to lower the cost of COVID-19 drugs if all a product’s patents are owned by the federal government, which is not the case for remdesivir.

Catalyst Pharmaceuticals is pushing back on a federal magistrate judge’s recommendation to throw out the company’s lawsuit against FDA, which alleges the agency violated Catalyst’s orphan drug exclusivity for its Lambert-Eaton myasthenic syndrome drug, Firdapse.

If the president insists that federal agencies buy domestically made essential drugs, those agencies should guarantee higher prices and sales volume in long-term contracts with drug makers, and the government should give generic drug makers tax breaks and grants because other countries lured away production with similar incentives, Association for Accessible Medicines Interim CEO Jeff Francer said Thursday (Aug. 6).

FDA this week finalized a guidance that provides additional clarity on when the agency will change a drug’s marketing status in the Orange Book -- information insurers had told the agency was essential to companies’ efforts to bring new generics to market.

Generic drug makers are pleased the president is again saying he’ll eliminate rebates because it would fix an aspect of Medicare Part D that encourages plans to use brands over generics.

The Democratic presidential ticket now includes two moderates who support aggressive measures to rein in drug prices and reform health insurance markets.

FDA is launching a Pandemic Recovery and Preparedness Plan (PREPP) that will apply best practices and lessons learned from the COVID-19 response so far to chart the agency’s response efforts going forward, FDA Commissioner Stephen Hahn said Monday (Aug. 10) during a webinar hosted by the Reagan-Udall Foundation for the FDA.

FDA Commissioner Stephen Hahn and biologics center director Peter Marks say they plan to convene the agency’s vaccines advisory committee to review any COVID-19 vaccine, whether it be for emergency use authorization or licensure.