Rx Drugs

Xavier Becerra, President-elect Joe Biden’s nominee for HHS secretary, recently asked the federal government to use a controversial monopoly-busting mechanism to lower the cost of the COVID-19 drug remdesivir, and there are several COVID-19 drugs and vaccines that are susceptible to the government’s so-called march-in rights.

President Donald Trump on Tuesday (Dec. 8) said his administration will consider invoking the Defense Production Act if there are any problems with manufacturing enough COVID-19 vaccines for U.S. citizens, coming amid reports that the U.S. government did not take the opportunity to buy more doses from Pfizer over the summer and that the drug makers’ remaining doses through next June have been allocated to other countries.

A pharmaceutical economics professor says the federal government should consider creating an agency, separate from FDA, of which the sole purpose would be to track drug use, create multiple drug shortage lists and develop shortage mitigation strategies.

FDA biologics center director Peter Marks and Operation Warp Speed chief Moncef Slaoui say it remains unclear whether people who have recently experienced severe COVID-19 infection and likely have higher levels of antibody protection will need to get the vaccine when it’s available.

The Pharmaceutical Research and Manufacturers of America and three groups representing doctors and patients filed suit Friday (Dec. 4) against the Trump administration’s demonstration that ties Medicare doctor reimbursement to foreign drug prices, and at press time the Biotechnology Innovation Organization was poised to file a separate suit in a federal court in California.

FBI cyber official Tonya Ugoretz and CISOs from Johnson & Johnson and Eli Lilly discussed extensive collaboration efforts underway to protect development and distribution of COVID-19 vaccines and therapies, at an event sponsored by the Aspen Institute.

In the months leading up to COVID-19 vaccine sponsors’ newly submitted applications for emergency use authorization, FDA and its advisers, as well as advisers for the Centers for Disease Control and Prevention, discussed whether to push expanded access as a way to initially deliver experimental vaccines to narrow segments of the population in advance of broader EUAs and full approvals.

The most-favored-nation demonstration, which aims to lower drug prices, undermines price-competing biosimilars by subjecting them to international reference pricing, according to Coherus BioSciences, the maker of the biosimilar covered by the demonstration.

CMS backed away from its proposal to increase cuts to Part B pay for 340B drugs by an additional 6% in 2021, citing the COVID-19 public health emergency, and instead finalized its alternative proposal to continue paying hospitals for those drugs at the Average Sales Price minus 22.5% as part of the final 2021 hospital outpatient pay rule.