Rx Drugs

A federal court on Wednesday (Feb. 17) dismissed hospitals and pharmacists’ lawsuit over drug makers’ limitations on 340B discounts available via contract pharmacies and told the providers to first take their concerns through HHS’ new administrative dispute resolution process.

One of the four facilities that were built with the help of taxpayer money to respond to pandemics is not making coronavirus vaccines or therapies because the company the government partnered with sold the facility in late 2016, and the new owner isn’t required to let the government claim production capacity, sources familiar with the sale said.

Democratic Sens. Tim Kaine (VA) and Michael Bennet (CO) Wednesday (Feb.17) previewed an updated version of their legislation to create a new public option in the exchanges that relies on Medicare infrastructure and allows for higher reimbursement rates for rural hospitals than did earlier versions.

A federal appeals court on Tuesday (Feb. 16) upheld a lower court’s decision to dismiss a lawsuit by cancer doctors against sequestration cuts to Medicare Part B drug reimbursement rates.

HHS will extend liability protections under the Public Readiness and Emergency Preparedness Act to any federal government employee, contractor or volunteer who prescribes, administers, delivers, distributes or dispenses a covered countermeasure, including COVID-19 vaccines, the department announced Friday (Feb. 12).

The Biden administration bought another 200 million doses of coronavirus vaccines from Pfizer/BioNTech and Moderna, and the prices remain the same as previous purchases.

The United States would save $1.3 billion annually if FDA were to approve seven complex generics already available in Canada or Europe, according to report by US Matrix Global Advisors.

A bipartisan group of senators on Thursday (Feb. 4) introduced narrowly tailored legislation to let FDA remove orphan drug exclusivity when drug companies cannot prove that drugs would be economically unviable if they were to face competition.

The House Energy & Commerce Committee will mark up pandemic relief legislation Thursday (Feb. 11) that would give FDA $500 million to support review, development and postmarketing surveillance of COVID-19 vaccines, therapies and diagnostics and to take action to mitigate drug and device shortages.