Author Archives: Bowman Cox

How BARDA locked up COVID-19 vaccine manufacturing capacity for Operation Warp Speed

by

The government agency that develops medical countermeasures for the US stockpile says it had to move quickly to secure contract manufacturing plant capacity for COVID-19 vaccines before the private sector could “capture†it. There was no time to give other contract manufacturers a chance to bid for the work, which the Health and Human Services Department’s Biomedical Advanced Research and Development Authority, or BARDA, recently awarded in a pair of task orders totaling nearly $900 million. BARDA awarded a $628…

August 12, 2020

How to avoid a post-COVID manufacturing crisis

by

How pharmaceutical companies should plan to catch up after the pandemic and explain what happened to inspectors. It is important to start planning for post-COVID-19 recovery even as the pandemic continues to impact pharmaceutical manufacturing operations, an expert panel told Food and Drug Law Institute members during a 19 May webinar. Manufacturers should set priorities in advance so they can attack the most important backlogged activities first. They also should approach recovery with the right mindset: the need to act…

June 4, 2020

Continuous manufacturing back in second Act

by

House tries again to promote advanced technology for the return of pharmaceutical manufacturing to the US in post-COVID-19 era. The new HEROES Act legislation revives a proposal to establish national centers of excellence for continuous pharmaceutical manufacturing that had earlier made it into the US House of Representatives’ version of the CARES Act but not the final enacted CARES pandemic relief law. The HEROES bill (HR 6800) authorizes $100 million for the centers of excellence, available until expended. That’s up from the $80…

May 22, 2020