FDA gets in on the stimulus action from new relief bill

March 9, 2021

President Biden’s $1.9 trillion COVID-19 relief bill is set to be signed into law this week, and will dole out a host of benefits to the FDA and pharma industry.

Weeks ago, The House Energy and Commerce Committee added a nifty $500 million boost in funding for the FDA to the bill, which has dealt with a major increase its workload due to coronavirus-related activities. Thus, the fresh funds will be earmarked to support the development and post-market surveillance of COVID-19 vaccines and therapeutics. But the agency is also being asked to tackle other long-standing goals with the money, such as drug shortages and supporting the development of continuous manufacturing. 

And because the agency was forced to delay and halt many inspections due to the pandemic, the FDA will also be tasked with using the funds to help clear its backlog of inspections. 

The stimulus package will also set the stage for big R&D investments in pharma with a whopping $20 billion being pegged for federal research on vaccines and manufacturing for therapeutics, along with another $3 billion allocated to increase the national stockpile of vaccines. 

In addition, states will receive $8.75 billion to aid vaccine rollout.  

The one downside for the pharma industry in the bill will be the removal of a cap states can collect in rebates for certain drugs for Medicaid. The new provision, aimed at lowering drug prices, will go into effect in 2023 and impact Humira, some insulins and more.