Has everything else stopped in the wake of the coronavirus? It certainly feels like it.
Government agencies, like the Food and Drug Administration, are on the front lines of responding to the COVID-19 outbreak. The FDA has taken drastic steps to speed clinical trials for COVID-19 treatments, opened up telemedicine guidelines and protected its workforce by suspending some inspections.
But other important news has happened between the daily coronavirus updates. Keep reading for a sampling of other FDA news during the outbreak.
Drug approvals
A new treatment for hepatitis C in children was approved. It’s the first drug that can treat any strain of hepatitis C in pediatric patients. The drug, Epclusa, is made by Gilead and was previously approved to treat hep C in adult patients. A relapsing multiple sclerosis drug developed by Bristol Myers Squibb was also approved last week.
In fact, during the month of March, the FDA approved nearly 400 drug applications, from simple labeling updates to new drug applications. That’s higher than last March when there wasn’t a pandemic to worry about.
Biosimilars
The FDA also created a new regulatory pathway for biosimilar products that treat diabetes and other serious medical conditions. The move allows products like insulin, which were approved as “drugs” instead of “biologics,” to transition to biologics, allowing copies of these drugs to follow the regulatory path of biosimilars rather than generics. The new pathway is meant to make products like insulin, often in the spotlight for its high cost, more easily accessible and potentially less expensive due to having more choices in the market.
Tobacco
On March 17, the FDA issued a final guidance on new health warning requirements for cigarette packages. The guidance finalizes a proposed rule from 2018. The new warnings will be larger, more specific about the health issues caused by smoking and include (sometimes graphic) photos. The rule brings U.S. cigarette packaging and warnings in line with cigarette warnings around the world.
