Virus Spread Threatens Clinical Research

Due to the continued COVID-19 outbreak, biopharma companies face disruptions from delays in conducting clinical trials in China. Many U.S. and global drug companies have launched studies in China as part of multi-regional development programs, as well as local trials to support the marketing of a drug in China that is already approved in other regions, as documented in clinicaltrials.gov data analyzed by www.biocentury.com. Sponsors looking to test potential antivirals and vaccines for effectiveness against COVID-19, moreover, are experiencing difficulties in identifying and enrolling suitable study participants who have been exposed to the virus but have not had previous treatment.

The outbreak has also fueled fears of drug shortages, primarily for active pharmaceutical ingredients (APIs) produced in China, including key ingredients in antibiotics, painkillers, and diabetes drugs. Although several Chinese manufacturers recently reported they were back in business after the holiday closures, U.S. and European regulatory officials continue to anticipate supply shortages in multiple areas, as are generic drug producers in India, which also obtain APIs from China.

FDA is paying attention to these issues, as seen in a statement by FDA Commissioner Stephen Hahn last week acknowledging that the continued spread of the coronavirus could lead to disruptions and shortages of critical medical products in the U.S. So far, the main supply problems have involved respirators, surgical masks and other protective gear, which FDA is monitoring to identify excessive orders to distributors. The agency also wants drug manufacturers to report on emerging supply issues and is beefing up resources to review and coordinate such data.

At the same time, FDA has postponed planned inspections of medical product manufacturers in China due to a State Department travel warning. The agency usually conducts some 500 inspections a year in China, but now has put on hold routine surveillance site visits scheduled for February and March. In the meantime, Hahn said the agency will increase import sampling and seek to review records of uninspected facilities to determine the need for any import alerts. And as with all APIs, FDA will continue to hold manufacturers of finished dosage forms “responsible for ensuring the quality of their products.

FDA also is concerned about manufacturers making false claims or marketing fraudulent products related to preventing or treating the virus. An FDA task force is closely monitoring for such activities related to COVID-19 and is working with retailers to help monitor online promotions making illegal claims.