House GOP threatens to subpoena FDA commissioner in foreign drug quality probe

House Republicans are threatening to subpoena the head of the Food and Drug Administration (FDA) as the Energy and Commerce Committee ramps up its inquiry of the agency’s foreign drug inspection program. 

In a letter sent Thursday to FDA Commissioner Robert Califf, committee Chair Cathy McMorris Rodgers (R-Wash.), along with leaders of the subcommittees on health and oversight, demanded answers to questions about the agency’s inspections conducted on manufacturing plants in India and China. 

The committee’s investigation began in July, as lawmakers said they had concerns about the U.S. becoming overly reliant on sourcing from foreign manufacturers even while some companies have a “demonstrated pattern of repeatedly violating FDA safety regulations.” 

The committee called for a response by August but said the FDA has not provided any responses or documents to date.  

“The Committee has a right to the requested information and documents, which are necessary to carry out its constitutional oversight responsibilities and to inform pending legislation,” the lawmakers wrote.  

Since July, there have been additional drug recalls from Indian manufacturers and plant closures in the United States. But drug shortages have persisted due to issues with domestic production and as a result, the agency allowed temporary imports of otherwise unapproved drugs from China and India. 

“Drug shortages plague our nation,” the lawmakers wrote in the letter. “The U.S. cannot afford additional disruptions to the drug supply chain that reduce the availability of essential medications and force doctors and patients to make difficult treatment decisions.” 

In the latest letter, lawmakers asked for answers by Jan. 5 to the same questions from July. The lawmakers said they are prepared to issue a subpoena if the FDA does not produce the requested documents. 

The FDA said it has received the letter and will respond directly to the representatives.

— Updated at 2:44 p.m.