House Energy and Commerce Committee Chair Cathy McMorris Rodgers, Subcommittee on Health Chair Brett Guthrie, and Subcommittee on Oversight and Investigations Chair Morgan Griffith, on behalf of the Health and Oversight Republicans, have sent a follow-up letter to Food and Drug Administration (FDA) Commissioner Robert Califf. The letter addresses a previous request for information regarding the FDA's foreign drug inspection program and comes in the context of the committee's efforts to address drug shortages. The FDA has yet to respond to the committee's request.
In the letter, the committee expresses concerns about the effectiveness of the FDA's foreign drug inspection program and emphasizes the importance of addressing drug shortages. The committee states, "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."
The letter also highlights recent events that underscore the urgency of addressing these concerns. It mentions drug recalls from Indian manufacturers and plant closures in the United States. Indian drug manufacturers Alembic and Aurobindo Pharma issued voluntary recalls due to quality and manufacturing deficiencies. Alembic recalled over 80,000 bottles of tobramycin, used to treat bacterial eye infections, while Aurobindo recalled rufinamide tablets used to treat seizure disorders. Both companies have a history of drug recalls and quality control failures.
Furthermore, the letter reveals that the FDA ended its unannounced foreign inspection program because it believed it hindered collaboration with India. There are also allegations that the FDA undermined a Department of Defense initiative to independently test the quality of imported drugs used by the military out of fear that it would undermine the FDA's credibility. A recently published study confirms that FDA foreign inspections in 2022 decreased by 79 percent compared to 2019, while the number of citations rose dramatically.
The committee's concerns extend beyond foreign drug inspections. Domestic production of vital medicines is also under stress. Pfizer, for example, announced in August that it would limit the distribution of injectable drugs manufactured at its North Carolina plant due to tornado damage. Additionally, autoinjector maker Aktiv Pharma Group announced the closure of three manufacturing facilities. These closures have implications for the supply of life-saving treatments.
Despite some improvement in the availability of cancer drugs, demand continues to outstrip supply. It is clear that addressing drug shortages is a pressing issue that requires immediate attention.
The committee is prepared to issue a subpoena if the FDA fails to produce the requested documents by January 5, 2024. The committee's dedication to resolving these concerns and ensuring the availability of essential medications is evident in their efforts to hold the FDA accountable.
For further information, the full letter can be accessed by clicking here.
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For additional details, please follow this link: https://energycommerce.house.gov/posts/e-and-c-republicans-send-follow-up-letter-to-fda-regarding-foreign-drug-inspection-program
