E&C Republicans Send Follow Up Letter to FDA Regarding Foreign Drug Inspection Program
Chairs signal intent to subpoena if FDA continues stonewalling crucial request
Washington, D.C. — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Subcommittee on Health Chair Brett Guthrie (R-KY), and Subcommittee on Oversight and Investigations Chair Morgan Griffth (R-VA), on behalf of the Health and Oversight Republicans, sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf.
The letter follows up on a previous request for information related to the agency’s foreign drug inspection program and comes amid the Committee’s work to address drug shortages. To date, the FDA has not provided any response to the Committee.
KEY LETTER EXCERPT:
“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. Members of this Committee have repeatedly expressed concern regarding the effectiveness of the FDA’s foreign drug inspection program, including at two separate hearings this Congress before the Subcommittee on Oversight and Investigations and the Subcommittee on Health. Addressing drug shortages remains a top priority for the Committee.”
- Since the Committee’s July letter to the FDA, there have been additional drug recalls from Indian manufacturers and plant closures in the United States.
- In August, Indian drug manufacturers, Alembic and Aurobindo Pharma, issued voluntary drug recalls citing quality and manufacturing deficiencies, respectively.
- Alembic recalled over 80,000 bottles of tobramycin, used to treat bacterial eye infections, due to “failed impurities/degradation specifications.”
- Aurobindo recalled rufinamide tablets used to treat seizure disorders.
- Both companies have a history of drug recalls and quality control failures.
- Last year, the FDA issued Alembic a Form 483, which cited its manufacturing plant in Panelav, Gujarat with four observations following a 10-day inspection.
- It has come to light that the FDA ended its unannounced foreign inspection program out because the agency believed it was an obstacle to deeper collaboration with India.
- The reporting also alleges 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.
- In addition, a newly published study has confirmed that FDA foreign inspections in 2022 were down 79 percent compared to 2019 while at the same time the number of “citations rose dramatically, despite all establishments being given advance notice of inspections.”
- Domestic production of vital medicines continues to be under stress.
- In early August, Pfizer announced it would limit the distribution of injectable drugs manufactured at its North Carolina plant after the facility suffered damage in the aftermath of a tornado.
- In September, autoinjector maker Aktiv Pharma Group (“AktiVax, Inc.”), which produces autoinjectors to treat life threating conditions, announced the closure of three manufacturing facilities.
- Just last year, the company was awarded over $45 million to supply a nerve agent antidote to the Strategic National Stockpile.
- While shortages of cancer drugs appear to have eased slightly in recent months, demand continues to outstrip supply.
The Chairs are prepared to issue a subpoena if the FDA does not produce the requested documents January 5, 2024.
CLICK HERE to read the letter.