Rubio Questions FDA for Sourcing From China
Sen. Marco Rubio, R-Fla., asked the FDA commissioner to justify importing a different formulation of the cancer infusion drug cisplatin that has been approved in the U.S., from Qilu Pharmaceutical in China.
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"The shortage of critical pharmaceuticals in recent months has caused hospitals to begin rationing life-saving treatments, including those to treat aggressive cancers. As the FDA works to alleviate these shortages, it must carefully consider the health and safety consequences of foreign drugs it is allowing into the country. I am concerned that the FDA’s solution to this problem, so far, is to import more drugs from the PRC, an adversary with a poor health and safety record," Rubio wrote June 20.
Rubio said that the shortages began because FDA inspectors found deficiencies at Intas Pharmaceuticals, a manufacturer in India, and noted, "According to the FDA’s database, the last time the FDA inspected and gave Qilu a passing grade was December 2019 -- nearly four years ago, and before the pandemic. A separate review by the European Medicines Agency (EMA) found 30 deficiencies in Qilu’s production of active pharmaceutical ingredients (APIs) for an antibiotic, resulting in the EMA implementing special measures to oversee production."
He asked Commissioner Robert Catliff to answer these questions:
1. What criteria did the FDA use to evaluate Qilu Pharmaceutical as the best and safest manufacturer to import cisplatin to the United States?
2. When was the last time the FDA completed an inspection of Qilu Pharmaceutical facilities? Did they pass the FDA’s criteria? Did Qilu resolve any concerns flagged by the FDA, if any were identified?
3. Why did the FDA decide to import cisplatin from a Chinese company instead of an allied country?
4. What other pharmaceutical manufacturers were considered in the FDA’s search for an alternative foreign importer of cisplatin?
5. Does the FDA intend to request additional foreign manufacturers to temporarily supply the United States with cisplatin?
6. Does the FDA intend to import carboplatin and methotrexate, two other chemotherapy drugs experiencing a shortage, from Qilu Pharmaceutical or other Chinese manufacturers?