CPA Questions FDA Commissioner on Faulty Data on Indian Generic Drugs

WASHINGTON — The Coalition for a Prosperous America (CPA) today sent a letter to Dr. Robert Califf, Commissioner of the Food and Drug Administration (FDA), over the agency’s controversial decision to allow the continued sale of generic drugs from India despite faulty data and a lack of proof of therapeutic equivalence. FDA did not prohibit sales to patients as other countries have. According to the FDA, a rating of “BX” means that the generic drug products are insufficient for FDA to determine therapeutic equivalence with brand drug products. Read CPA’s full letter here.

Last fall, the FDA notified two Indian companies, Synchron and Panexcell Clinical Laboratories, that bioequivalence studies needed to be repeated due to problems with the tests. At the same time, the FDA changed the therapeutic rating to “BX” for any approved drugs that relied on data for those companies. Unlike the FDA, the European Medicines Agency (EMA) recommended the suspension of marketing and authorization for dozens of generic drugs after finding problems with bioequivalence tests.

“We write regarding FDA’ actions allowing certain generic medicines to be sold to patients despite faulty, and potentially fraudulent, bioequivalence data that should support their safety and efficacy,” the letter states. “EMA took issue with quality and reliability of data in bioequivalence studies run by Synchron. Generic manufacturers that relied on Synchron testing must now provide alternative data to demonstrate bioequivalence for most of the 100 medicines examined.

“And while EMA has suspended authorizations for all generics tested at Panexcell’s Mumbai, India site – FDA has not. We have grave concern that FDA has lost its ability to be the “Gold Standard” of safety and efficacy and is instead jeopardizing patient health and safety to appease foreign generic drug manufacturers,” the letter continues.

CPA’s Americans for Safe Drugs campaign recently highlighted the FDA’s failure to address shortages of essential and lifesaving products, the agency’s failure to help increase domestic production, and why the FDA continues to allow foreign manufacturers in China and India that repeatedly violate FDA regulations to continue to export generic medicines to the U.S. 

CPA’s letter to Dr. Califf requested answers to questions regarding the FDA’s actions to protect American patients from unsafe drugs, including testing products from foreign manufacturers that have violated FDA’s regulations.

“In lieu of these events and inactions – what is FDA doing to ensure patients are made aware of these faulty generics?” the letter asks. “Will FDA follow EMA’s lead in banning these potentially dangerous medicines? Is FDA regularly testing product to keep patients safe? What are you and the Biden administration doing to increase domestic approval and production of these medicines in a fully regulated environment?”

Earlier this year, Americans for Safe Drugs released a public poll of registered voters, conducted by Morning Consult, which shows that Americans overwhelmingly want to stop importing unsafe generic drugs. Key findings from the poll show that:

  • 84% of Americans want the FDA to ban imports of generic medicines from foreign manufacturers that have received a Warning Letter.
  • 86% of Americans support the FDA testing generic medicines imported into the U.S. from foreign manufacturers that have received a Warning Letter.
  • 72% of Americans oppose importing generic medicines from China.
  • 85% of Americans think it’s an important priority—with 43% saying it should be the top priority—for the U.S. government to establish the U.S. as a leader in the generic pharmaceutical manufacturing industry.

Read CPA’s full letter to Dr. Califf here.


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