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Pink Sheet — Congress Wants Answers From US FDA On India And China Inspection Plans

Pink Sheet — Congress Wants Answers From US FDA On India And China Inspection Plans

The House Energy and Commerce Committee Republican leadership is asking the US Food and Drug Administration for a wealth of information about its approach to inspections in India and China coming out of the COVID shutdown period.

A July 18 letter to Commissioner Robert Califf focuses squarely on a key vulnerability for the agency: how to assure public confidence in prescription drug quality after the long physical site inspection hiatus in two of the largest suppliers for the US. Concerns about the vigor of the FDA’s foreign inspection program predate the pandemic and GOP leadership in the House has redoubled its focus on the topic as a key part of FDA oversight now that pandemic restrictions are receding.  (Also see “US FDA’s Biggest Post-COVID Challenge May Be Helped By Small Inspections Tweak In FDORA” – Pink Sheet, 31 Jan, 2023.)

The letter also sets the table for upcoming legislation intended to address drug shortages.  (Also see “House Republicans: Drug Shortage Solutions Must Move Beyond FDA” – Pink Sheet, 13 Jul, 2023.)

The letter highlights the relative dearth of inspections in China and India since the COVID-19 pandemic began alongside the history of quality issues from suppliers in those countries.

“Given that approximately 32% of generic drugs and 45% of active pharmaceutical ingredients (APIs) are from these two countries, we are worried that the United States is overly reliant on sourcing from foreign manufacturers with a demonstrated pattern of repeatedly violating FDA safety regulations,” the letter declares.

Among the nearly two dozen questions posed to the FDA are requests for detailed updates on the number of inspectors working on domestic and foreign inspections, the backlog in foreign inspections, historic data on the percentage of inspections that are preannounced, and plans to resume unannounced inspections, particularly in India, where the agency ran a pilot program in 2014 and 2015.

The letter also spotlights recent quality problems at one Indian supplier, Intas Pharmaceuticals Ltd., that have prompted a significant shortage of key cancer medicines. Part of the FDA’s solution has been to permit imports from a Chinese firm Qilu Pharmaceutical Co., Ltd., whose products are not approved in the US.

The letter asks for deeper information about the Intas situation in one of the longest of the questions posed to the agency.

“As early as November 2022, the FDA was aware of significant, repeated quality control failures at Intas Pharmaceuticals’ Ahmedabad, India manufacturing facility,” the letter notes. “At the time, this facility was one of only five finished product manufacturers supplying the U.S. market with chemotherapy drugs carboplatin and cisplatin. Intas voluntarily stopped operations at its Ahmedabad plant in response to quality control failures on June 5, 2023.”  (Also see “US FDA Finds Poor Data Integrity At Second Intas Plant” – Generics Bulletin, 17 Jul, 2023.)

“During a June 9, 2023, briefing with congressional staff on cancer drug shortages the FDA stated that it was not aware of the company’s plans to halt operations at its Ahmedabad, India, manufacturing facility until after the plant had shut down operations,” the letter continues.

That point was also made publicly by Drug Shortage Staff Associate Director Val Jensen during a recent Friends of Cancer Research workshop. A shutdown “was something that definitely was not in our plans,” she said. “We didn’t expect that, and we didn’t want that.”

The House committee wants to hear more: “This lapse in communication is concerning, as the FDA was ostensibly aware of the ongoing quality issues at the plant, as well as Intas’ significant U.S. market share for cisplatin and carboplatin and the disruption a plant closure would cause in the supply of these drugs,” the letter says. “It is important for the committee to understand exactly how and when the FDA was made aware of Intas’ plans to voluntarily halt operations at its Ahmedabad facility. Explain in detail and provide copies of any communications between the FDA and Intas Pharmaceuticals from January 2023 through June 2023 related to the company’s decision to voluntarily halt production at the Ahmedabad plant closure.”