On July 18, 2023, the Chairman of the Energy and Commerce Committee, the Chairman of the Health Subcommittee and the Chairman of the Oversight and Investigations Subcommittee of the US House of Representatives, on behalf of the US Health and Oversight Subcommittee, sent a letter to the Commissioner of the US FDA, questioning the US FDA's overseas inspection work, which they believe is insufficient in the inspection of drugs imported from India and China.

In the letter, the FDA said that because of the shortage of drugs in the United States, the FDA has temporarily reduced the requirements for drugs imported into the United States to meet its demand, and more drugs are imported from abroad, especially from China and India, so the committee believes that the inspection of importing countries has become critical. They cited concerns that about 32 percent of generic drugs and 45 percent of active pharmaceutical ingredients come from China and India, and that manufacturers with a history of repeated FDA violations are among them. In addition, the impact of Covid-19 has hampered FDA's on-site inspections of overseas drug manufacturers, and while some alternative methods, such as remote interactive inspections, have been replaced, the Committee concluded that the level of inspections is significantly lower than before the pandemic.

The letter also noted that of the approximately 2,800 foreign manufacturing facilities, the FDA inspected only 6 percent of them, and only 3 percent of Indian manufacturers were inspected. Between 2020 and 2022, the FDA conducted only 40 inspections in China, which is obviously insufficient compared to the 131 inspections conducted in 2019.

In addition, the committee asked a number of questions and asked the FDA to respond. Overall, the letter emphasizes inspections in China and India, and in combination with other news, there is pressure in the United States on the FDA's overseas inspections. In fact, after the epidemic, the United States' overseas inspection program, especially for China, has increased significantly, and the above information can also be seen that the future will continue to increase.

At present, from our project this year, we also clearly feel the improvement of FDA inspection, not only have a number of customers have accepted the inspection, but also received a number of customers facing FDA temporary emergency inspection notice. Here, Dexiao En takes this small article to give everyone a bell, if there are products or products will enter the US market, then it is necessary to actively evaluate and prepare. If you have questions related to FDA inspection, you can also support small window Dehn at any time!

The original text can be found at:
https://d1dth6e84htgma.cloudfront.net/Letter_to_FDA_on_Foriegn_Drug_Inspections_dc7bf60a6d.pdf
For other news, see:
https://endpts.com/house-republicans-question-fdas-progress-on-pharma-inspections-in-india-and-china/
https://pink.pharmaintelligence.informa.com/PS148576/Congress-Wants-Answers-From-US-FDA-On-India-And-China-Inspection-Pl ans