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# House Committee Pressures FDA on China Oversight
- URL: https://www.fdaweb.com/house-committee-pressures-fda-on-china-oversight/
- Published: 2024-05-07T12:00:00.000Z
- Updated: 2026-09-14T14:30:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156937

The House Committee on Oversight and Accountability is stepping up pressure on FDA and its oversight imported Chinese active pharmaceutical ingredients and finished drugs. In a [5/6 letter](https://oversight.house.gov/wp-content/uploads/2024/05/05.06.24-Letter-FDA-China-influence.pdf?ref=fdaweb.com) to FDA commissioner **Robert Califf**, Committee chair **James Comer** (R-KY) calls on FDA to “do everything in its power to counter undue CCP \[Chinese Communist Party\] influence in Americans’ pharmaceutical, medical, and tobacco products.”

Last November, a similar letter from Comer called on the agency to provide extensive information on its response to a growing number of what he said were critical drug shortages delaying and preventing patients from receiving lifesaving medical treatment ([see story](https://www.fdaweb.com/house-oversight-panel-probes-drug-shortages/)). He said the shortages pre-dated ( the Covid-19 pandemic and have been “worsened by factors including an overreliance on manufacturing facilities located in foreign countries.”

Comer’s latest letter tells FDA it has “a duty to identify and help address the People’s Republic of China’s (PRC) efforts to further dominate the pharmaceutical market and monopolize data collection to the detriment of Americans.” He writes that the “PRC’s strict national security laws require companies associated with the PRC or CCP to share data with the Chinese government, creating significant risks for American consumers. As the People’s Liberation Army (PLA) becomes more ingrained in the biotechnology sector, it becomes increasingly clear that the CCP seeks to weaponize genomic and medical data and use strategies like its united front work to selectively export drugs and medical supplies.”

Comer notes that the U.S. depends on APIs and medical devices from China, so much so that the agency maintains a boots-on-the-ground inspection office in the country. “However, the FDA’s monitoring in the PRC has not been compliant with regulatory requirements for some time, even prior to the Covid-19 pandemic,” he writes. “There is a backlog of mandatory inspections of foreign companies that have either never been inspected or have not been inspected in the last five years. Foreign drug manufacturing inspections remained 79% lower in 2022 compared to 2019.”

Under the PRC’s amended Counter-Espionage Law, FDA and other regulatory body inspectors may be arrested for accessing CCP-owned drug companies’ records if the Chinese government determines such access constitutes foreign access to “documents, data, materials, or items related to national security,” Comer warns in the letter. “Recently, the PRC used this ‘law’ to detain an employee of Japanese pharmaceutical company Astellas Pharma Inc., under suspicion of espionage, during a routine drug manufacturing site visit in China. It is critical that the FDA do everything in its power to counter PRC influence in the American pharmaceutical market, and take necessary steps to protect its employees subject to counter-espionage laws and tasked with conducting important inspections for Americans.”

Comer says that the CCP’s economic warfare “targets the global pharmaceutical and medical device markets in an effort to solidify the PRC’s position as the world’s foremost manufacturing source and leverage the world’s reliance on certain commodities to garner more power.” His letter requests a briefing with committee staff to discuss the following:

1. How FDA strives to inspire and equip Americans to strengthen their communities, innovate, and create the technologies and phenomena that will secure a strong and prosperous future for our nation;
2. How FDA leadership ensures from the top down that all FDA employees are aware of CCP warfare and influence operations against America, and are equipped to address them wherever they arise;
3. How FDA conducts outreach to the pharmaceutical and medical communities about the threat posed by the CCP and the PLA to U.S. intellectual property, genomic and medical information, data, technology, and national security;
4. How FDA conducts outreach to the pharmaceutical and medical communities about the known quality risks to relying upon and importing PRC-sourced API, finished drugs, tobacco, and medical devices;
5. FDA’s efforts to train its employees and partners in the pharmaceutical and medical communities about the dangers of the CCP’s destructive ambitions and the risks posed by collaboration with the PRC’s pharmaceutical and medical sectors given the PRC’s continuous theft of American intellectual property, data, and technology;
6. FDA’s efforts to train investigators assigned to complete inspections in the PRC and employees of the FDA China Office about the dangers of the CCP’s destructive ambitions and the risks posed by their activities in the PRC given the PRC’s counterespionage statutes criminalizing information gathering of “documents, data, or items related to national security”;
7. Measures in place to protect employees of the FDA China Office from influence operations or security threats;
8. The current justification for the FDA China Office;
9. Any FDA programs, processes, or mechanisms to incentivize the commercial sector to protect U.S. intellectual property and report CCP influence operations as well as intellectual property or trade secret theft by the CCP and its entities;
10. FDA’s efforts to effectively and consistently regulate tobacco and nicotine products to eliminate loopholes allowing for the importation of illegal and illicit Chinese products;
11. How foreign inspection frequency fits into the FDA’s latest annual budget request to Congress;
12. FDA’s efforts to clear the backlog of foreign inspections of pharmaceutical and medical manufacturing sites in the PRC; and
13. FDA’s efforts to bring foreign inspection frequency and protocols in line with domestic inspections, to ensure that foreign manufacturing meets the FDA’s highest regulatory standards.