Is Big Pharma running drug trials in China? House committee wants answers from FDA
The House Select Committee on the Chinese Communist Party wrote to FDA Commissioner Robert Califf, demanding answers on the clinical trials conducted with China’s military for new U.S. drugs.
As the U.S. is seeking to sever ties with some Chinese biotech players, a bipartisan group of lawmakers on Tuesday called on the Biden administration to ramp up scrutiny of hundreds of clinical trials conducted by U.S. drug companies with the Chinese military, citing the risk of intellectual property theft, as the nations compete on biotechnology.
Rep. John Moolenaar (R-MI), who chairs the House Select Committee on China, and ranking Rep. Raja Krishnamoorthi (D-IL) said U.S. drug companies have collaborated with Chinese military-run hospitals to conduct hundreds of clinical trials over the last decade, including in Xinjiang, home to millions of ethnic minorities where the Chines government has launched a campaign of human rights abuses.
“For over a decade, it appears that U.S. biopharmaceutical companies conducted clinical trials with China’s military organizations, and specifically with medical centers and hospitals affiliated with the People’s Liberation Army’s (PLA), to determine the safety and effectiveness of new drug candidates prior to approval,” Moolenaar and Krishnamoorthi wrote in a letter dated Aug. 19 and addressed to Robert Califf, commissioner of the Food and Drug Administration.
“These collaborative research activities raise serious concerns that critical Intellectual Property (IP) is at risk of being transferred to the PLA or being co-opted under the People’s Republic of China…,” said the letter. “We believe that U.S. biopharmaceutical entities could be unintentionally profiting from the data derived from clinical trials during which the [Chinese Communist Party] forced victim patients to participate.”
The letter was also signed by Democrat Anna Eshoo and Republican Neal Dunn.
The Chinese embassy in Washington said “accusations of intellectual theft” were “groundless,” and described the allegations of genocide in Xinjiang as “sheer falsehood.”
In April, Krishnamoorthi and Moolenaar’s Republican predecessor Rep. Michael Gallagher called on the Biden administration to add seven Chinese biotech firms to a list created by the Defense Department to highlight firms it says are allegedly working with Beijing’s military.
The lawmakers have asked the FDA commissioner to respond to the House Committee by Oct. 1.
In May, the House Committee on Oversight and Accountability voted overwhelmingly to approve the Biosecure Act. The. Senate Homeland Security and Governmental Affairs committee already approved similar legislation in March. The bipartisan legislation would end U.S. contracting with Chinese firms such as WuXi AppTec and others deemed a threat to national security by 2032.
Related: Congress targets Chinese biotech, but will drug shortages becomes even more dire?
“This bill is a necessary step toward protecting America’s sensitive health-care data from the Chinese Communist Party before these companies become more embedded in the U.S. economy,” Committee Chair Rep. James Comer, R-Ky., said.
This fall, Congress is expected to take up the Biosecure Act.