The Trump administration is weighing the imposition of severe restrictions on medicines from China that, if enacted, could sow “chaos” in the U.S. pharmaceutical industry, especially generics, The New York Times reported Sept. 10.
At the center of the proposed crackdown is a draft executive order that would block U.S. pharmaceutical companies from licensing Chinese experimental drugs, many of which target cancer, heart disease, obesity and Crohn’s disease.
The Times obtained a copy of the draft order, which has triggered a battle between biotech investors with ties to the White House, including Peter Thiel, Sergey Brin and members of the Koch family against drugmakers like Pfizer and AstraZeneca, who have turned to China for promising drug candidates, bypassing costly U.S. biotech firms.
The draft order proposes boosting U.S. production of several kinds of drugs believed to have substantial production in China, including antibiotics and acetaminophen. It also proposes giving preference to U.S.-made drugs in government purchasing and offering tax credits to companies that move manufacturing to the U.S.
One policy would also require “mandatory review” of deals in which U.S. pharmaceutical companies acquire rights to experimental drugs from Chinese developers by the Committee on Foreign Investment in the U.S. Another policy would also discourage the use of clinical trial data from patients in China by requiring more rigorous FDA review and higher regulatory fees.
While a White House spokesperson told the Times the administration is not actively considering the draft order, discussions with administration officials have continued.
Becker’s has contacted HHS to request comment.
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