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White House plans potential restrictions on Chinese-developed drugs, sparking lobbying from investors and pharmaceutical giants amid national security concerns.
The executive order could affect experimental treatments used by leading drugmakers in boosting their pipelines.
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White House officials are drafting an executive order with the potential to impose severe restrictions on experimental treatments discovered in China according to The New York Times. Reports of the order resulted in billionaire investors along with top company executives with close relations to the Trump Administration to begin behind-the-scenes lobbying efforts, with mixed opinions in response.
Influential investors such as Venture Capitalist Peter Thiel and Google co-founder Sergey Brin currently hold illiquid investments within U.S. biotech startups and stated their respective opinions on suppressing the order, according to people familiar with the lobbying efforts. Additionally, select leading pharmaceutical companies such as Pfizer and AstraZeneca relied on replenishing its pipeline through licensing deals and acquiring low-cost experimental drugs from China.1
According to a White House spokesperson, the administration denies “actively considering” the order, while continuing to say, “safeguarding our national economic security is a top priority for the administration.”1
The order calls for multiple provisions to “crack down” on drugs developed and produced in China, proposing an increase in examinations of current deals U.S. drugmakers signed that include no restrictions on buying rights for China-based medicines. According to the order, these deals will be placed under mandatory review by a U.S. national security committee (Committee on Foreign Investment in the United States). Additionally, the order proposes means of discouragement for the use of clinical trial data collected from patients in China, demanding more thorough reviews from FDA along with an increase in regulatory fees.
According to the New York Times, many people within the U.S. desire to move manufacturing back into the U.S, claiming it will safeguard American patients against supply shortages if future pandemics force China to halt exports. A draft of the order was reportedly sent to billionaire investors along with top pharmaceutical companies, claiming, “China and other hostile actors have exploited gaps in our scientific and regulatory systems.”2
The draft of the order continues by calling for acceleration of U.S. production for multiple medications, that are believed to have significant amounts of production in China. These medications include antibiotics and pain reliver acetaminophen. Following escalation of the U.S.’ production of these medications, the government is expected to give preference to these products when purchasing, according to the draft of the order. Additionally, the draft prompts offering tax credits to companies that relocated its manufacturing sites within the U.S.2 The Trump administration is reportedly also considering alternatives outside of the executive order, such as accelerating FDA review processes, allowing for drugmakers to shorten safety testing duration.
“Right now, the United States has the lead in biotechnology, but we’re losing that lead, and we need to act now,” said John Crowley, president of the Biotechnology Innovation Organization.2
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