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26 February 2017
Nick Paul Taylor / FierceBiotech
Editors at The BMJ have warned that President Trump’s policies could damage biomedical research and regulation around the world. The journal has committed to fostering open debate and supporting those who “speak truth to power” to counter the actions of an administration it sees as heading for a “head-on collision with the scientific and health communities.”
The editorial was written by two of The BMJ’s U.S. editorial team, its U.K.-based executive editor and a professor at the Harvard TH Chan School of Public Health. But, while the composition of the list of authors skews toward the U.S., the message is centered on the global implications of a Trump presidency, including its possible effects on drug development and regulation around the world.
“Proposals to reform the Food and Drug Administration will scale back the agency’s ability to ensure the safety and efficacy of approved drugs, harming not only people in America but those in other countries that often follow the FDA’s lead,” the authors wrote.
Concerns about the cross-border consequences of radical FDA reform resonate in Europe. With the European Medicines Agency entering a period of potential upheaval as it relocates and perhaps loses the support of the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) following Brexit, its own ability to provide global leadership could be compromised. And, on the other side of the coin, with Brexit triggering chatter about MHRA forging closer ties to FDA, changes in the U.S. could influence the upcoming rethink of regulatory oversight in the U.K..
The BMJ editorial covers the implications of a Trump presidency with more breadth than depth, touching lightly on the myriad of ways the effects of U.S. scientific policies ripple outward around the world. Of note from a biotech perspective, The BMJ worries the misdirection of the influence the U.S. wields as a result of its “unparallelled research capacity” and global health spend could damage efforts to create a healthier world.
In the face of this perceived threat and evidence the administration places “little value on facts or analysis,” The BMJ has committed to encouraging the generation of evidence and debates about its application for policy and practice.
“Arguments, whichever side of the debate they fall on, should be based on data, evidence and, ultimately, the scientific method. Clinicians, researchers and policy makers in the U.S. and elsewhere need independent evidence and open debate,” the authors wrote.
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