Pharma industry shuns Trump push for radical shift at FDA

Wed Feb 15, 2017 1:26am EST
 
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By Deena Beasley

(Reuters) - U.S. President Donald Trump's vow to roll back government regulations at least 75 percent is causing anxiety for some pharmaceutical executives that a less robust Food and Drug Administration would make it harder to secure insurance coverage for pricey new medicines.

The prospect of big change at the regulatory agency comes as drugmakers are under fire for high prices, including Marathon Pharmaceuticals LLC, which said Monday it was "pausing" the launch of its Duchenne muscular dystrophy drug after U.S. lawmakers questioned its $89,000 a year price.

Industry trade group Biotechnology Innovation Organization told Reuters that during high-level discussions with Trump advisors, lobbyists urged the administration not to name a new commissioner of the Food and Drug Administration who would act rashly to speed up the agency’s approval of new medicines.

That sentiment was echoed by executives at more than a dozen pharmaceutical and biotechnology firms, who told Reuters that the FDA is already adopting new drug development models and warned that a looser review process would put patients at risk.

"People often argue that the FDA is too restrictive," said Roger Perlmutter, head of research and development at Merck & Co Inc. "We have the sense that the balance is pretty right ... you have to have a well-characterized risk/benefit profile."

That stance underscores the unique position the drug industry finds itself in when it comes to regulating its products. While most sectors welcome less oversight, drugmakers say a robust review process is critical in convincing physicians and insurers that a pricey new medicine has value.

Otherwise, the time and money it takes to get a new drug to market - estimates run as high as $2.6 billion - would be lost if insurers are not willing to pay for the product.

"It is great that the administration is seeking deregulation ... to make sure the private sector can be more competitive," said John Maraganore, chief executive officer at Alnylam Pharmaceuticals Inc and co-chair of BIO's regulatory committee. "But payers are looking for evidence of value."   Continued...

 
A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo