“People often argue that the FDA is too restrictive,” said Roger Perlmutter, head of research and development at Merck & Co. “We have the sense that the balance is pretty right … you have to have a well-characterized risk/benefit profile.”
While many players in the drug industry would welcome less federal oversight, drugmakers rely on the FDA’s extensive review process to help convince physicians and insurers that their new drugs have clinical value.
“It is great that the administration is seeking deregulation … to make sure the private sector can be more competitive,” said John Maraganore, CEO of Alnylam Pharmaceuticals. “But payers are looking for evidence of value.”
The time and money it takes to bring a new drug to market — sometimes as much as $2.6 billion overall — would be lost if insurers do not agree to pay for the treatment, according to the report.
“It is one thing to get a drug approved, but you have got to get reimbursed,” said Paul Perreault, CEO of the biotech company CSL. He said reimbursement won’t occur unless payers see proof a new drug is better than already available treatments.
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