Industry Concerned Over CMS-FDA Parallel Product Reviews

The agreement between the FDA and the Centers from Medicare & Medicaid Services (CMS) to conduct parallel reviews of products -- which would allow drugmakers to receive both a drug approval and reimbursement coverage simultaneously -- could speed some products to market, but it also raises concerns for the pharmaceutical industry, according to experts.

The concern is that CMS and the FDA might collaborate early in the review process, said Scott Gottlieb, a senior fellow at the American Enterprise Institute and a former adviser to both agencies. This would be similar to the system in the UK, which has pricing authorities and approval authorities basically vested in one body, Gottlieb said. "There are problems with that kind of system," he said.

"Particularly if you have the pricing authorities weighing in early in the development process, helping companies structure trials that satisfy the pricing people and the drug-approval people simultaneously," Gottlieb said. "The last thing you want is clinical trials to become longer and more expensive because companies are doubling the size of their trials to satisfy CMS."

But Gottlieb also noted that the agreement was careful to put in boundaries about CMS' involvement in structuring the clinical development process around the needs of reimbursers. Still, firms may be nervous about any kind of collaboration between the agencies, he said. "You could set limits today and somebody could come in tomorrow and just forget about those limitations," Gottlieb said.