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Gottlieb: Too Much FDA-CMS Collaboration Is a Bad Thing

Ever since Johnson & Johnson got reimbusement for Cypher lined up before FDA approval, it has been common for device companies to be advised to work with CMS early on in the product development process, and even to design clinical trials with CMS-relevant endpoints in mind.

But going too far down that road is likely to cause problems, said a former FDA and CMS official at yesterday's Medical Device Manufacturers Association coverage, reimbursement, and healthcare policy conference. Scott Gottlieb, MD, who was deputy commissioner for medical and scientific affairs at FDA and a senior adviser to Mark McClellan when he was administrator of CMS, said the problem is that CMS does not have many experts who know anything about clinical data. Because it lacks the expertise, he said, it often won't have much to say about what it wants to see, or may give the wrong advice. "I do not advocate that sponsors [seek CMS input at the clinical trial design stage], and I was not happy that FDA/CMS collaboration was advanced on my watch," he said. "There are opportunities, but they need to be narrowly construed. Involving CMS further downstream could be highly problematic." Gottlieb, now a resident fellow at the American Enterprise Institute, also said that CMS is not happy with how the "coverage with evidence development" policy has been implemented because "it has created political vulnerabilities. It is embarrassing if the completion of a registry [created as a condition of coverage] does not answer all the questions that it was supposed to."

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