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Medical Device Review Reform Proposed by Representative Paulsen

6/21/11

 

 

 

Medical Device Review Reform Proposed by Representative Paulsen

Posted: 12 Jun 2011 10:13 PM PDT
by Michael Harkness

Rep. Erik Paulsen (Minn.) announced his plan to propose new legislation before Congress's August recess aimed at reforming the FDA's approval procedure for medical devices. Testifying at an Oversight and Government Reform Health Care subcommittee hearing on June 2, Paulsen said he plans to simplify the approval process used by the FDA's Center for Devices and Radiological Health ("CDRH") in order to compete with regulatory agencies in Europe. Paulsen pointed out that European regulatory agencies are approving medical devices two years faster, on average, than FDA.

Paulsen further testified that FDA's long approval process and "lack of consistency, predictability, and transparency" have allowed European countries to lure away successful new biotech startup companies. Once the unopposed leader in the device market industry, the United States is losing its competitive advantage "not by cheap overseas labor or countries with more competitive tax structures, but by the bureaucracy within our own borders," Paulsen testified.

Paulsen, who serves as the co-chair of the bipartisan House Medical Technology Caucus, said that he hopes to make the approval process more predictable for biotech companies who feel "frustrated with what appear to be FDA stalling techniques." Observers are speculating that Paulsen will propose a change to the European standard of review for medical devices. The European standard demands a demonstration of safety and performance, compared to FDA's standard of safety and effectiveness.

Rep. Danny Davis (Ill.), a ranking member of the Reform Health Care subcommittee, said that a move to the European standard is "troubling to me because in the European Union, medical device manufacturers do not have to show that their product is actually effective." Rep. Elijah Cummings (Md.) also expressed concern. "If I needed a medical procedure, and certainly if my child needed one, I would want to know that the medical device being used is both safe AND effective," Cummings said in prepared opening remarks. "And if Medicare or Medicaid is going to be paying for any part of this procedure, I think the American taxpayer deserves to know that the medical device that they are buying works."

CDRH Director Jeffrey Shuren, M.D., J.D. also had doubts about the European model. "I'm actually astonished that some in the device industry are calling for us to lower our standards to that of Europe," Shurin testified. "I don't think it's in the best interest of patients ... or U.S. companies." FDA has said that it is addressing the concerns of Congress and the industry, and is conducting an internal review of its approval process. The proposed FDA timeline for internal changes can be accessed here.

Read Article online Here.