NCPA - National Center for Policy Analysis

Medical Device User Fees: They're Not Working

October 27, 2014

In 2002, the Food and Drug Administration began extracting "user fees" from medical device manufacturers in exchange for the promise of faster device approval times. The FDA's approval process for medical devices was lengthy and slow, thus, as NCPA Senior Fellow John R. Graham has explained, the agency promised to use the fee revenue to improve application review time.

Has it worked? Graham says no: despite the increase in funds, the FDA has done little to improve its review time. A new study from the California Healthcare Institute confirms that the fees have been unsuccessful. According to the study:

  • There is an average lag time of three to five years between approval of medical devices in Europe and approval in the United States. That lag time has not improved since 2002, when user fees were first instituted.
  • From 2000 to 2006, medical device review time held steady. After 2006, review times became even longer; in 2010, review time was 60 percent longer than in 2000.
  • While there has been some improvement in review time in the last two years, it is still far higher than it was before the user fees were instituted.

Graham notes that the medical device industry supported the user fees in 2002 because they expected to see results. So far, little good has come of them.

Source: John R. Graham, "Industry's User Fees Fail to Improve FDA's Approvals of Medical Devices," NCPA Health Policy Blog, October 24, 2014.


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