It’s Not About Faster Approvals, but About Better Availability, says FDA Commissioner Hamburg

By Sangita Viswanathan
October 9, 2014


• Categories: 05-Quality/Regulatory, Market Access, RC - Medtech Regulatory Resource Center

The past few years have seen the same complaints from the medtech industry – delayed, and long approval process, a convoluted 510(k) system, lack of transparency in review processes, and as a culmination of all this, new and innovative medical device technologies seeking other markets – such as Europe – to be launched first there. What has changed?

At AdvaMed’s 2014 annual conference in Chicago this week FDA Commissioner Dr. Margaret Hamburg referred to some progress made by the agency in shortening approval timelines and in creating new processes for innovative but risky technologies to be reviewed and brought to market quickly, referring to FDA’s Expedited Access PMA program, which is intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition.

Hamburg also responded to a question about FDA working to encourage device makers to conduct their first-in-human trials in the U.S. and not elsewhere. It’s not about who’s first, but about getting the best possible product to people, Hamburg said, adding that in terms of market penetration, “approval in Europe doesn’t mean it’s broadly available in the healthcare systems of those countries.”

The expedited approvals can be attributed to the fact that they have a different system for review and determining reimbursement, she clarified. “If you look at how quickly a product actually gets into the market, some of the numbers aren’t quite as striking as the review timing,” she pointed out.

However, in a follow up discussion, Mark Deem, managing partner of medical device incubator The Foundry LLC, was not convinced, and described what he sees as a wholesale offshoring, with tax inversion deals looming, and more start-ups setting shop in Europe. According to Deem, “the horse has left the barn. And now we are just moving our early-stage medical device companies overseas, lock, stock and barrel.”

Deem particularly pointed to the area of clinical trials, which increasingly have been moving outside the U.S., largely due to FDA taking longer to approve trial designs. “People naturally need to make progress where progress can be made, so it’s going overseas,” Deem said. “The industry has institutionalized this as the way to do business.”

The EU is currently going through a phase of overhauling its device regulations, following safety issues such as the massive PIP breast implant scandal, involving over 300,000 women across 65 countries, who reportedly received these implants. FDA is working European regulators, Hamburg said, to transform regulatory practice – harmonizing standards and approaches, databases and ways clinical trials can be used for regulatory approval. It is expected that EU regulators may meet FDA mid-way – with their tightening of their review times, and FDA working to reduce their approval times, and make the process more transparent.