How can the FDA fix its device-approval process?

The U.S. houses many of the world's top medical device firms, and it's home to millions of patients with the means to pay for medical treatments at some of the best hospitals around the globe. Why, then, do so many devicemakers turn first to Europe to introduce their innovations?

According to Andrew von Eschenbach and Ralph Hall, the FDA's slow, outdated and ineffective device-approval process is to blame. Writing in The Wall Street Journal, the two contend that the agency desperately needs to reform its methods for the sake of American companies, investors and, most of all, patients.

European patients get access to new medical devices about two years earlier than Americans, the authors write, and the problem is getting worse: U.S. patients wait up to 60% longer today than in 2005 for innovative devices, according to the Government Accountability Office.

The problem, von Eschenbach and Hall write, is threefold:

  • The agency over-relies on clinical trials. While there is value in testing devices on patients, lab-based studies and computer modeling can often more effectively test for the wide range of problems that could emerge in the long term. Furthermore, the agency's yen for traditional trials isn't necessarily keeping patients safer. In a 6 year study, Hall found that more than 99.5% of medium- and high-risk devices were never subject to Class I recalls, and, for those that were, fewer than 9% of the cases could have been discovered with more clinical trials.
  • The FDA's postmarket surveillance is lacking. Instead of waiting on reports from manufacturers, patients and payers, the agency should embrace new technology to make its system more robust, the authors write.
  • And most importantly, according to von Eschenbach and Hall: The FDA and industry must collaborate throughout the development process, not just at its end. If the two parties can work together, everyone wins and safer products make it on the market faster.

And if the agency doesn't change? Von Eschenbach and Hall say the U.S.'s device industry will simply drift away from the American market. Already, 85% of venture-backed devicemakers polled in a 2011 survey said they plan to seek European approval first for their new techs, the authors report, and if the stateside process remains labyrinthine, they may ship their whole operations overseas, too.

- read the WSJ commentary (sub. req.)

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