Critics of the FDA's device approval process often call the agency clunky and sluggish, pointing to Europe, where the task of getting a device on the market is much speedier. There's just one problem with that assertion: It's completely false, according to an article in The New England Journal of Medicine.
Comparing data from the U.S. and the four top European markets, the two authors discovered that it takes a similar, if not smaller, amount of time to get innovative devices to patients in America. It takes just as long as in the U.K. and Italy, half as long as in France, and one-third of the time in Germany.
The key is device availability. The authors looked at the time from when a devicemaker files for approval to when the candidate device is in the hands of patients, and that's where the U.S. makes up ground. The process of obtaining a CE mark is often faster than FDA approval, but, in the EU, that clearance is followed by discussions of pricing and reimbursement that often dilate by months, keeping new devices from the market.
The major difference maker is the nature of insurance coverage between the two sides of the Atlantic. In the U.S., the majority of patients are covered by private insurers, which the authors say make decisions on coverage within a few months. In Europe, however, public payers are the norm, and those institutions are considerably slower to rule on innovative techs.
The authors of the article are Saptarshi Basu, a graduate fellow at Cornell University's Institute for Public Affairs, and John Hassenplug, an FDA operations research analyst.