Originally Published MDDI February 2002
Whoever is ultimately named to lead FDA will face an aging regulatory structure for medical devices. The time may be right for a bottom-up review of medical device law.
As of this writing, it has been slightly more than a year since the Food and Drug Administration has been led by a commissioner. According to many sources, the Bush administration is about to nominate a candidate, so it appears that President Clinton's record delay of nearly two years in naming previous commissioner Jane Henney will remain unchallenged.
We have decidedly mixed feelings about this situation. On the one hand, no one truly benefits from a leaderless FDA. Particularly at a time when the head of Health and Human Services, Tommy Thompson, is occupied with the aftermath of September 11, the void at the top within FDA is worrisome.
On the other hand, this delay could be an opportunity in disguise. As established by the 1976 amendments, the regulatory framework governing medical devices is now nearly 30 years old. Despite several legislative adjustments in the interim, the law has been vastly outpaced by advances within the medical device industry. Before naming and confirming a new commissioner, perhaps the administration and Congress should agree to review and rethink medical device regulation in the next year.
In fact, the House is now considering amendments to the medical device law. Introduced by James Greenwood (R–PA) and Anna Eshoo (D–CA), HR 3580 proposes several significant revisions to the FD&C Act. These include
There is little to object to in these proposals. The emphasis on dealing effectively with combination products and speeding review of new types of devices is particularly welcome. But is this legislation enough to prepare the agency for the new devices of the 21st century? We suspect not.
Incrementalism will not be sufficient for the future of medical device regulation. As radically new technologies proliferate in the industry, the old regulatory framework will be increasingly challenged. The goals for industry, government, and the public will remain the same: to bring safe and effective medical devices to the market as quickly as possible. But the way to reach these goals is changing. Moreover, reforms must not just address approval and oversight of the devices, but must streamline reimbursement as well.
As the next commissioner is named and confirmed, we hope Congress will consider forming an advisory panel to do a bottom-up review of the current regulatory structure. Particularly if the new FDA chief is a partner in the process, the outcome could be extraordinarily positive for industry, regulators, and the public.
Three years ago in these pages, Kshitij Mohan, then head of research at Baxter, wrote that "since the 1960s, enough advances have occurred . . . that the best of the medical device industry may be yet to come. Some of these advances, such as the wildfire progress of information technology and the further maturing of biological sciences, could well lead to a paradigm shift in our industry."
That paradigm shift is nearly upon us. It is time for the regulatory side to catch up.
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