Prescription Remedies

A broad coalition of deregulators is gearing up to reform the FDA. How far will they go?

Rick Henderson from the August/September 1995 issue

(Page 3 of 3)

The MDMA's approach appears to be working. Barton praised the blueprint at the MDMA meeting. And freshman Sen. Rod Grams (R-Minn.) chose that same gathering to announce the formation of the Senate Medical Technology Caucus, which will concentrate on FDA reforms.

To date, no one has drafted comprehensive FDA legislation. Barton will hold hearings throughout the summer, saying that Congress won't have time to concentrate on FDA reforms until the budget is passed. Bills do exist in both houses to repeal export controls, but not much more is out there yet.

Meanwhile, medical manufacturers have to hope the FDA will sway with the political breezes. Industry and advocacy groups are pushing devices the FDA hasn't yet approved as "poster children" for reform: the Ambu CardioPump, a CPR device that is available in almost every country but the United States; the Canadian-produced Inventive Products Sensor Pad, a 9-year-old breast-cancer diagnostic device which consists of two sheets of plastic with silicone inside that greatly enhances the ability of women to detect lumps in their breasts; and the "bipolar" shoulder implant, developed by Richmond orthopedic surgeon Richard Worland in 1990. Ten countries approved Worland's implant in less than two months, but the FDA still hasn't approved it here, four years after Worland applied for approval. Ironically, Worland suffers from rheumatoid arthritis, needs a shoulder replacement, and may have to go to England to get his own device implanted.

And then there's Mark White, one of 50 device-making CEOs the MDMA flew into Washington for meetings with legislators before the trade group's annual meeting. White, an emergency-room physician in Indianapolis, had designed and produced a quick, safe, one-handed method for physicians to recap needles and remove them from syringes after they've injected their patients--a real help to a harried doctor. White began producing his "cap cards," which are about as big as a credit card and twice as thick, after complying with Occupational Safety and Health Administration guidelines established in 1988. While not a breakthrough life-saving device like, say, a heart valve, the cap card quickly found a market. Drug companies and medical suppliers started ordering the cards in bulk, using them as an advertising vehicle, and giving them to physicians.

Glaxo Pharmaceutical was ready to place an order for the cards. First, however, it asked to see a copy of White's "510(k)," the approval form the FDA requires before a medical device can be sold. White had sold cap cards before and considered them safety devices subject to OSHA regulations, not medical devices under the purview of the FDA. He had never submitted a 510(k) before, and says one of his customers told him to forget about the potential Glaxo account--the hassle of dealing with the FDA would cost far more than he would receive from the pharmaceutical giant.

"I should have listened to him," White says. Instead, in July 1993 he submitted a 510(k) to the agency. And that's when Mark White's troubles began.

White says his cap card should be "what you'd consider a Class I no-brainer"--a device that, like a tongue depressor or bed pan, poses no threat to the health of the patient or doctor if used as intended. But the cap card is used to recap needles, and an inadvertent needle stick could transmit hepatitis or the AIDS virus. The FDA thus ruled the cap card a Class III device, whose use is potentially as life-threatening or life-sustaining as an artificial lung or a dialysis machine.

"They turned my 510(k) into a full-blown approval process," White says. Even though the FDA is supposed to approve devices within 90 days of the submission of an adequate 510(k), 22 months from the time he submitted his application, White still hasn't gotten approval.

After spending more than $30,000 in a tug-of-war with FDA reviewers, White came to Washington for the MDMA meeting. Bruce Burlington, head of the agency's device center, had just addressed the group and told them how his agency was becoming more flexible and cooperative. White met Burlington in the hall, and showed him the cap card.

"Dr. Burlington told me, 'This is pretty neat,'" White says. "I asked him why his center considered it a Class III device. He didn't look too happy then."

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