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Legislating a New and Improved FDA

Medical Device & Diagnostic Industry
Magazine
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Originally published June 1996

James C. Greenwood

U.S. Congressman (R­PA)

Two months ago, more than 300 individuals and patient groups signed an "open letter" to Congress. They made an astounding statement, one that was powerful in its simplicity: FDA delays are killing people. Consumer protection means more than just keeping unsafe and ineffective products off the market. It is at least as important that safe and effective products are made available to people who need them as quickly and as efficiently as possible.

That's not happening now, not when it takes twice as long for approval of the average new medical device as it did just six years ago. Premarket approval reviews for medical devices, which are supposed to take 180 days by statute, average 773, twice as long as just five years ago. The average clinical testing time for investigational drugs has increased from 21/2 years in the Johnson administration to six years today.

Commerce Committee chairman Thomas Bliley (R­VA) designated me to head a team to spearhead the effort at meaningful, sweeping FDA reforms. We began by reviewing many studies and recommendations for FDA reform and scores of proposals now pending in Congress introduced by Democrats and Republicans alike in both the House and the Senate.

What emerged from that review, I believe, is a balanced, even-handed approach that will streamline the approval process to allow safe and effective drugs, devices, and foods to reach American patients and consumers more quickly and more efficiently. These proposals will enhance, not jeopardize, public health and safety.

At the outset, we redefined FDA's mission, stressing the objective of approving safe and effective products as quickly and efficiently as possible, and stressing the encouragement of new product development.

THIRD-PARTY REVIEW

On the issue of FDA-approved third-party review organizations, we will strike a middle ground between those who call for outright privatization of the agency and those who prefer that third-party reviews be used only as a stick when legislative carrots fail. Under our approach, applicants would have the option to use an independent FDA-approved review organization in every case, provided they bear the costs.

In my meetings with FDA commissioner David Kessler, he expressed concern about the effectiveness of the independent reviews. Under our plan, FDA will accredit qualified review organizations. FDA will monitor the activities of those organizations with tight, rigorous oversight and will review the recommendations of those organizations before any product can reach the marketplace. Such FDA-approved review organizations will use the same standards the agency uses. But unlike FDA, third-party organizations will be free of the bureaucratic delays and overload that currently slow the conventional approval process. By ridding ourselves of the bureaucracy, the average approval time for supplemental applications covering new uses for already approved products can be measured in weeks, not years, for example.

FDA has recently announced its latest initiative in this area, a limited experiment using third-party reviews for certain simple medical devices. However, this is not enough. It is a pity that as American heart patients travel to Italy for life-saving cardiac stents and FDA delays cause one-fifth of the U.S. medical device industry to move overseas, the best the agency can come up with is a pilot program for third-party review of tongue depressors.

Besides changes in FDA's mission and creating accredited review organizations, our legislation also will take the rapid approval approach that's now used for AIDS drugs and will soon be used for cancer drugs, and will make it applicable for all serious and life-threatening diseases.

FDA REFORM

In the Senate Labor and Human Resources Committee markup of Senator Nancy Kassebaum's FDA reform proposal, an amendment passed by a vote of 11 to 4 to allow a three-year experiment with third-party reviews of all medical devices, including Class III devices. This action makes a successful House-Senate conference on FDA reform a lot easier to imagine.

The House approach is more comprehensive than the Senate one. But these ideas have been kicking around for a quarter of a century, and by no means are they radical.

As for the House, we will soon begin legislative hearings in Chairman Mike Bilirakis's health subcommittee. Our ultimate goal is to report this legislation out of the Commerce Committee by mid-June.

Momentum is on our side. That's what prompted President Clinton's pronouncements about cancer drugs last March, and what prompted FDA's announcement of the pilot program for third-party reviews of some medical devices. Our goal, all along, has been to enact legislation that the president will be eager to sign.

I believe that we will pass a bill in the House before summer. A House-Senate com-promise on FDA reform has become a lot more likely based on developments in the Kassebaum committee.

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