The Fda: No Heroic Measures Required

Just a few weeks ago, the Food & Drug Administration was threatened by a nasty, partisan struggle over its future. Republicans and their allies at conservative think tanks charged that the agency was killing people--to say nothing of jobs--by holding up approvals of lifesaving products. Democrats and consumer groups, in turn, blasted the critics' proposals to overhaul the agency. Their plans would "tear the fabric of the world's safest and most effective health-care system," declared Representative Ron Wyden (D-Ore.).

But instead of gearing up for an explosive confrontation, the two sides seem to be headed toward a consensus. "There's been a sea change," says Carl B. Feldbaum, president of the Biotechnology Industry Organization (BIO), a trade group. Instead of the right's radical proposals to relax the agency's high standards for drug approvals, Congress is likely to order a streamlining of many FDA procedures. That will mean farming out product reviews to outside experts, relaxing bans on exports of non-FDA-approved drugs and devices, and exempting stethoscopes and other low-risk medical devices from lengthy reviews (table). All of this would make life easier--and more lucrative--for food, drug, and medical-device companies.

HIDEBOUND. The shift away from confrontation stems from a mix of political expediency and the recognition on both sides that the issues are more complicated than they seemed. Democrats, for instance, are starting to acknowledge that parts of the agency are hidebound. And conservatives learned to their chagrin that they had accused the FDA of failing to approve products, such as a pump for cardiopulmonary resuscitation, that will have little benefit. What's more, companies told both sides that industry, in general, wouldn't sign on to their more radical schemes for gutting the agency--such as allowing many drugs to be sold without FDA review. "Their early shots were poorly aimed--and in many cases backfired," says a top FDA official.

Now, much to the surprise of the GOP, the Democrats are seizing the initiative. At an Apr. 6 hearing, for example, Senator Barbara A. Mikulski (D-Md.) warned FDA Commissioner David A. Kessler that without more progress in cutting approval time, "Congress is going to roll right over you." The same day, the White House, led by Vice-President Al Gore, unveiled a package of reforms that conservatives admit are a step in the right direction. Wyden also jumped in that week with far-reaching proposals that won industry plaudits.

The Democrats' proposals would eliminate two of the biotechnology industry's big bugaboos: the requirement that full-scale manufacturing plants be built before drugs are approved, and the need to get approvals for small changes in manufacturing processes. They also would throw a bone to medical-device makers by exempting many more products from review and reducing export barriers. And reformers hope to speed drug development by making it easier to get promising treatments into clinical trials.

But the Administration and its allies won't go along if the GOP tries to weaken protections in such areas as safety and efficacy standards for new drugs. "The White House thinks this whole thing is about getting the jump on the bad guys and keeping them from doing worse things," explains one top FDA official.

NEW WRINKLES. Many details remain to be negotiated, of course. For instance, experts predict a major tussle over whether companies should be allowed more freedom to publicize unapproved uses for products already on the market. Such a change would give Johnson & Johnson, for example, more latitude to plug its Retin-A acne treatment as helpful in smoothing out wrinkles--something the company has gotten into trouble for in the past. Republicans also are miffed that Kessler is still spending money on an antitobacco investigation. One bit of GOP strategy that's still undecided: whether to push for a single major reform bill, which could be as tough to pull off as the Clinton Administration's failed health plan, or several smaller bills.

Whatever approach the GOP takes, the odds are good that the two sides can reach a compromise. Neither will be entirely happy. But some deft minor surgery may be all that's needed to make the FDA more efficient--instead of the radical bypass operation some Republicans had been pushing for.


Reforms that the Food & Drug Administration may implement:

FARM OUT some product reviews to outside experts, speeding approvals

ALLOW EXPORT of some drugs and devices not approved for sale in the U.S.

EXEMPT LOW-RISK medical devices and routine changes in drug manufacturing processes from FDA reviews

SPEND LESS TIME reviewing applications to test drugs, allowing therapies to get into clinical trials faster and freeing up the agency for actual product approvals

LOOSEN TIGHT CONTROLS on advertising unapproved uses of products already on the market