The Wall Street Journal - 22 Feb 1996
Laurie McGinley, Staff Reporter of The Wall Street Journal

Last year, drug-company officials and conservative think tanks dominated the debate, bashing the agency and demanding major changes. This year, patients' groups are jumping into the fray on both sides, and will have a big influence on the ultimate fate of the FDA.

The biggest and best organized is the Patients' Coalition, which is made up of more than 50 national nonprofit health groups, including the American Cancer Society, the Arthritis Foundation, the National Hemophilia Foundation and several AIDS organizations, such as AIDS Action Council and Gay Men's Health Crisis. The coalition is rushing to the FDA's defense, urging Congress to reject proposals it says will weaken the FDA and hurt consumers. But some patient groups take an opposing view and are pressing for sweeping changes at the agency.

Yesterday, the battle was joined as Chairman Nancy Kassebaum of the Senate Labor and Human Resources Committee began hearings on her bill to overhaul the agency. Derek Link, a spokesman for the Patients' Coalition and an assistant director at the Gay Men's Health Crisis, warned that several provisions in the bill could weaken FDA standards that ensure that drugs be safe and effective.

In particular, Mr. Link objected to provisions that would establish strict deadlines for drug approvals and require the FDA to use outside, private reviewers if it failed to meet the deadlines. He also faulted a provision to allow drug firms to submit one, rather than two, well-controlled studies as proof of effectiveness.

Mr. Link's testimony echoed comments from FDA Commissioner David Kessler, who warned that if the FDA were pressed to review drugs within four to six months, as required under Sen. Kassebaum's bill, the agency ultimately would make a mistake. "If something goes wrong, I'm going to be sitting here answering the question, `Where was the FDA?'"

But Ellen Stovall, executive director of the National Coalition for Cancer Survivorship, took a different view, arguing that the FDA hasn't been responsive enough to people with cancer. She urged the panel to pass legislation requiring the FDA to speed drug approvals and to allow companies to distribute scientific information on alternative, unapproved uses of approved drugs. "We are tired of watching more people die while they continue to work on these issues," she said.

The Patients' Coalition was begun last summer after several nonprofit health groups got tired of hearing industry proposals described as good for consumers when they didn't support them. They were particularly irked that a GOP-backed FDA-reform conference last fall, entitled "Putting the Consumer First," featured only industry representatives and congressional critics of the FDA.

"We had the industry hijacking the patients' perspective," says Michael Langan, policy director for the National Organization for Rare Disorders, a nonprofit group for people with unusual diseases.

Some AIDS groups criticize the Patients' Coalition for being too cautious. Jules Levin, director of the National Aids Treatment Advocacy Project, says that while he applauds the agency's recent rapid-fire approval of promising AIDS drugs, "the question is, will the FDA be this fast next year, when the political pressure passes?"

Meanwhile, the industry is trying to work to counteract the coalition. On Tuesday, the Pharmaceutical Research and Manufacturers of America, the main drug-industry trade group, paid for an advertisement in the Washington Post that featured the American Autoimmune Related Diseases Association and stressed that FDA reform could be accomplished without hurting safety and effectiveness. A letter circulated by the trade group calling for reform legislation was signed by several other groups, including the National Depressive and Manic-Depressive Association and the Spina Bifida Association of America.

Nevertheless, the Patients' Coalition, with its roster of well-known members, is emerging as a major FDA ally. Even its detractors say it represents one of the agency's best hopes for staving off big changes. "The Patients' Coalition could have a very damaging effect" on efforts to reshape the FDA, says Jim Driscoll, director of AIDS policy for the Log Cabin Republicans, a gay Republican group that backs a restructuring of the agency.

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