The Wall Street Journal - 29 March 1996
Hilary Stout and Laurie McGinley Staff Reporters of The Wall Street Journal

The measures, expected to be announced today by President Clinton, are aimed at giving promising cancer therapies the same fast-track treatment new AIDS drugs have been receiving. Administration officials hope the changes, which take effect immediately, will slash FDA review time of new cancer-drug applications by more than half, to about six months from an average 12.4 months. Officials also estimate the changes will knock up to a year off cancer-drug development times, which normally range from three to 20 years.

There are currently more than 200 cancer drugs under development in the U.S., with applications for 19 of them pending before the FDA, including Immunex Corp.'s leukemia drug Leukine, Bristol-Myers Squibb Co.'s lung-cancer drug Etopophos and Zeneca Group's breast-cancer drug Armidex, according to Pharmaceutical Research and Manufacturers of America. Administration officials estimate that about 100 of the drugs in development could get quicker approval as a result of the change in the FDA's review criteria.

"We will have to redefine our strategy for all our drugs currently under development," said Andrew Dorr, medical research adviser to Eli Lilly & Co. "This will shorten it a lot and make it a lot less expensive." But, he added, "there is some risk in this" because the drugs may not have as extensive preapproval testing.

The measures revise the criteria for approval of cancer drugs, giving the agency the authority to approve drugs based on "partial responses," such as a therapy's effectiveness in shrinking tumors. Until now, a cancer drug had to demonstrate improvement in patients' survival time and in quality of life -- both of which required a much longer period of evaluation.

The FDA will also begin "actively soliciting" makers of cancer drugs approved abroad but not in the U.S. to submit their therapies for use in experimental programs. "This will help make experimental therapies available to patients shortly after they are approved in other countries even if they are early in their development within the United States," a draft document outlining the measures says.

Administration officials say cancer science has developed to the point that tumor shrinkage and other partial responses are clear indicators, called surrogate markers, of prolonged survival and enhanced quality of life. Consequently, they argue, the science justifies the changes.

The initiative comes as the FDA is trying to fend off congressional efforts to overhaul the agency, and some FDA critics suggested that the timing was intended to blunt the FDA-overhaul movement. Both the House and Senate are working on bills that would increase the role of private reviewers in conducting drug approvals -- a step that FDA critics say would expedite drug approvals but that FDA defenders say would raise fundamental questions about the role of the agency.

In 1992, the FDA put in place procedures to speed approvals for drugs for life-threatening illnesses. Those changes have led to the lightening-fast approval of a new class of breakthrough medications, called protease inhibitors, for AIDS. One such version, manufactured by Merck & Co., was cleared earlier this month after just six weeks, the fastest FDA drug approval ever.

AIDS activists in recent years have used their political muscle to press the agency to speed approvals to treat the disease. In general, cancer drugs haven't gotten such fast handling; administration officials say that's largely because it had been thought that there aren't as good surrogate markers for cancer as there are for AIDS. Some cancer activists say the lack of speedy approvals also may be the result of their group being less organized and politically active than their counterparts in the AIDS community -- something they aim to change.

"We are clearly willing to work inside and outside the FDA to get what we need for people with cancer," said Ellen Stovall, executive director of the National Coalition for Cancer Survivorship, which comprises individuals and organizations.

In any case, while most cancer activists are likely to be pleased with the changes, the new cancer intitiative won't solve all the differences between the FDA and some activists, who have been critical about the lengthy review process for the drugs and about the widest possible use of therapies.

Many cancer groups are opposed to the agency's rules that prohibit companies from promoting the unapproved uses of drugs already on the market. The cancer groups, who say that much of cancer treatment involves these so-called off-label uses, want the policy softened so that the companies can volunteer to physicians articles from medical journals and other sources.

The FDA and some other patient groups have argued that allowing drug companies to promote off-label uses of drugs will only discourage the companies from doing the testing needed to get official approval for additional uses.

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