The Clinton administration announced Friday that it would take steps to streamline the Food and Drug Administration’s rules to speed cancer drugs to patients.
President Clinton said the regulatory changes would apply to at least 100 drugs now under study. “Dozens of them will get to the market sooner and that means they can help Americans suffering from cancers of the breast, lung, ovary, prostate and colon, among others,” he said at the White House.
The administration hopes that the steps announced Friday will blunt a Republican drive to reduce the regulatory reach of the FDA. For some time Republicans have been pressing for changes at agencies like the Environmental Protection Agency and the FDA, arguing, for example, that delays in drug approval are bad for patients, drug companies and the nation’s competitive position.
The administration has already taken steps to streamline or reduce some drug approval regulations.
The reforms will go into effect immediately, said Dr. Donna Shalala, secretary of health and human services.
But the agency acknowledged that the new approach ran the risk of sometimes making drugs available whose safety and effectiveness had not been as thoroughly tested as they might have been previously.
Until now, makers of cancer drugs had to show that they could lengthen the survival of cancer patients or improve the quality of their lives before the drugs would be approved for marketing.
Under the new rules, however, all a company has to show is that the drug can measurably shrink the size of a tumor, even for only a short time.
In another significant change, the FDA will accept evidence of a cancer drug’s effectiveness from 26 other countries, essentially all those with some system for reviewing and approving drugs, rather than requiring lengthy testing in the United States.
Drugs approved in the 26 countries could become widely available in the United States long before companies submit applications for approval to market them.
Under this so-called expanded-access program, which already covers AIDS drugs, any doctor can get one of these drugs from its maker by promising to provide information on the outcome of the treatment.
The FDA said it would monitor the approval of drugs by the 26 countries so that the agency could quickly review data and permit such expanded access to a drug if there was evidence that it worked.
The average approval time for so-called breakthrough therapies for life-threatening diseases is six months, but it is longer for drugs that are very similar to those already on the market.
“Science has matured to the point where we can actually make much earlier decisions,” Dr. Shalala said. “This is a genuine reform, not just putting an artificial time frame on the FDA. We are reconceptualizing the drug-approval process based on science.”
Vice President Al Gore called the new initiative a “common sense approach to approving promising new cancer therapies.”
But the commissioner of food and drugs, Dr. David Kessler, said in a telephone interview: “We are taking a risk here. We are going to make mistakes in this process. There will be some drug that comes along that is not as effective as it looked like or has much more severe side effects than we thought. But that risk is worthwhile when patients are facing life-threatening illnesses, we feel.”
The Pharmaceutical Research and Manufacturers Association, the industry’s trade group in Washington and a leading backer of Republican efforts to modify FDA procedures, applauded Friday’s announcement as “long overdue.”
The statement said, “The administration’s effort is an acknowledgment that FDA must be reformed, and it draws attention to the need to pass comprehensive legislation to improve drug development.”
The main measure in Congress to streamline the agency’s drug-approval process was approved by the Senate Labor and Human Resources Committee on Thursday, by a vote of 12-4.
The bill, sponsored by Sen. Nancy Kassebaum, R-Kan., chairwoman of the committee, would require the FDA to evaluate every drug or medical device within six months. The bill also takes the first steps to turn over drug approval to private groups paid for by the pharmaceutical industry.