Cancer Institute Officials Urge Faster Drug Approval
Officials from the National Cancer Institute Wednesday joined the growing effort to change the approval process for new drugs to treat life-threatening illnesses, urging that “significant regulatory obstacles” that hinder the drugs’ development be removed.
“It is of utmost importance that the regulatory process not unduly slow the efficient transfer of the newest drug discoveries to cancer and AIDS patients,” said Dr. Bruce Chabner, director of the institute’s division of cancer treatment. “For many patients, certain drugs or drug combinations, while technically experimental, provide the patient with the only realistic hope for survival.”
Testify Before Panel
The officials were testifying before a new federal advisory panel convened by Dr. Armand Hammer, top executive of the Occidental Petroleum Corp., at the request of President-elect George Bush to study ways to improve the process of evaluating drugs for AIDS and cancer. The new panel is a subcommittee of the President’s Cancer Panel. It is expected to complete its work in about a year.
In recent months, there have been increasing complaints from the public sector--especially activist gay groups--and some federal health officials over the pace at which new drugs reach desperately ill patients. Last fall, about 1,000 angry gay demonstrators and their supporters attempted to shut down the headquarters of the Food and Drug Administration in suburban Maryland. About 150 protesters were arrested on misdemeanor charges.
In October, the FDA announced new, streamlined procedures that it said would hasten the drug approval process, but critics called the proposals “smoke and mirrors,” saying that they could not be implemented without significant increases in staff and funding.
Hammer and others said Wednesday that the FDA proposals are not adequate. “They’re just not enough,” Hammer said.
But FDA Commissioner Frank E. Young told the committee that improving the quality and speed of the process “continues to be FDA’s highest priority.”
“We are not complacent,” he said. “As commissioner, I pledge that FDA will continue to do all it can to ensure that important medical advances reach the desperately ill as soon as possible.”
Chabner told the panel that there should be greater leeway in allowing new drugs to be tested quickly on humans and that researchers should be permitted more flexibility in changing trials in their early stages to allow them to administer two or more experimental drugs that show promise working together.
Early Tests on Children
Further, Chabner said, the FDA should encourage the early testing of new drugs on children with AIDS and cancer, rather than waiting until they have first been tested on adults, “particularly in life-threatening diseases when there is currently no curative treatment.”
Also, he said, the institute believes that insurers and the Health Care Financing Administration should “negotiate a more liberal reimbursement policy” for experimental drugs.
“We are encountering a growing resistance on the part of government and third-party payers to reimburse for the costs of medical care to patients receiving experimental therapies,” he said. “ . . . Such a situation is clearly contrary to the Administration’s goal of delivering effective new treatments to the public as expeditiously as possible.”
