FDA plans to implement reforms to speed approval of drugs

November 09, 1991|By Los Angeles Times

WASHINGTON -- The Food and Drug Administration plans to implement a series of reforms that will shorten dramatically the time it takes to approve new drugs, changes that are expected to save more than 1 million lives by the turn of the century, according to Bush administration officials.

The reforms, to be announced early next week by Vice President Dan Quayle, Health and Human Services Secretary Louis W. Sullivan and FDA Commissioner David A. Kessler, include an accelerated approval process for drugs to treat life-threatening illnesses and the use of private contractors to review applications for some kinds of new drugs, said the officials, who spoke on condition of anonymity.

The recommendations, proposed by the White House Council on Competitiveness, headed by Mr. Quayle, will reduce drug companies' research and development expenses by at least $1 billion a year, administration officials have estimated.

The reforms "will have a real impact both on lives saved and on costs for companies," an official said.

Federal regulators have been under growing criticism in recent years for the seemingly sluggish pace of bringing new and important drugs to the marketplace, particularly in the context of the AIDS epidemic. But FDA officials long have complained that they are too overburdened and understaffed to carry out their overall mandate.

The FDA already has initiated efforts to speed up the approval process for certain drugs used to treat life-threatening conditions such as acquired immune deficiency syndrome and cancer, but the sweeping reforms are expected to affect the approval of all drugs the agency reviews.

"For more than a decade, patients . . . health-care providers and the pharmaceutical industry have demanded that FDA simplify and expedite the approval of promising new drugs," said an internal White House report, a copy of which was obtained by the Times.

"Other modern industrialized countries have shorter development times and faster licensing systems, with the result that patients abroad have access to drugs not available in the U.S."

It takes an average of 9.75 years to bring a new drug to market. The process starts when a company begins preclinical, or non-human, testing of a compound, and ends when the FDA approves the drug for sale.

Under the new system, drugs for life-threatening diseases would take 5.5 years to develop, a reduction of 4.25 years. All others drugs would take seven years, a reduction of 2.75 years.

There has been little opposition to accelerating access to drugs for patients suffering from illnesses for which there are few if any therapeutic alternatives. But some have questioned whether speeding the process for other drugs would compromise their safety.

Administration officials dismissed such criticism. "Current delays in the system have nothing to do with a careful review of safety but have had more to do with an overburdened FDA," an official said. "Classes of drugs for non-life-threatening conditions have already been studied, so you're not breaking new ground. The reason for the delays is because the bureaucracy usually focuses on the big-ticket drugs, so the secondary drugs get backlogged."

Most pharmaceutical companies "don't separate their budgets, so their money for research and development includes a whole range of drugs," he added. "That's why it's important to ease the regulatory burden all across the board."

To implement the new system, the council recommended, the FDA should use qualified organizations outside the agency to participate in drug reviews and use existing FDA advisory committees to a greater extent and at an earlier stage in the process.

The council also proposed greater use of outside institutional review boards. Such boards typically review the design of clinical trials, particularly with respect to ethical issues and informed consent, for researchers about to begin such trials.

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