FDA Likely to Speed Approval of New Drugs

The Food and Drug Administration is expected to implement a series of reforms to dramatically shorten the time it takes to approve new drugs--changes expected to save more than 1 million lives by the turn of the century, The Times has learned.

The recommendations, proposed by the White House Council on Competitiveness headed by Vice President Dan Quayle, also will reduce drug company research and development expenses by at least $1 billion a year, Bush Administration officials have estimated.

The reforms “will have a real impact both on lives saved and on costs for companies,” said one Administration official, who requested anonymity.

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 burgeoning AIDS epidemic. But FDA officials have long complained that they are understaffed and too overburdened to carry out their overall mandate.

Although the FDA already has initiated efforts to speed up the process for a limited number of drugs to treat life-threatening conditions, such as AIDS and cancer, the sweeping reforms are expected to affect the approval of all drugs that move through the agency pipeline.

The proposals are slated to be announced at a press conference Tuesday by Quayle, Health and Human Services Secretary Louis W. Sullivan and FDA Commissioner David A. Kessler.

“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.”

The Council on Competitiveness, which has been studying the drug approval process for nearly two years, is a special panel established by President Bush to review the policies and practices of federal agencies and assess their impact on the economy.

“This (drug approval) area has been one of the council’s top two or three priorities,” the Administration official said.

Members of the council include several Cabinet members, White House Chief of Staff John H. Sununu, Budget Director Richard G. Darman and Michael J. Boskin, chairman of the Council of Economic Advisers.

The reforms, which the FDA can implement without new legislation, will require a budget increase for the agency, and Administration officials said Bush intends to ask Congress for the money. “The Bush Administration will support the added resources,” the official said, adding that the precise amount has not yet been determined.

The new system almost certainly will be welcomed by the pharmaceutical industry and by organizations representing the fight against various diseases. Both groups have been impatient with the time-consuming, cumbersome drug approval process now in effect.

It now takes an average of 9.75 years to bring new drugs to market. The process begins 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 savings of 4.25 years. All others drugs would take 7 years, a savings of 2.75 years.

There has been little opposition to accelerating drug access for patients suffering from illnesses for which there are few or no therapeutic alternatives. But some have questioned whether speeding the process for other drugs would compromise their safety, a trade-off that seems less justified since alternative therapies often are available for treating the affected condition.

Dr. Sidney Wolfe, director of the Public Citizen Health Research Group, said speeding up the process for such drugs “may well yield a significant risk because of dangers that might have been overlooked in the process,” with no significant benefit to patients.

“The companies will benefit: Their drugs get out of the starting block faster and can more easily compete with other drugs,” Wolfe said. “But, given that most of these drugs aren’t any better than existing drugs, the companies may benefit at the patient’s expense.”

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,” one 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.”

Moreover, he said, most pharmaceutical companies “don’t separate their budgets, so their money for research and development includes a whole range of drugs. That’s why it’s important to ease the regulatory burden all across the board.”

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

Typically, advisory committees are brought in only after the agency has begun its final pre-market evaluation of a drug. The council has proposed that the FDA tap committee expertise at an earlier point, during the development and execution of human studies.

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 who are about to launch such trials.

The council said institutional review boards should be allowed to approve a proposed human study of a drug, in lieu of FDA approval. Now, both the FDA and the review boards are involved in the process.

The council also recommended that the FDA take advantage of foreign approvals of drugs not yet sanctioned in the United States by using the resources already expended by other countries and, when possible, by forgoing repetition of clinical trials.

The council suggested that the FDA select two or three countries believed by the agency to have an approval process that ensures safety and efficacy. The council said the FDA should then initiate bilateral discussions to establish reciprocity for approvals, develop common standards for clinical trials, develop a common format for submission of drug approval applications, develop a common set of requirements for animal testing and develop criteria to govern good manufacturing practices and plant inspections.

The council also proposed that a new working group study the economic implications of such an arrangement on international trade.

Finally, the council recommended that approval of drugs for life-threatening or extremely serious illnesses, or for conditions for which there are no alternative medications, be accelerated by using earlier--but unproved--measures that indicate their potential efficacy.