FDA Reviews Modernization Act, Drug Approval Acceleration

WASHINGTON--The mission of the FDA has historically been to respond to public needs and to protect public health, and the 1997 Modernization Act "will not divert the agency from this agenda," Michael Friedman, MD, the FDA’s lead deputy commissioner, said at a consumer forum sponsored by the FDA’s Office of Consumer Affairs.

Dr. Friedman explained that the Act simply codifies what the agency had already been doing and adds a plan to match regulation standards of biological products to those of drugs and to further streamline the approval process for both.

He emphasized that despite these additional responsibilities, the agency plans to adhere to strict procedures to maintain the same high standards. He noted that the FDA has been provided with extra resources, such as increased revenue for staff support and computer infrastructure, that will allow the agency to manage the added workload.

Fast-Track Review

Jane Axelrad, Esq, associate director for policy at the FDA’s Center for Drug Evaluation and Research, said that section 112 of the Modernization Act, which deals with fast-track drug approvals, "essentially codifies our existing accelerated approval regulation."

Her center is concentrating on developing guidances on how to designate products for the fast-track procedure and how to review products so designated. "We are under a statutory deadline to make decisions on these designations within a 60-day period," she added.

Dr. Friedman said this fast-track review was developed to bring potentially lifesaving drugs for serious and life-threatening diseases, such as cancer and AIDS, and debilitating neurological disorders to the market quickly.

He said the FDA’s acceleration efforts have had dramatic results: Its drug approval times are now the fastest in the world.

A ‘Paperless’ Process

Rebecca Devine, PhD, associate director for policy at the FDA’s Center for Biologics Evaluation and Research, said that one of her center’s goals is to become "paperless" by the year 2002, that is, to receive applications for investigational new drugs, new drugs, and biologic licenses electronically. She emphasized that the center intends to maintain close communication with the industry to streamline clinical research on drugs and provide feedback on clinical protocols.

The Modification Act also addresses mammography standards. On October 28, 1997, the FDA issued final regulations that will take effect in April 1999 to establish quality standards for mammog-raphy personnel, equipment, and practices. Until then, mammography facilities will continue to operate in accordance with the interim regulations known as the Mammography Quality Standards Reauthorization Act.

Other measures of the Act include:

Stipulating that patients receive advance notice if a manufacturer plans to discontinue a drug on which they depend for life support or sustenance, or one used to treat a serious or debilitating disease or condition.

Abolishing the prohibition on manufacturers to disseminate information on off-label uses of their products .

Allowing drug companies to provide economic information to large-scale buyers of health care products so buyers can make informed procurement decisions; however, companies may not disseminate that information to individual medical practitioners whose prescription choices might be affected by cost.

 Ensuring, subject to certain conditions, that compounded drug products prepared by pharmacists to meet special needs continue to be permitted.

Beefing up FDA’s surveys of high-risk medical devices.