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 FDAs lead deputy
commissioner, said at a consumer forum sponsored by the FDAs
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.
Jane Axelrad, Esq, associate director for policy at the FDAs
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,"
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 FDAs 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 FDAs
Center for Biologics Evaluation and Research, said that one of her
centers 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
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
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 FDAs surveys of high-risk medical devices.