U.S. to Speed Up Entrance of New Drugs Into Market

Health and Human Services Secretary Margaret M. Heckler, in what she called “the most important change in drug regulation in more than 20 years,” announced the implementation of new rules Thursday that will accelerate the entrance of new drugs into the marketplace by as much as six months.

The move will make “beneficial drugs . . . available to Americans more promptly,” Heckler said at a news conference.

She noted that the regulations “will dramatically speed up the review of new drugs, cutting as much as six months--or 20% on the average--from the two years or more that it now takes for drug approval.”

Heckler also said that additional rules expected shortly will simplify procedures for the “compassionate use” of drugs still in the research phase on patients with serious conditions “who are anxious to try the new therapies at the earliest feasible opportunity.” These rules also will require manufacturers for the first time to report adverse reactions or fatalities during clinical or human trials of an experimental drug.

In addition, Heckler outlined a broad, general “action plan” for the Food and Drug Administration that she said ultimately would “result in better drugs and medical devices for Americans, tighter and quicker safety review, productive relationships with private-sector manufacturers and a positive, supportive policy toward the technologies which can improve Americans’ health and lives.”

She called the shortened drug review process a response to the availability of new drugs in Europe, where such products often reach the public much faster than in the United States. “Individuals found they could more easily obtain these drugs in Europe,” she said. “This was one of the factors that led to the review.”

The new process provides for the concurrent review of data by chemists, pharmacologists and physicians, instead of the current sequential review, described by Heckler as “tortuous.” It also introduces a new standard application format, reduces the number of required individual case report forms and increases the use of foreign research data.

Heckler said the agency also would seek “better use” of outside scientists to complement existing staff by recruiting consultants, part-time researchers and “special FDA fellows” from the scientific and medical community outside the FDA.

To ensure that safety is not compromised, she said, the FDA will continue its “stringent” post-market monitoring of drugs by requiring manufacturers to report adverse drug reactions or deaths within 15 days.

New Data System Due

Furthermore, Heckler said, the FDA will build into its drug review process an automatic data delivery and transmission system that will enable companies to submit new drug applications electronically--an innovation she predicted will reduce paper work at the agency by as much as 70%.

“In the past, new drug applications have been delivered--literally by truck--in some 100 volumes, containing an average 100,000 pages of data,” she said.

The agency also intends to augment post-marketing surveillance by encouraging physicians and other health professionals to report adverse drug reactions directly to the FDA, rather than through manufacturers, she said.