New FDA Plan Will Aid City's Biotech Firms

A Food and Drug Administration (FDA) plan unveiled last week will provide a boost to Cambridge's biotechnology industry, officials at a number of local firms said yesterday.

The three-point plan, designed to aid the rapidly developing field, will greatly expedite the review and approval of new products, according to FDA Commissioner Dr. David Kessler.

"It was a very positive announcement," said James L. Vincent, chief executive officer of Biogen, a Cambridge pharmaceutical firm. "It's important not only for biotechnology, but for all the drug industry."

The plan, which was discussed at the monthly meeting of the Massachusetts Biotechnology Council in Boston, focuses on improving and accelerating the FDA approval process so that drugs will become available to consumers more quickly.

"For the young, start-up, single product company, the time taken up by the FDA review process can mean the difference between success and failure," said Kessler in a speech to the council last Thursday.

"And for the patient who desperately needs the new therapies, the speed of the review can literally mean the difference between life and death," he said.

The most significant provision of Kessler's plan is the creation of 50 additional FDA research and review staff positions. These new employees will work exclusively on evaluating biotechnology products.

"We know that the review time is critical to the industry," said Kessler. "We are positioning ourselves to meet the demands of an ever-growing number of product licensing applications."

Mark Goldberg, director of the Massachusetts Biotechnology Research Institute, said the additional appointments will be of the utmost importance in improving the efficacy of product review.

Improved Coordination

In addition to the appointments, the FDA will establish a collaborative working agreement between the Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research, two federal agencies which oversee the drug approval process.

The new plan will attempt to coordinate better the efforts of the two centers in the interest of minimizing delays. It will ensure that the center with responsibility for medical review of drugs is separate from that which retains power over administrative actions and review of product quality, Kessler said.

Vincent said the coordination of efforts would expedite the clinical trials in the approval of testing for AIDS and cancer drugs, and would therefore be extremely important for the drug industry as a whole.

But the federal government can help the biotechnology industry even more by further harmonization of its agencies, Kessler said.

In order to supervise the plans outlined by Kessler, the FDA has elected a new director of the Center for Biologics Evaluation and Research, FDA regulator Dr. Kathryn C. Zoon.

The measures announced by Kessler are of landmark importance not only to the biotechnology companies in Cambridge, but also to those of the entire nation, firm representatives said.

And Vincent agreed, saying that the nation's status as a leader in biotechnology research is largely dependent on the efficiency of its federal agencies.

"The FDA is not a theoretical bogey man," said Vincent. "It's a reality that can change U.S. competitiveness."