FDA seeks to clear away obstacles to drug development

Washington -- Troubled by the trickle of innovative drugs in the nation's pharmaceutical pipeline, the Food and Drug Administration is offering a helping hand to speed research findings from bench to bedside.

"Many of the most dramatic scientific findings in the lab have not yet had an impact on patient care," said FDA commissioner Mark B. McClellan, MD, PhD, when unveiling the recommendations on March 16.

Despite an explosion in genomics, proteomics, nanotechnology and next-generation information technology, fewer new products are actually reaching the FDA, he said.

To spur on the process, the FDA will hold workshops and other meetings to discuss ideas, said Dr. McClellan in a briefing on the agency report, "Challenge and Opportunity on the Critical Path to New Medical Products."

The agency is well-positioned to provide help because few other groups are able to see the broad picture of drug development, according to the report. The FDA can determine why some products fail while others succeed and can provide advice that would enable firms to avoid pitfalls.

"We think by identifying concrete examples of obstacles on the path from good ideas to safe and effective treatment, we can work much more effectively with outside groups," said Dr. McClellan.

He said the FDA intends to take on roles similar to those held in previous years that resulted in:

• Development of new animal models for assessing safety and efficacy of medicines to combat anthrax, smallpox and other possible bioterror agents.
• A large, four-company trial to compare the accuracy of digital and conventional mammography.
• A joint effort with the Centers for Disease Control and Prevention that produced target viral assays required for the successful manufacture of blood screening tests for West Nile virus.
• More than 250 approvals of orphan drugs during the past 21 years.

Yeas and nays

The Pharmaceutical Research and Manufacturers of America welcomed the FDA's overtures. "We have been actively engaged for more than a year in looking at ways to facilitate pharmaceutical innovation and speed important medicines to patients in partnership with the agency," said Caroline Loew, PhD, PhRMA's vice president for scientific and regulatory affairs.

Carl B. Feldbaum, president of the Biotechnology Industry Organization, called the report "a courageous statement from a government agency recognizing the serious problems that are preventing new, innovative drugs and biologics from getting to the patients who need them."

Although companies have made strides in the drug discovery process, said Feldbaum, the costs and difficulties of seeing a product through to completion "cannot be overstated."

However, those costs were questioned by Sidney Wolfe, MD, director of watchdog agency Public Citizen's health research group. "The agency's claim that the cost of bringing a new drug to market, between $0.8 and $1.7 billion, was inflated," he said. "So they lose credibility right off the bat."

"While there is little doubt that the pipelines of these companies are empty of new drugs, the companies' themselves are at least partly at fault," said Dr. Wolfe. "The companies seem hell-bent on developing an unprecedented number of 'me-too' drugs."

Pharmaceutical firms have even gone beyond developing drugs that involve only slight changes from those already on the market to selling exactly the same drugs as those already available, he charged.

It would be more helpful to pass a law denying approval of a new drug unless there is evidence that it is safer and/or more effective than an old drug, said Dr. Wolfe.

"But that wasn't even mentioned in this dogma paper," he said.

Another useful law would be one requiring a head-to-head comparison between drugs, added Dr. Wolfe.