Washington Editor

WASHINGTON - In one of his first acts as FDA commissioner, Mark McClellan on Friday released a plan aimed at helping the drug industry save money by reducing the time it takes a product to make it through the approval process.

The agency hopes to reach such a goal in part by communicating with companies earlier in the drug application process, and by providing clearer up-to-date guidance for particular diseases and for emerging technologies.

As part of the agency's report titled "Improving Innovation in Medical Technology: Beyond 2002," the FDA cites a Tufts University study that says cutting total clinical development and regulatory review time could produce a savings of $100 million (or 25 percent of total cost) per drug. The agency's press statement said, "Savings could be used by the sponsor [company] to develop other innovations, and passed on to patients as lower product prices."

McClellan, who was nominated to his post by President Bush in September and unanimously confirmed by the Senate in October, appears to be quickly winning support from the industry. (See BioWorld Today, Oct. 21, 2002, and Sept. 26, 2002.)

"Dr. McClellan is making significant strides at the FDA and we congratulate him on it," Steve Lawton, vice president of regulatory affairs and general counsel for the Washington-based Biotechnology Industry Organization, told BioWorld Today. "It is absolutely clear that he's taking a look as a physician and an economist, and his concerns of approval times for priority products is most welcome."

Of the report, Jeff Trewhitt, spokesman for Washington-based Pharmaceutical Research and Manufacturers of America, told BioWorld Today, "We are encouraged based on what we know about the plan at this point. It is essential to resolve the problems of the drug approval process at a time when so many potentially important medicines are pending in the regulatory pipeline."

Before McClellan came on board, his predecessor, deputy commissioner Lester Crawford, tried his hand at speeding the biologics review process by transferring some responsibilities from the biologics division to the drug division. The FDA has long known that it takes longer to move a biologic through the application process than it takes for a drug. In the past, the agency has blamed it on the complexity of the biologics applications.

Apparently there are other problems with the FDA's system, as noted last summer by several members of Congress during hearings about the business practices of ImClone Systems Inc., the New York-based company seeking approval of the cancer drug Erbitux. The agency was criticized for miscommunication while the company was filing its rolling biologics license application. Part of the problem centered on two sets of protocols for one trial. The FDA made a decision based on a protocol considered outdated by the company. (See BioWorld Today, June 18, 2002.)

To that end, McClellan's plan seeks to define the "root causes" of poorly designed trials so that the problems can be addressed before they occur and cost a company millions of dollars. Indeed, these root causes can result in "cycling," in which the application must be reviewed several times before it is approved. The Prescription Drug User Fee Act requires the agency to review - not approve or reject - a priority application in six months and a standard application in 10 months.

In his prepared remarks, McClellan said, "Improvement in the rate of single-cycle approval must result from better product development, not lower standards. It should benefit patients and general public health by expediting the availability of new medical products whose efficacy and safety are well documented in a more time- and cost-efficient manner."

When the FDA, in conjunction with the pharmaceutical and biotechnology industries, was seeking reauthorization of PDUFA last year, the agency agreed to spend $7 million over five years to pay for initiatives targeted at improving the review process. PDUFA gives the FDA authority to charge companies a fee when they file drug and biologics applications. (See BioWorld Today, March 26, 2002.)

According to the agency, in 2002 it cleared for marketing slightly fewer than 5,000 new drugs, biologics, medical devices and animal drugs, representing an increase of almost 400 new products over 2001.

While there were a significant number of innovative and life-saving products approved, the agency reports a decrease in the numbers of applications for "truly innovative products."

The agency says this is a worldwide trend that can be attributed to a weakened investment climate, a trend toward development of relatively minor improvements in the types of drugs already on the market, concerns that companies are interested only in "blockbusters," and additional time required for product developers to cope with new scientific findings such as advanced areas of genetics, genomics and proteomics.