- The Washington Times - Friday, January 31, 2003

WASHINGTON, Jan. 31 (UPI) — The Food Drug Administration said Friday it is launching a plan to speed the availability of new drugs and medical devices and make it cheaper for companies to develop innovative products.

The plan is intended to streamline the approval process to "improve the development of innovative medical technology and reduce the costs of technology development, while maintaining FDA's traditional high standard of consumer protection," FDA Commissioner Mark McClellan said in a written statement.

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The FDA is taking the step due to concerns that high costs of developing new medical products is forcing companies to make fewer of them. Although the agency approved more products overall last year, it received fewer applications and approval times increased for some drugs and medical devices.

"There is some evidence that this finding is a result of technology development becoming more costly," McClellan said. "These results call for decisive action now, so that the trends of the future are not toward fewer products with higher development costs," he said.

The Pharmaceutical Research and Manufacturers of America, a trade group representing major drug companies, released a statement Thursday reporting the number of new drugs in clinical trials in 2002 was up by 15 percent compared to 2001.

"2002 was a very good year for patients because of pharmaceutical research," PhRMA president Alan Holmer said in a written statement. "The future looks equally bright because of the rising number of new medicines that are in the research pipeline."

In addition, PhRMA's annual membership survey found companies increased research and development spending by nearly 8 percent last year to a record $32 billion. "These findings offer hope of important breakthroughs for patients in the future," Holmer said.

Asked how this fit in with FDA's concern about a potential shortcoming of new drugs, PhRMA spokesman Jeff Trewitt said, "The numbers we have calculated show that we are keeping up our end of the bargain." He said PhRMA has heard the concern before about a decline in new drug applications but added, "We have not studied the drug approval process in a comprehensive way."

PhRMA was still reviewing the FDA's plan Friday but Trewitt said, "We find it encouraging based on what we know about (it) at this point." The review time for new drugs has increased "and that could be cause for concern and it certainly is very encouraging that McClellan has put the drug approval process at the top of his agenda," he said.

The FDA plan will apply to drugs, vaccines, devices and veterinary medicines. A key part of the plan will be to improve communication with manufacturers so they know exactly what to include in their applications for new product approvals. This will help ensure their products do not have to undergo multiple approval reviews by the FDA, which will reduce "the delays and avoidable product development costs," the agency said.

"The whole statement is sort of a fraud," Sidney Wolfe, director of the consumer advocacy group Public Citizen's Health Research Group, said of FDA's plan. "Nothing is seriously wrong with the FDA approval process," Wolfe told UPI, noting the agency has a long history of trying to work with drug and device manufacturers to inform them of what is required in new drug applications.

"The FDA has invited companies to consult with them before" they conduct clinical trials and the companies have largely refused, Wolfe said. "The FDA can't go out to the companies' offices and beg them to do better studies," he added.

"FDA seems to be taking the rap for something that is primarily the fault of a withering industry," Wolfe said, adding the situation could be due to McClellan's "pro-industry" viewpoint.

"If there is a problem in medical product innovation, it's a problem with industry," Wolfe argued. Drug companies are not developing innovative products because the "therapeutic categories they make the most money in are choked with drugs already," including arthritis, pain-relief and high blood pressure medications, he said.

The FDA's plan also calls for enhancing its training of reviewers and taking other steps to improve the review process so it is more efficient. The agency will also develop clearer guidelines for developing products for specific diseases such as diabetes and obesity and emerging technologies such as gene therapy, pharmacogenomics and new drug delivery systems.

FDA officials did not return calls for comment.

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