By Lisa Seachrist

Washington Editor

WASHINGTON — With the anniversary of the passage of the FDA Modernization Act (FDAMA) a mere six weeks away, the Federalist Society, a conservative and libertarian policy organization, hosted a meeting to look at how the agency is managing the law's implementation.

Industry and agency representatives, along with congressional staffers, participated in the forum.

Like House Commerce Committee members on Wednesday, key staffers who steered the legislation through the contentious 104th Congress to final passage in the 105th Congress took great pride in the results of their efforts: the reauthorization of the Prescription Drug User Fee Act (PDUFA), and the most sweeping changes to the FDA in more than thirty years.

"This legislation is, in my judgment, a matter we should celebrate," said Nick Littlefield, a partner at the Boston-based law firm Foley, Hoag, and Eliot LLP, and staff director for Sen. Edward Kennedy (D-Mass.) during FDAMA negotiations. "This enterprise was mired in hundreds of issues and fiercely held beliefs. At the end of the day, democracy triumphed," Littlefield said.

Nevertheless, industry representatives and FDA lawyers voiced concerns over whether the agency has adequately moved toward compliance with FDAMA.

Lisa Raines, vice president for government relations for Cambridge, Mass.-based Genzyme Corp., noted that her company had recently been informed that they would receive a not-approvable letter for a drug review although, under FDAMA, that type of action letter had been abolished in favor of less pejorative, completed-review letters.

When Genzyme pointed out that such action letters had been replaced under FDAMA, Raines said the FDA reviewer had never heard of the change. Raines printed the information from the FDA's web site and faxed it to the reviewer.

Critic Says FDA Reviewers Don't Know Regulations

Dvorah Richman, a partner in the Washington office of the Atlanta-based law firm King and Spalding, related a similar situation, in which a client was trying to provide a medical device to a patient as part of the expanded-access provision of FDAMA. The staffer was so unfamiliar with the procedures under the legislation that, in the end, the patient received the device under the pre-FDAMA mechanisms.

"My client, of course, was pleased with the end result," Richman said. "But it has been my experience that the FDA reviewers don't know the regulations and have no inclination to understand the new rules. I tell my clients that you map actions out for the agency under FDAMA, and you make it happen."

Richman said her impression was that understanding of FDAMA had yet to trickle down to many FDA employees who must review drugs and devices under the act.

William Schultz, deputy commissioner for policy at FDA, said that the agency has been focused on the large number of reports, guidance documents, rules and notices that they must produce as a result part of FDAMA.

"There are a number of efforts being undertaken at the level of the individual centers," Schultz said. "Each center has its own program. We will never be 100 percent successful."

Raines had much praise for agency employees as well, noting that some of the provisions in the fast-track drug program came directly from efforts that agency personnel took on their own initiative. For example, the rolling review of new drug applications allows the agency to start reviewing clinical data while the sponsor continues to gather the necessary manufacturing data.

As a result of that initiative, Crixivan (Whitehouse Station, N.J.-based Merck & Co.'s protease inhibitor) and Pulmozyme (Genzyme's cystic fibrosis drug) were able to receive rapid approval.

"We looked to the best regulatory practices found at the agency when looking at PDUFA and fast-track [drugs]," Raines said. "In industry we call it 'skunk works.' And rolling review was the result of skunk work."

Diane Robertson, a former FDA insider and current Kennedy staff member, pointed out that much of the legislation enacted with the passage of FDAMA will, by design, require further congressional review. For example, the incentives for pediatric studies of drugs will expire in five years without congressional action.

"Following the lead established with PDUFA, the pediatric drugs provision has a sunset clause in five years to give Congress and the agency an opportunity to determine whether the program is working," Robertson said. "We've created a situation where FDA issues will come up again and will be revisited by Congress."

In effect, Congress will have the opportunity to reassess issues ranging from the dissemination of medical information to the third-party review of medical devices, rather than simply passing cast-in-stone procedures that may be ineffective as medical breakthroughs come to light. *

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