By Lisa Seachrist

Washington Editor

WASHINGTON — Whoever the Clinton Administration picks to step into David Kessler's shoes as FDA commissioner will face the task of reforming an agency that became increasingly entrenched under Kessler's tenure, according to a panel assembled by the Washington Legal Foundation, a pro free enterprise policy center.

The panelists identified management, regulatory and trust issues that the agency needs to address in order to speed drug and medical device development and approvals and make the agency more efficient and responsive to the needs of the industries it regulates.

While the project may be daunting, the panelists advised the new commissioner to look to the reform efforts of the 104th Congress for guidance.

"The first thing for the new commissioner to do is to pull out the draft legislation from the last Congress," said John Calfee, resident scholar at the American Enterprise Institute. "On the whole those reforms were quite moderate."

Calfee pointed out that some of the regulatory reforms suggested in those drafts were implemented under Vice President Al Gore's Reinventing Government Initiative. For example, Calfee is encouraged by the proposed guidelines the agency released last week that would ease requirements for adding new indications to the label of already- approved cancer therapies.

"What they would create are 'paper new drug applications' that would allow companies to provide existing data as support for the new indication, rather than another set of clinical trials," Calfee said. "We have seen this before. I hope something comes of this proposal."

Alan Slobodin, majority counsel for the House Com-merce Committee, agreed, noting, "these ideas are not new, they have been kicking around for very many years."

Even so, whoever takes the helm at the FDA will need to establish a consensus for these changes as well as for management changes in an agency that resists change, Slobodin pointed out.

Slobodin attributed much of the difficulty to the fact that, with a six-year tenure, Kessler served a relatively long term as commissioner. "[Changing the management] at FDA is going to be an unprecedented challenge," Slobodin said. "Kessler has left a legacy of political appointees in the agency."

In addition, Kessler established four new deputy commissioner positions at the agency. Larry Pilot, a partner with the Washington law firm of McKenna & Cuneo, said these positions served only to create another supervisory layer, separating the commissioner from the people conducting FDA business.

"At a time when industry was downsizing, the agency was adding more management layers," Pilot said. "It is important to take a good look at the organization of the agency. I suspect there are a large number of supervisors over relatively few employees."

Calfee added that the agency also needed to harmonize its procedures within itself.

"How quickly you pass through the approval or inspection process often depends on which district you are in and which reviewer or division of the agency handles your product," Calfee said.

In the 104th Congress, both the Senate bill and the House bill provided provisions for third-party review of drugs and medical devices. "It is time for the commissioner to contemplate the role of third-party review," Pilot said.

Slobodin noted that in addition to scientific review, third parties can offer the agency a way to resolve disputes between industry and the agency over potential breaches of confidentiality, as well as offer assurances about scientific decisions.

"There have been several cases over the years of the agency having difficulty protecting confidential information," Slobodin said. "It is impressed upon me that the agency is going to have to use outside consultants to settle these sorts of disputes."

Slobodin and Calfee also identified drug development time as an area the agency would need to address. "Drug approval times have been dropping," Calfee said. "But, drug development time has been skyrocketing, largely because the agency enters into the picture too early in the process."

Calfee said that the agency is too involved with the design of clinical trials and that this early development serves only to slow drug development. Calfee also suggested that the agency needs to keep the regulation of advertising out of the approval process.

"The next commissioner will have to look at how the agency regulates advertising information and promotion," Calfee said. "There is no reason to assume that a practice guideline of the American Heart Association is intrinsically misleading if it is distributed by a pharmaceutical company."

While none of the panelists claimed to have any knowledge about who the leading candidates for the job may be, they all noted that changes in the agency are necessary. And, they pointed out, the job will be quite a challenge.

"What has been proposed is modest but essential," Pilot said. *

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