Washington Editor

WASHINGTON - Policy changes implemented during the short tenure of former FDA Commissioner Mark McClellan often were viewed as favorable to the industry because they usually improved the regulatory process of drug approval.

But a few insiders believe there's room for more transparency and improvement within the agency.

Michael Petty, an attorney with Ropes & Gray LLC, of Boston, offered a few suggestions on Friday about how the FDA could further improve its relationship with the industry.

Petty, alongside Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research (CBER), were panel members at the Food and Drug Law Institute's 47th annual Science, Regulation, Business and Law Conference held here.

The panel, charged with bringing attendees up to date on CBER business, met one day after McClellan, administrator for the Centers for Medicare and Medicaid Services, and Lester Crawford, acting FDA commissioner, addressed the same audience about improving the speed and method at which drugs and biologics make it through reviews.

Unlike Goodman, McClellan and Crawford, Petty views the situation from a different vantage point - that is, he's an attorney whose firm represents small biotechnology companies.

Bearing that in mind, Petty started out by praising the FDA for inviting external consultants to sit in on meetings between the industry and agency. The independent consultant program was approved in mid-2002 as part of the reauthorized Prescription Drug User Fee Act (PDUFA) III. (See BioWorld Today, May 23, 2002.)

Regarding PDUFA III, Goodman said that CBER in 2003 reached all of its performance goals associated with drug review.

According to figures released by the FDA, CBER approved 22 biologics license applications in 2003, compared to 21 in 2002 and 16 in 2001. The median review time for priority BLAs (six in total) was 12.1 months, up slightly from 12 months in 2002 (five in total). The median approval times for regular user-fee BLAs was 20 months, down from 28 months in 2002, and the median approval time for non-user-fee BLAs was nine months, compared to 13 in 2002. (See BioWorld Today, Jan. 20, 2004.)

Overall, the FDA said the median review time for BLAs in 2003 was 12.8 months, compared to 12.9 months in 2002 and 13.8 in 2001.

The figures do not include all product classes, since many were transferred to the Center for Drug Evaluation and Research (CDER). Classes currently under the authority of CDER include monoclonal antibodies for in vivo use; cytokines, growth factors, enzymes, immunomodulators and thrombolytics; and proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions of those products (except clotting factors). (See BioWorld Today, June 30, 2003.)

The transfer of certain responsibilities from CBER to CDER was intended to improve efficiency and speed the review of biologics.

Meanwhile, as part of PDUFA III, the agency vowed to improve its communications with companies. Again, that is an area that McClellan has addressed in many speeches. For his part, McClellan believes drug companies could save money and introduce new breakthrough drugs to market more quickly if they could head-off problems in the regulatory process and avoid multiple review cycles.

Petty suggested a little more work could be done in that area, particularly from the standpoint of clinical holds.

"I know the agency tries to be sensitive to this," Petty said. "But the impact of a clinical hold on a small biotech company can be catastrophic. It has been incredibly valuable in the past when the agency has gotten with a company before it gets to the point of a clinical hold."

Petty suggested that the agency conduct more workshops so the industry can gain a better understanding of what's expected. Issues of that nature are expected to be handled in the critical path initiative introduced by McClellan. The initiative will be further discussed at the FDA's upcoming Science Forum. (See BioWorld Today, April 15, 2004.)

Nevertheless, Goodman responded to Petty's comments by saying that the agency does its best to communicate with companies, but oftentimes, FDA suggestions fall on deaf ears.

"If we suggest that a study could be done in a certain way and it doesn't work out, then everybody is mad at the FDA," Goodman said. "And sometimes when we suggest something, companies interpret it as meaning that it must be done in a certain way."

Whatever the case, Goodman said companies are responsible for deciding how to develop their own products.

Another area of concern for Petty is the agency's dispute-resolution process.

Petty said companies complain that the agency's ombudsman only handles administrative and procedural matters, while most disputes are related to science.

Petty also suggested that the agency consider providing guidance on regulations and processes surrounding orphan drugs, and on its view of follow-on or generic biologics.

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