Washington Editor

WASHINGTON - During Mark McClellan's first full year as head of the FDA, the agency said it stepped up the pace of drug reviews and slightly increased the number of overall approvals.

All told, the agency's Center for Biologics Evaluation and Research (CBER) approved 22 biological 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.

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.

Clearly, every day counts when companies are hoping to launch, and based on his policies and public comments, McClellan, an internist and economist, appears to be acutely aware of that.

About a year ago, McClellan released a plan aimed at helping the industry save money by reducing the time it takes to make it through the approval process, which often takes years due to numerous "cycles." (See BioWorld Today, Feb. 3, 2002.)

The cycles occur when an application is reviewed several times before it is approved, oftentimes because of poorly run trials or incomplete data. McClellan's plan seeks to define the root causes of delays that then can be addressed before they end up costing companies millions of dollars.

Another element of McClellan's plan to improve the process involves a quality-systems approach in which best management practices are identified and implemented internally for the FDA's scientific review processes.

In a prepared statement, McClellan said, "[The] FDA is committed to using the latest science and all our available resources to get innovative, safe and effective medical technologies to more patients, and helping to reduce the costs of developing these products, while maintaining the agency's traditional high standards of consumer protection."

Meanwhile, Carl Feldbaum, president of the Washington-based Biotechnology Industry Organization, told BioWorld Today: "I think the results show that Commissioner McClellan is walking the walk and this is not just about verbal encouragement to reviewers; this is hard ana-lysis of what it takes to reduce, for example, multiple cycle reviews. This shows evidence of hard work within the agency to streamline the process. We're certainly encouraged by this continuing development."

Beyond BLAs, the Center for Drug Evaluation and Research (CDER) reportedly approved 72 new drug applications, compared with 78 in 2002 and 66 in 2001. Of the total approved, 21 were new chemical entities (NMEs), up from 17 in 2002. Priority approvals, or approvals for products of special medical importance, increased to 14, nine of which were NMEs, compared to 11 and seven in 2002, respectively.

The median approval time for CDER's priority NDAs was 7.7 months, compared to 19.1 months for 2002. The FDA said the higher 2002 figure could be attributed to a few applications with unusually long regulatory histories; when only a small number of applications are approved, older applications can have a notable impact on the median, the agency said.

The median total approval time for standard NDAs was 15.4 months, compared to 15.3 months for the previous year.

CDER also approved 362 generic drugs in 2003, compared with 384 in 2002.

PhRMA To Seek New Leader

After five years of running the Washington-based Pharmaceutical Research and Manufacturers of America (PhRMA) trade association, Alan Holmer, president and CEO, will retire.

Holmer said he'll stay on board until a successor is selected.

Robert Essner, chairman of PhRMA's board and chairman and CEO of Madison, N.J.-based Wyeth, released a prepared statement saying, "I understand and respect that Alan considers this the right time for the board to designate a successor to build on his many accomplishments. The timing of this announcement gives us sufficient time to designate a successor and achieve a smooth transition."

Appropriations Bill With Patent Language On Table

Congress reconvenes today for the second session of the 108th Congress, and among the legislation expected to be handled is the omnibus appropriations bill.

The legislation is key to the biotechnology industry this year because it includes an amendment introduced by Rep. David Weldon (R-Fla.) that prevents the U.S. Patent and Trademark Office (USPTO) from issuing patents on "human organisms." (See BioWorld Today, Dec. 22, 2003.)

At issue is the interpretation or definition of human organisms.

Michael Werner, chief of policy at BIO, has told BioWorld Today that he believes the amendment is meant to reaffirm current USPTO policy, which prohibits the patenting of humans. Nevertheless, he admits the language is a little imprecise and he's concerned that it could be interpreted more broadly.

The appropriations bill passed the House in November and is expected to pass the Senate early in the session. Since it is part of the larger omnibus appropriations spending bill, it would have to be approved (or rejected) by Congress annually.

No Comments