[ SF Chronicle & Washington Post articles below ]
WASHINGTON -- The Food and Drug Administration is planning to switch approvals of biotechnology drug products from its biologics division to its drug division, a change that could help speed the approval of biologic-drug applications, according to people who have been briefed on the matter.
The change, which could be announced as early as Friday, is considered important to the biotechnology industry, which has complained about the slow approval process and inconsistent standards between the two divisions -- one focused on traditional drug products, the other on relatively new biotechnology products.
A person briefed on the change Thursday said that biotechnology companies have "complained for years" that their approvals took longer compared with reviews for traditional drugs. Industry officials have seen the drug division as more responsive to industry and better managed. While the biologics center has often pointed out that biologics products rely on newer, more complex science, the industry has said the division simply doesn't move as quickly.
The biologics division was also singled out for criticism recently by the House Energy and Commerce Committee, which was investigating the stock-market collapse of ImClone Systems Inc. While much of that investigation has centered on insider trading allegations, the committee also found that the division's approval process "needed improvement." The trading occurred just before the division refused to consider an ImClone cancer-drug application.
Outside of the criticisms of the biologics division, industry and congressional sources said it makes sense to have the same set of standards apply to all drug products coming to the FDA for approval. Right now, the feeling is that applications are subject to different scientific standards and levels of proof between the two divisions.
An FDA spokesman had no comment.
Congressional officials were informed of the change Thursday, and were told a formal announcement was imminent. The biologics division will retain many of its functions, including those over blood products, vaccines, gene therapy and tissues. It is expected that the reviewers themselves will be shifting divisions, meaning there won't be new people reviewing applications, according to people briefed on the change. But by blending operations with the larger drug division, the biologics reviews could come to employ many of the same standards as drug reviews.
Some new drugs developed through biotechnology will be approved in the future by the Food and Drug Administration's drug evaluation center rather than its biologics center, the agency announced yesterday.
Many biotechnology companies have recommended the shift, saying the agency's drug evaluation center is better staffed and can review the applications more swiftly.
FDA officials said the move makes sense because the testing, evaluation and use of the pharmaceuticals is similar, whether the drugs are created through traditional chemical means or through newer biotechnology.
While the Center for Biologics Evaluation and Research will lose its review authority over the drugs created through biotechnology, it will maintain control over vaccines, blood safety, gene therapy and tissue transplantation.
In recent years, the Center for Drug Evaluation and Research has gained in industry respect because of its relative speed in reviewing applications. It was the first center at the FDA to be given additional staff and funds through the user fees that drug companies have paid since 1994 when they apply for approval to sell their products. The biologics center will not begin receiving user-fee funds until next year.
Carl Feldbaum, president of the Biotechnology Industry Organization, said his group welcomed the change, which he said reflected concerns that were raised when the user-fee legislation was reauthorized over the summer.
"The industry has been impressed with [the drug center's] close attention to review time clocks," he said, adding that the biologics center did not have as good a record.
Feldbaum said BIO also believed that CDER had developed straightforward and consistent rules about clinical trials for new drugs that the biologics center had not always followed.
The question of how quickly a drug is reviewed by the agency is of prime importance to drug companies, which cannot begin to recoup their costs of drug development until they can begin to sell their products.
The FDA said yesterday that details of the shift will be worked out by January by a group chaired by Murray M. Lumpkin, a senior associate commissioner. An FDA official said the group would decide questions such as which classes of drugs would move to the drug center, how resources might be changed and whether employees would be transferred.
Hoping to streamline the approval of biotechnology drugs, the Food and Drug Administration will transfer responsibility for their review to one of its long-established units that currently evaluates only conventional pharmaceuticals.
The move was hailed by the biotech industry, which has argued that the existing review process is too cumbersome and takes too long. Critics say a speedier process could be dangerous to patients, and some question whether the reorganization will quicken the approval of biotech drugs.
The FDA reorganization will shift the approval process for biologics -- drugs produced from living sources like microorganisms -- out of a specialized office that had been criticized by biotechnology groups for issuing decisions more slowly than the conventional drug unit.
FDA Deputy Commissioner Lester Crawford said that by consolidating review of all new pharmaceuticals in the Center for Drug Evaluation and Research, the FDA will review all experimental drugs "promptly and rigorously in an accountable and consistent manner."
The unit that now reviews biologics, the Center for Biologics Evaluation and Research, will retain jurisdiction over vaccines, blood safety, gene therapy and tissue transplantation.
Carl Feldbaum, president of the Biotechnology Industry Organization, said the established drug review unit is not only better at meeting timetables than the biologics section, but also issues clearer guidelines for the scope of clinical trials. A time line for the reorganization will be developed by January.
"Although the details and their full implications have yet to be determined,
we are pleased with the Bush administration's efforts to bring life-saving drugs to patients faster alongside greater consistency in the drug development and review process," Feldbaum said.
The drug industry watchdog group Public Citizen, however, warned that the conventional pharmaceuticals unit could be subject to political pressure to speed up approvals of novel, high-tech drugs that by their nature should be subjected to diligent safety scrutiny.
"These are, after all, complex and new molecules," said Public Citizen spokesman Peter Lurie. "It's not surprising that it would take a lot of effort to review them."
One analyst is betting that the transfer of biologics to another unit will have no impact on the speed of their review.
Patrick Mooney, a biotech analyst for Thomas Weisel Partners in San Francisco, said the FDA's conventional drug unit has faster average review times only because many of the drugs it reviews are familiar "me-too" versions of the approved, chemically synthesized small molecules that end up as the pills or tablets most people are used to taking.
In fact, Mooney said, review times for biologics might end up taking longer because the traditional pharmaceutical review unit will tread carefully with high-tech drugs produced by genetically engineered bacteria or tissue cultures.
Walter Moore, vice president of governmental affairs for Genentech Inc. of South San Francisco, acknowledged that the complexity of protein-based biotechnology drugs may add to their review time no matter who evaluates them. But he said the FDA is on the right track with the drug unit consolidation.
"If it achieves clarity and consistency, it's a good thing for our patients, " Moore said.
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