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By Brian Reid

October 15, 2002 | Biologics, long reviewed by a different FDA branch than traditional pharmaceuticals, will now be evaluated by the agency’s drug division, a move that both the agency and analysts says should make reviews of new biotechnology products more efficient and consistent.

The change follows a review of the FDA’s operation by outside consultants and months of lobbying by the biotechnology industry, which analysts says has long been stymied by a less predictable approval process than the one used for drugs. Though an agency task force is now hammering out the details, the Biotechnology Industry Organization (BIO) says it expects the biotechnology companies to benefit from the reorganization when complete.

“BIO and its members will do everything we can to facilitate this transition toward streamlined development and review of biologics,” said BIO president Carl Feldbaum in a statement, adding that the effort should “bring life-saving drugs to patients faster.”

The speed of reviews throughout the agency has been an industry concern for more than a year. In 2001, the median time to approval in the drug division for novel drugs was 19 months, up from 13.4 months in 1998.

Though the FDA didn’t cite cases where poor consistency had hampered biologics reviews, the agency says the move is designed to eliminate longstanding industry concerns that one set of standards is applied for drugs and another is applied for biologics.

“We’ve heard a lot from the industry – as has Secretary [of Health and Human Services Tommy] Thompson – about problems with consistency,” says Steven Galson, the deputy director of the agency’s drugs branch. “We really think that we can do better.”

In addition to streamlining the process for companies, Galson says moving some responsibility to the drug division should be more resource-efficient, possibly saving the FDA money.

Galson says he expects a portion of employees in the agency’s biologics center – those who oversee pharmaceutical products – to be integrated into existing offices within the drug branch, along with support staff such as compliance officials and information technology experts. The biologics division would continue to regulate cutting-edge biotechnology, including gene therapy and tissue transplantation, as well as vaccines and blood products.

The exact shape of the plan won’t be established until next year, the agency says, giving officials a chance to determine how a single office can handle the separate regulations governing biologics and drugs. That makes it difficult to predict whether approvals will come faster – or more often – or whether the agency will alter its guidances, the FDA’s non-binding set of rules that govern everything from trial design to how to prepare electronic submissions, as part of the reorganization

Still, the move should begin benefiting biotechnology companies as soon as the transition takes place, analysts said.

“In the long-term, it should be good for the [biotechnology] group,” says Michael King, a biotech analyst at Banc of American Securities LLC, who called reviews by the FDA’s biologics group, the Center for Biologics Evaluation and Research (CBER), “just awful.”

“CBER has been pretty abysmal at turning around applications. It makes sense that this reorganization should happen,” King says.

The move returns to the Center for Drug Evaluation and Research (CDER) control over the approval of all drugs, regardless of how the products are made. The FDA’s current organization structure predates therapeutic biologics, such as the anemia drug Epogen or recombinantly produced growth hormone. When biotechnology companies began producing therapeutics two decades ago, the responsibility for evaluating those products was given to CBER.

That has long been an uneasy relationship, according to Ira Loss, an equities analyst with Washington Analysis. CBER had traditionally focused on complex scientific research, not the process of reviewing and approving products. Many CBER employees work outside of the agency’s Rockville, Md., headquarters at an FDA facility on the National Institutes of Health’s nearby campus, reflecting the primacy of science over regulation, Loss says.

“When this biotech revolution occurred, these scientists were making decisions on therapeutics – something they didn’t do before – and they were like fish out of water,” he says. “It wasn’t what they did.”

Loss says that the primary effect of the CBER reviews wasn’t slowed reviews or more rejections, but instead less predictability. “You can equate this to fewer surprises,” he says of the new effort. Case in point, according to Loss: ImClone Systems Inc., which vaulted into headlines when the agency told the company at the end of the December that the drug’s application was too flawed to review.

“If you paid attention to what the FDA people were saying at the ImClone [congressional] hearing, it was pretty clear to me that the FDA had decided in early December that ImClone’s drug was tapioca, but they didn’t say it,” Loss says. The FDA’s drug division, in contrast, usually telegraphs its decisions to companies ahead of time, which Loss says leads to less astonishment when final decisions are reached.


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