In a move biotech companies hope will speed reviews of their products, the Food and Drug Administration said Friday that it will streamline the evaluation process for biologic drugs by consolidating it under the same unit that reviews other drugs.
Quickening reviews has been a top priority for biotech companies, which have complained about the slow approval process for their products. The issue is also important for pharmaceutical companies that are increasingly either developing their own biologic products or buying rights to products from biotech companies to fill their drug pipelines.
Biotech companies can be more vulnerable to longer reviews because the product under review is often their only one, as opposed to the diverse portfolio of pharmaceutical companies, said Paul Thomas, CEO of Branchburg-based LifeCell Corp. and a board member of the Biotechnology Council of New Jersey.
"It's been frustrating at times the lengthy process the industry has had to go through with the agency," Thomas said. "This is a step in the right direction ... to the extent we can minimize the lengthy approval periods while maintaining safety and efficacy."
Currently, the FDA generally reviews synthetic drugs derived from chemicals under one unit and those made with live organisms - or biologic drugs - under another. Biologic drugs are considered more complicated and are injected. They include products such as Herceptin, a breast cancer medication; Epogen, an anemia product; and the rheumatoid arthritis treatment Enbrel.
Calling the agency's review process the "gold standard" for the world, FDA Deputy Commissioner Lester Crawford said:
"By carefully combining part of our present biologics review operation responsibilities with our drug review operation, FDA will be optimally positioned to uphold that gold standard by continuing to review novel pharmaceutical products promptly and rigorously in an accountable and consistent manner."
The industry's national trade group, BIO, applauded the FDA's move. According to data from BIO, since 1998, the FDA's review for standard applications under the biologics unit has taken about twice as long as for the main drugs unit, generally two years compared with one. Reviews in the drugs unit took 14 months last year, whereas biologics took 22 months, according to BIO estimates.
Carl Feldbaum, BIO's president, said biotech companies are impressed with the drug unit's attention to the review timeclock.
"Improving review times is critical for the biotech industry because reviews are extremely costly," Feldbaum said.
"For many companies, the reviews are for their first drugs."
Feldbaum said another benefit could be the drug unit's clarity on agreeing to goals for clinical trials before the trials begin.
Crawford said a plan for the consolidation would be in place by January.
Nancy Bradish Myers, a healthcare political analyst with Lehman Bros., said it would be difficult to weigh the impact of the consolidation until the plan is fleshed out.
Myers said it was not so certain that the consolidation will speed review times, noting that the industry has also complained about the timeliness of the drug unit's evaluations.
"I think the jury's still out," she said. |