BioMedNet: FDA Divorces Chemistry from Biology

Subject: BioMedNet: FDA Divorces Chemistry from Biology

Date: Sun, 15 Sep 2002 10:25:07 -0400

FDA maintains two administrative oversight branches for medical products: Center for Biologics Evaluation and Research (CBER)–is responsible for overseeing the safety of bio-tech based therapies, vaccines, blood safety, and gene therapy. Center for Drug Evaluation and Research (CDER) –oversees chemical-based treatments. On Sept 6, 2002, the FDA issued a press release, announcing that biologics (bio-tech based) therapies–one component of CBER–will be moved to CDER. http://www.fda.gov/bbs/topics/NEWS/2002/NEW00834.html [See, AHRP Infomail, Sept. 9, citing reports in the Washington Post and FDAWeb]

Below is BioMedNet follow-up news story: “Both industry and advocacy groups believe that this consolidation will speed up the process of review, which delights the former and troubles the latter.”

The article cites AHRP’s concerns: “The FDA policy in the last 10 years had clearly benefited the pharmaceutical industry and harmed the public,” said Vera Hassner Sharav, President and founder of Alliance for Human Research Protection. She refers to 13 drugs that have [been] taken off the market because of their adverse effects, which she attributes to expedited processes.

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http://news.bmn.com/news/story?day=020913&story=1 BioMedNet 13 September 2002

FDA divorces chemistry from biology 12 September 2002 17:51 EST by Graciela Flores

The US Food and Drug Administration (FDA) has announced a major reorganization, transferring the review of biotechnology-based drugs from its biologics center to its drugs center. At present such work is performed in both divisions. The administration intends for this consolidation to focus the scientific expertise and efforts of its Center for Biologics Evaluation and Research (CBER) division on the crucial areas of vaccines and blood safety, as well as cutting-edge procedures such as gene therapy and tissue transplantation, all of which will remain under its jurisdiction.

Both industry and advocacy groups believe that this consolidation will speed up the process of review, which delights the former and troubles the latter. However Deborah Henderson, director of FDA drugs center’s Office of Executive Programs, says this is a misconception, that the goal is increasing efficiency and consistency. “We want to use the taxpayers’ money as best we can, as well as the money that we get from industry,” she told BioMedNet News.

Since its creation, the drug center, formally known as Center for Drug Evaluation and Research (CDER), reviewed new drugs made through chemical methods, while its biologics counterpart – the Center for Biologics Evaluation and Research (CBER)- reviewed pharmacological products made by living organisms, such as monoclonal antibodies and cellular products. According to Henderson, as biological drugs regulated in CBER and the traditional drugs regulated in CDER became more alike over the years, it has become increasingly clear that it would make better sense to combine the two functions.

But some advocacy groups believe these changes are fueled by pressures from the pharmaceutical industry, which has repeatedly expressed complaints about the difference in speed of drug approvals from the two centers. Some are also concerned that speeding the review process could harm the public by reducing the number of steps required for approval.

“The FDA policy in the last 10 years had clearly benefited the pharmaceutical industry and harmed the public,” said Vera Hassner Sharav, President and founder of Alliance for Human Research Protection. She refers to 13 drugs that have taken off the market because of their adverse effects, which she attributes to expedited processes.

Industry welcomed the news. “This means a great deal to our members,” cheered Carl Feldbaum, president of the Biotechnology Industry Organization (BIO). Although Feldbaum said he had seen very little solid information about the reorganization, FDA told BIO the move will “consolidate the review process in a way to speed up reviews,” adding that it looks forward to scheduled meetings with both divisions to learn more details. (FDA has established a working group, chaired by Senior Associate Commissioner Murray Lumpkin, to develop an action plan and a timeline for the consolidation.)

Scott Gottlieb, a fellow at the American Enterprise Institute for Public Policy Research, believes the consolidation will not affect the speed of reviews at all. “The process at CBER is not easier than at CDER,” he said. “This is not about speed.” What differs between the two divisions is culture.

Gottlieb approved the merger as a first step in the effort to bring greater transparency and uniformity to the way the FDA works. “Basically, Americans have two FDAs, CDER and CBER,” he said. “With this reorganization, we’ll have one.”

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