Center for Drug Evaluation and Research

Regulation of therapeutic goods in the United States

Prescription drugs Over-the-counter drugs
Law Federal Food, Drug, and Cosmetic Act Comprehensive Drug Abuse Prevention and Control Act of 1970 Controlled Substances Act Prescription Drug Marketing Act Drug Price Competition and Patent Term Restoration Act Hatch-Waxman exemption
Government agencies Department of Health and Human Services Food and Drug Administration Department of Justice Drug Enforcement Administration
Process Drug discovery Drug design Drug development New drug application Investigational new drug Clinical trial (Phase I, II, III, IV) Randomized controlled trial Pharmacovigilance Abbreviated New Drug Application Fast track approval Off-label use
International coordination International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Uppsala Monitoring Centre World Health Organization Council for International Organizations of Medical Sciences Single Convention on Narcotic Drugs
Non-governmental organizations Institute of Medicine Research on Adverse Drug events And Reports

FDA Building 51 houses the Center for Drug Evaluation and Research.

The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research. The center reviews applications for new and generic pharmaceuticals, manages US current Good Manufacturing Practice (cGMP) regulations for pharmaceutical manufacturing, determines which medications require a medical prescription, monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market.

CDER reviews New Drug Applications to ensure that the drugs are safe and effective. Its primary objective is to ensure that all prescription and over-the-counter (OTC) medications are safe and effective when used as directed.

CDER receives considerable public scrutiny, and thus implements processes that tend toward objectivity and tend to isolate decisions from being attributed to specific individuals. In keeping with this, reviews are generally staffed by teams that are intended to come to consensus on decisions . The decisions on approval will often make or break a small company's stock price (e.g., Martha Stewart and Imclone), so the markets closely watch CDER's decisions.

The center has around 1,300 employees in "Review teams" that evaluate and approve new drugs. Additionally, the CDER employs a "safety team" with 72 employees to determine whether new drugs are unsafe or present risks not disclosed in the product's labeling.

The FDA's budget for approving, labeling, and monitoring drugs is roughly $290 million per year. The safety team monitors the effects of more than 3,000 prescription drugs on 200 million people with a budget of about $15 million a year. The FDA requires a four phased series of clinical trials, with phase three being the largest and usually requiring 1,000-3,000 patients.

Janet Woodcock is the director of CDER.^[1]

History

In 1982, when the beginning of the biotechnology revolution blurred the line between a drug and a biologic, the Bureau of Drugs was merged with the FDA's Bureau of Biologics to form the Center for Drugs and Biologics during an agency-wide reorganization under Commissioner Arthur Hayes.^[2] This reorganization similarly merged the bureaus responsible for medical devices and radiation control into the Center for Devices and Radiological Health.

In 1987, under Commissioner Frank Young, CDER and the Center for Biologics Evaluation and Research (CBER) were split into their present form.^[2] The two groups were charged with enforcing different laws and had significantly different philosophical and cultural differences.^[2] At that time, CDER was more cautious about approving therapeutics and had a more adversarial relationship with the industry.^[2] The growing crisis around HIV testing and treatment and an inter-agency dispute between officials from the former Bureau of Drugs and officials from the former Bureau of Biologics over whether to approve Genentech's Activase (tissue plasminogen activator) led to the split.^[2]

In 2002, the FDA transferred a number of biologically produced therapeutics to CDER.^[2]

References

↑ U.S. FDA Center for Drug Evaluation and Research Key Officials
1 2 3 4 5 6 Reid, Ken. "CBER and CDER have long history of being lumped together and split up." Bioresearch Monitoring Alert Sept. 2002. page 4.

External links

CDER website.

Food and Drug Administration of the United States

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