CDER History and the Evolution of FDA Drug Regulation
The regulation of pharmaceuticals in the United States has evolved through a series of legislative milestones and organizational shifts to ensure public safety. Central to this effort is the Center for Drug Evaluation and Research (CDER), the entity responsible for ensuring that brand-name and generic drugs are safe and effective.
The Foundation of Drug Oversight
The FDA's authority to review medications began with the 1906 Pure Food and Drugs Act. However, the framework for modern drug applications was established by the 1938 Federal Food, Drug and Cosmetic Act. This landmark legislation mandated that all new drugs undergo testing before they could be marketed, requiring the submission of an original new drug application. The demand for this oversight was immediate; within the first year, the FDA's Drug Division—the predecessor to CDER—processed over 1,200 applications.
Further rigor was added via the Drug Amendments of 1962, which shifted the burden of proof to manufacturers. Companies were now required to prove to the FDA that their products were both safe and effective. By 1966, the agency reorganized to create the Office of New Drugs, specifically tasked with the clinical testing and review of new drug applications.
The Biotechnology Shift and Organizational Mergers
The 1980s brought a technological revolution in biotechnology, which blurred the distinction between a drug (typically a chemically synthesized substance) and a biologic (a product derived from living organisms). In response, Commissioner Arthur Hayes led an agency-wide reorganization in 1982.
During this period, the Bureau of Drugs and the Bureau of Biologics merged to form the National Center for Drugs and Biologics. Simultaneously, the bureaus overseeing radiation control and medical devices were combined into the Center for Devices and Radiological Health.
The Emergence of the Modern CDER
The current structure of CDER was established in 1987 under Commissioner Frank Young, when the National Center for Drugs and Biologics was split into CDER and the Center for Biologics Evaluation and Research (CBER). This separation was driven by distinct legal mandates and differing institutional cultures; at the time, CDER maintained a more cautious, adversarial approach toward industry approvals.
The split was further precipitated by the urgent crisis surrounding HIV testing and treatment, as well as an inter-agency dispute regarding the approval of Activase (tissue plasminogen activator), a product from Genentech.
Initially, CDER consisted of six offices: Management, Compliance, Drug Standards, Drug Evaluation I, Drug Evaluation II, Epidemiology and Biostatistics, and Research Resources. To address the surge of AIDS treatments, the Division of Antiviral Products was added to Drug Evaluation II in 1989. The Office of Generic Drugs was also established during this era.
Expanding the Scope of Therapeutics
As medical science advanced, the boundaries of CDER's jurisdiction expanded. In 2002, the FDA transferred several biologically produced therapeutics to CDER's oversight. These include:
- Therapeutic monoclonal antibodies: Laboratory-made molecules that act as substitute antibodies.
- Proteins intended for therapeutic use.
- Immunomodulators: Substances that stimulate or suppress the immune system.
- Growth factors and other products designed to alter the production of blood cells.
Key Facts
- 1906: FDA begins drug review responsibilities via the Pure Food and Drugs Act.
- 1938: New drugs must be tested and applications submitted before marketing.
- 1962: Manufacturers must prove both safety and efficacy.
- 1987: CDER and CBER are split into their current forms.
- 2002: Monoclonal antibodies and certain proteins are transferred to CDER.
| Year | Event/Legislation | Primary Impact |
|---|---|---|
| 1906 | Pure Food and Drugs Act | Established initial drug review responsibility. |
| 1938 | Federal Food, Drug and Cosmetic Act | Mandated pre-market testing and applications. |
| 1962 | Drug Amendments | Required proof of safety and effectiveness. |
| 1982 | Agency Reorganization | Merged drugs and biologics into one center. |
| 1987 | CDER/CBER Split | Created the modern separate entities for drugs and biologics. |
Frequently Asked Questions
When did the FDA start requiring drugs to be tested before they were sold?
This requirement was established by the Federal Food, Drug and Cosmetic Act of 1938, which mandated the submission of a new drug application based on testing results.
What is the difference between the 1938 Act and the 1962 Amendments?
While the 1938 Act required testing before marketing, the 1962 Drug Amendments specifically required manufacturers to prove that a drug was both safe and effective.
Why were CDER and CBER separated in 1987?
The split occurred due to different legal mandates, cultural differences in approval philosophies, the HIV crisis, and a specific dispute over the approval of Genentech's Activase.
What types of biological products does CDER oversee since 2002?
CDER oversees therapeutic monoclonal antibodies, therapeutic proteins, immunomodulators, and products that alter blood cell production, such as growth factors.
What was the purpose of the Division of Antiviral Products?
Established in 1989, this division was created to handle the high volume of drug proposals intended to treat AIDS.