Continuing the federal laws related to pharmaceuticals and the FDA, this week, we present the

• FDA and the Food and Drug Administration Modernization Act of 1997, and the
• Food and Drug Administration Amendments Act of 2007

As noted previously, the FDA was established in 1938 to administer and enforce the Federal Food Drug and Cosmetic Act. Starting with this initial authority, today, the FDA is responsible for enforcing many additional pieces of legislation.

The mission of the FDA is to protect the public health against risks associated with the production, distribution, and sale of food and food additives, human drugs and biologicals, radiologic and medical devices, animal drugs and feeds, and cosmetics. In carrying out the intent of legislation it is mandated to enforce, the FDA

• Sets policies, establishes standards, issues guidelines, and promulgates and enforces rules and regulations governing the affected industries and their products
• Monitors for regulatory compliance through reporting requirements, product sampling and testing, and establishment inspections
• Establishes product labeling requirements, disseminates product use and safety information, issues product warnings, and directs product recalls
• Acts as the government's gatekeeper in making safe and effective new drugs, clinical laboratory tests, and medical devices available through a carefully conducted application and review process

The FDA, an agency of the Department of Health and Human Services, is organized into appropriate units to support its various responsibilities and functions. A complete and detailed FDA organizational chart may be found on the agency's Website:

http://www.fda.gov/AboutFDA/CentersOffices/OrganizationCharts/default.htm

We will look at some of them in detail later; each of these offices and centers has a highly organized substructure and personnel to address agency policy, regulations, and operational responsibilities.

The FDA Modernization Act of 1997 was enacted to streamline FDA policies and to codify many of the agency's newer regulations. The bill expanded patient access to investigational treatments for AIDS, cancer, Alzheimer disease, and other serious or life-threatening illnesses. It also provided for faster new drug approvals by using drug sponsors' fees to hire additional internal reviewers, by the authorized use of external reviewers, and by changes in the requirements demonstrating a drug's clinical effectiveness. It also provided incentives for investigations of drugs for children.

The legislation included provisions to track clinical trial data in a joint program with the NIH, established a system to follow and review studies of the safety and efficacy of marketed drug products, established a program for the dissemination of information on off-label uses of marketed drugs and encouraged applications for additional therapeutic indications, and fostered the expansion of the FDA's information management system and the agency's progress toward paperless systems for human drug applications.

To codify, enable, and enforce legislative authority, the FDA develops relevant guidelines and regulations. These are first published in the Federal Register (FR) for public comment, and when finalized, in the Code of Federal Regulations (CFR).

Next week, we will look at the H.R. 3204 Drug Quality and Security Act (DQSA) of 2013.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
IJPC
Remington: The Science and Practice of Pharmacy Twenty-second edition