Food and Drug Administration (FDA)
FDA Information:The Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating food (humans and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal) and radiation emitting devices (including non-medical devices), biologics, and blood products in the United States.
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Authorization and mandate
The FDA derives its authority and jurisdiction from various Congressional acts. The main source of the FDA's authority is the Federal Food, Drug, and Cosmetic Act. Additionally, as a Federal agency, the FDA is required by Executive orders 13132 to review all proposed new rules for Federalism issues.
The main purpose of the FDA is to protect citizens from products that are inherently unsafe or that make claims of effectiveness that cannot be substantiated. Because of the vast number of products or substances that may affect the public and the expertise required to evaluate them, Congress delegates this task to a specilized administrative agency.
The FDA thus has the power to regulate a multitude of products in a manner that ensures the safety of the American public and the effectiveness of marketed food, medical, and cosmetic products. Regulations may take several forms, including but not limited to outright ban, controlled distribution, and controlled marketing. Additionally, the FDA sets the standards under which individuals may be licensed to prescribe drugs or other medical devices. Regulatory enforcement is carried out by Consumer Safety Officers within the Office of Regulatory Affairs and criminal matters are handled by special agents within the Office of Criminal Investigations (OCI).
Anyone can request or petition the FDA to change or create an Agency policy or regulation through the Citizen's Petition process. 21 CFR Part 10.30. . Despite the name, this process is primarily used by companies seeking a change to an FDA policy.
Since the FDA derives its authority from enabling legislation, it is principally a delegate of Congress to handle the large number of detailed issues related to its authority. As such, it at any time may be redirected, reorganized or even dissolved at the discretion of Congress. This puts the purpose of the FDA at risk with any change in the balance of power in Congress.
In addition to direct control over the agency's charter, Congress has leverage over the FDA's operations by means of budget allocation. Since budgetary legislation and amendments are very common and many times have a "must pass" status, this method of control is much easier to implement than to gain the wide agreement by Congress to modify the charter of an agency.
Additionally, the FDA's Commissioner is nominated by the President and confirmed by the Senate. This allows the President to select Commissioners who may be sympathetic to political issues he deems important. Additionally Senate rules allow for nominations to be blocked by means of filibuster, whereby the Senate must first obtain a super-majority of 60% to close debate on an issue before vote.
Finally, the Commissioner himself has discretion regarding the staff employees within the agency and has the power to influence their decisions simply by being able to dismiss those who are not aligned with his views.
The FDA does not pre-approve dietary supplements on their safety and efficacy, unlike drugs. In contrast, the FDA can only go after dietary supplement manufacturers after they have put unsafe products on the market. However, certain foods (such as infant formula and medical foods) are deemed special nutritional because they are consumed by highly vulnerable populations and are thus regulated more strictly than the majority of dietary supplements.
Under former Commissioner David Aaron Kessler the FDA in the 1990's attempted to regulate tobacco as a pharmaceutical. The courts determined in FDA v. Brown & Williamson Tobacco Corp. that the FDA did not have Congressional authority to regulate tobacco.
One aspect of its jurisdiction over food is regulation of the content of health claims on food labels. However, because regulating the content of labels impacts First Amendment issues, FDA must balance concerns about the public health with the right to free speech. Daniel Troy, Chief Counsel of the Food and Drug Division from August 2001 to November 2004, raised the agency's focus on First Amendment issues.
Currently, the FDA is divided into five major Centers, each with its own origins and history:
• The Center for Drug Evaluation and Research (CDER)
• The Center for Biologics Evaluation and Research (CBER)
• The Center for Devices and Radiological Health (CDRH)
• The Center for Food Safety and Applied Nutrition (CFSAN)
• The Center for Veterinary Medicine (CVM)
• National Center for Toxicological Research (NCTR)
• Office of Regulatory Affairs (ORA)
• Joint Institute for Food Safety and Applied Nutrition
• National Center for Food Safety and Technology
The CDER, which regulates human pharmaceuticals, 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.
Within the CDER "Review teams" employs around 1,300 employees to approve new drugs. Additionally, the CDER employs a "safety team" has 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.
The CBER, which is the oldest operations center, oversees blood products, vaccines, and newer therapeutics related to stem cells and gene therapy.
Above article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "The Food and Drug Administration (FDA)".
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