CDER, in particular, controls prescription medications. Prescription medications are any drugs that require a doctor's approval to acquire. Generic Medicine begins with the brand name drug. The generic version of a drug is available at a lower price than the brand name drug because it does not have the expensive research and development costs associated with bringing a new product to market. A pharmacy cannot give a customer a generic version of a drug if that drug has been found to cause problems for some people. For example, if some people develop lung diseases when they take the drug, the FDA will not let the pharmacy sell it even as a generic.
In addition to controlling the drugs that come on the market, the FDA also regulates the manufacturing process used to make them. If the FDA finds problems with the way a drug or device is made, it can issue warnings about its safety issues or pull it from the market.
Some drugs, including vaccines, need to be approved by the FDA before they can be sold in the United States. Other medications may be available only through a special program where they are given away for free to certain patients.
The Center for Drug Evaluation and Research (CDER) plays an important public health role by ensuring that safe and effective medications are accessible to enhance people's health in the United States. CDER works with other parts of the agency and within the science and medical communities to evaluate new drugs and drug products, confirm their safety, and issue approvals. When necessary, it takes action to remove unsafe or ineffective drugs from the market.
CDER is made up of three main divisions: (1) the Drug Products Division prepares monographs for approval of new drugs and drug products; reviews existing ones to ensure they remain safe and effective; and responds to adverse event reports about drugs and products. (2) The Regulatory Science Division conducts research to better understand how drugs are used and managed in healthcare settings so that evidence-based decisions can be made on issues such as medication errors, adverse events, and problems with drugs that need to be removed from the market. This division also works with industry and others to develop best practices for postmarketing surveillance of drugs. (3) The Policy Division works with federal agencies, Congress, and other groups to help set drug policy priorities and provide information on drug regulation issues before they become public.
New drugs and products must go through several steps before being approved by the FDA.
Although the FDA authorizes all prescription pharmaceuticals sold in the United States, the agency has no authority to restrict how doctors prescribe drugs after they are on the market. Doctors frequently advise patients to use drugs that have not been authorized by the FDA. This is known as off-label drug usage. In some cases, doctors may recommend drugs for uses other than those for which the company that makes the drug paid for marketing it. For example, a physician might prescribe an unlicensed drug if he or she had confidence that it would be effective for another condition that the patient also had. Off-label prescriptions make up a large portion of all prescriptions written.
The FDA does monitor drug safety after they are on the market through its Adverse Event Reporting System (AERS). The AERS database contains information about adverse events suspected to be caused by medications. Any person can report an event to the AERS website. Physicians and nurses are asked to report serious adverse events they encounter while treating patients.
Events reported to the AERS do not necessarily indicate that a drug causes the event. They only show that someone thought it was important to report it. Physicians need to know that there are many products available over-the-counter and by prescription that could potentially cause an adverse reaction if used incorrectly. Drugs can be dangerous when abused either intentionally or unintentionally.
Offices and Divisions of the CDER
Purchasing, owning, and providing controlled substances [4, 7]
New Drug Development The FDA's Center for Drug Evaluation and Research is the primary consumer watchdog in this system (CDER). The center's most well-known function is to analyze new medications before they are sold. But it also has other duties, such as reviewing medical devices and food products that contain drugs.
The CDER is made up of eight divisions that each work on a different type of product: neurologic disorders; cancer; cardiovascular disease; diabetes mellitus; pulmonary diseases; reproductive health; and gastrointestinal diseases.
New medications must be proven safe and effective before they can be sold or distributed. This process is called "regulatory approval." The first step is to file an application with the FDA. If the agency decides to review the application, it will do so by writing guidelines for companies seeking market authorization for their products. These guides include advice on how much evidence is needed to prove effectiveness and safety and how the company should conduct its studies.
If the FDA approves the application, it may ask for additional studies or report its concerns to the company about issues such as side effects not included in the application. Once approved, medications become eligible for marketing in the United States. However, they may still be reviewed by other agencies before they are released to the public.