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How does the FDA regulate a new drug?

FDAThere are many different types of pharmaceutical products on the market. How do we know that they are safe for consumption? Most of us do not think twice when the physician prescribes a drug for use for any condition. Drugs can range from prescriptions given by a spine surgeon to a simple over the counter anti-inflammatory medication. The FDA is responsible for ensuring the American public that the drugs available to consumers are safe whether they are prescribed or not.

The Role of the FDA

The Food and Drug Administration has five centers and the largest of them is the Center for Drug Evaluation and Research (CDER). The CDER is in place and has the mission of ensuring that drug marketing in the United States are safe as well as effective. The CDER is not in charge of testing drugs but they do conduct some forms of research as far as the drug’s quality, effectiveness and safety. The center oversees both prescription and non-prescription drugs. The other four centers of the FDA are responsible for other medical areas such as radiological devices, cosmetics, biologic, food and veterinary drugs.

How a Drug is introduced

To introduce a new drug for the FDA’s approval companies must submit a New Drug Application (NDA). The company which is seeking to market the pharmaceutical product has to present the evidence of testing and prove that it is both safe to use and that it is effective. Once the application has been turned in, then the CDER will review the data. The CDER is comprised of statisticians, physicians, pharmacologists, chemists and other scientists. It is their responsibility to review the data and determine if the benefits will outweigh the risks of the new drug. If the evidence supports the drug’s effectiveness then the CDER will release the drugs for sale to the American public.

Monitoring Released Drugs

After a drug has been approved for sale to consumers in the US, the FDA continues to watch for problems with the drug. The drug is monitored for unexpected risks to patient’s health. After a drug is approved, if there are previously unknown health risks that develop, it is the FDA’s responsibility to remove the drug from the market. Even the manufacturing of the drugs are monitored to ensure that any changes will not have an adverse affect on the product’s efficacy or safety. The FDA also evaluates reports that consumers or health-care professionals may file about suspected problems. They also want to ensure that there is an adequate supply of drugs to meet the needs of patients whose health depends on them.

Monitoring of Information and Advertising

To ensure the safe use of pharmaceuticals it is important that consumers are given complete and accurate information. Drug companies used to only promote products to physicians. In recent years, drug companies have begun promoting products to consumers. The FDA oversees advertisements pertaining to prescription drugs whether they are geared toward consumers or physicians. They carefully monitor advertising for over the counter drugs. Advertisements for drugs have to contain truthful information about the drug’s effectiveness, any possible side effects, and the circumstances which must be avoided when it is in use.

Protecting the Quality of Drugs

The FDA sets the standards for both safety and effectiveness. But they also set the standards for manufacturers and drug quality. The FDA works very closely with manufactures to explore where streamlining may be able to cut red tape without compromising the quality of the drug.  In order to ensure that there is a safe and effective supply of drugs, the FDA enforces all the federal requirements for drug approvals, labeling and manufacturing. When it becomes necessary, the FDA will take legal action in order to stop the distribution of products which are being made in violation to these requirements. This has become more complicated as the pharmaceutical industry has become international; but the FDA is becoming increasingly involved in negotiations with other countries in order to create a harmonized standard for drug quality. They are also trying to encourage the development of an international approval system for drugs. This can be very effective at reducing redundant tests by manufacturers and will help ensure higher drug quality for consumers in the US and around the world.

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