FDA's Role in Regulating Drugs and Protecting Health

The U S Food and Drug Administration (FDA) is an agency that is part of the United States Department of Health and Human Services. It is responsible for the regulation and oversight of many products consumers use on a daily basis, such as foodstuffs, drugs (both prescription and over the counter, or OTC drugs), medical devices (for example pacemakers and artificial joints), vaccines, radiation emitting devices (x-rays), veterinary products and even cosmetics! In 2004 the FDA employed 14,000 persons in its various departments. In 2009, the FDAs budget was nearly 2.5 billion dollars, with nearly 628 million of that coming from user (pharmaceutical company) fees.

Before the 20th century there were little or no attempts to regulate the substances that consumers put into their bodies. A patchwork of state laws were in place that attempted to ensure the safety of a limited number of foods and early drugs, but it was not until 1906 with the passage of the Food and Drug Act that the US government took the first affirmative steps to establish regulations directed at the protection of consumers. The FDA was formally created in 1927 under a new United States Department of Agriculture body known as the Food, Drug and Insecticide Organization. This was later changed to the Food and Drug Administration in 1930.

In 1938 the Food, Drug and Cosmetic Act was passed by Congress. This gave FDA, among other powers, control over cosmetics and therapeutic devices and, more importantly, requiring the manufacturers of new drugs to demonstrate that the drugs were safe before they could be offered for sale to the public. Since that historic day, the FDAs jurisdiction has expanded, and it is today the first line of defense for the consumer in relation to foods, drugs and medical devices.

The FDA is responsible for nearly all drugs currently on the market, both prescription and OTC. FDA is also responsible for assuring that new drugs are safe and effective before they can be sold to consumers, or prescribed by doctors. As you can imagine, this is an enormous responsibility and an enormous task.

FDA must evaluate new drug applications for compounds drug companies wish to market. A new drug application, or NDA can contain the electronic data equivalent of as many as 500,000 pages! It was not uncommon in the very recent past when new drug applications were submitted in paper that each NDA could require its own room to contain the application. What most people dont know about FDA is that FDA does not do any testing itself—it relies completely on the testing done by the drug company when it evaluates a new drug application.

FDA must also monitor drugs that have already been approved and are on the market or being prescribed for patients by doctors. FDA receives reports of adverse events—or side effects—through the MedWatch system. Drug companies are also required by law to report adverse events when such events are reported to them. FDA then compiles reports, usually on a quarter year basis, and performs an analysis in order to keep the safety profile of that drug as current as possible. When signals are received that the safety profile of a drug has changed, or there are new side effects that were not known at the time the drug was approved, FDA has the power to call for Advisory Committee hearing to evaluate the new data. If warranted, FDA can require new warnings on the product insert or label. In rare instances, they can also recommend that a drug be withdrawn from the market.

The FDA has come under fire in the recent past with critics claiming that the Agency was under funded and understaffed, and thus unable to meet its responsibilities. Other criticisms have come from those who believe that the user fee act, PDUFA, encourages FDA to move too quickly when evaluating new drugs for safety because of the money and fees received from the pharmaceutical industry and to cause an imbalance in the allocation of resources between new drugs and monitoring existing drugs for safety.

It is abundantly clear that this agency regulates many of the consumer health products that we all use, every day. It would serve us well to remind our representatives that the health of the nation is of prime importance. The FDA should be given the resources it needs—and the freedom from industry, governmental and consumer group pressures in order to do the best, scientific job it can do protecting our health.

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