Wednesday, July 27, 2011

The Ever-Changing World of the FDA

Photo Source: NCI, Linda Bartlett
Have you ever been watching T.V. when a commercial comes on? You see happy people playing with their kids, eating ice cream, or biking in the park while a soft spoken person tells you the benefits of their latest medication with soothing music playing in the background. Suddenly, the voice quickly starts listing possible side effects like nausea, heart attacks, stroke or even death. What is that all about? You have just been offered the message of regulatory science and the FDA.

Although safety is the utmost concern of regulatory science, enforcing magazine and T.V. ads is only a small part of it. Regulatory scientists examine toxicology reports, monitor clinical studies, make recommendations and restrictions, and may even perform laboratory tests when necessary to ensure marketed food and drugs are not hazardous to our health. They basically have the last say on whether these items are allowed on the market for consumption.

The Food and Drug Administration (FDA) is the key Federal agency for regulating food and pharmaceuticals for public use in the United States. This agency was established in the early 1900’s, but actually arose from the U.S. Department of Agriculture (USDA) Department of Chemistry created in the late 19th century to monitor the additives in food and drugs without regulatory powers.

In 1906, Upton Sinclair reported on the unsanitary conditions in meatpacking plants in his book, “The Jungle.” That year, public pressure led the federal government to pass both the Meat Inspection Act and Pure Food and Drug Act. The latter would eventually lead to the formal establishment of the FDA as a regulatory agency nearly two decades later.

Since then, the FDA has shown its flexibility through its numerous decisions. As times change, food and drug industries evolve and this means the FDA must always restructure itself to meet the needs of both companies and the public. In 1938, Congress gave the FDA authority over the expanding cosmetics and therapeutic device industries, which were then unregulated, after changes to the Food and Drug Act are proposed by the agency earlier that decade.  In the 1940’s, the FDA demonstrated its authority over medications, assuming responsibility for testing insulin used to treat diabetes and also requiring testing and certification of the popular antibiotic, penicillin.

Perhaps, the case most noted in FDA history is its decision on thalidomide in the 1960’s. Thalidomide was a sleeping medication that caused birth defects in many babies after its release in Europe. When the media reported the FDA’s role in preventing thalidomide’s release in the U.S., there was overwhelming public support for increased pharmaceutical regulation.

It has remained a regulatory force since then, although it has received a number of “facelifts,” especially in recent years. Many argue whether FDA regulations should be loosened to make new drugs available more quickly, but others feel they should remain very careful in their decisions to prevent unnecessary deaths. In fact, a 2010 Research!America poll indicates that Americans are split on this issue. It highlights why the FDA process has been a topic of debate for many years, factoring into the many changes made to the agency throughout its history.

How do you feel about the FDA and the role of regulatory science in the pharmaceutical industry?

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