Public Health

Drug Approval Times, Food Standards
by Food and Drug Administration (FDA)

(Page 6 of 6)

FDA Review and Approval Times

The next great change at the FDA came during the 1990s with the long dispute over the agency's efficiency and funding to get its work done. It was the natural result of the struggle over standards - how much study should be devoted to each drug's safety and effectiveness? How long should review take?

Scholars have explored the different parts of the problem and found that there are several key issues. Are the drugs companies put forward worthwhile? Are the applications well done and complete? Many people assume that all drugs and all drug applications put forward are worthwhile. Studies, however, show that is not always the case. The debate over the years has tended to ignore these fundamental questions and focused not on whether the companies were doing their job effectively, but on whether the FDA was. The debate came to a head after the 1994 elections, when a movement for "FDA reform" was pressed in government and before the public. It centered on the question of how long the FDA staff members take to review applications. What is a reasonable time?

Advertising appearing in major media put the matter in the most radical terms, calling for a retreat to the days before food and drug regulation. "If a murderer kills you, it's homicide. If a drunk driver kills you, it's manslaughter. If the FDA kills you, it's just being cautious." The argument, put forward by lawmakers as well as radical think tanks, suggested that the time taken to review the safety of a drug was lost time and that delays cost lives.

Congressional leaders and the FDA took the efficiency of the reviews seriously, despite the provocative rhetoric. Over several years, different approaches were discussed to produce the speediest feasible reviews. The Prescription Drug User Fee Act was passed in 1992, and quickly had an impact.

Before the act, review times were similar to those of other developed countries, but after it, review times were dramatically better. The General Accounting Office - now the Government Accountability Office - said that by 1994, "FDA review and approval times were faster than those in the United Kingdom - a country whose regulatory system many critics like to cite as a way of doing things faster and better."

The History of Food Standards

The advances, and battles, have continued on food as well. The first food standards to be issued under the 1938 act were for canned tomato products. By the 1960s, about half of the U.S. food supply was subject to a standard. As food technology changed and the number of possible ingredients grew, the agency developed recipe standards for foods, lists of ingredients that could lawfully be included in a product. A food that varied from the recipe would be required to be labeled as an imitation.

The FDA pursued many cases of food misbranding during the 1950s and 1960s, most of which stemmed from false nutritional claims and unscientific enrichment. In 1973, after hearings convened by the FDA to address the vitamin fortification of foods and the claims made for dietary supplements, the FDA issued regulations for special dietary foods, vitamins, and supplements. The public response to these regulations helped lead Congress in 1976 to prohibit the FDA from controlling the potency of dietary supplements. The agency maintains authority to regulate enriched foods.

During the 1990s, the agency took a step beyond just the wholesomeness of food, and created the landmark food labeling system. Using it, consumers could read the ingredients and nutritional values in processed food, and reasonably easily determine for themselves what was most wholesome, and how to avoid too much of the more deleterious fare.

Working in the Public Interest

Over the years, the FDA, because it is in the center of modern commercial and intellectual activity, has had to evolve to do its job and, in fact, to survive in the sometimes contentious political atmosphere in Washington. It began as a shop in which decisions were largely made behind the scenes; its decisions are now open to inspection and challenge; and its reviews routinely include many outside experts and some consumer voices. It established with intellectual work, the basic standards for scientific testing, and with the cooperation of industry, enforced them.

Its work has produced credibility for industry and a standard on which industry and government have built extraordinary progress. Much remains to be done. Because the agency remains near the front lines of discovery, new information challenges old practices. Today, the two areas that loom ahead clearly are the best way to deliver reliable drug information to citizens, and the best way to study and report on safety after a drug is marketed.

But the role is essentially the same as that imagined by Harvey Wiley - to bring science to bear in food and medicine, to advance commerce safely and effectively. It may be that one of the most important discoveries during the evolution of the FDA is not just that science can be used effectively to make food and medicine safe, but that it can be used to set high standards that launch business success as well.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.