The Safety of Generic Drugs

by Food and Drug Administration (FDA)

By now, much of the nation has heard at least something about the Food and Drug Administration's investigation of the generic drug industry. The investigation has not only gripped the agency over the past several months, but also has had broad impact on an industry whose products represent about one-third of the prescriptions filled in the United States each year.

The generic drugs saga that unfolded over the summer has been rather complicated. At times, it has been difficult, even for me, to separate the wheat from the chaff in all of the various accounts of what has happened. In this issue of FDA Consumer, I would like to describe what's happened with respect to generic drugs, and what FDA has done to respond.

FDA takes its responsibility of ensuring the quality of all drugs — generic and brand-name — very seriously. This is our ongoing mission, and we shall always act promptly to remove from the market any drug that is found to fall short of our high standards.

The generic drug saga has underscored a point seen so often in life: that the poor behavior of a few tends to obscure the good done by the many. This is not to suggest that we do not have serious concerns about the conduct of a small handful of generic drug companies and three of our own former FDA employees. The entire agency, myself included, feels a deep sense of hurt and anger at the conduct of three of our own. Clearly, there was a problem, and a remedy was needed.

The problem, as it has unfolded, has at least three distinct parts. Let me explain:

It was discovered that officials of some generic drug firms offered illegal gratuities to FDA employees in our generic drug program. Regrettably, three FDA employees — now former employees — accepted the offers. These employees represent a tiny fraction of the 7,500 dedicated public servants who make up the FDA and of the 80 or so persons who work in the office that reviews generic drugs. I'm not trying to diminish the crimes, but I do want to keep in the proper perspective the work of the vast majority of FDA employees.

The second, and perhaps even more fundamental, part of the problem was the discovery that several generic drug firms had submitted false data in their applications to FDA for approval to sell new generic drugs. For example, one generic company admitted to submitting the brand-name maker's drug as its own in an effort to win swift approval of its generic copy.

Truthful and accurate information submitted by companies that manufacture drugs is crucial to FDA's continuing ability to ensure that their products are properly tested and manufactured.

Finally, FDA has also uncovered evidence that some generic drug firms have violated the good manufacturing practice regulations that govern overall production procedures and techniques that help guarantee the safety and effectiveness of drug products.

These revelations required the agency to act swiftly and conclusively to ensure that what was on the market was safe and effective for consumers of generic drugs. And, on Aug. 18, 1989, Health and Human Services' Secretary Louis Sullivan announced a comprehensive plan to accomplish this important objective. As part of that plan, with the help and support of the secretary's office, we are preparing new proposals for the Congress to seek to make certain that these problems do not occur again.

First and foremost, we needed to ensure that generic drugs are safe. Last April, when the allegations of gratuities first came to light, FDA launched "for cause" inspections of 11 generic drug firms. That number eventually grew to 13 firms after some irregularities in two other companies were reported by FDA investigators.

When we discovered that some companies had provided false data to FDA in the application process, we took a second major step — a comprehensive sampling and analysis of the 30 most-prescribed generic drugs. Our FDA labs across the country worked exceptionally hard to complete this huge task. I was able to visit several of the labs during this time and see for myself the painstaking work our laboratory staff were doing. Generic drugs, as well as the brand-name counterparts, were tested to make sure that each had the proper qualities of potency, dissolution and composition. The results of these tests showed no significant difference in the quality of these generics compared to the brand-name products.

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.