Why Should FDA Regulate Drugs? : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Q. Could reforming FDA make it more efficient and save American tax dollars?

A. I think the center's efficiency has come far, but we still have improvements to make. When we talk about legislation to reform the agency, the first thing that must be done is to identify what problem exists. What problem are you trying to fix?

There has been a lot of rhetoric about FDA reform that hasn't been related to identified problems. Some people are saying the problem is that we're too slow. That clearly isn't the problem. During my three years as director of the center, some important changes have been made to make the center's work proceed faster and more effectively.

We are making as many processes as possible computer-based. But one of the biggest changes is the ever-improving review times for new drugs under the user fee program.

The idea behind user fees is that the industry is getting a service from the government in having their applications for marketing reviewed. And they should contribute directly to that. So five years ago, Congress, the industry, and FDA negotiated this user fee program. Industry would pay fees to add to FDA's resources for reviewing new drug applications. In exchange, FDA made a commitment to meet certain goals for review times.

CDER has been meeting all those goals. In fact, we've exceeded almost all the goals, and we expect to continue to exceed them. Basically, we've doubled the number of new drugs we're approving, and we've halved the review times.

One of the unique things about the user fee program, though, is that Congress only authorized it for five years, which expires at the end of September. So all the stakeholders — Congress, industry, the public — have to decide whether or not they're satisfied enough with the results to continue the program. Most of the interested parties I have talked to support the continuation of the user fee program.

In generic drugs, the workload has also gone up in the last couple of years. We're maintaining our review times — we've had difficulty shortening them on the generic drug side — but the generics staff has started some streamlining strategies over the last year to try to deal with the increased workload. They're working more closely with manufacturers — by faxing them information, communicating more by telephone, and meeting with them if necessary — to try to minimize the back-and-forth when an application has shortcomings.

So we still have work to do, but if you look at speed of introducing new medicines, we're the fastest agency among all the countries in the world with a formal regulatory system.

It takes a long time to change perceptions, though. For years, we were behind other countries in approvals, and there was what is called a "drug lag." In many cases, it took us years longer to review drugs than certain other countries. And that remains in people's minds.

But review time is only one facet of an effective center. People are now bringing up drug development times: the time it takes from a chemical's discovery in the laboratory, to its testing in animals, to its testing in people, to its review by FDA, which is necessary before marketing. People are saying that the drug development time is too long, and that maybe FDA has a part in that.

I think there are some things FDA can do to shorten the drug development times. What FDA does in drug development is to set certain standards. Clearly, if we did away with all the laws we have now, drug development time could be very short. A person could make a chemical, say, in their basement, and then they could put it on sale. That's going too far.

What we can do is evaluate our standards to make sure that all the information we require is absolutely necessary, and there are no extras. And we must be very clear about what information is required at each stage of drug development. The clearer we are, and the more the standards are universal, the easier drug development will be.

About a year ago, we streamlined what's called the IND process. That is, we provided some guidance on the minimum amount of animal chemistry information necessary to start the drug development milestone of testing in humans.

Also, over the last few years, FDA, Japan, and the European Union have been negotiating to standardize technical requirements under the International Conference on Harmonization (ICH). Then, companies won't have to repeat things unnecessarily.

What the harmonization among countries means is that data that a drug company collected to submit to, say, Japanese authorities will be the same or similar data as that required for FDA. It means reducing the amount of testing, but each country would still make its own decision about whether to approve a drug.

So far under the ICH, major progress has been made toward standardizing the information that is filed about side effects to help us detect unexpected side effects earlier, and standardizing the kinds of safety testing in humans that is required.

But to say FDA alone should decrease development times would be a big stretch. Because pharmaceutical companies develop the drugs, not FDA, much of the burden for shortening development times and decreasing development costs lies with them.

I think manufacturers are very interested in shortening drug development times. We know it can be done. For example, with the AIDS drugs, where people put in a full-court press on developing drugs, they were developed very rapidly, from the test tube to the clinic to marketing.

CDER's mission involves not only assuring that safe and effective drugs are available to the public, but that unsafe or ineffective drugs are kept off the market.

It's an interesting balance, and even consumer groups disagree about what the right balance is. Some groups are very risk-averse, and they don't believe FDA should approve any drug that has harmful effects. Well, most drugs have harmful effects, and you have to make sure that the drug's benefits outweigh its harmful effects.

We at CDER think we've achieved the proper balance, given all the different parties and their different interests. While there will never be complete agreement, most people seem to agree on one thing: FDA should keep drugs off the market that ultimately will harm or kill people and have to be withdrawn.

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.