‘Opportunity for Improvement'

It's been a rough couple of months for the Food and Drug Administration. In September, a much-anticipated Institute of Medicine (IOM) report, commissioned by the FDA and the Department of Health and Human Services in the wake of the Vioxx recall and safety concerns about other high-profile medications over the last few years, condemned the FDA’s drug safety system as “impaired.” IOM investigators cited, among other problems, a lack of resources, a dysfunctional organizational culture, and insufficient enforcement capabilities as particular areas of weakness. This week, in an article published in the Archives of Internal Medicine, five scientists who are current or former members of an FDA committee on drug safety supported many of the IOM report findings, claiming that the FDA needs to do more to keep America’s drug supply safe. NEWSWEEK's Julie Scelfo spoke with Dr. Steven Galson, director of the FDA’s Center for Drug Evaluation and Research, about the reports and whether they will lead to changes at the FDA. Excerpts:

NEWSWEEK: Some current and former member of the FDA's Drug Safety and Risk Management Advisory Committee say that the FDA's system can miss serious problems with a drug both before and after its approval. Do you agree changes are needed?

Steven Galson: I feel very strongly that we always have to be evaluating our drug safety policies and figuring out how we can make improvements. I see the IOM report as a fantastic opportunity for improvement.

So do you think there should be changes at this particular juncture?

I think we'd be in trouble if we weren't always looking at changes. We consider changes every month in how we do business to try to make it better and better.

I've heard from a lot of doctors that patients request a specific drug by name, in part because of direct-to-consumer advertisements. It wasn't that long ago that drug companies were prohibited from advertising directly to consumers. Are ads are changing the way people think about prescription drugs?

There have been a lot of studies about this and the data shows it's really a double-edge sword. There may be some drugs that people wouldn't otherwise get, that they only get because they ask for them. But much of that is positive. For example, we know that drugs to treat high cholesterol, hypertension or depression are actually underused in the population, so we know the ads are reaching a lot of patients who can benefit from these drugs who otherwise wouldn't get them. But there are potential negatives as well, such as people ... convincing doctors to give them drugs they may not necessarily need.

Do you think it would be better if these ads were prohibited?

Currently the law allows direct-to-consumer ads. There are constitutional and other legal issues, but we are looking at these policies and I know Congress is, as well. So there may well be changes ... We pay very careful attention to the fact that the ads have to be truthful and they can't be misleading. If either of these two things occur, we take regulatory action against the company and make them change the ads.

What do you think about proposals to give the public better access to results from drug trials?

We support that. We already have a public database of clinical trials available now.

A new editorial in the New England Journal of Medicine calls for "all clinical trials beyond phase 1 [to be] registered in a public database." What does that mean?

There is a publicly available database now, www.clincialtrials.gov , where drug companies post trials. We’re in favor of full reporting of [more] clinical trials into this database but we have to study the recommendations in the IOM report before coming to a firm conclusion about how to do that.

The arthritis drug Vioxx was voluntarily recalled in 2004 due to the risk of heart attack or stroke. Have any changes already been implemented to avoid another Vioxx situation?

We have invested a lot of time and effort in the agency to improving the science of drug development and the industry has, as well. There's always change taking place in how effectiveness and safety are evaluated. There's a lot that's changed in how clinical trials have been designed, how we detect drug adverse events after approval, but we think there's a lot of room for additional improvement. Specifically, we're working on initiatives in personalized medicine that will help us better predict for individuals whether a drug will work, whether a person will have adverse events resulting from taking that drug. And we're also looking at ways to detect ... problems that occur postmarketing more quickly.

Why is there so much interest now in postmarket evaluation as opposed to premarket?

We know that when a drug is approved, because of the way clinical trials are designed, we're never going to know everything about how a drug works and whether it causes adverse events. We just can't study the drugs in enough people to know that. Hopefully with changes in our information about genetics and people's individual predisposition to whether drugs work or cause problems, we'll do better at that before approval. Right now we know when a drug is approved that we're not going to know everything. Events like the cardiac problems that have resulted in some people taking Vioxx, some of these adverse events don't come to light until many years after a drug has been on the market. I think that's why there's been a lot of attention to making sure we have a robust monitoring system, so that when drugs do run into trouble that we can detect those troubles early.

The IOM report found the FDA doesn't have adequate enforcement powers. What do you think?

We have tremendous authority right now to take a lot of enforcement actions. But that's one of the recommendations that we're going to be carefully evaluating but don't have a position on right now ... One thing that's very clear is if we did have more enforcement authority it wouldn't really do any good unless it was matched by more resources, more people, who could implement the new responsibilities.

Is the FDA's drug safety program adequately funded?

Congress and the administration and the FDA have been investing more and more money in drug safety in last few years. We're talking with [the pharmaceutical] industry now about reauthorizing the user-fee legislation which lets us collect fees from the industry. And we're talking about increasing the share of those funds that are used on drug safety. And those discussions are going on ... But it's important to keep in mind that we have increased our investment [in drug safety] substantially in the last few years.

If Congress would grant you one wish, what would it be?

Unfortunately, there's no fairy godmother in Congress, but we are working within the system we do have to try to make sure we have the best possible legislative agenda for the agency and for public health.

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