Should FDA Tighten Rules for Drugs on Market? Does the Food and Drug Administration have sufficient control over drugs once they've been approved?
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Should FDA Tighten Rules for Drugs on Market?

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Should FDA Tighten Rules for Drugs on Market?

Should FDA Tighten Rules for Drugs on Market?

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This is far from the first time that we've heard questions about widely used drugs: Vioxx, or a slew of anti-depressant drugs, or other diabetes drugs besides Avandia. So the question becomes could the Food and Drug Administration do a better job to keep those problems from happening in the first place? We've asked Dr. Bruce Psaty from the University of Washington to talk with us about how drugs are monitored once they are on the market.

Mr. Psaty, welcome to the program.

BRUCE PSATY: Thank you.

INSKEEP: How hard does the FDA try now?

PSATY: The FDA has two major activities for post-market surveillance. One is the adverse event reporting system, and the other is phase four trials requested of sponsors.

INSKEEP: What's a phase four trial?

PSATY: A phase four trial is a post-market trial agreed to by a sponsor at the time of approval.

INSKEEP: Meaning we're going to let you put this drug on the market, but we actually want to keep testing it even as you're selling it?

PSATY: That's correct. And the primary difficulty here is that these trials are assembled and designed quickly at the time of approval. Sometimes not well designed and frequently not completed. In the recent period of '98 through 2003, only about 24 percent of the post-market trials were even completed.

INSKEEP: And how good is the FDA at that other activity of just gathering information from the people taking the medication in the real world? Because I suppose that can amount to a massive survey or study if it's done the right way.

PSATY: Well, the adverse event reporting system gets over 400,000 reports per year and the quality of the data is not good. It's an important system for identifying rare adverse events, but it's not a high quality system.

INSKEEP: What's lacking?

PSATY: What's lacking is an ongoing evaluation of drugs after they're on the market. For Avandia, which was discussed at the hearing, the FDA medical officer recommended a post-market study that would evaluate cardiovascular risks like heart attack. Unfortunately, the manufacturer did not conduct such a trial in a timely fashion. We're eight years out and we still don't have high-quality information about the risks of heart attacks associated with Avandia.

INSKEEP: Just to understand the process, when somebody from the FDA says I see a reasonable potential of a risk here, I want a study of that, doesn't the drug company then have to study it?

PSATY: Well, this is the problem. It's a negotiated process. The FDA has virtually no authority to compel activities by companies after a drug is on the market. The FDA needs finer levels of authorities and tools to compel companies to behave well.

INSKEEP: Is - what happened with Avandia normal?

PSATY: I think what happened with Avandia has happened with other drugs. There was a potential signal of an adverse event for Vioxx. And an important question was whether the cardiovascular risks would be an adverse effect and whether the benefits to the stomach would outweigh those risks. That trial - those trials - were also not done in a timely fashion when Vioxx came on the market.

INSKEEP: You just talked about benefits outweighing risks. Is that perhaps sometimes brutal calculus that has to be made by somebody at the FDA? There may indeed be a risk from a particular drug, but it's decided that it's worth that risk?

PSATY: That's the decision that actually patients, physicians and the FDA have to make all the time. All drugs are associated with risks. They are also associated with benefits, and it's a matter of quantitatively how those risks and benefits play out. And in part patient preferences about what risks they're willing to take and what benefits they seek.

INSKEEP: Bruce Psaty of the University of Washington, thanks very much.

PSATY: Thank you.


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