User Fee Goals Needed To Balance FDA Caution, Former Counsel Troy Says

The prescription drug user fee program must be preserved to prevent FDA from becoming overly cautious on drug approvals, former FDA Chief Counsel Dan Troy told the Milken Institute Global Conference in Los Angeles April 18.

"FDA is right now in a bad place," Troy said. "There is really a risk of deadly overregulation and deadly overcaution, so the counterweight to that has got to be continued defense of the Prescription Drug User Fee Act."

Troy left FDA in November; he is now a partner at Sidley Austin Brown & Wood.

The deadlines set by the user fee program are as important as the resources FDA gains from the program, Troy maintained.

The user fee system takes "the dynamic scientific negotiation that is the drug approval process and it makes sure that it keeps moving along. And that...as much as the money, has had a big difference in getting drugs approved."

"There are many bureaucratic incentives to not approve the drugs, because every time FDA approves a drug it puts its own credibility on the line. And there's nothing more important to FDA than its own credibility. That's true of any organization," Troy said.

FDA's "incentives towards caution" have been balanced in recent years by the user fee program, "not because of the money that it gives the agency, but because it commits the agency to deadlines, and giving regular feedback to companies."

In addition, "the understanding and the awareness" that FDA personnel have "of the problems and the people that die because of the drugs that are not approved, serves as the counterweight to this bureaucratic incentive to not approve a drug and only ask for more data," Troy said.

However, the balance between potential risks and benefits in drug evaluation is disrupted "if people get pilloried because they approve a drug and the drug later gets taken off the market."

"If a product's not available, that's a risk too," Troy stressed.

"The concern that I think we all have right now is that the lessons of the 1980's and the early 1990's that were taught by the AIDS patients and the cancer patients in particular have been unlearned in the last six months with remarkable speed," Troy said.

An independent Office of Drug Safety would only further disrupt the balance of risk-benefit assessment, Troy maintained.

Separating the agency's evaluation of drug safety from evaluation of efficacy "is a colossal mistake," Troy said. "If you incentivize people to find safety problems, they will find safety problems. You cannot look only at safety, because placebo is almost always safer than drug."

Current FDA officials, including Center for Drug Evaluation & Research Acting Director Steven Galson, have emphasized the importance of keeping risk and benefit analyses together (¹ (Also see "FDA’s Crawford Open To Discussing Independent Drug Safety Office" - Pink Sheet, 21 Mar, 2005.), p. 5).

At a meeting of FDA's Science Board, Galson said the agency's risk threshold has not changed since the advent of the user fee program (see ² ).

Rather than requesting more information pre-approval, FDA's system needs to be better equipped to handle inevitable post-marketing safety problems, Troy said.

"There are always going to be problems that are found when the drug goes out into broader distribution. We just need to recognize that we need to do a better job measuring that and responding to it, but we have to understand - and the folks at FDA by and large do understand - that...at the end of the day, we're going to find out stuff once the product is approved."

The benefits of some medicines, including Vioxx , have been undervalued in the current environment, Troy indicated. "There are many people who really want Vioxx. Vioxx did not have to come off the market. Many people would accept the additional risk that Vioxx creates in order to have...a pain-free life and get the benefits of the medication."

"The public's perception is that drugs should be risk-free, and they're never going to be risk-free," Troy said. "We have to educate people about the fact that drugs have risks."