February 28, 2007 The Pump Handle 0Comment

By Liz Borkowski

Last week, the Project on Scientific Knowledge and Public Policy (SKAPP) held a panel discussion on the FDA featuring four former FDA Commissioners. While all of the panelists made a point of saying that there are a lot of wonderful people working at the FDA, they also acknowledged that the agency has some serious issues that must be addressed.

David Kessler, MD (FDA Commissioner from 1990 – 1997) remarked that being at the event was “in some ways very bittersweet.” He reflected:

I left the agency now a decade ago and I thought had done a pretty good job. Frank had approved the first drug for HIV. We then approved another close to a dozen. Review times were — when I got there it was like 33 months — it came down dramatically to 12 months. HIV was no longer a death sentence. It was an historic period in pharmaceutical development. If you got sick in this country and you needed access to an important medicine, the chances were that you could have access first in the United States. I thought those were all good things.

Kessler contrasted that to the current situation, in which an Institute of Medicine report on drug safety recommends major reforms at the FDA and the agency’s scientific integrity is being questioned.

So what happened? And why are we here? No doubt a couple of things contributed to that. I think three in particular. I assume we’ll have an opportunity to talk about Plan B. It will come up, right? If you’re going to do something for political reasons, okay. You’re going to do it. At least say you’re going to do it for political reasons. Come out and admit it. Don’t do it under cover. You lose credibility, and the agency lost a lot of credibility.

Since the event was organized and moderated by Susan Wood, who resigned her position as FDA’s Assistant Commissioner of Women’s Health over political interference in the Plan B decision, that particular issue was probably on a lot of people’s minds. (The other two items on Kessler’s list were Vioxx and commissioner turnover.) In general, though, panelists voiced their fears about eroding FDA credibility in general terms. Jane Henney, MD (Commissioner 1991 – 2001) said:

First and foremost is the integrity and credibility of the agency that has also rested on its decision making abilities — that decision making is clearly based in its legal framework but has always rested soundly on the bedrock of scientific evidence. …I think the American people have always believed – in terms of many of the surveys that have been done – they have confidence in this agency’s decision making because they believe it is based on science. I think in more recent days there have been question about that, even in some recent surveys.

Henney was probably referring to surveys about public attitudes on the FDA, but the survey that immediately came to my mind was the survey of FDA employees conducted by the Union of Concerned Scientists (UCS) and Public Employees for Environmental Responsibility (PEER). Of the survey respondents, 18.4% reported that they “have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or their conclusions in a FDA scientific document.” If the public is going to continue to have confidence in FDA decision-making, that number needs to be zero, not close to one-fifth.

Donald Kennedy, PhD (Commissioner 1977 – 79) put it this way:

And I also am concerned even more deeply about the tendency of political appointees and officials to rework or reinterpret scientific findings in the pursuit of particular policies. There is a pretty important cart-horse relationship between science and public policy and they science horse ought to go first and I think the public is concerned and eventually disillusioned when it appears that the policy cart is coming first.

The panelists were careful to distinguish between the public perceptions of FDA workings and their insiders’ views of the agency. While acknowledging that political appointees have put politics before science in some specific instances, these former commissioners seemed to maintain strong faith in FDA employees.

Who pays for drug review – and what are they buying?
The distinction between public perception and insider knowledge came up most notably around the issue of the Prescription Drug User Fee Act (PDUFA), which is up for Congressional reauthorization this year. Congress first passed this legislation in 1992, setting up a system in which drug companies help fund the FDA’s drug application review process by paying annual fees and fees for each prescription drug product they market.

In other words, drug companies are paying the FDA, and the FDA is either approving or rejecting the companies’ products. Henney emphasized that the drug companies were buying the review, not the approval, and that this has been clear from the start; she also re-iterated her belief “in the ultimate integrity that the reviewers at the agency bring to that review process.” She noted, though, that public concern about this funding mechanism increased when the user fees started to make up more than 50% of the drug review budget.

In describing his time at the agency, Kessler said PDUFA seemed like a good thing – it brought additional resources to the agency, and no one at the time said that drug companies were buying their reviews. Later in his remarks, though, he conceded that “maybe we got PDUFA wrong.” Much of the problem, he suggested, is that the blockbuster-drug model isn’t sustainable. During the Q&A, he pointed to a major problem with how PDUFA legislation is created: the FDA negotiates it with the drug industry – the very entity it’s regulating.

Kennedy said he didn’t know whether PDUFA had played a significant role in damaging public confidence in the FDA, “but I don’t think it’s the right way for Congress to exercise its responsibility to all the people.”

At the end of the discussion, Frank Young, MD, PhD (Commissioner 1984 – 89) asked his fellow panelists, “Given a choice of having PDUFA or an appropriation of equal amount, which would you take?” They responded quickly and unanimously: appropriations.

Congressional and White House cooperation needed
In addition to expressing a preference for appropriated drug approval funds, panelists characterized current appropriated funding as inadequate. Henney and Young both suggested that FDA is not well served by being part of the Agriculture Appropriations process. Young denounced Congress’s tendency to heap new mandates on the FDA without supplying additional funding. He also suggested that the agency get more money for training and research, so that FDA scientists could remain current in their fields.

Panelists seemed to agree on the need for the FDA to be able to do more to monitor the safety of drugs already on the market and address safety problems that emerge; this would require both more funding and additional legal authority from Congress.
The executive branch also plays a role in how much money the FDA gets. Henney described one experience in which, following a major recall, an internal FDA group came up with a report that included a dollar figure for creating a rigorous, robust risk management program – but Congress never even saw that figure, because the White House Office of Management and Budget always stripped it out during the budgeting process.

In short, there are a lot of FDA issues that need to be addressed, and panelists seemed to agree that doing so will require legislative and executive branch cooperation.

Panelists also had specific comments on issues including length of commissioners’ terms, direct-to-consumer drug advertising, and experimental drugs; check out Kaisernetwork’s transcript or webcast for more details. You can also visit SKAPP’s website to learn more about the workshop that convened the day after this panel to discuss ideas for strengthening the FDA; as in the panel discussion, agency credibility and funding were major themes. We’ll be posting materials from some of the workshop participants, plus news about steps they’re taking to strengthen the FDA.

Liz Borkowski works for the Project on Scientific Knowledge and Public Policy (SKAPP) at George Washington University’s School of Public Health and Health Services.

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