“The Blockbuster Model’s What Got Us Into Trouble,” Says Former FDA Commissioner Kessler

The recent Kaiser webcast asked four former FDA commissioners what they might do to strengthen the Agency today.  The event was sponsored by SKAPP, the Project on Scientific Knowledge and Public Policy, moderated by Dr. Susan Wood, Research Professor at George Washington University's School of Public Health's Department of Environmental and Occupational Health, and web cast by Kaiser, which promises to have a full transcript available shortly. Invited were former FDA Commissioners  Jane Henney, David Kessler, Frank Young and Donald Kennedy, president emeritus of Stanford and Editor of the AAAS's Science, who phoned in from the West Coast.  Dr. McClelland couldn't make it.  (And, although including him would definitely have shaken things up, Dr. Crawford was  (ahem) not invited.)  "FDA is a mirror of the crisis in medicine today," said former Commissioner Frank Young, now CEO of Cosmos Life Sciences Alliance, who served from 1984 to 1989, during which the first HIV/AIDS drug was approved on a fast-track basis, and the first generic drugs were also approved.  "Integrity in FDA is a mirror of integrity within Congress, the Administration and the public. We can't hold FDA to a different standard," he said later in the program.

Perhaps Dr. Crawford has become too much of a scapegoat. But, although he may not have been the root cause of all these problems, many of the huge issues that the Agency is struggling with today took concrete shape during Crawford's very tentative tenure, notably:

  •  Politicization of the Agency, with questions of politics superseding science, as was seen with the about-face over Plan B
  • Questions of drug safety and scientific integrity within the Agency, and, of course,
  • Questions of conflicts of interest, which eventually prompted Dr. Crawford's resignation.
In addition to discussing potential solutions to these problems, the former commissioners offered  interesting insights into the Agency and those who have run it for the past 20 years.  A Wish List from Commissioner Alumni Here are a few sound bites, briefly distilling their comments and suggestions (a more detailed analysis will appear in our next issue of Pharmaceutical Manufacturing):
  • A reasonable, professional recruitment process is needed for incoming Commissioners, panelists agreed, with some suggesting that a six-year term-time be set for any Commissioner
  • Adequate funding.  Dr. Young recalled having to fulfill 22 unfunded mandates during his tenure.  This funding would cover increased training for FDA scientists, as well as improved inspection and regulation of food. It should also cover a new IT infrastructure--not only the platform but training---that will be required to mine and coordinate data
  • More attention paid to Agency staff morale and retention. As Dr. Henney (Commissioner in the late 1990s, and deputy commissioner under Dr. Young)  pointed out, funds have not been available for the past few years to allow reviewers and others to keep their skills sharp. "You want people at the top of their game looking at the scientific evidence thats coming into the Agency in terms of product reviews.  You dont want someone whose knowledge is even five years old because you need someone who can go toe to toe with any industry scientist and say 'No, but' or 'you need that.' Otherwise you dont have the caliber of person required to make the decision," she said.
  • Increasing Agency authority, and funding, for food-related issues. Establishing a separate Food Agency is not the answer, panelists agreed, but increasing authority over food issues and providing adequate funding for enforcement would be critical. Funding should no longer be under the purview of the Senate Agriculture Committee, Henney said.
  • A re-examination of users' fees.  Panelists appeared to be against the concept of user's fees, or felt that the concepts behind them should be revisited.  Said Henney, "We need to have an in-depth discussion of appropriated funds vs. users fees and the perception that has resulted from user fee funds funding so much of the Agency's pre-approval work."
  • More of an R&D focus, and increased scientific training.  Dr. Young recalled when NIH was part of the Center for Biologics, how helpful it was that the reviewer who approved the first interferon, had had six months to study them carefully before beginning the review process.

  • A more effective system for the epidemiology of adverse drug reactions, including data collection. Dr. Kennedy adovcated this, recalling what happened during the VIoxx crisis, when much of the ADR data were provided by Kaiser.  

  • Educating the public about the Agency's role in determining the critical balance between approving a new drug prematurely and stymying innovation.  Dr. Kennedy suggests that this balance is still misunderstood and contributing to the credibility issue facing FDA.

  • Increasing the Agency's  ability to monitor the safety of a drug once it's out there, either through mandatory Phase IV or better focus on post-market reactions.  Direct authority to recall drugs might be another positive solution.

One of the most interesting (of many) quotes during the program came from Dr. Kessler, who led the Agency from 1990 through 1997---an M.D. with a law degree and Congressional experience, who is now dean of UCLA's Medical School.


(This was, clearly,  a group of overachievers)


"The model that we've based pharmaceutical development on for the past 10 years is simply not sustainable," he said. "The notion that there are going to be drugs that millions of people can take safely, the whole notion of the blockbuster, is what has gotten us into trouble."  By us, he didn't only mean the FDA, but the industry.


The issue is not primarily about the Agency, or about drug safety itself, but about "the right drug for the right person in the right dose at the right time," Dr. Kessler said.


A whole economic discussion has to take place, he said, because Big Pharma can't be sustained within this new framework.  He expects to see retrenching over the next few years, with companies focusing on more, less lucrative drugs targeted to individual patient segments.


Dr. Kessler also suggested that it will be the Agency's job to develop the pharmacogenomics data that personalized medicine will require, rather than leaving that entirely to the industry or academia. "But it will require a higher level of science than the Agency's seen for years," he said.


For the record, Dr. Woodcock seems to be moving forward on several of these fronts, notably scientific education within the Agency, and she's even addressing the IT investment and training issues that go along with it.