Nostalgia isnt what it used to be.
Peter De Vries
IT'S EASY TO FEEL NOSTALGIC about the heyday of the blockbuster drug, or even to openly mourn the time when one commercial success seemed to follow another, and corporate budgets and job security were assured.
In fact, some drug companies today are likely experiencing one of the five stages of grief immortalized by psychiatrist Elisabeth Kubler-Ross. Which stage best describes the mood at your company: Denial, Anger, Bargaining, or Depression?
The sooner everyone moves on to the final stage, Acceptance, the better off the industry will be. Acceptance doesnt mean giving up, but acknowledging that the blockbuster model has created many of the industrys most challenging problems. Not only has it led to the notion of an infinite number of potential therapies being out there, just waiting to be discovered, but it has damaged the industrys reputation and led to serious concerns about drug safety.
This whole subject came up last month, when four former FDA commissioners met to discuss how to address the challenges facing the Agency and the industry. (Editor's Note: For more information on this meeting, click here to read our blog entry.)
Rather than pointing the finger of blame at the former Commissioner Whose Name Must Not Be Spoken, speakers agreed that problems within the FDA simply mirror those within the drug industry. The model that weve based pharmaceutical development on for the last decade is not sustainable, said Dr. David Kessler, who led the FDA from 1990 to 1997. Its the notion of the blockbuster, the idea that well be able to come up with drugs that millions of people can take safely, that has gotten us in trouble.
The industrys new paradigm, he said, should instead be about the right drug for the right person and the right disease, at the right dose and the right time. Drugs should be made for those who will truly benefit from them. Revenues and volumes will be smaller for each product, but collectively, will add up. And, as Dr. Kessler noted, the tools required are just becoming available.
Instead of Big Pharma well have Agile Pharma, and companies that make a number of $300 million-per-year products rather than focusing all resources on a few $1 billion-per-year blockbusters.
The individual patient, rather than a vague market, will guide development, manufacturing and compliance, and the public will once again view drug makers as healers rather than product pushers.
But the new framework will require a new discussion of scientific and economic underpinnings. As Dr. Kessler asked at the meeting, Can FDA provide the intellectual firepower required to lead this discussion?
Therapies of the future, whether combined drug-devices or biosimilars and biogenerics, will require even more highly trained reviewers. A level of research and science will be needed at FDA that hasnt been seen for years, Dr. Kessler acknowledged. The Agency will also require funding for the IT needed to handle data, and training for those who would use it. FDAs Chief Medical Officer, Dr. Janet Woodcock, is focusing on these efforts through the Critical Path and related initiatives, with the goal of moving science forward.
At this point, lawmakers in Washington are talking about giving the FDA more power to mandate Phase IV post-approval safety testing. But at the same time, theyre talking about eliminating the user fees that currently fund some of the Agencys work. What will replace the money from those fees?
This year, $6 million has been devoted to the FDAs Critical Path initiative, and $4 million for drug safety. Considering the complexity and importance of the work involved, thats a pittance.
The death of the blockbuster means a new and better model for the industry. But building that model will require an FDA thats at the top of its game, in order to establish the scientific and compliance ground rules. Unfunded mandates can only set back the effort, and keep the blockbuster model on life support, to the continued detriment of the industry and the risk of the patient.
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