Tuesday, April 13, 2004
One-year evaluation of new FDA director shows progress needed
[Henry I. Miller, "Can Dr. McClellan Cure the FDA?," The Hoover Digest, No. 1, 2004.]
Hopes were placed on Mark McClellan’s appointment as head of the FDA that a new era of culture and regulatory reform would sweep through the extremely bureaucratic agency. After one year on the job not much has changed, but there might still be hope:
The FDA regulates products that account for about 25 cents of every consumer dollar, more than a trillion dollars worth annually, and excessive or ill-conceived regulation is detrimental both to innovation and to public health.
Drug development is particularly unwell.
The total time required to bring a single drug to market, from synthesis of the molecule to marketing approval, has more than doubled (from 6.5 to about 15 years) since 1964. In spite of more powerful and precise technologies for drug discovery, purification, and production, development costs have skyrocketed. According to the Tufts Center for the Study of Drug Development, between 1970 and 2003 a company’s average expenditure to develop a single new drug increased from $138 million to more than $800 million. And although between 1970 and 2000 research-based companies’ R&D outlays soared from about $2 billion to $30 billion, the number of new drug approvals barely budged.
An important reason is that the highly risk-averse FDA keeps raising the bar for approval, especially for innovative high-tech products. Human gene therapy and other treatments tailored to individual patients have been hit especially hard. Americans are, literally, dying for regulatory reform.
Even granting Dr. McClellan the benefit of the doubt—a year is, after all, not terribly long—his best efforts at reform ultimately may be frustrated by history. The FDA’s long-standing hostility and regulatory excesses toward drug companies have caused the number of submissions for marketing approval to decline steadily since 1995, so there is now relatively little in the pipeline awaiting approval. Not even the most highly motivated bureaucrats can approve applications that haven’t been submitted.
Thus, even if Dr. McClellan is able to make good on his promise to improve the agency’s efficiency, it is unlikely that in the near future we’ll see a marked increase in the number of drugs approved. But if he is able to begin in a serious way the process of reforming the infrastructure, internal performance standards, and attitudes at the FDA, Dr. McClellan will have left a valuable legacy.
[Henry I. Miller, "Can Dr. McClellan Cure the FDA?," The Hoover Digest, No. 1, 2004.]
Hopes were placed on Mark McClellan’s appointment as head of the FDA that a new era of culture and regulatory reform would sweep through the extremely bureaucratic agency. After one year on the job not much has changed, but there might still be hope:
The FDA regulates products that account for about 25 cents of every consumer dollar, more than a trillion dollars worth annually, and excessive or ill-conceived regulation is detrimental both to innovation and to public health.
Drug development is particularly unwell.
The total time required to bring a single drug to market, from synthesis of the molecule to marketing approval, has more than doubled (from 6.5 to about 15 years) since 1964. In spite of more powerful and precise technologies for drug discovery, purification, and production, development costs have skyrocketed. According to the Tufts Center for the Study of Drug Development, between 1970 and 2003 a company’s average expenditure to develop a single new drug increased from $138 million to more than $800 million. And although between 1970 and 2000 research-based companies’ R&D outlays soared from about $2 billion to $30 billion, the number of new drug approvals barely budged.
An important reason is that the highly risk-averse FDA keeps raising the bar for approval, especially for innovative high-tech products. Human gene therapy and other treatments tailored to individual patients have been hit especially hard. Americans are, literally, dying for regulatory reform.
Even granting Dr. McClellan the benefit of the doubt—a year is, after all, not terribly long—his best efforts at reform ultimately may be frustrated by history. The FDA’s long-standing hostility and regulatory excesses toward drug companies have caused the number of submissions for marketing approval to decline steadily since 1995, so there is now relatively little in the pipeline awaiting approval. Not even the most highly motivated bureaucrats can approve applications that haven’t been submitted.
Thus, even if Dr. McClellan is able to make good on his promise to improve the agency’s efficiency, it is unlikely that in the near future we’ll see a marked increase in the number of drugs approved. But if he is able to begin in a serious way the process of reforming the infrastructure, internal performance standards, and attitudes at the FDA, Dr. McClellan will have left a valuable legacy.
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