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Commentary By David Gratzer

'Caution Syndrome' Infects The FDA

Health, Health, Health, Public Safety FDA Reform, Pharmaceuticals, Pharmaceuticals, Policing, Crime Control

This week, Dr. Margaret Hamburg, President Barack Obama’s nominee for FDA Commissioner, was confirmed by the Senate. Dr. Hamburg is an impressive sort, with dual degrees from Harvard and a career that includes important positions at the Department of Health and Human Services and as New York City health commissioner (the youngest in the city’s history, no less).

During her confirmation hearings, which she sailed through, she emphasized that she wants to restore confidence in the agency and spoke of respecting scientists’ opinions. But the FDA will need more than platitudes; it needs an overhaul.

The Hoover Institute’s Henry Miller, who served with the FDA for years, tells a story about bureaucratic malaise: In the early 1980s, he was part of the group that reviewed the agency’s first-ever biotech application for manufacturing insulin through gene-splicing techniques. After four months of deliberations, armed with data and with all concerns addressed, his team was prepared to give the approval--one that would revolutionize diabetic management and cost.

The catch? Most approvals took two-and-a-half years, so his supervisor wanted to delay the decision, worried the speedy approval would be indefensible should anything go wrong. In other words, to delay for the sake of delaying.

Things have gotten worse at the FDA in the last quarter-century, when Dr. Miller was mulling insulin data, with the agency growing ever more cautious in its approval process. In the mid 1980s, the average drug trial involved 1,300 patients; today, a drug is typically tested on 4,300 people. The FDA is even stricter with applications for primary-care drugs--a recent trial for a blood thinner involved some 30,000 people.

Call it the “Caution Syndrome”: fearful of bad press and Congressional hearings, the agency errs on the side of caution, leaving new and potentially life-saving medications lingering in the approval stages while potential patients suffer. The results are maddening: How many tens of thousands died, for example, because of the seven-year delay in approving beta-blocker drugs?

And it’s not just drug approvals. In recent years, the FDA has grown more and more eager to issue warnings on medications. A case in point: the use of antidepressants for adolescents with depression. Concerned about side effects, the agency issued a black-box warning on Prozac and its sister drugs. The consequences? The youth suicide rate--which had been steadily falling since 1987--rose by 14% from 2003 to 2004, the sharpest rise in three decades of data collection. A one-year anomaly? The increase was sustained into 2005.

Dr. Hamburg needs to change the culture of the FDA, one that is now quick to hesitate and eager to defer. To do this, she must shake up the bureaucracy. First, she can take a page from Dr. Miller’s book and create an ombudsman’s office, thereby developing a non-political way of addressing errors and sluggish approvals. That office would not simply investigate bureaucratic malaise, but be empowered to penalize staff for flawed decisions.

Further, she can end tenure for FDA staff. While the original intent of this job-security measure was to ensure diligence, it has become protection for incompetence. Doctors and pharmaceutical companies don’t have tenure protections; why should their regulators?

Finally, she can recognize that the FDA doesn’t need to do all the number crunching and statistical work in house. In the late 1980s, the administration of George H. W. Bush embarked on a two-year trial where new drug applications were reviewed by the FDA but also by a nonprofit organization. Reviews outside the Agency were faster and less expensive.

Dr. Hamburg has spoken in favor of respecting scientists--that should include scientists outside her Maryland office. The FDA should build on this pilot project and look to non-government organizations to speed the approval process. This initiative would carry an additional advantage: It would enhance transparency, giving the FDA’s leadership a better understanding of performance through comparison.

Dr. Hamburg takes over the agency at a difficult time. Rocked by the Vioxx controversy and a string of other failures, confidence in the FDA is hardly robust. She needs to address that by addressing the Caution Syndrome--and that will require strong medicine.

This piece originally appeared in Forbes

This piece originally appeared in Forbes