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The new pragmatism at FDA

Merrill Goozner says the pragmatic centrism that’s a part of most Obama administration appointees is also at the core of the new Food and Drug Administration team. Nearly every constituency with a stake in FDA regulation will like the initial statements by Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein, but “if there is any group that should come away emboldened by this first broadside by the Hamburg and Sharfstein leadership team, it is the career scientists at the FDA.”

Merrill Goozner is an award-winning journalist and author of “The $800 Million Pill: The Truth Behind the Cost of New Drugs” who writes regularly at Gooznews.com.

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In an online article in the New England Journal of Medicine, the new leaders at the Food and Drug Administration have laid out their public health orientation in broad strokes, promising a new era where the agency that oversees more than one-seventh of the U.S. economy puts science at the helm and gives safety equal standing with the new product approval process.

But they also pledged a new day for drug developers who worry the agency is failing to keep up with the frontiers of medicine. Indeed, nearly every constituency with a stake in FDA regulation will find something to like in the guideline offered recently by newly-installed Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein.

Drug safety advocates will be heartened by their promise to use the tools created by the 2007 reform law that allow the agency to pay greater attention to the risks of newly approved drugs. At the same time the drug and biotechnology industries can point to their pledge to speed new life-saving drugs to market and develop the new science of personalized medicine.

A pragmatic centrism that has been characteristic of most Obama administration appointees lies at the core of their philosophy. Will the FDA hurdle for new drug and device applications become more or less stringent? Wrong question, the new leaders say.

Some benefits are not worth the risk; some risks are worth taking. Key considerations are the severity of the illness at issue, the availability of alternative treatments or preventive interventions, and the current state of knowledge about individual responses.

Regulation of the pre-approval stage of drug development is in for an overhaul. Echoing the rhetoric of the Critical Path Initiative, which has come under fire from some consumer groups as a Trojan horse to undermine drug safety standards, the new leaders pledged to work more closely with scientists funded by the National Institutes of Health and the pharmaceutical and biotechnology industries as they explore potential breakthroughs. “As scientists identify fruitful pathways for research on treatments for debilitating diseases, FDA regulators should discuss with them the level of evidence necessary for the initiation of human trials and the eventual approval of treatments,” they wrote. And in what should be music to innovators’ ears, Hamburg and Sharfstein offered to collaborate with the Centers for Medicare and Medicaid Services “to explore ways of shortening the time from approval to reimbursement.”

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Food safety has dominated the headlines in recent months, and food processors — many of which are crying out for more inspections and tighter regulations — are going to see major changes in the months ahead.

The recent salmonella outbreak linked to contaminated peanut butter represented far more than a sanitation problem at one troubled facility. It reflected a failure of the FDA and its regulatory partners to identify risk and to establish and enforce basic preventive controls. And it exposed the failure of scores of food manufacturers to adequately monitor the safety of ingredients purchased from this facility.

The agency is also likely to pay much more attention to nutrition issues under their leadership. Not only are they promising to crack down on false nutritional claims (such as the recent Cheerios claim that it lowers cholesterol), but they want to work with consumer groups and industry “to promote more healthful foods.”

It’s never wise to read too much into broad statements made at the outset of an administration. This is as true for regulatory agencies as it is in politics. But if there is any group that should come away emboldened by this first broadside by the Hamburg and Sharfstein leadership team, it is the career scientists at the FDA.

“We recognize the importance of a management approach that respects the expertise and dedication of the FDA’s career scientists,” they wrote. “Establishing the FDA as a public health agency requires a culture that encourages scientific exchange and respects alternative viewpoints along the path of decision making.”

There will be no winners and losers in that approach. It pragmatically recognizes that when it comes to promoting and protecting public health, the facts on the ground matter most.

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