FDA Says SCIENCE, But Is the Agency Spin Doctoring?

FDA is building policy in the name of science. Or is the agency hiding behind it?

Heather Thompson

October 27, 2011

3 Min Read
FDA Says SCIENCE, But Is the Agency Spin Doctoring?

Earlier this year, FDA commissioner Margaret Hamburg put science at the forefront of the agency’s strategic priorities, saying, “I would like to emphasize one priority in particular: Advancing Regulatory Science and Innovation. Science underlies everything we do at this agency, and to serve the public health we must have the capacity to effectively oversee the translation of breakthrough discoveries in science into innovative, safe, and effective products and life-saving therapies for the people who need them most.” Note: I’ve left the capitalization from the original press release in, to demonstrate FDA’s emphasis.

Top_sml.jpgIn achieving that goal of translation, FDA has outlined its intentions to approach regulatory science in a new way, one that takes on a risk-based approach and establishes a host of experts in innovation from various disciplines.

Nearly everything the agency has released in the last few months is branded as science with a capital S. The agency has created a Strategic Plan for Regulatory Science. It has also issued a report titled, “Regulatory Science in FDA’s Center for Devices and Radiological Health: A Vital Framework for Protecting and Promoting Public Health,” and established a science board that includes multidisciplinary experts to counsel FDA on its most crucial clinical questions.

When CDRH director Jeffrey Shuren, MD, spoke at the AdvaMed 2011 conference held September 26–28 in Washington, DC, he acknowledged the agency’s shortcomings, noting that past programs have been neither consistent nor transparent, admitting that FDA has not held up its end of the process, and citing the scientific advisory panel. “Without the right cadre of experts we are hurting both industry and patients,” Shuren told attendees.

To that end, Shuren outlined the plan to introduce interactive review, with greater emphasis on structure and tracking. “FDA will set up a network of experts to address scientific questions.” Those questions center on patient tolerance for risk and determining what treatments are critical for the market.

With such moves, FDA is clearly trying to bring its science into alignment with regulatory needs, meet industry requirements, and realign its own branding. It is clearly embracing a call from the Obama administration to reestablish FDA as an authority while still working within the limited budget afforded to the agency.

Many in industry may be thinking that this effort by FDA is a lot of flapping, without much substance to back it up. And I have to admit, positioning FDA behind a science wall, so to speak, strikes me as somewhat disingenuous. But it is a very effective defensive move (after all, can a rational person argue with science?). I sincerely hope that is not the main reason for FDA’s approach.

I will say, I’m very excited to see the names associated with FDA’s science board. People such as John H. Linehan certainly have interests in keeping industry innovative. And I’ve heard rumors that Dean Kamen (inventor of the Segway and the first portable drug infusion pump, among other advances) has been asked to join.

I suppose that ultimately it doesn’t matter whether this is a marketing campaign by FDA or whether the agency is spinning its wheels. If the power of the science increases consistency among reviewers and fulfills the need for innovation, then Science will have done its job.

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