By Peter J. Pitts
The FDA is not a monolithic entity. The agency is comprised of over 11,000 dedicated public servants whose areas of expertise and responsibilities range from pharmaceuticals to food, veterinary products, cosmetics, medical technology, dietary supplements, and beyond.
No one person calls all the shots – but the Commissioner is in charge and sets the tone and direction of the body that regulates more than a quarter of the American economy. A really good commissioner is measured by the impact he continues to have once she has departed. By that measure Peggy Hamburg rates an “A.”
It’s fair to say that Dr. Hamburg came to White Oak at a time when the FDA was under a cloud. Whether or not the criticism the agency was receiving was fair (most of it was not) isn’t the point. Morale was low. Moral authority amongst constituents was fading. Global leadership was ebbing. PDUFA reauthorization was pending. Peggy did not walk into a cushy job and had a steep learning curve.
As every FDA commissioner, she faced many issues. Some specifically worth noting:
- The authority to regulate (at least after a fashion) cigarettes
- The controversy over opioid pain medications
- Medical device review reform
- A regulatory pathway for biosimilars
- Social media draft guidances
- Expedited approval pathways
- Expanded Access reform
- 21st Century bioequivalence strategies
- Adaptive clinical trial design partnerships
- A rethinking of FDA’s role in global harmonization
- Forward motion per Patient-Focused Drug Development
- An Office of Pharmaceutical Quality
… to name only a few. That’s not to say that all of these items are tied up in a bow, that there haven’t been errors, blunders, sins of omission or that important initiatives are progressing to everyone’s satisfaction – far from it. But as Mark McClellan used to say when he sat in the Commissioner’s chair, “If some people think we’re moving too fast and others think we’re moving to slow – then we must be doing something right.”
A successful FDA Commissioner quickly realizes that a sure path to failure is to try to make everyone happy or micromanage. That ain’t the way it works. She’s empowered the agency’s senior staff to follow her lead and do the right thing as they see it. The best example of this was her decision to allow Plan B (“the Morning After Pill”) to go OTC – publicly bucking political pressure from the White House to submarine the considered decision of the FDA’s professional regulatory staff – and quieting those who claim FDA decisions are “politically motivated.”
Perhaps most importantly is that faith in the FDA is stable and improving and staff morale is vibrant. Rather than the facile and ignorant drumbeat of “blame the FDA,” groups ranging from the pharmaceutical industry, to patients groups, Congress, academia, and healthcare practitioners are beginning to realize (some faster than others) that FDA is a crucial partner – indeed a senior partner — in the innovation ecosystem.
Peggy Hamburg is leaving the agency in a better place than she found it. She has successfully set the tone for the 21st Century FDA — an impressive and gutsy millennial course.
And that’s as good a legacy as any commissioner could want.
Peter J. Pitts, a former FDA Associate Commissioner, is President of the Center for Medicine in the Public Interest.