Reform of the U.S. Food and Drug Administration must be about serving the public health—not partisan political interests. That’s why I was honored when the Obama FDA transition team called and asked for my advice on how the incoming administration could make the agency a more robust and forward-looking regulatory instrument.

 

The transition team’s initial request was a memo, of no more than two pages, outlining key issues and offering general recommendations. Never have two pages seemed so inadequate. But I did my best and here’s what I delivered.

 

Everybody benefits from an FDA that leads. This means the agency has to be out in front of every issue for which it is responsible. Every specific action the agency takes is an opportunity to speak to a larger public health issue. The controversy over the safety of Vioxx, for example, was a missed opportunity for the FDA to seize the day on the issue of drug safety. When the FDA confidently leads, other stakeholders follow with their expertise, resources and sense of duty. This is not a people-intensive proposition. But it does require the commitment and the skill to do it—and do it right and regularly.

 

The Reagan/Udall Foundation: A Partnership of Unequals
The FDA must be both regulator in protecting the public health and colleague in helping to advance it. This is a delicate balance and in the current political climate the agency gets no merit points for being seen as collaborating with those it regulates. The best way to do this is via the Reagan/Udall Foundation, the private and independent nonprofit charged with modernizing product development, innovation and safety. Now that the election is over, an immediate first step should be for the new FDA Commissioner to meet with Representative Rosa DeLauro, D-Connecticut, and issue a joint announcement on moving forward with the work of the FDA’S Critical Path program to develop the tools necessary for 21st century pharmaceutical and medical device development and regulation. But FDA must be seen as leading rather than simply participating in the process.

 

Regulators often love ambiguity—because ambiguity is power. The problem is that such a philosophy can lead to regulatory dissonance—ranging from completed Phase III trials supported by the agency at advisory committee meetings, and then derided by a division afterwards, to warning letters sent to companies over marketing materials that have been “pre-cleared” by The FDA’s Division of Drug Marketing, Advertising, and Communications. If people want the various industries regulated by the FDA to follow the rules, there need to be as many bright lines as possible—and they need to apply to everyone equally. While a high degree of pragmatism will always be required, this is not an excuse for “I-know-it-when-I-see-it” regulation. 

 

The FDA’s information management system is dysfunctional. The FDA sits at the crossroads of vast amounts of information that is of vital use to both protecting and advancing the public health—yet most of it is unusable. The new Commissioner should immediately appoint an IT Czar who, as her first order of business, should audit existing systems and draw up an information technology roadmap for the agency. A solid “taskforce of talent” is needed to address this tremendous opportunity. Solid information management systems will allow the agency to do its job better, faster, and less expensively. A solid public health triple play.

 

Food Safety and Security
The agency’s programs on food safety and security are failing. Resources at the Center for Food Safety and Applied Nutrition are stretched drum tight. More money is needed—but there is also a crisis in confidence that the agency knows what it’s doing—or that it cares. The issue of BPA (bisphenol A)—the chemical used to harden plastic that is found in baby bottles, compact discs, and other consumer goods—is a good example. The FDA was purely reactive in its call for a review by its panel of experts. As a result, the agency was destined to have its judgment called into question whatever the decision. And this is precisely what happened. This further cements the general perception that the FDA doesn’t care and/or is beholden to the industries it regulates. The BPA issue was out there for a long time in a visible way. And the agency didn’t do anything. It didn’t lead, it followed. And the consequences shouldn’t have surprised anyone.