PharmExec Blog

Memo to President Obama on Reforming FDA

In recent weeks, the incoming Obama administration has solicited input from across the policy community as it begins to shape priorities for its forthcoming term. As a former FDA official, I was honored to be asked for my advice on the pharma industry.

Demand for drugs is on the rise, yet FDA remains undermanned, underfunded, and misunderstood. If President Obama is serious about healthcare reform, he needs to make a concerted effort to improve drug safety in this country. Priority number one should be a renewed commitment to educating the public about drug safety. FDA should be the public’s number-one source for information on pressing drug safety issues. Every regulatory action the agency takes should be seen as an opportunity to speak to a larger public health issue.

FDA should also increase its support for the Reagan/Udall Foundation, a joint public-private partnership that supports innovation in the pharmaceutical industry. The new FDA commissioner should work with foundation administrators to develop the regulatory tools appropriate for today’s medical technologies.

Secondly, key drug regulations need to be clarified. Too often, regulators love ambiguity. Why? Because ambiguity is power. But ambiguity can lead to regulatory inconsistencies, hampering the drug approval process. Oftentimes, safety trial protocols are approved by one FDA committee and carried out by drug manufacturers, only to be derided by another agency committee after the fact. Likewise, FDA has been known to send warning letters to companies over marketing materials that have already cleared another branch of the agency. It will be much easier for industry to follow FDA regulations if those regulations are well-defined and applied equally.

Thirdly, FDA needs to reform its information management system. The agency sits atop a vast accumulation of vital public health information, yet most of it is unusable because FDA has yet to develop a reliable means for determining which information is important. The new commissioner should immediately appoint an information technology czar charged with modernizing and streamlining existing systems. Solid information management will allow the agency to do its job faster, cheaper, and more effectively.

The agency’s food safety and security programs are also in need of substantial reform. Witness the case of bisphenol A, an industrial ingredient often used in plastics that has been the source of health concerns for decades. Yet only after a significant controversy arose over the use of bisphenol A in consumer products did FDA decide to order an expert review of the chemical. Behavior like that cements the perception that the FDA is ineffective – or worse, apathetic.

Similarly, rather than proactively stepping forward with regular and transparent risk communications programs, FDA has been driven by the winds of crisis. The agency has implemented certain programs that provide risk information, but without any context. The effect is confusion among patients and physicians.

Drug labels – the most important piece of communications material the agency regulates – also need to be improved. The agency must ensure that new labeling rules are adopted for all products, even those licensed prior to the new rules’ implementation. The agency also needs to educate physicians about how to use drug labels, particularly when it comes to “safe use” recommendations that deal with administration – rather than composition – of pharmaceuticals.

These are urgent reforms that must be carried out with determination, creativity, and passion by the new administration. I look forward to continuing to work with President Obama to ensure that the new commissioner can hit the ground running, and take important steps to set the tone for a newly confident FDA.

Peter Pitts is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.

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