PharmExec Blog

Asking the Right Questions on FDA Reform

When it comes to reforming the (FDA),if you don’t ask the right questions, you won’t get the right answers. Look at the recent media coverage of the agency’s 2008 drug approval numbers.

Last year, the FDA approved more “first-of-their-kind” drugs (21) and instituted fewer “black box” warnings (46) than it did in 2007 (18 and 62, respectively). So what do these numbers mean?

Some see them as a sign that the FDA isn’t as concerned with safety as it was 12 months ago. More drugs approved? Fewer black box warnings? These same FDA watchers wonder, isn’t the agency’s Division of Drug Marketing, Advertising and Communication (DDMAC) sending out more warning letters to curb the abuses of pharmaceutical marketing—particularly for off-label prescription drugs?

And these are the media-friendly questions, the public hearing questions, and the trial lawyer questions. In other words, the “politics before public health” questions.

For those of us in the know, there is a different set of questions. Namely: Why did the FDA miss review deadlines for at least 15drugs? Why are a growing number of complete response letters sounding more and more like the old-style, not-approvable variety?

And why are more and more complete response letters requesting information that was never discussed during the review process or the advisory committee meetings? Savvy pharmacenti also want to know what exactly is going on with “early safety” communications and signal-to-noise ratio issues.

But the most important question we should be asking is: Why is ambiguity trumping predictability in the regulatory process?

This is a key issue that must be addressed by the new FDA commissioner. If the FDA keeps siding with the precautionary principle and doing nothing until it knows everything, the pharmaceutical industry will almost certainly respond by dialing back R&D into new drugs.

The industry needs clear, predictable rules. But right now the FDA is a bureaucratic kulturkampf. Regulators need to shift from the vague regulatory definitions they’ve employed in the past to a system of bright lines and clearly demarcated rules.

This kind of change will require a commissioner who can seek out career officials within FDA who are smart and gutsy enough to embrace new ways of doing business. The commissioner needs to find people within the agency who support clear rules over draft guidances, and pragmatism over dogmatic doctrines.

I know from personal experience that there are many FDA staffers who are excited about the possibility of an FDA that leads rather sways with the political winds.

FDA’s Critical Path initiative indicates the agency’s desire to change. Going forward, FDA stakeholders will be looking for other “surrogate markers” to gauge the agency’s willingness to continue the McClellan era’s commitment to the protection and advancement of public health.

Despite recent attempts to clarify regulations, determining what is “in compliance” remains more art than science. Right now the industry is confused, and, as a result, the public health is not being served. What’s needed to resolve this problem is forward-thinking leadership that rises above the bureaucratic ambiguity that currently characterizes the FDA.

Creating change won’t be easy for the new commissioner. But if that person communicates this philosophy honestly, leads by example, and empowers change agents within the FDA career staff, the tide will turn.

Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.

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