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Why the Alliance Goes to Bat … Over and Over Again

October 12, 2012

I don’t have an opinion — and neither does the Alliance — as to whether FDA under-regulates drug compounding facilities, as Congress seems to think. Likewise, I have no position on whether FDA should develop a security plan for wireless implantable medical devices, as the General Accounting Office (an arm of Congress) has recommended.  However, it is hard to miss the message in these headlines.

Whenever there is any concern about any food, drug, device, or other FDA-regulated product, Congress or GAO are going to knock on FDA’s door asking for action. And FDA is rarely in a position to say “no,” even if it’s not a priority or not timely to act or just a plain bad idea.  As a society, we expect FDA to get the job done, regardless.

This expectation constantly meets the reality of FDA’s situation. FDA regulates products that account for nearly one-fourth of consumer spending. In addition to domestic production, FDA-regulated products and ingredients originate in more than 300,000 overseas facilities located in more than 150 countries. Anyone involved in drug and device development will tell you that the underlying science grows more complex every year. The industries that FDA regulates are growing. Congress provides new mandates, such as biosimilars, FSMA, and FDASIA. And then things happen — and new needs are identified that FDA must deal with — whether the mandate is found in legislation or not.

FDA will have to do more in FY 13, regardless of what funding it receives. To think otherwise is unrealistic.

Yet, FDA doesn’t have the resources to keep saying “Yes.” For FY 13, the agency will see no growth in revenue from the budget authority (taxpayer) side. Scheduled increases and new funding from the user fee side have not been appropriated in the FY 13 Continuing Resolution. So, at least for the meantime, FDA has zero new dollars to work with.

The even greater risk is that a sequester occurs. In that case, FDA will be trying to carry out its FY 12 (prior year) workplan plus new items, but with $319 million less than it did in FY 12. It can’t be done.

While Congress can fix the problem, the dis-connect (heavier workload, the same or less money) will not be as obvious as we might hope. As it has in the past, FDA will do the best it can with the resources it is given. There will be program cutbacks and furloughs, but the agency will try to keep all the balls juggling in the air. Everyone at FDA will have to work harder and cover more ground — which sounds “just right” to those who advocate smaller government.

However, in the case of FDA, it means that more and more energy will be devoted to preventing disasters (external) and maintaining basic functions (internal).  Much less time will be available to developing and implementing improvements: converting food safety from a failure to a prevention model; scheduling more feedback meetings with drug and device sponsors; using regulatory science to re-think the requirements of clinical trials; and figuring out the best policies in emerging areas such as diagnostics.

And that is why the Alliance fights to gain additional needed resources for FDA.

Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance for a Stronger FDA.

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