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Can FDA Survive the Next Round of User Fee Legislation?

If FDA is to have sufficient money to operate in fiscal year 2013 (and thereafter), drug and device user fee legislation must pass Congress next Spring. That is the immovable object of the agency’s future. To pass legislation, Congress will need to plow through dozens of amendments touching every aspect of FDA and the industries it regulates. This is the irresistible force of Congress.

What happens when this irresistible force meets this immovable object? Something will need to give. FDA Matters hopes it will not be FDA’s ability to carry out its mission.   

The threat to FDA is created by two constraints imposed on the legislative process to reauthorize drug and medical device user fees.

First, the legislation needs to pass at least 90 days before the existing user fee programs expire on September 30, 2012 (i.e. by June 2012). During the last renewal cycle five years ago, the legislation wasn’t signed into law until September 21. As a result, FDA had to delay hiring new staff and the agency was compromised in its ability to implement the new law during the first year of the cycle.  

This time, there may be greater awareness by Congress of the problems created by delayed passage of the user fee legislation. However, this Congress has (thus far) a poor track record of reaching compromises on even simple matters and has demonstrated serious problems meeting deadlines.

Second, the user fee legislation is likely to be the only FDA-related legislation that “must pass” during this Congress (2011-2012). It provides Members of Congress a “one-time only” opportunity to advance their favorite issue or concern about FDA.

A partial list might include: drug re-importation; the exclusivity provisions of the new biosimilars law; approval of genetically-engineered salmon; regulation of dietary supplements; changes in the way that medical devices are regulated; and the use of Bisphenol A (BPA) in consumer products.  In addition, Congress now has some Members who might offer more fundamental amendments, such as revising FDA’s authority to review the efficacy of drug products.

The user fee reauthorization legislation will essentially have two parts. The core bill (“the inner bill”) will include renewals of drug and device user fees and adoption of new fees for generic drugs and other programs. In the best case, disagreements on these programs will be negotiable and compromises found.

Any additional amendments (“the outer bill”) are problematic. There may be some areas of agreement, such as new authority for drug import inspections, incentives for development of antibiotics, and provisions for addressing drug shortages.

However, as mentioned above, the outer bill will face a pent-up demand for resolution of controversial FDA-related issues. The House and Senate committees and leadership are going to have to deal with the onslaught—by allowing votes, negotiating compromises or adopting procedural barriers to prevent consideration of their colleagues’ amendments.

The risk for FDA is twofold. Even if “the inner bill” can be moved without problems, a lot of time will be required to deal with “the outer bill.” The clock will be ticking and June 2012 will arrive quickly. If Congress misses, FDA will be hurt. The longer it takes, the greater the damage.

Second, no one can predict which of the items proposed for “the outer bill” might be adopted. Some may make important and possibly undesirable changes in the agency’s mission and activities.   

Reauthorization of FDA’s user fee programs is essential, but difficulties are unavoidable and extend well beyond the fees themselves. FDA needs to be talking now with its many Congressional friends—not just about the details of the inevitable clash, but how to control the battle so it doesn’t get out of hand.


“Must-Pass Legislation” Key to FDA’s Future     December 12th, 2010

FDA Matters believes that the 2010 election will profoundly affect the FDA’s mission, priorities, funding, standards and work flow. Eighteen months from now, FDA’s leadership team will probably be the same, but the agency won’t be.

Identifying and understanding the likely changes to FDA requires examining the meaning of “must-pass legislation” and its escalating importance as a quarrelsome Congress turns into a divided Congress. At the moment, there is only one “must-pass” item on Congress’ FDA agenda: the next round of user fee renewals that will come before Congress in the Spring of 2012.  Read the rest of this entry

It’s Time to Change CDER Funding   September 17th, 2009

I did some crunching of FDA budget numbers for my column earlier this week on the Office of Regulatory Affairs (ORA). A by-product of my efforts was an analysis of how the Center for Drug Evaluation and Research (CDER) is funded. We often hear how dependent CDER is on user fees. The actual numbers are startling and deserve to be well-aired. Read the rest of this entry

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