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“Must-Pass Legislation” Key to FDA’s Future

This is the fifth straight column looking at FDA and Congress. This reflects FDA Matters‘ belief that the 2010 election will profoundly affect the agency’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. 

"Must-pass" legislation is a bill or resolution that Congress is compelled to pass in order to maintain the functions or functioning of government. The best examples are appropriations bills, Congressional budget resolutions, and legislation to increase the limits on the national debt. Sometimes, "must pass" is defined by the agenda of a political party or the President, as was the case with health care reform.

Looking at this Congress’ two FDA-related legislative accomplishments, "must pass" played a role in both. Representative Anna Eshoo (D-CA) had the votes to advance her version of bio-similars in place of the version supported by House Energy and Commerce Committee Chair Henry Waxman (D-CA). Occasionally Committee Chairs don’t have the votes to prevail; they re-gain leverage by not scheduling a mark-up. This was not an option for Waxman because Eshoo’s bio-similars bill was offered as an amendment to the "must pass" health care reform bill.

Because of the breadth of mostly bi-partisan support for food safety legislation, it was possible for it to advance as regular legislation in both the House and Senate. However, procedural barriers have now stalled the Senate-passed version in the House and it might not become law. The House responded by adding food safety legislation to the FY 11 Continuing Resolution (CR) that will fund the government when the current one runs out at midnight on December 18. This tactic may not ultimately work, but the CR is definitely "must pass legislation."

With some exceptions, it is hard to anticipate what pieces of legislation become "must-pass." In theory, FDA might go an entire Congress without enactment of any major legislation. This can’t be the case for the incoming Congress because authority to collect both prescription drug and medical device user fees expires on September 30, 2012. In the months prior to that date, Congress will face a choice: pass re-authorizing legislation or deprive the agency of $700 million in revenue each year. Thus, "user fee legislation" = "must-pass legislation."

User fees need to be renewed every five years. The last round of user fee re-authorizations resulted in the Food and Drug Administration Amendment Act (FDAAA). It is complicated and emerged after extremely tough negotiations. The final legislation was 155 pages long and had 11 separate Titles. It is at: http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf.

Commissioner Hamburg, Members of Congress, and most FDA stakeholders have wish lists of ways they would change FDA and the laws it implements. None of these–at least not any major ones–are likely to pass in 2011 without broad bi-partisan support.

But 2012 will be another story. In the process of adopting the "must pass" user fee reauthorizations, we can anticipate Congress considering dozens of provisions and programs that don’t relate to user fees. Lawmakers and stakeholders will all have a chance to put their mark on the FDA in 2012.


Two Strategies for FDA Legislation in 2011          December 5th, 2010
The current Congress has two primary FDA-related accomplishments: an abbreviated approval pathway for bio-similar drugs; and a food safety bill that may be enacted before Congress adjourns. FDA Matters believes that any FDA-related legislation will falter in 2011 if it does not follow the strategy behind one or the other of these efforts. Read the rest of this entryy

FDA Funding and the Appropriations Drama       November 28th, 2010 
 The process for passing appropriations bills should be similar from one year to the next. After all, it is a one-directional, regimented process. Yet, I have been through 30 or so appropriations cycles and each one seems to have its own unique story to tell. This year’s efforts would make a riveting "made for television" movie "based on a true story." FDA Matters doesn’t know how it will end, especially for FDA. Read the rest of this entry

FDA and Election 2010: Oversight and Investigations   November 13th, 2010 
President Obama’s election and the health reform debate have distracted us from the disruption that "divided government" imposes on FDA. With the new Republican majority, the agency will find itself buffeted by political forces that are as concerned about "scoring points" as they are about improving government. FDA Matters thinks this will have a large impact on FDA, as well as the agency’s stakeholders. Read the rest of this entr 

FDA and Election 2010: Deficit Reduction and Appropriations     November 6th, 2010 
 So-called "wave elections"–where one party overwhelms the other–are particularly hard to judge. The ground rules are going to change dramatically– in ways that no one can fully anticipate. At first, each side refuses to compromise. Then, something happens that sets the pattern for whether people will work together and on what issues. This may take months to resolve or may occur before the new Congress arrives. As things change, FDA Matters thinks there are some key issues for FDA-watchers to monitor. Read the rest of this entry  

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