The FDA's Washington Monument Strategy

On Friday morning, FDA Week scooped all of us by reporting on internal FDA documents that describe the agency’s view of the impact of proposed House funding cut. Before discussing the specifics, it is important to establish the context within which these types of documents are viewed.When times are tough and budget cuts seem inevitable, federal agencies tend to employ what is called the Washington Monument strategy. It goes like this: the National Park Service declares that the only way that they can achieve proposed cuts is to severely reduce visiting hours at the Washington Monument. Congress says “the American people wouldn’t accept that,” and the money is restored.

Variations of this have been tried for decades ... not always successfully, but with a fairly good track record. So, not surprisingly, Congress has developed a certain cynicism about the lists agencies produce on the impact of cuts. The list published by FDA Week is noteworthy in itself, but it is also important to look at how credible the FDA’s list is.According to FDA Week, the FDA thinks these are the likely consequences of cutting the agency by $284 million in FY 12:

Food:

• Significant delay in implementation of the new Food Safety Modernization Act (including the law’s 19 priority areas, especially import oversight, training, and inspections);

• Delay and reduce inspections and increase the risk of foodborne disease in the United States;

• Slow development of food safety guidance documents and implementation of improved data sharing with state and local agencies;

• Preclude implementation of mandated foreign supplier verification, accredited third-party certification, and voluntary quality importer programs provisions;

• No updates to risk-based targeting of import activities.

Medical Products:

• May delay or prevent development and implementation of a regulatory pathway for bio-similars;

• Significantly reduce efforts to stop importation of illegal products;

• Slow efforts to approve generic drugs;

• Undercut our nation’s investment in development of medical countermeasures in the case of pandemic disease or bio-terrorism.

The agency also asserts that reductions at FDA will hurt the economy and result in significant vulnerabilities to the safety of food and medical products.

Most importantly: across the entire spectrum of FDA activities, the agency would be far more reactive in its actions, rather than innovative and geared to prevent problems.

Do these projected programs cuts look like the Washington Monument? In a sense they do, because they are the items that Congress most wants FDA to accomplish. They are the items that the American people are most likely to notice if they don’t occur.Is it a realistic and credible list of what activities won’t happen if the FDA loses 11.5% of its appropriation? Yes, it is.

As advocates, it is our job to make this and similar lists meaningful to Congress. No amount of FDA belt-tightening “on the small stuff” is going to prevent disasters if the agency sustains a large cut in its funding.

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