The comment periods for many of FDA’s proposed regulations implementing the Food Safety Modernization Act (FSMA) have closed or are soon slated to end. Hundreds of companies and trade associations have filed comments with the agency; some believe that is the end of the public participation process. Nothing could be further from reality.
Filing a comment with FDA is often the first, not the last step in participating in the development of a final regulation.
The comments that have been, or will soon be submitted to FDA, will be analyzed by mid-level agency staffers and summaries will be given to senior FDA policy makers in the Commissioner’s office. Under the Administrative Procedure Act, FDA is required to review and respond to the comments and provide a “reasoned explanation” in a preamble to any final regulation explaining why the agency agrees or disagrees with the views that have been expressed.
That may sum up the textbook description of the rulemaking process, but in reality, numerous other factors will influence FDA’s final regulations. Concerned companies should consider the following actions:
- Review the comment record: The comments already submitted to FDA on key proposed regulations can provide a treasure trove of information. By reviewing the comment record, companies can discern which entities may share their viewpoint. In some cases, companies may be surprised at what they find. For example, reviewing the comment record may identify additional stakeholders that can support a company’s position. The comment records for FSMA rulemakings should be carefully reviewed and analyzed for these and related purposes.
- Meet with FDA officials: Agency officials will sometimes agree to meet and sometimes will not. But the importance of formal or informal face-to-face discussions with agency decision makers cannot be overemphasized. As in any business development situation, meeting personally with those in charge can be infinitely more valuable than communicating merely by written correspondence.
- Contact the White House Office of Information and Regulatory Affairs (OIRA): OIRA is a department within the White House Office of Management and Budget (OMB) and plays a major role in reviewing regulations proposed by FDA and other agencies by conducting rigorous economic and public policy analyses before permitting proposed regulations to be finalized. Contrary to conventional wisdom, OIRA has assumed a particularly strong role under the Obama Administration, substantially rewriting rules submitted by FDA for publication in the Federal Register. For example, FDA drafted a requirement in its version of the proposed rule implementing FSMA’s Foreign Supplier Verification Program that required on-site audits in cases involving potentially serious adverse health consequences or death. That FDA proposed requirement was literally “redlined” by OIRA and replaced with two options; one providing for an on-site audit and another permitting an exporter to use any available means to ensure that foods destined for the U.S. are in compliance with FDA requirements.
OIRA officials may agree to meet with stakeholders after FDA submits the agency’s final regulations to the White House office for approval. Meetings may be difficult to obtain, but should remain a key objective of concerned companies because in the case of FSMA implementation, OIRA, not FDA, may make the final determination about what the agency’s FSMA rules actually require.
- Meet with key Members of Congress: To maximize the chances of seeing final FDA regulations that comport with the recommendations in a company’s written comment, stakeholders should meet with key Members of Congress (or their senior staffs) to inform Hill offices about the issues at stake, the tentative position of the FDA, and a company’s concerns. It is particularly effective to request meetings with Members of the House and Senate Committees that have jurisdiction over FDA’s annual appropriations, as well as leading Members from Congressional committees that have FDA oversight responsibilities and/or that shepherded the passage of FSMA through the Congress back in 2010. These Members of Congress have a particular interest in seeing that the agency is on the right course and making decisions on the basis of sound public policy. Ultimately, concerned companies can request that Members of Congress write the FDA, hold oversight hearings, or consider restrictions in FDA’s annual appropriations bill that require the agency to act in a particular manner.
These advocacy measures are well known in Washington, but are often not fully utilized by companies that will be subjected to FDA regulatory requirements and who may believe there is little they can do to affect FDA policy once a written comment is submitted. Companies wishing to maximize their chances of achieving changes in FDA’s proposed FSMA rules before they are finalized should consider availing themselves of these additional steps that can, and almost certainly will, affect the final regulatory requirements they will have to comply with in the not so distant future.