THE DEMISE OF RULE MAKING AND THE RISE OF GUIDANCES

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Bradley Merrill Thompson, Baker & Daniels (Indianapolis)

With authority from Congress, FDA makes and enforces law. But over the past two decades, the process of regulating the medical device industry has changed profoundly.

Traditionally FDA relied on a process called rule making, which often involves the publication of a proposed rule in the Federal Register, followed by a formal period for receipt of public comments. The process ends after public comments have been integrated and a final rule is published, again in the Federal Register. Although this process can take many months and absorb considerable staff resources, it has the advantage of collecting useful public comment on complex scientific and commercial subjects, while simultaneously educating the public about the agency's regulatory expectations.

But during the past 20 years, FDA has gradually shifted away from rule making toward a surrogate that has neither of the benefits afforded by rule making. As currently practiced this surrogate of rule making--the issuance of guidances--is not nearly so open to public scrutiny. Apart from adhering to a general policy that says FDA will always listen to suggestions offered by the public, the agency rarely seeks out broad public comment on a guidance. The consequent lack of public involvement in guidance development results in a corresponding reduction in the educational effect of the process.

Guidances have grown in popularity because of the agency's need to conserve money and manpower. These guidances may be any of several types, including formal guidelines, compliance policy guides, simple lists of points to consider, or even industrywide letters. And there is no all-encompassing process used to generate them. Because FDA generally does not solicit broad public involvement or take the time to respond to comments that the public might submit, the creation of guidances is generally less costly than rule making in terms of time, money, and staff resources.

Many forms of guidance used by the agency today were virtually nonexistent in the mid- to late-1970s, and only a trickle of such documents were released even in the early 1980s. But by the middle of that decade, the number of guidances began to grow rapidly (see chart) until today CDRH issues dozens of them each year. And these numbers reflect only what CDRH officially calls guidances. Controversially, the agency also has increased its use of speeches, warning letters, and even press releases to make industry aware of FDA regulatory expectations.

Legally, guidances are not binding on the public, whereas certain rules are. But for all practical purposes, there often is little difference between the two. Because of the important role that guidances have grown to play, many people are concerned that they do not measure up to quality standards.

Apparently, FDA has also recognized the need for quality assurance. On March 7, 1996, it announced that it will adopt good guidance practices that ensure public participation at critical points in the initiation, development, and dissemination of guidances.

If successful in applying these practices, FDA may be able to achieve an effective compromise between the decades-old tradition of rule making and the recent surge in issuing guidances--a compromise that balances the need to conserve FDA resources with the advantages of integrating public feedback and education into the regulatory process.

Return to "FDA Regulatory Programs: Cooperation and Common Sense Typify a Record of Success"