Four members of the Senate Health, Education, Labor, and Pensions Committee (HELP), including Chairman Lamar Alexander, wrote Food & Drug Administration (FDA) Commissioner Robert Califf earlier this month to reiterate their concerns with FDA’s use of guidance as regulatory tool. Members of the committee had previously written the FDA Commissioner about the agency’s use of guidance in May 2014, to which FDA responded nearly a year later in March 2015. During his confirmation hearing before the HELP Committee last November, Commissioner Califf addressed several questions about the use of guidance and pledged to investigate the Senators’ questions.
The May 6, 2016 letter raises two issues that implicate especially serious due process concerns for regulated entities. First, FDA informed the Senate HELP committee in its March 2015 letter that agency enforcement personnel often reach the same result as proposed in a draft guidance because the draft represents FDA’s current thinking on a statute or regulation. As the May 6 letter reminds Commissioner Califf, however, each FDA draft guidance includes a statement that the guidance will represent the agency’s thinking only when finalized. Businesses and others who receive warning or “untitled” letters based on draft guidance documents deserve clarification on this point.
Second, the letter notes that according to FDA’s own data, it takes the agency an average of 425 to 797 days to finalize a draft guidance. One or two years is an eternity in the ever-advancing industries that FDA regulates, so those draft documents can rapidly become obsolete or encourage the agency to regulate based on outdated information.
An October 9, 2015 WLF Legal Backgrounder by University of Florida Levin School of Law Professor Lars Noah provides a troubling example: the “Distributing Scientific and Medical Publications on Unapproved New Uses—Recommended Practices” that purports to guide drug and device manufacturers on communications about off-label uses. This March 3, 2014 “Revised Draft Guidance” replaced another draft guidance FDA published on January 13, 2009. The guidance, which Washington Legal Foundation and other interested parties have severely criticized on First Amendment grounds, has remained in draft form for an unthinkable 2,693 days.
It is unclear what solutions the four HELP Committee members have in mind to address FDA’s troubling overuse of guidance or its habitual foot-dragging on at least putting such guidance into final form. We feel that an idea Professor Noah raised in his WLF Legal Backgrounder is worthy of consideration: “why not dictate that drafts become inoperative if more than a year or two old?”