Is Draft Guidance More Than Meets The Eye? Senators Seek Answers From FDA
This article was originally published in The Rose Sheet
Executive Summary
Republicans on the Senate HELP Committee say they are concerned that FDA is using draft guidance documents to set substantive policy, which they argue puts companies in a difficult position.
Four Republican senators are pressing FDA about charges from industry that the agency is using draft guidance documents to make substantive policy changes.
The lawmakers want information from FDA on guidelines that currently remain in the draft stage, the agency’s plans for finalizing those guidances and FDA’s policies for ensuring that its staff does not follow draft guidance as if it is agency policy.
“Stakeholders tell us that draft guidances are increasingly becoming default FDA policy and position,” even though they are supposed to be distributed for “comment purposes only,” write Sens. Lamar Alexander, Tenn., Richard Burr, N.C., Johnny Isakson, Ga., and Orrin Hatch, Utah, addressing FDA Commissioner Margaret Hamburg in a May 6 letter.
Alexander is the ranking member of the Senate Health, Education, Labor and Pensions Committee, and the other three sit on the committee.
The senators say they have four fundamental concerns:
- FDA’s website does not sufficiently differentiate between draft and final guidance
- Draft guidances are not being revised, finalized or withdrawn in a timely manner
- Companies feel compelled to follow draft guidance as if it were final
- FDA issues guidance that “seemingly does not take into account, or may even conflict with, the scientific community.”
The letter includes a five-point information request for FDA:
- A list of all Level 1 draft guidances, including the data issued, and the planned timeline for withdrawing, revising or finalizing each guidance
- An update on agency-wide activities to implement “best practices” to more efficiently finalize guidance documents (Also see "Industry Involvement In Guidance Development Encouraged By FDA Working Group" - Medtech Insight, 9 Jan, 2012.)
- Whether FDA has implemented the President’s Council of Advisors on Science and Technology to “rely more on the biomedical community in help developing and revising guidances, and if so, could you provide examples of specific guidances?”
- Details on how FDA ensures that staff does not follow a draft guidance in the absence of any other policy or final guidance
- The average amount of time and the range of time that FDA has taken to finalize draft guidances during the past five years.
The senators do not specify a deadline by which they expect Commissioner Hamburg to respond.
Drug, Device Draft Guidances Cited
The senators offer examples of two pharmaceutical draft guidance documents in the letter – one on abuse-deterrent opioids and another related to cyclosporine emulsion bioequivalence.
They question Hamburg’s comments at a March 13th HELP hearing on the former draft guidance where she described the document as “very important,” noting it “lays out how we’re thinking about it.” The senators are trying to reconcile those remarks with the fact that the guidance is in draft form and states: “Not for implementation.”
The letter also points to recent FDA draft guidance on blood glucose monitoring systems, this as an example of the agency departing from recommendations advanced by the scientific community.
FDA issued two draft guidelines on blood glucose meters in January, one for over-the-counter claims and the other for point-of-care hospital use. The POC draft guidance has attracted widespread criticism, in part because clinicians and industry say the accuracy standards proposed by FDA are unreasonable and go beyond what clinical experts have recommended (Also see "FDA Guidances Aim For Better Accuracy In OTC, Professional Glucose Meters" - Pink Sheet, 21 Apr, 2014.).
FDA “chose not to follow the international scientific community’s recommendation on regulatory standards” in the draft, the senators write.
The letter captures familiar complaints from FDA-regulated companies, which face regulatory uncertainty and compliance challenges when proposed guidances remain in the draft stage for an extended period.
Concerns about the process by which FDA issues guidance – and possible misuse of the guidance mechanism – arose in late 2013 when the agency published final guidance related to clinical trials and the need for Investigational New Drug applications, which included recommendations for cosmetics and food products (including dietary supplements) that were absent from the draft version released in 2010 (Also see "FDA Should Strike Cosmetics From IND Guidance – Industry Counsel" - HBW Insight, 14 Apr, 2014.).
FDA reopened the guidance for comment on the cosmetics- and food-related material in February. The Personal Care Products Council took the opportunity to urge the agency to delete the cosmetics section from the guidance “in its entirety,” arguing that it violates federal law and creates an unfavorable environment for cosmetics research.