FDA Fine Tunes Guidance Disclaimers, May Undertake Broad Review

FDA is considering undertaking a broad guidance clean-up effort, agency Chief Counsel Daniel Troy indicated May 16 during a Generic Pharmaceutical Association legal symposium in Washington, D.C.

"I think we need to take a hard look at our draft guidances and really create an initiative to try to finalize those guidances that we want to finalize, because it isn't fair, it isn't right, it isn't transparent and it isn't efficient to regulate through draft guidance," Troy said.

"As problematic as guidance is, from an administrative law standpoint, interim, draft, proposed, maybe-it-is-or-maybe-it-isn't guidance is even more problematic," Troy said. "If we no longer agree with a draft guidance, we should withdraw it."

A broad guidance review would extend the now traditional practice of a periodic clean-up of proposed regulations. In April, FDA published a list of 84 proposed regulations that are more than five years old and are not "viable candidates for action at this time." FDA undertook a similar clean up of pending regulations during the first Bush Administration.

"We thought it was better, in the spirit of openness and transparency and clear communication, to make clear what FDA was moving forward on and what we were not moving forward on," Troy said.

Troy's interest in potentially expanding that effort to cover long-pending draft guidances is in keeping with the chief counsel's concerns about informal policymaking and good guidance practice (¹ (Also see "FDA Guidance Practices Are Good Model For HHS – General Counsel Azar" - Pink Sheet, 29 Apr, 2002.), p. 22).

During the GPhA meeting, Troy provided an update on the latest steps by the agency to ensure that its guidances are fully compliant with federal court decisions about appropriate practices.

"The D.C. Circuit has become increasingly vigilant against what some academics call spurious rules," Troy said. In recent cases involving the Environmental Protection Agency, the court has held that "these are rules that masquerade as guidances."

"We at FDA have been fortunate that we have not suffered the fate that some EPA guidances have," Troy declared. Guidances should not be used "to create rules that should go through notice and comment."

Troy noted language in many FDA guidances has now been changed from saying what a sponsor "should" do, to outlining what "we recommend." In addition, "there is now a runner across our guidances that says 'contains nonbinding recommendations.'"

The agency also wants to ensure that sponsors and agency employees understand that alternative approaches are acceptable. "An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations," guidances now state. "If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance."

More important than alerting stakeholders to this pathway is the "need to...train our people, to raise their consciousness that guidance is guidance," Troy said.

"I think if you take a look at the warning letters and the untitled letters that we have sent out, to the extent that we might have once ever cited to guidances as basis for violations, we don't do that anymore. We go back to the statute." The Office of the Chief Counsel began reviewing all warning and "untitled" letters in early 2002 (² (Also see "FDA Warning/“Untitled” Letters Will Be Reviewed By Chief Counsel" - Pink Sheet, 17 Dec, 2001.), p. 30).

One aspect of the regulation clean up that may require further attention is the status of the preambles to proposed rules, Troy noted. "Withdrawing these notices of proposed rulemakings is not necessarily intended to reflect one way or another on the preambles" of those proposals, Troy said.

Under 21 CFR 10.85, preambles to proposed regs are formally deemed to be advisory opinions from the agency. However, Troy suggested that "as a matter of administrative law, it is seriously open to question whether...something that is a preamble of a notice that has never been adopted...has any legal effect."

"There are some in the agency who think we need to rewrite 10.85...to clarify what the situation is vis a vis current administrative law. There are a lot of other things we need to do probably first before we do that, but as a matter of law...you can't take an old preamble to the bank as a binding...opinion."