Division of Drug Marketing, Advertising & Communications "untitled" letters will be included in a new FDA policy requiring prior approval from the Office of the Chief Counsel before warning letters are issued.

Deputy Secretary for Health Claude Allen is scheduled to visit FDA the week of Dec. 17 to discuss implementation of the new warning letter policy.

FDA Office of Enforcement Director John Taylor was expected to meet with agency leadership prior to Allen's visit to begin developing procedures for vetting warning and "untitled" letters to the chief counsel's office.

The policy was articulated in a Nov. 29 memorandum from Allen to acting FDA Commissioner Bernard Schwetz, PhD.

Allen's Nov. 29 memo refers to a recent meeting with HHS Secretary Tommy Thompson "on FDA issues." During the meeting, "considerable discussion was directed towards the practice of different components of the agency sending out warning letters and so-called 'untitled' letters which have not necessarily been first reviewed and approved by the FDA's Office of Chief Counsel," the memo states.

Therefore, "I believe that, even if these letters do not explicitly threaten a lawsuit, they should first be reviewed for legal sufficiency and consistency with agency policy," Allen's memo says.

"I have urged OCC to review these letters expeditiously, and to apprise the centers, their component parts, and/or the field as quickly as possible if OCC believes that a letter raises issues warranting further discussion or review."

The ad division "untitled" letters may face particular scrutiny if they are viewed in the Chief Counsel's Office as policy statements about limits on promotion that circumvent formal rulemaking procedures. FDA Chief Counsel Daniel Troy previously helped litigate the Washington Legal Foundation's First Amendment challenge of FDA's off-label promotion policy.

The agency decided to make "untitled" letters (previously called "notice of violation" letters) public in response to requests by industry to have more guidance from FDA on promotional topics (¹ Also see "House Oversight Subcmte. reviewing FDA ad division notice of violation letters." - Pink Sheet, 26 August, 1996., p. T&G-13).

Although FDA and HHS acknowledged that the policy will likely result in fewer letters coming out of the agency, they suggested that the remaining letters will carry more enforcement weight.

"What we hope will happen is that we can minimize the number of letters by laying out clear goals and objectives, clear guidance and then taking enforcement action," Allen said Dec. 12. The agency currently sends approximately 1,000-1,200 letters per year.

Allen emphasized that even if the fewer resulting letters are stricter, they will not supplant industry dialogues with FDA. "We don't want to disrupt what would be the informal practices that take place with industries."

FDA field offices are already indicating concern that funneling all letters through a single office will bog down the process.

Although the Office of Regulatory Affairs will continue to process the backlog of letters it intended to release prior to the memo, Allen said Dec. 12 that "as far as I'm concerned, the effective date was the date of my letter."

FDA field staff indicate that Associate Commissioner for Regulatory Affairs Dennis Baker sent out two memos Nov. 29. The first put a hold on further letters until a standard operating procedure had been defined; the second allowed letters to proceed as usual. FDA emphasized there is currently no embargo on warning or "untitled" letters.

Allen said the HHS Office of the General Counsel would offer assistance "immediately" to FDA's chief counsel in processing the letters. "Certainly we don't want [OCC] inundated," he said. OCC is currently staffed at about 60 counsels, and has been authorized to hire more.

"We've left it open....We've allowed the chief counsel and the FDA acting commissioner to come back to us if they have additional resource needs," Allen said.

One of the problems of having letters emanate from numerous locations is "that we don't have consistent practices from district to district," Allen explained. "So you can have one district sending a letter to one company and another district sending a different letter requiring a different practice to the same or another similarly-situated company doing the same thing."

HHS' decision to elevate FDA warning letter oversight from the Office of Regulatory Affairs to the Office of the Chief Counsel likely signals an attempt to keep a tighter rein on the agency in the absence of a commissioner.

FDA said the policy move was a joint decision on the part of the agency and HHS. Allen suggested FDA was "not considering some of the concerns that were raised initially, but I think that they see there is great benefit for this."

The HHS deputy secretary's emphasis on cooperation between FDA's OCC and the department's General Counsel is in line with comments Troy made during a Food & Drug Law Institute reception Dec. 11.

At the reception, held to honor Troy's arrival at FDA, the chief counsel advised industry lawyers to "get to know" HHS General Counsel Alex Azar. "He is an important player in establishing FDA legal policy."

Confirmed as general counsel Aug. 3, Azar was formerly Troy's partner at the D.C. law firm Wiley, Rein & Fielding (² Also see "FDA Chief Counsel Is Attorney From WLF Case; Porter Leaves After 11 Years" - Pink Sheet, 13 August, 2001., p. 3).

The timing of the warning letter policy change signifies HHS' "trying to get back to business as usual, [to] our domestic agenda," Allen said. "We're back on track by focusing attention on the FDA."

"Secretary Thompson has from the very beginning stressed the importance of one department, that we begin to function as one department," he noted. "We have been working with FDA in the absence of a commissioner there to review the policies and procedures that the agency has that merit further review from a policy perspective."

Allen's comments leave open the possibility that direct HHS oversight of FDA policy could extend farther than warning letters.

Allen said his planned FDA visit the week of Dec. 17 will focus on "other areas" in addition to the recent policy change. "This is a first step, but we will be looking at other areas, and if there are areas of concern that arise, we will take them under consideration and then devise that action consistent with department leadership."

Allen singled out "recidivist letters" for possible extinction. FDA's recidivist policy refers to establishments with repeated violative inspections.

Allen suggested the "recidivist letters" serve no function: "I send you a warning letter, you're out of compliance, and I send you another letter called a recidivist letter saying [what] I really meant in my warning letter...and that is, if you're out of compliance, to comply," he said.

As the only political appointee currently in place at FDA, Troy is likely to have a significant role in setting FDA's policy agenda.

Troy, who assumed the FDA chief counsel position in August, described his role as preserving "fealty to the powers Congress has given us. We at OCC are stewards of the agency's legal credibility."

"I believe in an open, flexible, responsive FDA," Troy said, urging FDLI participants to approach his office when concerns arise over FDA legal policy. "I prefer to see you in my office than in the court. Frankly, since beginning this job I have been able to resolve some issues by working things out with direct dialogue."

In stressing FDA legal consistency, Troy said he has "also been trying to further the secondary goal" of making sure the agency acts in consort with "all of HHS [as] one department."

"This is a department that cares a great deal about FDA, and is extremely engaged in FDA issues at the highest levels," Troy maintained.

Troy intends to take a much higher profile than his predecessor, Margaret Porter, in the chief counsel role. However, he indicated during the FDLI briefing that he does not view public presentations as an appropriate vehicle for policy announcements.

"I will announce today my podium policy," Troy declared: "I don't believe in podium policies."

"To the members of the press: if I have made any news, I have done so inadvertently," Troy joked. "I take back anything you think or consider newsworthy."

FDA Warning/“Untitled” Letters Will Be Reviewed By Chief Counsel

More from Archive

More from Pink Sheet