FDA Inspections Ombudsman Could Help Foreign Manufacturers

Foreign manufacturers could be the largest beneficiary from FDA's new Office of Regulatory Affairs ombudsman, at least at first.

The new position, intended to help get facility owners' ORA-related questions answered and improve communications, already is helping companies deal with inspection problems that previously had no easy path for recourse.

Jessica Zeller became the ORA ombudsman in October 2015, returning to FDA after a two-year stint as in-house counsel at Proctor and Gamble.

Douglas Farquhar, director at the law firm Hyman, Phelps and McNamara, said in an interview with "The Pink Sheet" that so far her value has been as a go-to person when a problem arises during a foreign facility inspection.

Farquhar said when inspectors appear to be overstepping their authority during domestic facility visits, manufacturers can complain to the local district director or compliance director for oversight.

But during a foreign inspection, it is "not clear who you would go to" because there is no obvious senior person above the inspector, he said.

Farquhar said one of his clients ran into the issue recently when an inspector demanded things that were beyond their authority. When the client would not comply, the inspector said it would be equivalent to refusing an inspection, which would be problematic for the facility's status.

Farquhar said his firm contacted Zeller, who was able to help. The inspector ultimately backed off, but Farquhar said "it was clear the ombudsman was going to intervene."

"That's somewhat unusual," he said. "Most ombudsmen are very non-judgmental."

Inspections The Primary Focus?

Zeller's focus will stretch across all product centers and include inspection concerns, as well as import detentions and refusals, laboratory analytical findings and review and interactions with ORA and other agency personnel.

FDA told "The Pink Sheet" that Zeller's office also has helped stakeholders find local resources domestically and internationally.

In addition, Zeller could help educate foreign firms on FDA practices, which the agency has been trying to communicate for several years in the wake of high-profile data-integrity and other problems that have been discovered (Also see "Culture Clash: U.S. FDA Tries to Re-educate Indian Firms on Processes And Accurate Reporting" - Scrip, 10 Oct, 2013.).

But inspections may occupy a large part of her time as the agency continues to grow its international facility visits to deal with globalization.

Agency foreign inspections have increased in recent years, but were estimated to decrease in fiscal years 2016 and 2017, compared to FY 2015 (see graphic).

Source: FDA budget request congressional justification documents

Interestingly, even though the agency has tried to spend more time on foreign inspections, the majority of the serious quality issues it unearthed were at US facilities (Also see "Despite Globalization, Three Quarters of Serious Inspection Issues FDA Found Were in US" - Pink Sheet, 7 Mar, 2016.).

FDA was mandated as part of the 2012 FDA Safety and Innovation Act to reach parity in its foreign and domestic inspections of generic drug facilities.

While the agency has increased the number of foreign inspections it conducts, reaching parity has proven difficult. The HHS Inspector General found that the most inspection requests pending at the end of December 2013 were for foreign sites (Also see "FDA To Pilot Remote Inspections Of Generic Facilities" - Pink Sheet, 6 May, 2015.).

Companies also want more information on facility inspections as part of the generic drug user fee program renewal (Also see "GDUFA II: Inspection Information Takes Center Stage" - Pink Sheet, 23 Dec, 2015.).

Growing Focus On Dispute Resolution

While the position is focused on ORA, the new ombudsman may have been created in part to take some pressure off colleagues.

Industry's use of FDA's ombudsman has increased as sponsors have tried to resolve disputes (Also see "If At First You Don’t Succeed, Try Dispute Resolution" - Pink Sheet, 9 Dec, 2013.).

CDER's 2014 ombudsman annual report, the most recent issued, said that among the most common contact topics from industry, law firms, consultants and others were decision delays or response delays for "issuance of establishment inspection reports."

The report also states that there was an increase in complaints about import detentions.

During the previous year, detained product or import issues also were listed as one of the most common contact topics.

Power Is Limited

FDA's ombudsmen likely will not be able to fix all problems, however.

Farquhar said he was not sure whether Zeller would be helpful in getting a Form 483 issue resolved or obtaining assurance that corrective action is adequate.

She could make sure phone calls are returned or deadlines for action are set, he said.

"I don't see the ombudsman as someone who can be sort of persuasive to the center or district on those decisions," Farquhar said.

FDA said that if a sponsor has a concern about how agency staff are handling inspection-related issues, those discussions should begin with the relevant district office or ORA headquarters, but if there is no progress or the discussion "becomes unnecessarily contentious, the ombudsman office is an appropriate contact point."

The ombudsman also can help determine the proper contact, the agency said.

Farquhar said Zeller likely will not be able to persuade FDA to close out a warning letter.

Lee Rosebush, a partner at the law firm BakerHostetler, told "The Pink Sheet" that the ombudsman will provide important insight to FDA and serve as a sounding board for questions despite her limited authority and jurisdiction.

Zeller reports directly to Associate Commissioner for Regulatory Affairs Melinda Plaisier, but is considered an unbiased third party.

Zeller worked in the Office of Chief Counsel and as deputy director of the Office of Compliance and Enforcement in the Center for Tobacco Products during an eight-year tenure at FDA. She joined Proctor and Gamble in 2013.

She becomes the seventh ombudsman at FDA. The position already is in place at the five product areas (drugs, biologics, devices, tobacco, and veterinary medicine), as well as for the agency overall.