FDA Shutdown Lands Hard On CFSAN-Regulated Industries

The federal shutdown interrupts FDA’s increasing enforcement against firms marketing violative supplement products in addition to slowing drug application evaluations and facility inspections. FDA would retain 8,180 staff members, about 55% of its total, mostly because they could be “paid from carryover funding.”

The partial shutdown of federal agencies likely will slow the enforcement activities that FDA has been increasing to identify non-compliant firms in the dietary supplement industry.

FDA and other federal agencies on Oct. 1 furloughed a majority of employees, with staff in essential positions continuing to work, after the House and Senate failed to agree on continuing to fund the government beyond Sept. 30, the end of fiscal 2013.

FDA will halt “the majority of its food safety, nutrition and cosmetics activities,” according to the Department of Health and Human Services’ contingency plan released Sept. 27.

Also on hold are “routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs … and the majority of laboratory research necessary to inform public health decision-making,” according to the plan, which did not provide further detail.

In a shutdown, “FDA would continue limited activities related to its user fee funded programs,” according to the plan. Overall, HHS expected to furlough more than half of its employees: 40,512. Another 37,686 would continue working.

FDA would “continue select vital activities including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues.”

The severity of the impact on FDA-regulated agencies depends on how long the shutdown lasts, but the supplement industry could feel an effect sooner than others. Stakeholders say the momentum the Center for Food Safety and Applied Nutrition has established in identifying and enforcing against non-compliant firms and violative products will be interrupted no matter the shutdown’s duration.

“We expect basically a hold on dietary supplement operations,” said Cara Welch, the Natural Product Association’s senior vice president of scientific and regulatory affairs.

“The routine inspections wouldn’t take place. Any case that they are working on would just stop for a while. It’s literally a break in the action that includes a break in the calendar,” Welch added in an interview before Congress failed to avert the shutdown.

Mike Greene, the Council for Responsible Nutrition’s government relations VP, noted FDA’s activity in the industry should resume quickly if Congress passes a fiscal 2014 budget in a matter of days.

“I think in the short term what this does is it stops FDA from thinking about what they’re going to be doing in the next weeks, months,” Greene said.

If the shutdown lasts only a short period, “I’m sure FDA would pick back up from where they left off and continue to be as active as they’ve been in terms of enforcement, inspections and various actives,” he added.

However, “if there’s a long period of time when the government is closed … I think what it does mean is that once FDA comes back they’re going to have to get back up to speed.”

Through press time for this issue of “The Tan Sheet” on “Oct. 4, the budget impasse continued in Congress.

User Fee-Funded Activities Continue

FDA said it would continue some user-fee funded duties in the shutdown Oct. 1 while stopping some facility inspections and other compliance activities. But the agency’s regulation of the supplement and other industries under CFSAN’s oversight is not yet augmented by user fees.

Although the Food Safety Modernization Act required user fees from supplement and food product firms for facility or import re-inspections or mandatory recalls starting in fiscal 2012, in October 2011 FDA delayed imposition of the fees on any firm until the agency establishes a waiver process for small businesses (Also see "Food Safety User Fees On Hold Until FDA Creates Waiver Process" - Pink Sheet, 10 Oct, 2011.).

“For all intents and purposes at this point, [supplement firms] don’t have user fees,” Welch said. “CFSAN for the large part doesn’t have any fees. That’s one reason I think this center will be hit harder by a shutdown.”

The user-fee related impact on CFSAN is apparent in the number of staff members still working during the shutdown.

“The bulk of the retained positions are people whose salaries are paid for by user fees,” said Steven Grossman, deputy executive director of advocacy group Alliance For A Stronger FDA.

“CFSAN will have only a small contingent,” and the Office of Regulatory Affairs, which conducts field activities for all FDA centers, “will only do slightly better,” Grossman added.

Despite FDA’s reduce staffing, supplement firms facing due-dates for submitting information to the agency – such as responses to form 483s following good manufacturing inspections – should adhere to the deadlines, says attorney Marc Ullman.

The American Herbal Products Association, in a statement to members, noted that while FDA will not initiate new GMP inspections, agency staff on duty include officials managing adverse event reporting, indicating that supplement firms are obligated during the shutdown to submit serious AERs within 15 days.

APHA also stated that an FDA official said the agency does not expect delays in the evaluation of import shipments in transit when the shutdown began. Additionally, FDA's Prior Notice System Interface is allowing submission of the forms required by importers when originating shipments into the U.S., the trade groups said.

At the National Institutes of Health, websites for the Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine have messages about not being updated, and no one is answering those divisions’ telephones.

Nearly 8,200 FDA Staff Retained

FDA retains 8,180 staff members, about 55% of the total. The majority of those, 7,311, are retained because they perform activities without funding issues, are officers appointed by the president or performing activities authorized by necessary implication, according to the plan.

More than 6,000 are classified as “staff paid from carryover funding” and another 40 are funded by “user fees appropriated in authorizing legislation.” More than 1,000 are exempt because they were considered officers appointed by the President and 225 are considered performing activities authorized by necessary implication.

FDA also comprises the majority of the HHS staff “excepted for the protection of human life” other than direct medical services, according to the department’s plan. This includes 578 product and manufacturer inspectors, import inspectors and others. Another 120 FDA staffers conduct and oversee adverse event reporting and lot release protocol reviews and other activities.

When HHS issued a plan in 2011 with a shutdown looming, FDA had 1,250 employees deemed essential for the safety of human life despite not being involved with patient care.