Fresh Pharm News

Concerns about conflicts of interests are all the rage these days. The FDA is debating whether to loosen rules over complaints that an insufficient number of experts are available for its advisory committees. And the National Institutes of Health just issued new rules covering academics who receive federal funding for their research and also have ties to industry (see here and here).

As it turns out, the US Department of Health & Human Services, which oversees both agencies, has its own problems with conflicts. A new report by the HHS Office of Inspector General found most conflict-of-interest waivers issued two years ago were not documented as recommended in federal ethics regulations and only a minority of waivers were signed and dated by HHS employees receiving them.

These waivers, by the way, covered both HHS employees and so-called special government employees, or SGEs, who serve as subject-matter experts on Federal advisory committees. Two years ago, the HHS issued 342 waivers, including 334 that were granted to SGEs on committees, and the OIG reviewed a random sample of 50 waivers, including 42 for SGEs on committees.

So what did the OIG find, exactly? Well, 56 percent of the 50 HHS were not documented as recommended; 14 percent of the sampled waivers failed to describe specific interests that posed conflicts, and 46 percent did not describe particular matters in which employees were permitted to participate. Meanwhile, 28 percent were limited waivers that did not describe the particular matters in which employees were prohibited from participating.

Moreover, 24 percent were not documented as recommended in at least two of the three selected provisions and 8 percent were not documented as recommended in any provisions or iinstructions. The waivers that were not documented as recommended were granted to employees at five of the nine operating and staffing divisions. All but one of these waivers were granted to SGEs on committees.

And though it is not a federal requirement for waivers to be signed and dated, only 18 percent of the 50 waivers in the sample included employee signatures and dates. The signed and dated waivers had been granted to employees in six of the nine operating and staffing divisions in the review. The OIG notes that, for a waiver to be legally effective, it must be in writing, signed and dated by the appropriate granting official and granted under the appropriate statutory authority.

The review also found that 24 of the waivers that were not signed or dated were also not documented as recommended in at least one of the three provisions in governmentwide federal ethics regulations and instructions from the HHS secretary, and 14 of these 24 were limited waivers. Moreover, the OIG warned that these 14 limited waivers represent the greatest vulnerability.

Why? “The employees receiving them may not know they have waivers or understand the limitations imposed on their participation in offcial duties. If these employees are not aware of their waivers or do not clearly understand them, they may violate the criminal conflict-of-nterest statute by participating in prohibited matters.”

So the OIG recommended that HHS require the divisions to document waivers as recommended in federal ethics regulations; develop additional guidance and training to assist divisions in documenting waivers; take action to revise waivers that were not documented as recommended in federal ethics regulations; expand waiver reviews for SGEs on committees, and require all employees to sign and date their waivers or otherwise document that they received and acknowledged them.

However, the OIG says the HHS Office of General Counsel did not agree with the first, third or fifth recommendations. Why?

In its response, the OCG wrote that the first requirement would “deprive” HHS of the “requisite flexibiliy” needed to address a “very wide range of situations and exigencies” and impose requirements which the (Office of Government Ethics) has expressly declined to mandate.”

The OCG also complains the analysis is simplistic and fails to evaluate documents in
their entirety, which is part of the reason for knocking down the second requirement. As to the last requirement suggested by the OIG to require employees sign and date waivers, the OCG writes:

“Current practices in each component provide employees notice of any waiver issued and afford each agency the means to document that notice so that employee accountabilty can be ensured. Although some components use a dated employee signature to meet these goals, requirng a ‘one size fits all’
approach unecessarly limits components from using existing procedures that meet the goals of this recommendation through other means” (here is the complete OIG report).