fb tracking

Outrage of the Month: When the Regulated Write the Regulations

Health Letter, December 2014

By Michael Carome, M.D.


If you’re not outraged,
you’re not paying attention!

Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

In this country, people reasonably expect that when government agencies draft regulations, the writers of the rules will be independent, objective agency staff who have no conflicts of interest that could improperly influence the rulemaking process.

Most people would be outraged if they learned, for example, that the pharmaceutical industry was asked to play a lead role in writing the Food and Drug Administration’s drug safety regulations, or that leading pesticide companies were invited to help write the Environmental Protection Agency’s rules on pesticide exposure limits for consumers and workers.

But these are exactly the circumstances that unfolded last month, when the Department of Health and Human Services (HHS) was overhauling critically important federal rules for protecting the rights and welfare of people who volunteer to participate in research, including high-risk clinical trials. These rules, last revised in 1991, are intended to ensure that the risks of the research are minimized, the potential benefits of research outweigh those risks and researchers obtain informed consent before research begins.

Emails leaked to Public Citizen revealed that in early November, one or more senior staff working for HHS Secretary Sylvia Mathews Burwell, including her chief of staff, abruptly transferred responsibility for rewriting key sections of a proposal to extensively revise the federal rules for the protection of human subjects. The responsibility for drafting the entire proposal originally lay with the Office for Human Research Protections (OHRP), the lead regulatory agency responsible for enforcing these rules. But responsibility for drafting the important preamble to the proposal — which will include sections describing the resolution of key high-level policy issues, the proposed changes to the rules, and the rationale for making those changes — has been transferred to the National Institutes of Health (NIH). NIH has an obvious, direct conflict of interest in the matter: As the largest federal funder and conductor of human research, NIH is bound by the very same rules being considered for revision.

While NIH, like any other regulated entity, should have an opportunity to comment on the completed proposal for revising the rules, it should not be permitted to be the lead drafter of the preamble to those rules. Allowing NIH to play such a role fundamentally perverts the rulemaking process and will shake public confidence in the rules when they are finalized.

The actions by one or more senior officials in Burwell’s immediate office undermined the authority of OHRP and echoed unethical conduct by senior HHS officials under Burwell’s predecessor, then-Secretary Kathleen Sebelius. In 2013, those officials knowingly allowed the NIH director and other senior NIH officials to interfere with the independence of OHRP’s ongoing compliance oversight investigation of the NIH-funded SUPPORT study in premature babies.

Such a shift of authority from the regulator to the regulated is unacceptable. On Nov. 20, we called on Burwell to immediately return full responsibility for the final drafting of federal rules for the protection of human subjects to OHRP and take steps to ensure that agencies such as NIH are not allowed to play a lead role in matters in which they have significant direct conflicts of interest. We also urged the secretary to remove the HHS official(s) who demonstrated such poor judgment in this matter from further involvement in overseeing OHRP activities and the drafting of the revised rules. These initial steps are essential for restoring integrity to HHS’ rulemaking process.