HHS quietly bolsters FDA’s role as a transparency regulator for clinical trial activities
From international law firm Arnold & Porter LLP comes a timely column that provides views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.
In late September, Secretary of the Department of Health and Human Services Kathleen Sebelius announced1 that HHS had formally delegated authority to the Commissioner of the FDA for oversight of the clinical trial posting requirements under Section 801 of the FDA Amendments Act of 2007 (FDAAA).2 Specifically, the announcement noted that the FDA now has authority to police whether a posting meets the statutory requirements, as well as determining whether or not the posting is accurate (ie, not false or misleading).3 According to HHS, the FDA may allow a party subject to the FDAAA posting requirements 30 days to properly post or correct a posting.4
To some, this announcement may seem like an administrative detail, but it is significant for two reasons. First, it implicitly clarifies that the FDA, and not the National Institutes of Health (NIH) or another public health agency, has ultimate responsibility for enforcing the requirements of Section 801. Since passage of the FDAAA, the role-sharing between NIH and FDA has been unclear; the FDA has never promulgated specific regulations on the posting requirements. Rather, parties subject to the requirement have relied on NIH guidance and a few statements endorsing those requirements by the FDA in other guidance documents. We should now expect to see greater clarity from the FDA on its expectations on the content and timing of the relevant postings (including whether it will continue to adopt the NIH “rules” or develop more granular ones of its own).
Second, while the push toward more transparency in human clinical trials can be beneficial in informing treatment choices, empowering patients, and curbing potential fraud, it will be interesting to see whether the FDA and other government authorities will use the posting requirements as an enforcement tool. Unfortunately the signs point to “yes.” The FDA and other enforcement authorities have long had the authority to police clinical trials and require the sharing of trial results. However there has been a marked shift over the past few years toward holding sponsors and investigators accountable under aggressive civil and criminal theories. For example, alleged failures to disclose certain clinical trial results were at the heart of the government’s landmark case against GlaxoSmithKline (GSK) earlier this year.5 GSK pleaded guilty to criminal charges, including a specific charge that it had failed to disclose to the FDA the results of post-marketing Avandia trials that were being conducted in Europe at the request of European regulators. In public documents, the government charged that those results included safety information that contradicted representations made by GSK sales staff and would have been material to US regulators. To resolve civil, criminal, and administrative claims, GSK paid a record-breaking $3 billion, and both companies were subjected to onerous compliance and probation requirements. Those requirements include a 5-year Corporate Integrity Agreement between GSK and the Office of the Inspector General of HHS, requiring that, among other things, GSK continue to post trials to clinicaltrials.gov in compliance with federal requirements and take specific steps to ensure transparency around its clinical trial practices.6
In this new era of “enforceable transparency,” it is therefore reasonable to expect to see additional compliance requirements likely down the pipeline. For example in January, prior to the HHS announcement, the FDA set forth its expectation that informed consent forms for post-FDAAA trials include a specific disclosure to patients that the trials will be posted on clinicaltrials.gov as well as a description of what content could be posted.7 A failure to include this disclosure could put a site out of compliance with Good Clinical Practices. And we can expect to see regulators both inside and outside the US using sites like clinicaltrials.gov, and other registries, as a way to monitor compliance and target wrongdoers. In fact, that is now the FDA’s express charge, and it will be important for manufacturers, researchers, and health care providers to keep abreast of these developments.
Mahnu Davar, JD, MBe, can be reached at Arnold & Porter LLP, 555 12th St. NW, Washington, DC 20004-1206; 202-942-6172; email: email@example.com.
- HHS Notice, 77 Fed. Reg. 59196 (Sept. 26, 2012) available at http://www.gpo.gov/fdsys/pkg/FR-2012-09-26/pdf/2012-23720.pdf
- Public Law 110-85 (Sept. 27, 2007) codified at 42 U.S.C. § 282(j) available at http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/html/PLAW-110publ85.htm
- The FDAAA requires that most controlled clinical investigations of drugs, biologics, and medical devices in human research subjects (other than Phase I clinical trials) be reported to FDAAA by either the sponsor or principal investigator with updates as to the status and results as clinical investigations progress. See Id. at Sec. 801. See also NIH Implementation of FDAAA http://grants.nih.gov/clinicaltrials_fdaaa/steps.htm (last accessed on Oct. 23, 2012) (setting forth a description of who is subject to requirements under Section 803 and what content needs to be posted).
- HHS Notice, 77 Fed. Reg. 59196.
5. DOJ News Release, GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data (July 2, 2012) available at http://www.justice.gov/opa/pr/2012/July/12-civ-842.html.
6. GSK Corporate Integrity Agreement (June 2012) at § III.4.u. available at http://www.justice.gov/opa/documents/gsk/plea-ex-d.pdf.
7. See FDA Notice of Final Rulemaking, 76 Fed. Reg. 256 (Jan. 4, 2011) (amending informed consent regulations at 21 C.F.R. § 50.25(c) to require that informed consent documents and processes for applicable medical product trials include a specific statement that clinical trial information will be entered into a databank). See also FDA, Guidance for Sponsors, Investigators, and Investigational Review Boards (Feb. 2012) available at http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM291085.pdf (helping small businesses better understand the change in informed consent requirements promulgated in January 2012 in a “Q&A” format).