HHS pushes FDA for clarity on internal disputes over device approvals

The U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) is steering the FDA toward clearer policies for settling spats when review staffers—managers as well as scientists—disagree over device-clearance decisions. For its part, the FDA has agreed to act on the advice.

In a report released last week, the HHS OIG also urged FDA to train reviewers and managers on resolving such scientific disagreements and to assign clear administrative accountability for documenting the disputes and their resolutions.

The OIG said in a report summary that the report project launched after a series of scientific disagreements inside the Center for Devices and Radiological Health (CDRH) played out in the media between 2008 and 2010. A substantial portion of the report looks at how well CDRH’s resulting policies and procedures have enabled CDRH reviewers and their managers to settle up-or-down disputes over device approvals.

The office said the report reflects its surveys of CDRH managers and reviewers, as well as reviews of administrative files related to 36 reported scientific disagreements. The surveys asked about knowledge of scientific agreements and awareness of the new policies and procedures.

“The nature and resolutions of these 36 disagreements varied widely,” said the OIG. “Scientific disagreements often involved multiple issues, and most of their resolutions did not lead directly to the approval or clearance of devices.” Most administrative files related to scientific disagreements contained the required documentation, said the OIG, but ownership of file completeness—in a word, accountability—was unclear.

CDRH also faces broader challenges in identifying and resolving scientific disagreements because of “uncertainty about regulatory definitions and processes,” said OIG, as well as “staff perceptions about expressing differences of opinion.”

On the latter concern, a blogger of the Union of Concerned Scientists (UCS) got straight to the salient point the day after the report’s release.

“I fear that the pressure to fast track drug and medical device approvals may discourage researchers from voicing dissenting scientific opinions,” wrote Francesca Grifo, PhD, a senior scientist with UCS and director of its scientific-integrity program, after expressing her overall appreciation for the report. “In the past, we have seen scientific disputes ruin careers. We have also witnessed cases … where reviewers who raise concerns about a drug or device’s safety and effectiveness face threats and retaliation.”

The scientific disquiet echoes developments of the recent past. In January, a handful of current and former CDRH review staffers filed suit against FDA, alleging that the agency had spied on their personal email activities and fired or antagonized them because they had warned Congress that FDA was approving risky devices. The latest on that case is that, on June 1, the National Whistleblowers Center filed a motion with a U.S. district court in Washington, D.C., seeking to compel the FDA to immediately release, under the Freedom of Information Act, all documents concerning the FDA’s alleged spying program.

With more than 1,700 employees, HHS’s OIG is the largest inspector general’s office in the federal government. The major bulk of its resources goes toward overseeing Medicare and Medicaid and, along with FDA, it also oversees the Centers for Disease Control & Prevention and the National Institutes of Health.

The office has posted the full report, Scientific Disagreements Regarding Medical Device Regulatory Decisions, for public review.