Regulatory Focus™ > News Articles > Reforms to FDA's Medical Device Disagreement Policies Needed, Says Report

Reforms to FDA's Medical Device Disagreement Policies Needed, Says Report

Posted 05 June 2012 | By Alexander Gaffney, RAC 

A new government report looking at scientific disagreements within the US Food and Drug Administration's (FDA) medical device branch recommends a number of changes at the agency after a series of high-profile disagreements between staff brought on unwanted media attention.

The report, by the US Department of Health and Human Services' (DHSS) Office of the Inspector General (OIG), looked at a population of 36 reported scientific disagreements occurring at FDA's Center for Devices and Radiological Health between 2008 and 2010.

The vast majority of disagreements occurred in 2008 and 2009, with just three of the 36 disagreements occurring after October 2009. OIG's report explained disagreements "involved multiple issues" and "varied widely," but tended to be well supported by required documentation when they were filed at the agency.

The report also noted FDA staff experience issues when trying to pin down the exact meaning of regulations, as well as cultural barriers to expressing dissent. "CDRH also faces broader challenges in identifying and resolving scientific disagreements because of uncertainty about regulatory definitions and processes and staff perceptions about expressing differences of opinion," wrote OIG in its report.

OIG recommended three courses of action in its report for CDRH to undertake: establish clear processes for resolving scientific disagreements, train all staff on the policies used for resolving scientific disagreements, and assign clear accountability for the contents of filed scientific agreements.

FDA wrote a statement saying, "in general, FDA agrees with OIG's findings and recommendations and it is committed to exploring each recommendation fully and to develop or revise procedures necessary to implement all recommendations."

Despite the report only looking at cases of scientific disagreement through 2010, one of FDA's largest cases of scientific disagreement came in early 2012 when a group of medical device reviewers known as the FDA Nine filed suit against the agency for purportedly violating whistleblower protection laws against the employees.

The group was primarily concerned about some medical devices cleared through the 510(k) substantial equivalence process, which the group said was being over-utilized by devices which should have been required to go through a more rigorous premarket approval (PMA) process instead. Shortly after airing their concerns both internally and externally, the staff said they suffered reprisals including alleged career stagnation, harassment, demotions and termination of employment.

The allegations, in addition to being the subject of an ongoing court case, are also being investigated by both Congress and the Office of Special Counsel (OSC) for potential violations of the Whistleblower Protection Act and any potential for agency reform recommendations. Senator Charles Grassley (R-IA) was pushing for additional whistleblower protections in the Food and Drug Administration Safety and Innovation Act, but it is not yet clear whether the provisions will make it into the final legislation.

Read more:

OIG - Scientific Disagreements Regarding medical Device Regulatory Decisions

Regulatory Focus - Whistleblowers Accuse FDA of Monitoring Correspondence to Congress About Medical Device Concerns

Regulatory Focus - Investigation into FDA Handling of Whistleblowers Widens

Regulatory Focus - FDA Asked To Explain Email Monitoring Policies

Regulatory Focus - Hamburg Discusses Plan B Decision, Lawsuit Against Agency

Regulatory Focus - Senator Grassley Expresses 'Concern' About FDA Treatment of Whistleblowers, Opens Investigation

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