FDA looks into morale issue, eventually

Share this article:
The FDA promised to address with all seriousness a survey of its scientists which reported poor morale and "pervasive and dangerous political influence of science at FDA"--despite agency initially disparaged the study as "unscientific."

After being briefed by the survey's sponsor, the 100,000-member Union of Concerned Scientists (UCS), acting commissioner Andrew von Eschenbach reportedly said, “If I have 263 people who say their morale is poor, I intend to address that. I want there to be an environment where there is free, open and vigorous debate and discussion.”

When the survey of nearly 1,000 FDA scientists was first announced three weeks previously, associate commissioner for public affairs Julie Zawisza said the FDA “would expect more rigor to support such far-reaching allegations and conclusions. We would expect others trained in survey methodology to question the validity of this survey and its findings, as do we.”

UCS recommended that to restore scientific integrity the FDA should ensure that data or results are never softened for any audience, that managers are punished if they retaliate against scientists who speak out and that it has a culture that supports a collaborative process of testing and challenging scientific hypotheses.

Without committing to any timetable or a plan for change, von Eschenbach invited the UCS to return in six months to help evaluate the agency's progress, the group said.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in News

Email Newsletters

More in News

Judge blocks FDA bid to allow generic Precedex

Judge blocks FDA bid to allow generic Precedex

The US District Court for Maryland granted Hospira a temporary restraining order (TRO) against FDA, after the agency determined that potential generic competitors of the company's injectable sedation drug Precedex ...

GSK drug gets aplastic anemia indication

GSK drug gets aplastic anemia indication

Promacta was previously indicated for chronic immune thrombocytopenia.

Five things for Pharma Marketers to know: Wednesday, August 27

Five things for Pharma Marketers to know: Wednesday, ...

Allergan sets a shareholder voting date, Novo describes the types of acquisitions it will consider, and the AstraZeneca-Pfizer talks can now reopen.