Sen. Charles Grassley (R-IA) is criticizing Office of Management and Budget (OMB) officials for weakening an HHS transparency rule on disclosure of financial ties between medical researchers and the drug industry. Grassley says the final rule has a diluted provision making the method of disclosing financial ties optional between a Web site and a response to a written request.
“Making the method of disclosure optional hurts public access,” he says. “An institution that doesn’t want to disclose information readily will be able to opt for the written request, knowing that receiving a request in writing is a barrier. . . . This is a missed opportunity to inject transparency.”
In August, Grassley wrote OMB, asking it not to dilute the proposed rule. The rule proposed for NIH grants would have made research institutions determine potential conflicts of interest grant-by-grant and post the details online for public access. OMB pulled the requirement for online disclosure, giving institutions a choice in how they disclose the conflict information.
The new rule does not apply to FDA, but observers say it could end up being a template used by FDA rule-writers who are currently reviewing comments made to a draft guidance.
From the October 01, 2011 Issue of MM+M - Medical Marketing and Media
