FDA Role In Risk Management Should Be “Broad Societal Decision,” Hamburg Says
This article was originally published in The Pink Sheet Daily
A survey of well-informed voters conducted by the health policy institute NEHI found respondents were in favor of marketing products that might pose a risk, as long as FDA disclosed the potential dangers. Commissioner Hamburg says she is “pleased and frankly a little surprised” by the depth of appreciation for the agency’s work shown by the survey.
You may also be interested in...
Reps. Stearns and Towns want the Senate draft to more closely align with their FAST Act by adding language that would allow greater flexibility for development of rare disease treatments.
Manufacturers and payers will continue to work on innovative pricing arrangements, roundtable panelists said, but they are likely to be less complex and resource intensive than many of the risk-sharing contracts announced to date, particularly in Europe.
Regulatory flexibility is the backbone of FDA’s success in efficiently reviewing new drugs and biologics, especially on the frontiers of unmet medical needs, Pharmaceutical Approvals Monthly’s 2011 series of drug review profiles shows.