Under new management from the Obama administration, the FDA is taking steps toward offering greater transparency in how it reviews drugs, offers up data on safety and reaches key conclusions on marketing. And agency officials heard an earful yesterday from consumer advocates who want to put drugs and data in a public spotlight--a prospect that makes many developers distinctly uncomfortable.
Francesca Grifo of the non-profit Union of Concerned Scientists wants the agency to highlight dissenting opinions on new drugs and devices from within its own ranks. Steve Findlay of Consumers Union thought the FDA should publicize meetings with drugmakers.
The FDA has been under intense criticism over safety issues presented by drugs like Vioxx and Avandia. The drug development world has been more open to admitting the mistakes, but the industry is leery of requiring so much transparency that confidential trade secrets get a public airing. This is one process, though, that still has a long ways to go.
- read the report from the Wall Street Journal