In January, FDA announced the launch of a new “FDA Basics for Industry,” the most promising of its faltering transparency steps to date.
The announcement and the site itself showed a determination to accommodate the concerns of product sponsors who pay so much to FDA in user fees— unlike the agency’s responses to those who don’t.
They continue to battle FDA’s growing penchant for secrecy. Recently, I peppered the agency’s press office with questions about how many members of the public had asked to speak at a public advisory panel hearing and got only evasions.
I fault the initiative’s design. Instead of assigning it to unconflicted outsiders to manage, this initiative was run by insiders.
Here’s my proposal to correct this:
1. Under presidential directive, accept the premise that everything FDA does is to benefit the public, and that the public at large is to define the meaning of its “benefit” in this context.
2. Using an external federal scientific agency organizationally unrelated to FDA and a jury of 12 public volunteers who demonstrate no conflicts of interest, reach out to learn their expectations of FDA.
3. Create an open public process to examine and adopt inputs received from the public as to their expectations.
4. Open all FDA processes and records to lawful public access as required by the results of (3) above.
5. Where laws impede public access, submit all these to a public review process and submit the findings to “town hall” meetings around the country.
6. Submit resulting recommendations to the country and to Congress.
James G. Dickinson is editor of Dickinson’s FDA Webview (fdaweb.com)
From the February 01, 2011 Issue of MM+M - Medical Marketing and Media
