Submitted via Docket No. FDA-2009-N-0247 at www.regulations.gov.
In July 2010, we filed comments in response to the FDA’s draft report on the agency’s public disclosure policies. We commended the FDA for the work done to-date in the Transparency Initiative, which provides clarification to patients and consumers regarding the work of the FDA.
And strongly recommended that as the FDA moves forward with increasing transparency at the agency, that they move forward first with implementing changes that will have a high impact for consumers while at the same time pose relatively few implementation challenges. The second tier of proposals that we recommended the FDA move forward with are those proposals that while high-impact, pose implementation challenges. We also identified a third tier of proposals that we do not recommend making an implementation priority given the low impact the proposals will have for patients and consumers.