The public comment period ends July 20.

There should be public cheers.

Assuming that this proposal goes through—and it is possible that the regulated companies could fight their way out of this—it will be a new day for the FDA if the agency also is given the resources and personnel to deliver on this plan.

That is part of the FDA’s story. Congress mandates. Congress often does not fund its mandates or not sufficiently.

The public needs to know about which foods, drugs, devices and cosmetics passed but it is just as important to know which ones did not and why.

Bloomberg Businessweek

“Drug rejections, plant inspections and detailed side-effect reports would be shared with consumers for the first time under a new plan from U.S. regulators. (Emphasis added)

“The Food and Drug Administration proposed 21 steps today to expand the public’s knowledge of medicines, medical devices, food and cosmetics, including when they fail to meet federal standards. Public comments on the proposals will be accepted until July 20. (Emphasis added)

“Lawmakers, doctors and consumer groups criticized the FDA under former President George W. Bush for failing to disclose heart risks with GlaxoSmithKline Plc’s diabetes pill Avandia and Merck & Co.’s painkiller Vioxx. The FDA created a Transparency Task Force in June in response to the Obama administration’s call for government agencies to be more open with information.” (Emphasis added)

“The task force, led by FDA Principal Deputy Commissioner Joshua Sharfstein, recommended that the agency start disclosing when products are tested in people, submitted for marketing authorization, withdrawn or denied approval. This would include releasing so-called complete response letters sent to drugmakers explaining why their products are rejected. (Emphasis added)

Source: Bloomberg Businessweek, May 19, 2010