Healthy Skepticism Library item: 9864

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Silverman E.
The PDUFA Debate: Senate Remarks
Pharmalot 2007 Apr 30
http://pharmalot.com/2007/04/the_pdufa_debate_senate_remark.php

Full text:

There won’t be any vote tonight, but there does appear to be a compromise in the works on the two-year moratorium on DTC advertising. Over the past week, a coalition of drugmakers, advertising agencies, media companies and assorted free-speech advocates galvanized supporters to protest the provision.

Interestingly, neither Kennedy nor Enzi mentioned the adveritising issue in any significant fashion in their prepared remarks. Here are a few qiuck excerpts:

Sherrod Brown (D-Ohio): He called the measure “a drug safety bill, a drug access bill, not a drug industry bill.’‘ He accused the drug industry of “consistently placing its own self interest’‘ above the public interest.

Ted Kennedy (D-Mass) “In many cases, companies have hidden evidence of safety problems. Our bill addresses this abuse by including a public database of all clinical trials and their results. A company will no longer be able to conduct a trial, and then hide the results if they don’t show what the company wanted.”

Mike Enzi (R-Wyoming) “With this new toolbox, FDA has the ability to identify side effects after the drug is marketed through active surveillance. FDA also has the authority to request a separate study or clinical trial to learn more about a particular, potential safety problem. FDA can also obtain timely label changes for the first time under the new system.”