Insider has commented previously on this sorry affair:
http://pharmagossip.blogspot.com/2005/09/unplanned-consequence.html
Now the US Government Accountability Office has released a report that reduces the FDA's credibility to zero.
The report, requested by Congress about 18 months ago, leads to one inescapable conclusion:
Top FDA officials bigfooted the decision in 2004 to deny over-the-counter sales of the pill, known as Plan B. Politics, not science, dictated the final outcome.
A final word from Dr. Susan Wood, former Assistant Commissioner for Women's Health and former Director of the Office of Women's Health (OWH) at the Food and Drug Administration (FDA). She released the following statement in regards to the GAO report on Plan B:
"The GAO report is an independent validation of the irregularities at the FDA in its decision to deny the Plan B over-the-counter (OTC) application in 2004. This astonishing series of decisions has continued and increased, culminating in the most recent delay announced on August 26, 2005. This report is a sad reminder of why I felt compelled to resign -- that instead of improving and advancing women's health, the FDA leadership is ignoring its process and not relying on science and medical evidence. Americans need a strong and independent FDA."
Insider applauds and and agrees with Dr Woods comments.
2 comments:
A huge plus for big pharma is this: "Apply enough political pressure and you can get what you want.".
"With enough political pressure I can stop my competitors products from ever entering the marketplace."
Eventually and it is only a matter of time now that the line has been crossed, with enough political pressure I can get my product approved irregardless of the science.
The FDA now has zero science credibility on any issue. The FDA must now rely on law enforcement as the only means of gaining the respect they muster.
The FDA is nothing but a tyrant relying on fear as the only means of generating compliance with rules based on political whims.
Anonymous makes some good points, but one might easily replace 'FDA' with 'Bush administration,' or 'corporations' and get more directly to the source of the problem with the FDA.
Nice blog. Good gossip.
Post a Comment