Do you suppose the FDA actually knows what the word “transparency” means?

Transparency? At the FDA? That’s as likely as a foot-long potato’n’pasta hoagie at the Atkins Foundation summer picnic.

The U.S. government has a new mandate to promote accountability and bring transparency to activities and decision-making. Well, sure – what the heck? It’s worth a try.

The FDA is part of the government, of course, so the FDA has to play along. And that’s why FDA officials have established a Transparency Task Force. The key word there: “task.” Because it’s going to be a loathsome chore to coax deeply entrenched old school FDA bureaucrats out into brightly lit public forums where they’ll be asked to…share.

Lots of kicking and screaming – I expect that’s what it looks like behind the scenes at the FDA TTF.

Naturally, if you’re going to have an official TTF in the 21st Century, then you’re going to have to find some web- savvy guy to set up a blog. Which brings us to fdatransparencyblog.fda.gov.

David Hart, the Senior Assistant Attorney General of Oregon, recently posted a comment on the FDA Transparency Blog. And Mr. Hart has a transparently good idea: When the FDA approves a drug, but does not give approval for one of the indications requested by the drug company, the FDA should offer the reasoning behind the non-approval.

Mr. Hart explains what e-Alert readers already know: Doctors are allowed to prescribe drugs to treat conditions for which the drugs are not approved – it’s called off- label prescribing. But Mr. Hart argues that if doctors were alerted to avoid using a drug for a certain condition (spelled out by the FDA at the time of the drug’s approval), patients might be spared a treatment that could be ineffective or dangerous when prescribed off-label.

The problem: Drug companies don’t want that kind of transparency. It’s just not good for business. So you can be sure that the drug giants would fight this idea tooth and nail. And who’s the FDA going to go with – David Hart, or Merck (or Pfizer, or Johnson & Johnson, or GlaxoSmithKline, etc.)?

The correct answer is transparent: NOT David Hart.

Source:
“For Further Discussion – Comment From the Public About Transparency #2” 7/23/09, fda.gov