A Universal Safety Symbol For Drug Web Sites?
3 CommentsBy Ed Silverman // November 10th, 2009 // 8:03 am
That’s the idea being floated by PhRMA, the industry trade group, ahead of the widely anticipated meeting this week in which the FDA will try to sort out how to regulate drugs and devices on the Internet and in so-called social media.
For its part, PhRMA suggested during a press briefing that a universal safety symbol, or logo, that would be coupled with a link leading Internet users to FDA-regulated info about a device or drug. Whether that one-click approach would take someone to the FDA web site or a drug maker’s site or elsewhere is up for debate.
“We’re intentionally not filling in all the blanks. We’re introducing a concept,” says Jeff Francer, PhRMA’s assistant general counsel, adding that the FDA should place conditions on its use, according to Reuters. This would “clearly allow for proper balance of benefit and risk information, even in abbreviated formats, such as sponsored search,” The Pink Sheet reports him saying.
The hoopla comes after the FDA last spring issued controversial warning letters to 14 drugmakers for failing to include risk info in their search ads. Since then, the industry has been grappling with ways to provide fair balance in sponsored search results without any actual guidance from the agency. The FDA, meanwhile, has already embraced social media - the agency has been tweeting on Twitter for some time (see here).
Laptop thx to Flickr Creative Commons ohadweb/Ed Silverman is an editor at The Pink Sheet
ex-FDA Reviewer
This would only serve Pharma’s agenda.
There are sites that would not be able to get the logo that sometimes provide important information that is covered up by companies.
A good example is http://www.healyprozac.com/GhostlyData/default.htm
Dr. Healy reveals that companies had information on SSRI induced suicide back in 1991.
As an FDA reviewer I would sometimes find information on toxicities on sites and (in particular patient sites) that after I looked into them realized FDA management was hiding from the reviewers (often buried in post marketing reports or if premarketing the documents would disappear out of the files.)
FDA management is corrupt and has unwritten SOPs on how to prevent information on toxicities from coming to light or to downplay them for the simple reason is that if we told the truth less drug would be prescibed and sales would suffer. (This is based on statements made by companies themselves in FDA meetings).
Fear and retaliation rule at the FDA.
Jack Conway
The FDA has the power to prevent false advertising so I don’t see what additional benefits would be gained from having this symbol.
It seems very similar to the VIPPS scheme for online pharmacies that most purchasers of online pharmaceuticals don’t know about.
JaT
Allow me to intentionally fill in the blanks.
The problem, Mr. Francer, is that FDA exists to regulate the industry. Because of regulations on DTCs they really do need to consider those regulations as they might relate to other mediums. For the protection of the industry. For the avoidance of consumer fraud suits, at the very least, but you know that.
FDA does not exist to regulate or influence freedom of speech, freedom of the press, religious freedom, freedom of assembly, and right to petition.
I mean what are they going to do? Direct people to this page?
http://www.coreynahman.com/FDA_Page.html
For crying out loud.
ex-FDA Reviewer,
The irony here is that people who are having problems with a product are not going to care if there is an ‘Energy Star’ type of label where they come together in mass.
Where there is industry funding credibility already causes concern.
One might think that an FDA approval rating might cause the same concern if people feel that FDA made a bad call. People do tend to feel that FDA becomes self serving if it doesn’t respond to the issues that arise.
This is destined to backfire if it comes about.
“This would “clearly allow for proper balance of benefit and risk information…”
Fairness Doctrines only exist to diminish opposing opinions. Everyone knows it.
Be careful what you wish for. One day it will come back and bite us in the ass. We may not like opposing opinions but we better like the ability to have them.