Congressman Wants Probe Into Med Guides
4 CommentsBy Ed Silverman // February 4th, 2008 // 11:52 am
Last fall, a spat emerged over the Medication Guide that drugmakers are required to have distributed with their antidepressants. The guide issued in 2005, shortly after the FDA first required Black Box warnings on the pills, was filled with tips and suggestions for parents and guardians - behavior that can be interpreted as worrisome; a reference to clinical study results, and specific info on when a doctor visit is a good idea.
A revised version is now out and, while similar to the 2005 guide, the language is different. The new two-page guide offers a more generalized alert for children, teenagers and young adults - the populations for which Black Box warnings were issued. But some specifics in the earlier guide are missing or condensed, and the emphasis that was initially placed on children is no longer there. (Old and new guides).
The differences drew a sharp response from Mike Ferguson, a Republican congressman from New Jersey, who accused the agency of taking a step “backwards” and putting children at risk. So he sent a letter to the FDA and demanded the agency scrap the new guide and ensure the older version is distributed. Last week, Ferguson received a reply - and he’s not pleased. That’s because the FDA isn’t budging. “There is always a tension between presenting very extensive information and focusing on the most critical points,” writes Steve Mason, an acting assistant FDA commissioner for legislation.
And so Ferguson is forwarding his files on the issue to the House Subcommittee on Oversight and Investigations, which is already conducting several investigations into pharma and the FDA. “This is a non-response, which took them three months,” says Chris Jones, Ferguson’s chief of staff. “I think we’ve been pretty clear - the new version dilutes the power of the first version. We don’t feel they’re truly addressing the main points. This is not a step forward in helping parents make informed decision for their kids. The bottom line is we’re disappointed.”
Lisa Van S
Hey Mike,
What can Dist. 7 Parents say to convince you to stay. We Thank You for your dedication, and the dedication of your staff for ensuring that Parents receive important information on the Safety and Efficacy of the medicines we give our children..
Jack2
QUOTE: “This is a non-response, which took them three months,” says Chris Jones, Ferguson’s chief of staff. END QUOTE
Is he surprised? Has he worked for the FDA before? Maybe if his party put something in the budget besides tax cuts and military spending he might have a more responsive FDA?
http://news.yahoo.com/s/ap/20080204/ap_on_go_pr_wh/bush_budget
Lisa Van S
Hey Jack2.
Do you truly believe that Chris Jones Gives a flying hoot to what you have to say?
Justice in Michigan
Interesting aside - the Drug and Device Law Blog devoted their latest entry to calling attention to this thread. Clearly, the folks who defend drug and device companies think that this is news of interest to their colleagues and clients.
Because of his positions on Energy and Commerce and New Jersey base, Rep. Ferguson has often been among the top recipients of pharma campaign donations. Interesting development.