FDA’s Toll-Free Side-Effect Hotline Is Not In Service
3 CommentsBy Ed Silverman // October 20th, 2007 // 8:36 am
Way back in 2002, when the Best Pharmaceuticals for Children Act was enacted, Congress required the FDA to enforce a regulation that required adding a toll-free number to product labeling for the purpose of reporting adverse events. This was two years before Vioxx was withdrawn, but safety concerns had already gained traction due to a rising number of recalls.
Only two years later, the FDA published proposed regulations in the Federal Register. Now, take a quick peek at your calendar. What year is it? If you answered 2007, you are correct. And guess what? Five years later, those regs were never finalized.
As the FDA Law Blog notes, the agency received rather few comments on its proposed reg, but still never published final rules. According to an October 11, 2007 Federal Register notice, “after the publication of the proposed rule and based on the comments received, it was decided to delay the issuance of the final rule in order to conduct research to study the wording of the proposed side effects statements.” That research was a ‘comprehension experiment - you know, a study to see how consumers would use an 800 number.
And so Congress, apparently more than a little frustrated with the slow pace of events, has given the FDA a deadline of Jan. 1, 2008, to roll out a number. (Please see page 68 of the FDA Amendments Act, Section 502f). Do you think the agency can meet the deadline? It’s only been five years. User fees make it possible for the FDA to review complex science in a matter of months, but studying the use of a toll-free number should take how long?
Hat tip to the FDA Law Blog
Lisa Van S
Ed,
This was a hot topic in September 2004 during the Congressional Hearings on antidepressants in children.
Gee,and they found the time to change the Med Guide.
Hank
Well, I guess all toll free numbers have dangers. And once the number is out there, it must preempt other numbers that would attempt to second-guess it….
But seriously. This is, of course, one more example of the classic disconnect between what Congress passes and what actually happens at FDA. It took the agency almost thirty years to put in place just a version of the Kefavuer-Harris amendments following thalidomide - just enough time for Newt & Co. to try to flush them away.
So I’d say, well, 2022 for the toll free number. By that time, of course, we will be able to communicate telepathically with the ODS. But there may be no one there to turn on their cortex.
On Pharma
[...] forward. The Agency still lacks a database for monitoring reactions. As Pharmalot and FDA Law blogs recently reported, a consumer 800-number hotline that was to be set up as part of the Best Pharmaceuticals for [...]