Comments on: Should TV Ads Carry Toll-Free Numbers?

By: dummie

dummie — Tue, 23 Dec 2008 18:50:50 +0000

So you are telling me that simvastatin is the same as Lipitor? Welcome to health care, you JUST figured this out. BTW come up with a better arguement because Lipitor is not simvastatin. Close yes, but I know i am not in a position to tell you which to take.

By: Rita

Rita — Tue, 23 Dec 2008 17:14:21 +0000

I’ve seen ads on TV for Caduet. It has two ingredients. One is Amlodipine and the other is Atorvastatin. With my RxDrugCard I can get 30 tablets of Amlodipine for $9 and 30 tablets of Simvastatin for $9. I’ll bet they are charging more than $18 for this new drug! The unthinking public is going to pressure their doctors into giving them something just because it’s new, when something old or generic would do the job for cheaper.

By: Bill Quimby

Bill Quimby — Thu, 27 Nov 2008 17:09:58 +0000

A toll free number is just a doorway. Whether it’s helpful or not really depends more on what is found on the other side of that doorway. It might be scary for a large company to have consumer doorways but how can anyone think that eliminating the toll free number doorways is going to help things?

By: Meg

Meg — Wed, 26 Nov 2008 21:34:53 +0000

Medwatch is a nothing. I found out about it after my son was killed by Zyprexa and filled out the information. Result. Zero. No reply from FDA. Ever. Even after 30,000 sued for diabetes or death of a loved one, no Medguide, no black box warning, NADA. As far as DTC ads go, they should be removed. I watch television very little, but when I do turn it on, bam - there’s a Cialis ad. Or an Abilify ad. Insulting to have those ads shoved in my face. I usually watch Netflix so as not to have such painful reminders.

By: Justice in MI

Justice in MI — Wed, 26 Nov 2008 18:59:17 +0000

Nathan - I put it together from several suggestons that have been put forward over the last few years, including early versions of the FDAAA which included a number of these, as well as the IOM report, commentary on IOM, and similar.

In terms of exclusivity, if a company did required studies and was formally approved (beyond provisional) after, say, three years - and then authorized to use DTC - I would tend to extend protection for those three years.

By: Nathan

Nathan — Wed, 26 Nov 2008 02:45:12 +0000

Justice — interesting idea. Is that your own, or did you get it from somewhere? I’m curious: #1, #2, and #4 are obviously going to cost companies some $$. You are attemping to make it more “income neutral” by adding #3. (which I like) But what length of time are you talking about? A couple years? More, less?

I (personally) still like the idea of having a “minimum exclusivity” period for any approved NME. (maybe on the order of 8-12 years)

By: Jaynesday

Jaynesday — Tue, 25 Nov 2008 22:10:00 +0000

Just a clarification. The warnings would not kick in until an number of similar/same cases had occurred.

By: Jaynesday

Jaynesday — Tue, 25 Nov 2008 22:07:09 +0000

Justice, I like your version.
How is this for an addition? (I think this is controversial and a bit off the subject but anyway..)
Every person should have a Medical Information Card. Much like a credit card and just as secure, hopefully more secure. There would be many uses for the card but one would be a means to communicate AE’s. When you did call the AE hot line you give your card number. With your current medical and personal information already in a database along with any AE information, we would be one step closer to an early warning system. When data revealed that a serious AE has occurred with certain combinations of drugs, medical conditions either psychological or physiological a flag would be thrown and the investigation and or warning process could begin. Card holders with similar conditions would then easily be alerted.

Also, when at a hospital or pharmacy the card scan could alert to potential prescription problems thereby heading off more AE’s.

By: Just A Thought

Just A Thought — Tue, 25 Nov 2008 22:02:09 +0000

It won’t matter if MedWatch is revamped until the cows come home. The response you will get is that, if they get 1 or 2 well documented cases, they MAY investigate.

Right. Was your AE anticipated or unanticipated? Anticipated, even if the reaction is far more serious than expected, is still included in the warning without severity being taken into consideration. There really needs to be someone looking at specific cases to determine if the warnings were truly meant to cover extreme instances of these anticipated reactions.

So yes, there should be a direct number to someone with more than a list of warnings sitting in front of them.

By: Emma

Emma — Tue, 25 Nov 2008 21:23:31 +0000

Good point about MedWatch. Maybe the word about MedWatch forms just needs to get out there. I know until I started working in Regulatory Affairs I had no idea the forms even existed. Also,I would argue that MedWatch submission forms are kind of confusing and hard to figure out. Maybe an overhaul is in order to make it more user friendly and also more tailored to the specific drug you are submitting information about (like Salmon suggested with pull down options and specific boxes with questions.)