The FDA plans to interview more than 1,500 consumers to decide whether DTC TV ads should urge patients to report side effects, theAssociated Press writes. However, some critics argue the toll-free number could distract viewers from other important safety info about prescription drugs.
Print ads already include contact info for the FDA, as required by a law passed last September. The legislation ordered the FDA to report to Congress by late March whether that info should also be mandatory for TV ads. But the agency requested more time to complete its work and is expected to soon begin a formal study - more than a year after the safety legislation was signed into law (back story here and here).
The agency has now made plans for a large-scale study to assess whether adding instructions about reporting side effects would overwhelm viewers who are already being bombarded by medical info. The "ads are already quite dense when compared with ads for other products," the agency states in documents posted online. "The risk information should not be compromised by the addition of the toll-free statement."
For its study, the FDA will show ads for a fictitious blood-pressure drug to 1,600 consumers, who would then be interviewed to see how much of the info they understood. Specifically, researchers will assess how the placement, time and wording of the statements affects comprehension. The FDA did not indicate when it would launch the study, but will accept comments for the next two months.
PhRMA has not taken a stance, but did support adding the language about side effects to print ads. However, some lawmakers and consumer advocates say ads can encourage over-prescribing before all side effects are known. By encouraging patients to report negative reactions to FDA, they hope regulators will be able to catch safety problems sooner, the AP writes.
By the time the FDA completes its study of the toll-free number, however, lawmakers may have already moved ahead with even stricter regulations. Rosa DeLauro, a Connecticut Democrat, introduced a bill in the House last spring that would ban consumer-directed advertisements during the three years after a new drug's launch, the AP continues. What do you think?
Should TV Ads Carry Toll-Free Numbers?
- Yes (71%, 60 Votes)
- No (29%, 25 Votes)
Total Voters: 85
16 Comments
Perhaps, rather than listing a separate toll-free number at the end of all advertisements, the FDA could establish a central website for patients to go to report effects. From that website, consumers could select their medication and either submit information on the web or via a toll-free number listed there. Having a different number for each drug is too much info for one ad and is also much harder for a person to remember. The simpler the process is made, the more likely people are to take the time to report side-effects.
It never ceases to amaze me what the industry and the FDA believes will "overwhelm" consumers. Don't provide people with study findings. Don't add an exorbitant amount of warnings. Don't announce that they can and should report AEs directly to the manufacturer and to MedWatch. Sounds to me that they want consumers under-informed.
The better question may be: If you report AEs will your reports actually be taken seriously and acted on?
I'll go ya one better. The public should have a direct line to someone with knowledge of the product and that the knowledgable person should be recording and documenting all reports. Not some generic number to some poor soul who has no information. Doctors will know the listed side effects but they may not report if their patients experience them.
Reporting of side effects like this has been tried in the past, i.e. H2 receptor antagonists on Rx to OTC switch.
It resulted in massive reporting of common, well known, and not very problematic side effects.
Reporting of rare and potentially serious side effects especially in detail is more important. Focusing on the number will definitely minimize knowledge about the more serious side effects that should be communicated.
I think Emma's idea is a better one. A single easy to remember weblink would in my opinion be best. A toll free number would still require diversion of massive amounts of resources into people to answer the phones and collect the information. A webform for self reporting with pulldown menus for controlled language and a box for comments for detailed information may be much more efficient both for reporting and analysis.
Salmon
You are describing what is already in place, Emma. MedWatch is admitedly overwhelmed.
A version of Rosa DeLauro's proposal was included in the original legislation that became the FDAAA. Bill Frist, among others, supported it.
Like much else, it was pulled out of the final bill via a series of deals and compromises.
The version I'd support:
1. Two years ban on DTC. 2. Longer if required phase IV not completed. 3. Some extension of patent protection to company. 4. All approvals are provisional through completion of phase IV as required. 5. Equivalent of UK's black triangle on med letting pts know that much remains unknown about the new drug.
https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm
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.)
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.
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.
Just a clarification. The warnings would not kick in until an number of similar/same cases had occurred.
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)
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.
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.
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?
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.
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.