Drugmakers: Moratorium On Advertising New Drugs
14 CommentsBy Ed Silverman // June 16th, 2008 // 9:06 pm
Responding to pressure from Congress, Merck, Schering-Plough, Johnson & Johnson and Pfizer agreed to a six-month moratorium on DTC ads for new drugs and will limit how docs are used in their ads.
The changes were disclosed in letters sent to the House Energy and Commerce Committee responding to a request from committee chairman John Dingell, a Michigan Democrat and, Bart Stupak, another Michigan Democrat who heads the committee’s oversight and investigations subcommittee.
Dingell and Stupak sought a two-year voluntary moratorium on DTC and possibly even longer in the case of drugs for which not all studies have been completed. The lawmakers also asked for limits on the use of docs in ads and to agree to Black Box warnings on ads if requested by the FDA. Here are the letters from Pfizer, Merck, Schering-Plough, the Merck/Schering-Plough joint venture, J&J and PhRMA.
In the letters, the drugmakers agreed to take several steps, while the PhRMA trade group agreed to hold further meetings with the committee. The companies will start following American Medical Association’s guidelines about using actors to portray docs, and J&J won’t use docs in ads to discuss the benefits of a drug.
“We have adopted internal guiding practices on direct-to-consumer advertising for prescription drugs (that) requires that our operating companies spend at least six months after approval of a new medicine educating health professionals before commencing a direct-to-consumer advertising campaign,” wrote Bill Weldon, J&J’s ceo, adding he “does not believe a particular fixed period of time for an advertising moratorium is appropriate in all circumstances.”
Dingell and Stupak, however, wanted a two-year limit. “Although we appreciate the drug companies’ willingness to change some of their business practices, they have not agreed to all of our requests, which would protect consumers from misleading and deceptive advertising,” Stupak says in a statement.
“We accept PhRMA’s offer to discuss these issues seriously. We hope the discussions with PhRMA will result in an industry position that addresses the concerns that Pfizer, Merck, Schering-Plough and Johnson & Johnson continue to ignore.”
Bob Freeman
A tiny step mostly for PR reasons: The six-month time period post launch is used to build physicians’ awareness and the companies don’t like to have patients requesting the drug before the prescriber community is fully detailed. In practice, I believe most companies would prefer NOT to promote the drug via DTC during the first six months but were reluctant for competitive reasons to be the first. Expect the rest to follow because it’s what they would prefer to do.
For reasons of public health the 2-year ban would be preferable.
Insider
Make it 3 and I’m in.
Justice in MI
This is good news. the 2-year ban was originally one of the IOM’s recommendations that got cut out of the FDAAA. Bill Frist supported it at that time.
The other pieces we need (also cut from FDAAA) are:
1. A re-app for approval after two years and/or whenever required phase IV studies are completed (and the stiff penalties for unreasonable delay that FDAAA includes).
2. Some equivalent of the UKs “black triangle” on new drugs that confirms the reality that we really don’t know yet what the safety profiles are - to be removed at the appropriate time.
3. As for as actor-doctors, I am ambivalent, since I personally would love to play a doctor on television. Marcus Justice, M.D.. Has a good ring to it.
How about the scene with the MD behind the big desk going over AEs? I have never had the pleasure of shmoozing with a doc across a big desk, but perhaps I’ll get lucky some day.
Paul G
This is fine, much better than nothing.
This coupled with other controls like having the FDA review ads before they are broadcast will ensure that people are not denied the ability to communicate (remember people, First Amendment, Free Speech, and all that), while ensuring the information is accurate and complete.
Personally, I’d rather be informed than having people who hate the industry censor speech.
Just A Thought
The graphic you used for this article couldn’t be more perfect, Ed.
Pharmaceutical ads run a close second to scantily dressed people writhing for phone calls, as my least favorite things to watch.
I love my remote. Click.
Atlex
FYI…I think that most, if not all, of these companies already had a 6-month moratorium in place. This was really a reiteration of existing policy.
MD Comment
Here’s a better idea - don’t advertise at all. Congress should ban it. In almost every other country in the world, DTC by pharmaceutical companies is not allowed. Why? Because it drives patients in to ask for drugs that they don’t need because they saw a commercial or an ad. The healthcare system simply can’t afford it. let the doctors do the doctoring. Let them make the diagnoses and decide on the treatments. Let them prescribe generics when there is no need to move to expensive products. If pharma stops advertising, then maybe they’ll have a little more left for R & D!
Laurie
MD, I’m with you. Somehow the pharmaceutical industry made money prior to DTC advertising and they will if it goes away. I talk to people all over the world daily and they are shocked that we allow DTC advertising here.
Nathan
Here’s a 2004 report from the FDA about 3 surveys conducted with patients and doctors in order to evaluate whether DTC advertising is a good practice. From what I could tell, the results were pretty favorable from both the doctor and patient perspective. If anyone has a more recent report, please post it. Here’s the link:
http://www.fda.gov/cder/ddmac/Final%20Report/FRFinalExSu1119042.pdf
Here’s a few (selected) stats from the article:
“72 percent of physicians agreed that DTC advertising increases awareness of possible treatments, and 44 percent of physicians believed that it facilitates earlier awareness of health conditions. About a third of physicians thought that DTC advertising increases the likelihood of proper medication usage, and a third believed it helps patients maintain their treatment over time”
“About half of all physicians reported no pressure to prescribe, and 91 percent of physicians reported that the particular patient they recalled did not attempt to influence their treatment in a manner that would have been harmful to the patient. Primary care physicians did report more pressure to prescribe than did specialists, however, with 22 percent of primary care physicians feeling “somewhat” or “very pressured” to prescribe a drug.”
“Finally, patients were asked about how DTC influences their own health. Thirty-two percent (32%) felt the ads help them make better health decisions. Eighteen percent (18%) of respondents agreed that DTC advertisements remind them to take their medications, whereas 17 percent reported that the advertisements cause anxiety about their health.”
“Generally, about three out of four respondents (77%) agreed that DTC advertisements increase awareness of new drugs (a decline from 86% in 1999). Fifty-eight percent (58%) felt the ads provide enough information to make a decision about whether to discuss the drug with a doctor. In terms of specific content within the ads, 60 percent felt the ads do not provide enough information about risks, and 44 percent believed the ads lack adequate benefit information.”
Justice in MI
My sense is that the issue has been discussed and surveyed up, down, and sideways - and virtually every position can find data and arguments to support it.
This is only one dimension among many, but I don’t think it is an accident that the general decline of public trust in the industry since ‘97 coincides with the surge of DTC televsion ads. That decline is very clearly documented in polls that do not ask about DTC but about how well and how reliably the industry does its job in general.
Coincidental?
James
No, Justice, I don’t think it is coincidental at all. Unfortunately, the oversaturation of pharma commercials, coupled with questionable marketing practices by some, has painted the entire practice as negative in many consumers’ minds.
The original intent, as has been noted here in the past, was for the ads to be educational and science-driven. Take Celebrex’s “Dig Deeper” ad. It is nothing like Viva Viagra, yet they get painted with the same brush.
What I find ironic is that, not long after the DTC ban was lifted, beverage companies ended their voluntary ban on hard liquor ads. I’m aware of far less backlash against those, and I don’t think anyone can argue that Captain Morgan’s has therapeutic value greater than Plavix.
I wonder if there are lessons to be learned from what the alcohol companies did?
DV Jr
Re Laurie’s comment:
People in other nations may be shocked that we allow DTC advertising, but they may also be shocked that the leader of our nation can be depicted in a cartoon as a petulant 7-year-old. They may be shocked by widespread gun ownership & by how largely autonomous our states are. Many sentiments in the Bill of Rights have been adapted by the laws of other countries, but the 1st, 2nd & 10th Amendments seem particuarly American, for whatever reason. Reacting to the opinions of people in ther nations would involve thoroughly re-thinking our own, in ways that may make all of us uncomfortable.
Paul G
FREEDOM OF SPEECH
We love it, we fight for it, we die for it…and some of you want to quash it.
Justice in MI
Paul G - Just for clarification, and trying to avoid the predictable debate we all had in Junior High about fire in theater, freedom of commercial speech has always been a good measured against other goods. Thus, tobacco ads (which I’m not equating), etc..
So it is a question of how and when. As you know, DTC is highly regulated, which certainly interferes with freedom to make whatever claims one wishes about about a drug’s benefits, lack of risks, etc.
Do you believe that that regulation also quashes freedom of speech? Serious question - some do think that way, and would be happy to take us back to 1904, before the Pure Food and Cosmetics Act regulated any promotional claims whatsoever.