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October 22, 2024 0

On 8/29/24, AbbVie received a notice from FDA’s OPDP that their Serena Williams DTC television ad violated the FD&C Act. The reasons cited are for overstating the benefits of Ubrelvy. The untitled letter illustrates the difficulties pharmaceutical companies face in presenting benefit information that satisfies FDA requirements.

Ubrelvy tried to meet FDA requirements and do it in a :30 second ad. For drug ads, this is very hard to do given most drug ads need :60 and :90 seconds because of complex benefit claims and fair balance. AbbVie has used Serena Williams as a migraine relief spokesperson for several years. She has been an excellent example of a celebrity endorser. Serena has the migraine condition and the ads are presented in a unique creative style.

What happened in this case that OPDP called the ad violative? In sum, OPDP said the stated benefit of providing one dose rapid relief was not consistent with clinical data. That data showed only a minority of users got relief that quickly. The television ad claimed in a large super, “Ubrelvy Quickly Eliminates Migraine Pain”. Serena’s audio says, “One dose works fast to eliminate migraine pain.”

OPDP also had concerns that Serena, as a celebrity, further added to the potential for consumers to believe the one dose rapid relief claim was true for all users of Ubrelvy. OPDP cites several studies supporting the idea celebrities add to claim believability.

OPDP acknowledges that the ad had a small qualifying super saying “some people had pain freedom within 2 hours.” That small super was insufficient in balancing the ad’s stated claims of rapid relief. OPDP says the speed of relief and one dose claims are misleading because they do not work for everyone.

The Ubrelvy case is important because it illustrates the difficulty drug makers have distilling complicated clinical results into concise advertising claims. Ubrelvy and almost all other prescription drugs provide benefits for some but not all users. Trying to get to that one compelling benefit in DTC ads is difficult given that clinical data is mixed in patient outcomes. Drug claims need to have significant enough disclaimers on efficacy to clearly communicate the extent of the benefit.

In this case, OPDP felt Ubrelvy did not present the proven clinical benefits clearly enough. I should point out the Serena ad in question is not vastly different from the other Ubrelvy ads run from 2022. The earliest ads from 2020-2021 were less declarative, however, in the claim using the word “can” help relieve migraines.

I am not sure if OPDP questioned prior ads or had discussions with Ubrelvy during the pre-clearance process. There is a redacted paragraph in the letter that indicated previous OPDP concerns about Ubrelvy ads. This was when Allergan owned the brand before being acquired by AbbVie. Most drug ads are pre-cleared at least for the first campaign used. Sometimes new versions are not pre-cleared if similar enough to earlier ads.

AbbVie has been asked to stop running the ad and it will be interesting to see their response to OPDP. Usually if the pharmaceutical company stops running the ad, the FDA will not take further action requiring corrective advertising.

 

 

 

Bob Ehrlich


September 1, 2017 0

The FDA is starting the process of possibly reducing the required number of risks presented in television ads. They have opened a docket to solicit public input on 8 questions they raised. I expect this process to be lengthy as speed has never been a guiding principle of the FDA’s Office of Prescription Drug Promotion (OPDP). They are taking their usual approach of being extremely cautious in making changes to their risk disclosure guidance.

Bob Ehrlich
“OPDP already has enough data.. to issue a revised guidance…”
-Bob Ehrlich

This is not the only area of a slow pace in recognizing the changes in consumer communication. They have, for years now, failed to recognize the role of DTC in social media and delayed any useful guidance that recognizes how consumers actually use the Internet. Thus, it is still prohibited to actually use a drug name and indication without the fair balance, as if consumers do not know how to click through to get more information.

Their own recently published research showed that less risk presentation is better for consumer comprehension and retention. For them that finding is the start of a rigorous research process to see if their hypothesis that “less is more” in risk presentation should be implemented in terms of changing their guidance.

Some conclusions are obvious and action is sometimes better than continued study. While I know OPDP is deliberate in making any changes to guidances, we have had broadcast ads for 20 years already. That is slow even by government standards. It is painfully apparent that DTC ads are presenting way too many risks and that litany approach is ridiculed by satirists and critics. Consumers complain about the many risks presented and have been for years. What does FDA do about it? They seem to want more and more studies so they can come out with a “perfect” guidance. This attitude is hurting consumers. A whole generation will have watched DTC ads with too much confusing risk information before FDA finally acts. OPDP already has enough data and should have the people with the judgement skills to be able to issue a revised guidance today.

Studying how risks are presented in DTC ads made sense in 1997 in the introductory DTC broadcast period. For them to just begin to study reducing the number of risk disclosures after 20 years is both puzzling and concerning. OPDP frequently says as a reason for slow progress on studies is that they have constrained human and budgetary resources. Yet they have managed to conduct several studies on things that many in the drug industry find tangential and not actionable. They should have focused more on this area as comprehensible risk presentation is critical information for consumers. They must develop a better strategic focus on what are their priorities for DTC research. If you look at their research web page, you see a lot of projects that seem to be all over the map that may satisfy the curiosity of their researchers but has no actionable benefit to consumers.

I am sure they will get a mountain of feedback from their docket request and they will meticulously wade through that to use as a basis for new studies. I personally know some of the researchers at OPDP and they are top notch professionals. Maybe they are as frustrated as I am. They must be caught in the bureaucratic ways of government, however, to be taking so long to resolve the risk disclosure issue. Maybe it is time for OPDP to move things along or get new leadership. No one in the private sector would still have a job after taking 20 years to resolve such a fundamental issue. Sadly, OPDP is allowed to operate in a different universe of accountability.

Bob Ehrlich