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DTC-In-Perspective by Bob Ehrlich

Congress Acts on Telemedicine Drug Advertising Regulation

March 4, 2025 0

The unbalanced playing field between pharmaceutical manufacturers and telemedicine sites selling versions of approved drugs is finally being addressed in Congress. Congress acts on telemedicine drug advertising as senators push for FDA oversight. A number of large telemedicine direct sell sites have emerged in recent years. These sites diagnose, prescribe, and ship versions of popular drugs. When they advertise, they are not currently held to the same regulation as pharmaceutical companies.

Sites like Hims & Hers advertise compounded drugs or the forms of drugs without fair balance requirements. Frequently prescribed categories are weight loss, antidepressants, insomnia, and erectile dysfunction. They are not currently regulated by FDA even though they are manufacturing drugs and advertising them.

Senators Durbin (D-IL) and Marshall (R-KS) are co-sponsoring a bill to require FDA regulation of advertising from these telemedicine sellers.  Pharmaceutical companies have been at a competitive disadvantage because these sites often use compounded versions or created combinations of drugs. Drug companies lose sales because these telemedicine drugs often are priced lower.

Telemedicine sites have made diagnosis, prescription, and fulfillment easy for consumers. The problem is they can make efficacy claims without risk and warning information. Drug makers are held to a much higher standard and therefore have an unfair competitive landscape. These direct sale companies are offering a great perceived benefit for consumers. Answer a few medical questions, get prescribed, and receive the drug by mail. I imagine few consumers are turned down from getting prescriptions under the telemedicine process.

Telemedicine sites have made diagnosis, prescription, and fulfillment easy—but without the same regulatory standards as pharmaceutical companies, is it fair competition?

Congress is worried about inappropriate prescribing and the overpromise of efficacy without fair balance, prompting action on telemedicine drug advertising. Drug makers are concerned that compounders are violating patents and creating versions of their drugs which are not going through rigorous quality controls.

While DTC drug advertising receives lots of criticism, it is the most heavily regulated advertising category. Hopefully, that rigorous regulation will now apply to the burgeoning telemedicine industry.

Bob Ehrlich

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DTC-In-Perspective by Bob Ehrlich

Trump and Pharma

November 12, 2024 0

The election of Donald Trump is having pharmaceutical companies evaluate how things may change in terms of legislation and regulation. Trump is not yet clear on his moves regarding pharma. In his first term, he criticized the drug companies for pricing higher in the U.S. than other developed countries. Republicans in Congress have generally not allowed punitive legislation on price controls. They understand the negative impact price controls would have on R&D. Trump wants lower prices and that is publicly popular.  Acting on PBMs would be one option. Another would be allowing and promoting reimportation of drugs.

The DTC Industry should be nervous about Robert Kennedy Jr. being given a large role in healthcare policy. He said on 11/4 that he wanted to get Trump back in D.C. so they can “ban pharmaceutical advertising on TV.”  Scary comment. Kennedy is known for anti-vaccine sentiment and the desire to get corporate influence reduced. He is anxious to focus on prevention of disease which he feels is neglected in budgetary decisions. Kennedy thinks DTC advertisers exert influence on editorial coverage. Anyone who has watched news coverage knows the drug industry has not historically been favorably covered.

I doubt Trump will act on DTC advertising. He did not in his first term and a Republican Congress will recognize the free speech rights to advertise. I do expect Trump to speed up the regulatory drug approval process and that should be a net positive for innovation. In fact, expansion of drug use and DTC ads promoting such should help in the disease prevention goal of Kennedy.

Will FDA be asked by Kennedy and Trump to make DTC harder to execute? It is already harder with the latest OPDP rule recently implemented. Can it be made so restrictive that DTC ads are impractical? That is certainly a possibility, but the drug, media, and advertising agency lobby is strong and persuasive. Usually, the pro advertising forces have prevailed. Republicans have historically been pro-advertising, and I expect Trump not to act even if Kennedy proposes a ban.

Uncertainty is never helpful in DTC planning and the anti-DTC proponents will make a lot of noise. I remain confident, however, that no actions will be taken to ban or further restrict DTC.

Bob Ehrlich

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DTC-In-Perspective by Bob Ehrlich

The Implications of the Ubrelvy Letter from OPDP

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

DTC-In-Perspective by Bob Ehrlich

DTC in Perspective: FDA Seeks Input on Risk Disclosure. More Study or Action?

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