What are 'Major Statements' for Direct-to-Consumer Pharmaceutical Advertisements

By: Ranier Simons, ADAP Blog Guest Contributor

In the United States, it is common to see advertisements for drugs. Ads appear in print magazines, on television, on the radio, on the internet, and mobile devices. In 2022, the pharmaceutical industry spent nearly $17.4 billion on advertising.[1] The majority of this spending is direct-to-consumer pharmaceutical advertisement (DTCPA) spending. Coincidentally, the United States and New Zealand are the only countries in the world allowing DTCPA. Other countries have banned DTCPA because they feel it does more harm than good. In addition to well-established prescription drug advertising regulations, the U.S. Food & Drug Administration (FDA) released a final rule in November of 2023, effective as of May 20, 2024.[2] Companies have until November 20, 2024, to come into full compliance. 

Photo Source: FDA

The new rule is specific to DTCPAs that are delivered in radio or television format, which name a drug and describe what it is used for. This rule focuses on the presentation of the ‘major statement’, which is the explanation of a drug's side effects and contraindications. There are five key standards the rule establishes. Major statements must be delivered in consumer-friendly language; audio information must be understandable; text must be presented clearly, conspicuously, and neutrally; text information must be readable; and ads cannot include distractions.

Requiring statements to be delivered in consumer-friendly language means that information regarding a drug's side effects and contraindications does not contain scientific and medical jargon. Most consumers must easily understand it. The rule’s requirements concerning the audio information are a direct response to the way ads used to appear and sound. Audio must be understandable in terms of volume, articulation, and pacing.[2] Previously, ads, whether on television or radio, would list a long line of side effects and concerns with a rapid cadence and sometimes in a less audible tone than the rest of the advertisement. This is because ads were required to list almost every possible side effect of a medication. The new rules now mean that only the major and most frequent side effects must be stated. They must be articulated in audio that is as clear as the remainder of the advertisement.[2]

With respect to text, the rule explains that textual information must be presented in an appropriate font, positioned in a visually advantageous manner, against an appropriately contrasting background, and appear for a proper duration of time.[2] Regarding distractions, the rule explains that ads cannot contain statements, text, images, or sounds that distract from the communication of the major statement of side effects and contraindications.[2] Most importantly, in terms of transparency, the contents of the major statement have to appear simultaneously in the audio and video portions of television ads, which is referred to as dual-modality.[2]

The new rule, in addition to the longstanding advertisement regulations, is meant to protect consumers and ensure they are not misled about what drugs can and cannot do. It also informs them about a medication’s risks. Many critics feel the new rules do not go far enough, primarily since they do not address the content of the information, only its presentation.

Photo Source: FDA

There are many pros and cons to DTCPA. Advertisements can educate patients about available treatment options, encourage people to seek care, especially regarding underdiagnosed conditions, and improve communication between doctors and patients. Moreover, when someone sees an ad for a drug they are already taking, it can be a reminder to take their medication as well as positively influence how they feel about the medication, which can increase adherence. Negative attributes of DTPCA are it can lead to overuse of some prescription drugs, which increases drug spending, can cause higher utilization of brand name drugs instead of effective lower-cost generics, and can negatively affect the patient-doctor relationship.[3] Consumers may see an advertisement for a drug and demand it from their physician. However, the physician may deny them a particular medication because the physician is knowledgeable of medical reasons why a drug may not be a good fit or actually be harmful. This could affect the trust and communication between a doctor and a patient.

A notable shift regarding DTCPA is regarding drugs to treat and prevent HIV/AIDS. Over the past few years, there has been a recognizable increase in the number of ART-related television, print, radio, and digital ads. In 2021, ads for ART accounted for six percent of total prescription drug ad spend. Gilead Sciences and GSK accounted for almost all of 2021’s pharmaceutical ad spending dedicated to HIV and AIDS.[4] For example, GSK spent all its 2021 Q4 advertising budget buying spots on ABC, A&E, CBS, CNN, Fox, NBC, and the USA network, which was 75% of what the company spent on television ads that year.[4]

ViiV Healthcare, which is majority-owned by GSK, with Pfizer Inc. and Shionogi & Co. Limited (Shionogi) as shareholders, has had a recognizable presence in television ads since 2017. In 2017, one of its first significant television campaigns was for Triumeq.[5] In 2022, ViiV spent $8.3 million in June alone, on television ads for Dovato. Advertisements for HIV-related drugs on television, in print ads, and digital forms are potentially not just beneficial for drug companies’ bottom lines.[6]

Photo Source: Trend Radars

Antiretroviral drug ads are educational in informing patients of drug options. The science behind treatment for HIV/AIDS is moving at a rapid pace, and many are not aware of all the treatment options available. Advertisements can empower HIV/AIDS patients to have discussions about treatment modalities their doctors may not have presented to them. Additionally, antiretroviral drug campaigns are a kind of social engineering. There are still negative perceptions and public stigma surrounding HIV despite scientific knowledge supporting the concept of undetectable viral load translating into a lack of risk of transmission, or “U=U undetectable = untransmittable.”[6] Many television ads depict subjects who are actual users of the antiretroviral medications, publicly revealing their status. This can add humanity to a disease that remains cloaked in stereotypes and misinformation for many.

Whether in a magazine, a television commercial, a print ad, a YouTube video, or a digital mobile pop-up, pharmaceutical advertisements in the United States are here to stay. There are valid pros and cons. The only way to ensure that the pros outweigh the cons is to monitor and regulate intentionally. Difficulties in the logistics of enforcing governmental regulations can mean slow adoption of and even violation of rules. Optimistically, the efforts of consumers, advocates, and medical professionals can facilitate acceptable and effective pharmaceutical advertisement utilization and execution.

[1] Faria, J. (2023, September 22). U.S. pharmaceutical preparations ad spend 2021-2022. Retrieved from https://www.statista.com/statistics/470460/pharmaceutical-preparations-industry-ad-spend-usa/#:~:text=In%20a%20survey%20of%20representatives,billion%20U.S.%20dollars%20on%20advertising.

[2] FDA. (2023, November 21). Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format. Retrieved from https://www.federalregister.gov/documents/2023/11/21/2023-25428/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear

[3] Keller, J., Hauschild, J. (2024, January 10). FDA Issues Final Rule and FAQ Regarding Direct-to-Consumer Drug Advertising. Retrieved fromhttps://www.faegredrinker.com/en/insights/publications/2024/1/fda-issues-final-rule-and-faq-regarding-direct-to-consumer-drug-advertising

[4] Media Radar. (2022, May3). HIV/AIDS Prescription Drug Advertising: Looking Toward the Future. Retrieved from https://mediaradar.com/blog/hiv-aids-prescription-drug-advertising/

[5] Bulik, B. (2017, December 4). ViiV starts 'Moving Forward' into first branded TV ads for HIV treatment. Retrieved from https://www.fiercepharma.com/marketing/viiv-s-first-branded-hiv-tv-ad-stars-real-patients-and-their-stories

[6] Adams, B. (2022, July 11). ViiV wants HIV patients to 'detect this' as it launches new Dovato TV ad. Retrieved from https://www.fiercepharma.com/marketing/viiv-wants-hiv-patients-detect-it-launches-new-dovato-tv-ad

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.  

CROI 2024 Highlights: Conference on Retroviruses and Opportunistic Infections

By: Ranier Simons, ADAP Blog Guest Contributor

The fight against HIV and other viruses like HCV and SARS-CoV-2 is a worldwide team effort. That is why the Conference on Retroviruses and Opportunistic Infections (CROI) convened from March 3rd through March 6th, 2024 in Denver, Colorado. Since 1993, CROI has brought together scientists, clinical scientists, and epidemiologists to present original groundbreaking research and collaborate to advance the treatment and prevention of HIV and other viral infections and opportunistic diseases.[8] CROI is one the first places research showing the effectiveness of triple-drug therapy for HIV was shared. It was also one of the first places where the results of the SMART study were shared, which proved that early treatment of HIV provides the best outcomes.[8] This year, 4,000 attendees gathered at CROI. Participants presented a multitude of novel and emerging therapies and studies. What follows are just a few notable highlights.

Photo Source: CROI

Long-Acting Injectables Blaze Forward

GSK’s long-acting injectable, cabotegravir, has already shifted the antiretroviral therapy (ART) paradigm. Coupled with rilpivirine, it is one-half of Cabenuva, the first complete ART injectable approved by the U.S. Food & Drug Administration (FDA). Cabenuva allows people who live with HIV (PLWH) to change from taking daily pills to the Cabenuva injection monthly or every two months. Studies have proven it is effective for those who have medication adherence challenges. It also presents an option for PLWH who wish to make medication management a less intrusive part of their lives.

ViiV Healthcare, the HIV-focused subsidiary of GSK, presented data from a clinical trial for a revolutionary new ultra-long-acting cabotegravir at CROI.[7] The new formulation has a higher concentration and double the half-life, potentially allowing it to be dosed every four months instead of every two.[7] Further clinical trials will be conducted to explore the use of the new formulation of cabotegravir as PrEP and as a treatment for PLWH. GSK’s goal is to have the first long-acting injectable for HIV prevention on the market by 2026 and for HIV treatment by 2027. The company also aims for an annual long-acting injectable by the first part of the 2030s.

DoxyPEP for STIs

DoxyPEP stands for doxycycline post-exposure prophylaxis. It is the practice of taking 200mg of oral doxycycline within 24 to 72 hours of condomless sex. Clinical trials have shown that DoxyPEP is effective in reducing the incidence of bacterial STIs such as syphilis and chlamydia. Results of Doxy PEP clinical studies of reducing STIs have been so promising that the CDC proposed guidelines for DoxyPEP usage in October 2022. However, those guidelines are not finalized.[1] 

Infectious disease professionals at CROI presented new data regarding DoxyPEP usage out in the real world among populations of people, mainly cisgender MSM and transgender women. Previous data was from clinical trials in contrast with new data that examined the results of DoxyPEP uptake in over 3,700 clients of sexual health clinics across San Francisco. Usage resulted in a 58% reduction in bacterial STI cases overall, a 67% reduction in chlamydia, and a 78% reduction in syphilis cases.[2] The real-world data indicated that when offered, there was a demand for DoxyPEP, and people consistently integrated it into their sexual health routine. As the Centers for Disease Control & Prevention (CDC) finalizes formal guidelines, DoxyPEP may potentially be solidified as another viable form of population wide STI prophylaxis.

Weekly Oral Antiretroviral Therapy

Long-acting injectable HIV therapy is not an optimal treatment modality for everyone. Nevertheless, other options for medication adherence that do not involve a daily regimen are needed for optimal health outcomes. At CROI, Gilead Sciences and Merck presented data from a clinical trial for a possible weekly oral antiretroviral therapy (ART) solution.

The solution is a weekly dosage of Gilead’s Sunlenca (lenacapavir), and an experimental drug named islatravir from Merck. [3,4] The phase 2 trial compared 104 patients taking daily Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets) with a group taking the weekly oral lenacapavir with islatravir. Data indicated that 94.2% of subjects taking the lenacapavir/islatravir combination maintained their viral suppression compared to 92.3% of the Biktarvy group.[3,4] The study will continue for another 48 weeks as open-label. This means that the study is no longer randomized. Both the medical professionals and the subjects know precisely what they are being given. There is no placebo. Studies move forward to open-label from randomized controlled studies once a high level of efficacy is proven and high benchmarks of defined endpoints are reached. 

Protecting Pregnant Women from HIV Infection

Research has shown there are physiological changes in the female body that cause a threefold increase in the risk of contracting HIV while pregnant.[5] This is especially troubling for countries where HIV is at an endemic level. Medications for HIV treatment and prevention are powerful, and it is crucial to find safe pharmaceuticals that will not harm the mother or the developing fetus.

At CROI, data from a multi-country (South Africa, Uganda, and Zimbabwe) clinical study presented safe options. A monthly flexible vaginal ring containing dapivirine as well as oral daily tenofovir disoproxil fumarate/emtricitabine PrEP (Truvada) were shown to be safe for use for pregnant women. The dapivirine vaginal ring is established in some African countries to be used as HIV prevention for cisgender women who are not pregnant. Truvada has already been proven to be safe for pregnant HIV-positive mothers to use.

The study was a randomized trial where pregnant women aged 18-40 used the dapivirine ring or received the oral PrEP up until delivery or for 41 weeks and six days, depending on which came first.[6] Only 1% experienced stillbirth or miscarriage, 95% of the women’s pregnancies went to term, and 4% of the births were premature.[6] Most importantly, none of the women contracted HIV. The results indicate that both the ring and Truvada are safe for pregnant mothers and their unborn fetuses to protect them from infection.

CROI continues to be a catalyst for pushing HIV and other infectious disease research forward. Scientific communities meet there, spurring the most qualified and passionate minds to collaborate and innovate. Whenever a cure for HIV is found, it would not be surprising if someone at a future session of CROI first presents it.

[1] DiMarco DE, Urban MA, Fine SM, et al. Doxycycline Post-Exposure Prophylaxis to Prevent Bacterial Sexually Transmitted Infections [Internet]. Baltimore (MD): Johns Hopkins University; 2023 Sep. Available from: https://www.ncbi.nlm.nih.gov/books/NBK597440/

[2] Carstens, A. (2024, March 6). DoxyPEP aces first real-world test. Retrieved from https://www.thebodypro.com/article/croi-2024-doxypep-real-world-clinical-data

[3] Clinical Trials Arena. (2024, March 7). Gilead-Merck’s combination therapy maintains HIV suppression in trial. Retrieved from https://www.clinicaltrialsarena.com/news/gilead-merck-hiv-trial/?cf-view

[4] Taylor, P. (2024, March 7). Gilead and MSD say weekly oral therapy controls HIV. Retrieved from https://pharmaphorum.com/news/gilead-and-msd-say-weekly-oral-therapy-controls-hiv

[5] Salzman, S. (2018, March 9).New study shows women's HIV risk triples during pregnancy, quadruples postpartum. Retrieved from https://www.thebodypro.com/article/new-study-shows-womens-hiv-risk-triples-during-pre

[6] HIV.gov. (2024, March 5). Vaginal ring and oral Pre-Exposure Prophylaxis found safe for HIV prevention throughout pregnancy. Retrieved from https://www.hiv.gov/blog/vaginal-ring-and-oral-pre-exposure-prophylaxis-found-safe-for-hiv-prevention-throughout-pregnancy

[7] Reuters. (2024, March 5). GSK's new HIV drug formula could support longer dosing intervals. Retrieved from https://www.reuters.com/business/healthcare-pharmaceuticals/gsks-new-hiv-drug-formula-could-support-longer-dosing-intervals-2024-03-04/

[8] CROI Foundation. (2024). General information about CROI. Retrieved from https://www.croiconference.org/about/

Disclaimer: Guest blogs do not necessarily reflect the views of the ADAP Advocacy Association, but rather they provide a neutral platform whereby the author serves to promote open, honest discussion about public health-related issues and updates.