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March 18, 2025 0

I recently came across a compelling article by Dr. John Goodman, a renowned economist and healthcare scholar, in Forbes (11/24), titled “What the FDA Gets Wrong About Drug Ads”. In it, Dr. Goodman argues for expanding drug advertising—without the mandatory listing of side effects in commercials.

His reasoning? Underutilization of prescription drugs is leading to widespread undertreatment of serious conditions like diabetes and hypertension. He asserts that direct-to-consumer (DTC) advertising plays a critical role in patient awareness, prompting people to ask their doctors about potential treatment options. So, if drug ads effectively drive doctor-patient conversations, why not focus on promoting benefits and leave discussions about risks and side effects to the professionals?

The real threat to public health isn’t excessive drug advertising—it’s the overly restrictive regulations that limit the promotion of valuable treatment options.

Dr. Goodman is particularly critical of the FDA’s new requirements (implemented 11/24), which mandate that TV drug ads include supers (on-screen text) matching the voiceover. He argues that this information overload makes it harder for consumers to absorb key messages. Instead, he suggests eliminating side effect disclosures in commercials altogether, allowing pharmaceutical companies to advertise more freely and increase public awareness of treatment options.

The Real Risk? Over-Regulation, Not Overexposure

According to Dr. Goodman, the real threat to public health isn’t excessive drug advertising—it’s the overly restrictive regulations that limit the promotion of valuable treatment options. He also criticizes the FDA’s strict stance on off-label drug advertising, despite the fact that many doctors already prescribe medications for off-label uses.

I completely support Dr. Goodman’s proposal. No other industry is forced to dedicate 50% of ad time to potential risks. Alcohol, fast food, high-speed cars, risky investments, and even over-the-counter medications all have risks—but none are subject to the same regulatory burdens as prescription drugs. Yes, medications can have side effects, but if the goal is to increase treatment adherence and improve public health, then drug companies should be allowed to communicate more freely about their products.

A Sensible Compromise

The FDA is unlikely to completely eliminate fair balance requirements, but a middle ground could be reached. Why not permit simple ads that encourage consumers to ask their doctor if a specific drug is right for their condition? A 15-second ad mentioning a drug and the condition it treats—without an exhaustive list of risks—wouldn’t endanger public health. Instead, these brand-and-condition ads could direct consumers to a website for full safety details.

This approach aligns with the “common sense” messaging that has resonated politically in recent years. The FDA should take a similar view when it comes to drug advertising. If the ultimate goal is to get more Americans treated and adhering to their medications, then allowing pharmaceutical companies to better promote their solutions just makes sense.

Do I think the FDA will move toward deregulation, given Mr. Kennedy’s views? No. But Kennedy is wrong about the negatives of drug advertising. We need to shift the conversation to the positives—because ultimately, more awareness and access to treatment could help make America healthier.

Bob Ehrlich

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September 25, 2019 0

Sponsored Content

I know the pain of losing a loved one to opioid addiction. My family continues to grieve the loss of an incredible young man who, after an awful car accident, began a decade-long battle against addiction to his prescribed painkillers. Three years ago, he lost that battle.

Countless other families have experienced similar losses due to our nationwide opioid crisis. According to the Department of Health and Human Services (HHS), more than 130 people die from opioid overdoses every day. It’s a devastating epidemic that impacts people of any age and from all walks of life.

To help combat opioid addiction, PatientPoint® collaborated with Shatterproof – a nonprofit organization focused on ending the stigma of addiction and improving addiction treatment – to create a powerful opioid education program at the point of care. It launched nationwide in October 2017 across the digital PatientPoint engagement platform, reaching an estimated 15 million patients and caregivers each month in waiting rooms, exam rooms, and in the physician back office. The content is designed to increase the awareness of opioid addiction and encourage doctor-patient discussions about other treatment options.

And the best news is, it is working and we are making a difference. An independent analysis by Symphony Health revealed that each of the 20,793 physicians who had the education program in their practices distributed 142 fewer opioid prescriptions over the eight-month study period than closely matched, non-participating physicians. That adds up to nearly 3 million fewer pills prescribed. If that doesn’t prove the effectiveness of messaging to physicians and patients at the point of care, I don’t know what will.

I often talk about the power of messaging at the point of care, but the results of PatientPoint-Shatterproof campaign really drive it home. I encourage you to read the case study for more details about this fantastic campaign and its impact on the fight against opioid addiction. You can find here.

Linda Ruschau

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February 10, 2017 0

Merck’s cancer drug Keytruda recently began its DTC campaign competing with Bristol Myers’ Opdivo. What is significant is that highly targeted drug categories continue to invest heavily in DTC. Keytruda is a biologic injection that has indications for non small cell lung cancer, advanced melanoma and head and neck cancer.

Bob Ehrlich
“Keytruda has done an excellent job in its DTC ad.”
-Bob Ehrlich

The market is small by size compared to mega categories like diabetes and cholesterol where sufferers are in the tens of millions. Lung cancer cases number about 200,000 newly diagnosed annually. Of course, when the treatment price is around $100,000 per year for biologic lung cancer treatment versus less than a thousand for cholesterol drugs; the DTC payback is certainly achievable.

Roughly the numbers show a $50 million ad campaign for Opdivo and Keytruda need only gain 500 new patients from DTC to break even on a revenue basis. While consumers are the DTC apparent target, these ads also reach oncologists. Once an oncologist knows patients are seeing the DTC and will ask about the drugs, it clearly provides the motivation to consider using them.

The Keytruda ad is very different from Opdivo. While Opdivo used a headline dramatic announcement approach, Keytruda chose an individual patient story. Using an actor portrayal Keytruda showed a 60ish age woman named Sharon telling her story in a tv production studio. Sharon says she learned her type of lung cancer could be treated with an alternative to chemo. She tells how she was given only months to live but a year later after treatment she is still there with her family.

The commercial is filmed in black and white which adds to the seriousness of the presentation. Sharon’s story in this 90 second ad is told very well. It is very informative and understandable using Sharon and supers emphasizing the key benefits. What is interesting is that they are showing Sharon in the production studio both telling her story and in the makeup room preparing to be filmed. Her family is also at the studio watching her being filmed telling her success story.

The sell portion of the ad is about 30 seconds with fair balance risks and warnings in the last minute. Clearly the ad is technical in terms of disclaimers about who can take the drug and one wonders if patients who have non small cell cancer are aware of their biomarkers and gene types mentioned in the ad.

Given the high prices for treatment stock analysts see Keytruda generating revenue in the billions. A DTC campaign costing $50-100 million for a drug bringing in billions is a small risk for Merck. Opdivo had been criticized by some doctors for advertising to patients in an area best left for oncologists. This is a fair question but advertising breakthrough therapies does help potential patients become aware of their options. It also puts pressure on insurance companies to cover the large expense.

Keytruda has done an excellent job in its DTC ad. This campaign will get attention and is very different in executional style from Opdivo, an ad I also think is very good. The broader concern is whether advertising $100,000 drugs to consumers causes Congress to look more critically at both drug prices and DTC ads. While individual patients get extra months and in some cases years longer to live, government payers and insurance companies are paying a lot for that life extension. While no one wants to put a price on those months, unfortunately it is a calculation needed to be considered by policy makers.

Bob Ehrlich