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DTC-In-Perspective by Bob Ehrlich

Trump’s Drug Pricing Executive Order: What It Means for Pharma and DTC Advertising

May 12, 2025 0

The monumental Executive Order announced on May 12 is sending a chill through the pharmaceutical industry. President Trump is proposing to significantly lower drug prices in the U.S. by implementing a most favored nation pricing model. In essence, this means that for drugs paid for by the government, the price would be set at the lowest rate charged by any developed country.

There’s a lot to unpack here.

First, this doesn’t apply to all drugs—only those covered under Medicare and Medicaid. Most drugs that patients pick up at a retail pharmacy are not impacted. Also worth noting: legal challenges are expected.

Even if drug profits dip, DTC advertising is not the obvious place to cut. More importantly, DTC delivers a solid ROI—and that’s not going to change.

The rationale from the administration? Trump argues there’s no justification for Americans to pay more for prescriptions than people in Europe, Canada, or other developed nations. According to him, we’re subsidizing the world’s pharmaceutical innovation by footing the entire R&D bill, while foreign countries enjoy cheaper prices due to imposed price controls. This Executive Order aims to put pressure on those countries to contribute more—and Trump intends to tie this issue into future trade negotiations.

Even though the order currently targets only a subset of drugs, the broader industry fear is that it sets the stage for sweeping price controls. Could Congress eventually mandate that all branded drugs follow a most favored nation pricing strategy? That would have massive repercussions—crushing drug company margins and threatening the long-term viability of R&D pipelines.

Faced with this possibility, some pharmaceutical companies may even choose to cut off sales to lower-paying countries. That would be a strategic move to drive up international pricing and allow more equitable pricing for American consumers.

So—will this shake up affect DTC investment?

In my view, probably not. Even if drug profits dip, DTC advertising is not the obvious place to cut. Drugmakers still need to drive demand, especially in a competitive landscape. While companies might scale back some expenses, the $8 billion spent annually on direct-to-consumer advertising is modest compared to total promotional budgets and operational costs. More importantly, DTC delivers a solid ROI—and that’s not going to change.

What this Executive Order does indicate, however, is that the pharmaceutical industry is clearly in the crosshairs. This isn’t your traditional business-friendly Republican approach. Trump and Bernie Sanders may not agree on much, but when it comes to populist pressure on drug pricing, they’re surprisingly aligned.

While DTC advertising may escape immediate scrutiny, this move shows Trump is willing to break from the norm. Is a DTC ban still on the table? I’d say not right now—but let’s not be naïve. The populist momentum is real, and DTC marketers should stay alert, committed to responsible and effective advertising.

Bob Ehrlich

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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

Congress and DTC Price Disclosure

January 30, 2025 0

The idea of mandating drug price disclosure in DTC ads is here again. A bi-partisan Senate bill was just introduced by Senators Durbin, Grassley, and six others calling for mandatory listing of the wholesale acquisition cost in ads. It is called The Drug-Price Transparency for Consumers Act of 2025.

As with prior attempts, this is bad policy. List prices are not what consumers pay. They are nowhere near what the overwhelming proportion of patients will eventually pay if insured. This bill is meant to discourage DTC advertising by creating a false belief that many drugs are “outrageously” expensive. Their rationale is consumers deserve to know the price of drugs being advertised. They say many other products list their price in ads so why not list them for drugs.

The problem is consumers only care what the final out of pocket cost is to them. Drug pricing is overly complex and that is a legitimate policy issue. Telling consumers a cancer drug is $5,000 a month in a DTC ad is not at all helpful to them if they actually pay $50 with insurance. All that faux disclosure might do is scare them into thinking they cannot afford it.

The bill sponsors’ logic is faulty that listing price creates transparency and price competition. There is no evidence that listing drug prices creates competition given the list price is nowhere near actual patient price. Yes, it may work for automobiles, but not for prescription drugs.

This bill is a blatant attempt to discourage drug ads because payers would prefer consumers not request information on high-priced drugs. Government, insurers, and other payers want to be the sole deciders on what drugs patients can get. DTC is inconvenient for them if a doctor prescribes a high-priced therapy. Does Congress think doctors are prescribing a $100,000 drug for cancer just because a consumer saw an ad?

If this bill passes, drug makers will have to add another useless super in the ad. They can do it if required but will not be intimidated into dropping their DTC ads. Clearly this bill is something the courts might weigh in on as the forced price disclosure inhibits commercial free speech.

Telling consumers a cancer drug is $5,000 a month in a DTC ad is not at all helpful if they actually pay $50 with insurance.

Unfortunately, this bill may just be one of many tactics Congress or HHS will use to try to discourage DTC ads. Robert Kennedy, Jr. wants to ban DTC TV ads outright, but that is unconstitutional so expect approaches that make it harder to do DTC. That could be through tax policy on deductibility of advertising costs, increased OPDP interpretations of violative language, more requirements for fair balance, and lobbying pressure by insurers and payers to limit DTC.

I get the frustration that Americans pay more for prescription drugs than other developed countries. This is a highly charged issue and deserves policy debate. Limiting DTC advertising for lawful products will not affect prices. That $8-10 billion being spent on DTC annually is not significantly driving up costs given our drug spending is over $500 billion annually. Of course, I admit drug companies advertise to increase demand. Given an average ROI of 2 to 1, advertising likely adds $16-20 billion to sales or about 2%. Would drug companies cut prices if they did not spend on DTC? No, they would reallocate to other promotional techniques or other investments.

It is time for Congress to stop trying to ban or restrict DTC. They are grandstanding to the American people with full knowledge their bill is not a real solution to reducing drug costs.

Bob Ehrlich

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DTC-In-Perspective by Bob Ehrlich

Jardiance and The Turtles

January 8, 2025 0


Media courtesy of Vivvix

 

Can a drug commercial shock me? I have been watching them, analyzing them, and critiquing them for almost 30 years. Jardiance is well known in the ad world for its musical- and dance-themed diabetes ads. Love them or hate them, they are different and effective.

In announcing a newer indication for Chronic Kidney Disease (CKD), Jardiance has gone about as far away from its use of musical format. It used animated CGI turtles playing soccer. It is very basic in its messaging. The main turtle says Jardiance can slow the progression of CKD and reduce the risk of kidney failure. Obviously, turtles know how to slow things down as the lead turtle tells us.

Was I shocked when I saw the turtle ad? Yes, but shock is not necessarily a bad thing in advertising.

I have no issue with the ad itself. It is different, easily understandable, and likable. The question is can or should a brand so dramatically change its creative approach without risking confusing its audience? The advertised CKD indication is different, but does that merit a 180-degree shift in creative?

Could Jardiance have just added the new indication to its current campaign with a super or voiceover? I assume they wanted a separate campaign because the CKD indication is not only targeted at people with diabetes. It is also hard to create a second song dedicated to CKD. That said, I still wonder if the brand image might be affected by such a drastic shift in creative approach.

As one who has argued that too many DTC ads are formulaic, I applaud the use of new approaches. The fact that the new Jardiance ad is so different from the musical version does make for some interesting discussion. There are many multi-indication brands in the DTC world. I have yet to see a brand that has veered so far away from its current creative approach as Jardiance when adding new indications. That is not a criticism because they obviously have research showing the ad works. Was I shocked when I saw the turtle ad? Yes, but shock is not necessarily a bad thing in advertising. On the Golden Globes, the turtles ad certainly broke through the heavy DTC ad clutter. We shall see if this ad is just a brief announcement campaign. But if getting noticed was the goal, it worked.

 

Bob Ehrlich

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DTC-In-Perspective by Bob Ehrlich

DTC Advertising and the Clutter Trap: A Call for Creativity

January 7, 2025 0

I have been a close observer of DTC advertising for about 28 years. One of the issues I have is that most DTC television ads still have a similar look. You all know the type of ad that starts with some actor patients saying they have condition X, so they asked their doctor about drug Y and then are feeling better. Then they show the fair balance scenes of active patients on the beach, hiking, playing with the grandkids. These vignette ads still seem to dominate the DTC landscape.

DTC advertisers only have about 28-30 seconds in a :60 second ad to make the selling case. It is hard to get all the information in about brand name, condition, and benefits. I assume that every drug company has a rigorous process to get consumer qualitative and quantitative feedback. Since all these pharma companies are data driven, I also must conclude that every ad aired has met some reasonable internal action standard for success. In other words, every DTC ad aired must be “good” by standard research testing methodology.

That being the case, why are so many DTC ads lacking breakthrough creativity? I have asked this question to many pharma marketers and agency people. Many agree that, aside from their own ad, this creative sameness is a problem. The reality is that most of the ads I analyze are too similar. They may test well pre-air but when on air, with so many other DTC ads in the same time block, they have challenges breaking out of the clutter. Of course we do not want creativity for its own sake. We also need consumers to remember the key selling point so they are interested enough to follow up with their doctor.

Kevin Clancy, a noted marketing guru and author, said at one of the early DTC National Conferences that an ad that tests in the top 20% is twice as effective per dollar spent than an average ad. That makes creativity a valuable goal.

Here are 5 reasons most ads fail creatively to break through:

  1. Most drug ads are trying to be straight forward and logical in their advertising. Drug companies are pretty conservative and problem / solution information rich ads are in their comfort zone.
  2. These ads may in fact test well in a research setting because they are logical. Consumers will understand them and repeat back the benefits.
  3. The internal legal and regulatory folks also appreciate the clarity of the standard ad.
  4. FDA’s OPDP may pre-clear a standard format ad faster, because they have seen hundreds just like it and are less concerned about consumer distraction.
  5. The standard ad is easier to sell up the management chain just because of the logical nature of people running drug companies.

Challenge yourselves and your agencies to do better. I know we are not selling perfume and creativity is harder to execute in drug ads. Be careful when interpreting research data that says your ad tests well with consumers. Make sure your test includes competitive category ads and other DTC ads to simulate clutter. Have a goal to excel on the creative score. There are creative DTC ads out there that also get their logical selling points across. Many cookie-cutter standard ads are still successful in ROI measures because of the level of spending. However, demand that your marketing team and ad agencies strive to get that 2X in spending effectiveness. There is no reason for being average.

Bob Ehrlich

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DTC-In-Perspective by Bob Ehrlich

Weight Loss DTC Will Boom: GLP-1 Drugs Reshape the Market

December 10, 2024 0

The obesity drug market potential is staggering. America is overweight. I am overweight. My friends are overweight. Willpower is obviously not the solution because most of us cannot sustain it. We need to get by with a little help. About 40% of adults in America are obese according to the CDC. Thankfully, we have two currently approved drugs in the GLP-1 category. Wegovy and Zepbound from Novo Nordisk and Lilly, respectively, currently lead the category. Others will follow.

There has never been a category so suitable for DTC advertising. High incidence, easy understanding of the condition, and fast action to see results are the hallmarks of a no brainer DTC drug. A JP Morgan analyst predicted the GLP-1 obesity market will grow to $71 billion by 2032. There are about 110 million Americans who could benefit from using obesity drugs. Currently only about 6% are using them according to the Kaiser Family Foundation.

Wegovy has been blasting its availability over the past year. We have all seen the great march of people down the street DTC ad. The power of “we”. Lilly’s Zepbound started DTC advertising mid-November. Supply issues made advertising unnecessary until capacity issues were resolved. Production has been recently expanded according to Lilly.

Lilly has set up its direct distribution system to consumers to offer that alternative to regular channels of retail pharmacies. They are ready to promote demand growth.

You can count on several new competitors in the next few years as the great gold rush for this market is making drug makers salivate. Lilly and Novo Nordisk know their premium priced drugs will be facing lower priced entries. The window for maximizing sales at premium prices is short. Insurers will be gradually increasing coverage because the added benefits of these drugs are exciting. At current prices, insurers are not rushing to cover them.

The weight loss category from GLP-1 drugs is set to become a massive DTC advertising spender, reshaping how America addresses obesity and its related health challenges.

Research studies are showing a litany of health outcomes beyond weight loss such as reducing blood sugar, blood pressure, heart disease, addictive behaviors, and potentially dementia. It is just a matter of time before they are covered because of the potential reduction in costs of treating heart disease, diabetes, and dementia.

The pressure will be on drug makers to make these drugs more affordable to the average American. Hearings in Congress were recently held with the Novo Nordisk CEO to pressure the company to lower prices on Ozempic and Wegovy, which run about $1,200 a month for self-pay. Discount cards are available, so the real consumer price is about $600 a month unless covered by insurance.

DTC ads will help keep demand high and new competitors will eventually drive down price. Expanding capacity will allow both Lilly and Novo Nordisk to reduce price and make it up on volume. After all, better to have more customers on these drugs for years at affordable prices than have them start and stop due to cost.

Once we see new competitors, we will see DTC ads evolve to highlight brand advantages. Those might be based on price, form of dose as in pill or injection, frequency needed, side effects, efficacy of weight loss, or other collateral health benefits. The weight loss category from GLP-1 drugs is going to be a massive DTC spender for years to come.

Bob Ehrlich

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DTC-In-Perspective by Bob Ehrlich

Revolutionizing Pharma: The Rise of Direct to Consumer Pharmaceutical Drugs

December 3, 2024 0

One of the current trends in DTC marketing is the availability of some branded drugs shipped directly from the manufacturer. Some pharmaceutical companies are starting to cut the wholesalers and retailers out of the purchase cycle. While still in its infancy, the direct to consumer operations have enormous implications for how consumers will get their drugs in the future. Eli Lilly and Pfizer are the first to offer this service.

The direct sales of drugs to consumers have been in place for nearly a decade from non-pharmaceutical companies. Hims started in 2017, and there are now many non-pharmaceutical companies diagnosing, prescribing, and shipping to consumers. Drug companies have decided to enter direct sales in the past few years.

Why are drug companies now getting into the direct sales business? There are several good reasons for this new approach. First, drug makers are now seeing a huge growth in direct sales companies offering compounded versions of their drugs. These are cheaper and, in categories like weight loss, have lots of appeal to consumers. Second, cutting out the middlemen gives drug companies better ability to lower drug prices. Third, there are enormous marketing advantages to knowing your customers and tracking their purchases over time. Fourth, drug companies are concerned about counterfeit drugs through reimportation which is a real problem for consumers ordering from the internet. Fifth, consumers like the convenience of getting diagnoses and prescriptions without having to see their doctor in person.

“Cutting out the middlemen gives drug companies better ability to lower drug prices, know their customers, and combat counterfeit medications – reshaping how consumers access healthcare”

I would expect that drug companies will greatly expand their direct to consumer programs and use traditional DTC advertising to make consumers aware of their purchase options. The direct business will not replace retail drug stores or drug wholesalers for most drugs. Most of the growth will come from lifestyle categories like weight loss, sexual dysfunction, sleep disorders, migraine, anxiety, and depression. Any category where an online survey and virtual healthcare can diagnose a consumer condition is an opportunity for direct sales.

There are legitimate ethical and policy implications to expanding direct pharmaceutical distribution. The non-pharmaceutical direct business makes it easy to get prescription meds through an online survey or telemedicine that inappropriate prescribing is possible. I expect pharmaceutical companies will have better controls in place to make sure a prescription is justified. After all, these big pharma companies have a lot more to lose in public reputation and through regulatory, public policy, and legal actions.

The Amazoning of America has certainly shown that consumers love the convenience of shopping from home. Getting a diagnoses, prescription, and delivery online is becoming accepted for many drug categories. Drug companies see the potential and expect major growth in this channel.

Bob Ehrlich

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The Power of Point of Care in the Marketing Channel

December 2, 2019 0

 

Your parents are the ones who always take care of you.  Mom kissed your knee when you fell on the playground, and Dad drove you to the hospital when you needed to get your tonsils out.  Your parents kept you healthy and safe.  They were your rock and knew all the answers and just what to do.

Time passes.  You’re in your thirties and somehow in an instant the role of caregiver has flipped.  This was the case for me.  Nothing could prepare me for the moment I learned my mom, my rock, was diagnosed with a form of non-Hodgkin’s lymphoma.  I recall googling “NHL” only to be served hockey statistics; I was frustrated and scared.  Every time we went to see her oncologist or when I accompanied her to chemo, I would get hit with a wall of anxiety.  Each time we stepped into the hospital, what my mom and I truly needed most was support.

As a caregiver and patient, I understand the emotional moments that can happen at the point of care.  As a healthcare marketer, I also understand the value of this space as a channel, and I’ve been fortunate to see it evolve over the tenure of my career.  Today, pharmaceutical brands and healthcare and lifestyle advocacy groups push messages at these point of care (POC) settings, hoping to educate patients about therapy options.

But POC as a marketing channel needs to be treated both similarly and differently from other marketing strategies if a marketer wants to appear relevant and connect in a meaningful and useful way.  The reality of distracted, concerned patients and worried caregivers means brands that want to engage with patients at the POC need to approach them with greater empathy and understanding, with content that resonates emotionally and rationally with this audience.

But what makes POC unique anyway?

The POC channel supports the patient at critical moments of their health journey. 

From acute illness to more chronic or prolonged conditions, important milestones of the health journey happen at the point of care.  Through a recent survey collaboration between Outcome Health and Nielsen, we learned that the wait times within the rooms of point of care are substantial, with patients waiting on average up to 38 minutes in the waiting room and then another 36 minutes in the exam room.  These wait times represent a huge opportunity to communicate with and impact patients, caregivers and physicians all at the same time — essentially turning a “captive” audience into a “captivated” and educated one.

Inventory is finite if POC content is done right.

POC differs from other digital ad channels because inventory is specific, targeted, and limited.  Think about it.  There are only so many rheumatologists in the United States, and there are only so many brands that treat or support patients who see a rheumatologist.  Factor in the attention span of the average person today, include the other places they can get content in the doctor’s office (like magazines, posters, pamphlets), as well as the fact that we are all walking around with smart devices that can deliver content that we ask it anytime, anywhere, and you realize how critical it is to provide content that is aligned with why a patient may be in that rheumatologist’s office in the first place.  This content (continuing with the Rheumatology example) could include anything from signs and symptoms of Lupus, to managing rheumatoid arthritis through diet, exercise, and lifestyle choices, to understanding how to best support a loved one who has osteoporosis — this is just the short list of potential content that may be pertinent to patients or caregivers seeing rheumatologists.  The funnel of dependencies leading to the opportunity to message a patient who is seeing their provider for an ailment and being able to support that patient on their journey means that there are finite opportunities like this, which makes messaging at the POC more sophisticated and challenging in the same breath.

The point of care is the final touchpoint of the marketing message. 

On many occasions, I’ve heard pharma marketers muse, “What if we could hold hands with patients when they have those important conversations with their provider?”  In the POC channel, you can.  Unlike TV, print, and digital that serve to create awareness for new therapies or reach patients before they reach the office, POC holds their hand in the office, moments before and during time with their physician.

POC drives patients to take action.

Messaging at the POC has been proven to impact and shift patient behaviors.  In a study by ZS Associates, patient behavior was measured after being exposed to digital signage at their provider’s office.  Of those exposed, 84% were more likely to ask their doctor about an ad they saw, 68% asked their doctor for a specific medication, 31% were more likely to fill their prescription, and 34% were more likely to take their medication as prescribed.

Where does POC marketing fit in alongside DTC and traditional channels?  The point of care should serve as a complement to your brand’s other marketing and sales efforts, with specificity and context for patients waiting to see their doctors, moving them forward towards treatment.  POC marketing can be leveraged as a digital tool, as a TV alternative, and even as a patient engagement solution to share benefits like co-pay assistance programs.  Because your ad is now in the room with patients and their physician, messaging must be tailored for this space; simply dropping your TV spot onto an exam room screen isn’t likely to cut it with patients who are waiting to see their doctor.  Advertisers should welcome the opportunity to become more deeply integrated into the patient-doctor experience and develop content that can be integrated into the clinical setting.

Because there’s such a range of experiences (and emotions) that happen at POC, it’s important that any content (sponsored or not) intended for this space is sensitive to that.  You can’t create effective content without considering the patient’s mindset.  Content must be curated and contextualized for each touchpoint of the point of care experience.  Videos should be relevant for that clinic’s specialty and help to facilitate physician-patient conversations.  When you’re at the doctor’s office, sitting in a gown (or in the passenger seat supporting an ill parent), wouldn’t you prefer fact-based, custom information that’s helpful and supportive of the conversation you’re about to have with your physician?

On the other hand, there are also moments of the health journey when patients don’t want to dig further into their treatment plan or condition and prefer access to content that simply entertains or distracts them.  We as marketers need to take into account the range of experiences that happen within the point of care and provide content that aligns with and supports these unique moments.

The most important thing to remember is that patient needs vary within the POC environment, and you can’t take a “one size fits all” approach with your messages within each channel.  The diversity of needs and experiences is prompting the space to evolve beyond just awareness.  New trends within the space include patient education, adherence, support group registration, and more.  The channel is poised for continued growth and we, as healthcare marketers, need to continue to innovate so that everyone entering the POC space can feel informed, inspired, entertained, and renewed during the most critical moments of care.

 

Matt McNally

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DTC-In-Perspective by Bob Ehrlich

DTC in Perspective: Drug Prices in DTC Ads? Bad Idea Gets Traction.

September 5, 2018 0

The Senate recently passed an amendment to a larger health care bill that requires drug prices be disclosed in DTC Ads. The Durbin amendment was adopted with bipartisan support. It really just gives HHS a million dollars to study a way to require the disclosure. What is clear is this idea has strong support from President Trump, Congress, HHS Secretary Azar, and the American Medical Association. So, like it or not, the drug advertisers may be forced to add some price information to ads.

Bob Ehrlich
“Drug makers may be forced to add… price information to ads.”
-Bob Ehrlich

On the surface, that list price disclosure seems reasonable. We see MSRP in car ads, so we know whether it is a premium or economy car. Not that we don’t know that already but it is not unreasonable. For cars, we know we will likely pay somewhat less than MSRP but we do know the range a Mercedes will cost us. Congress thinks consumers deserve to know the price of drugs they see advertised. To Congress that seems like it would help consumers decide if this advertised drug should be considered.

Drug pricing is not like car pricing. Consumers pay much less than the list price and sometimes pay nothing for the $50000 drug for cancer. Admittedly, drug pricing is a Byzantine process that confounds most of us. Each insurance company, PBM, and government payer negotiates prices. Each consumer depending on their insurance pays a different price no way near the list price. Sometimes the consumer would pay out of pocket more for their OTC cough medicine than the $50000 cancer drug.

So how should drug companies disclose drug prices? If the list price is not anywhere near what consumers pay, then how does disclosing it help them? It does not. It helps insurance companies in making DTC more difficult for drug companies to execute. The knowledgeable legislators know that if they force drug makers to talk about price that may discourage them from doing DTC Ads for expensive drugs. Drug makers advertising the $100000 cancer drug may decide that DTC is not worth trying to explain the complexities of drug pricing or face the barrage of criticism for having a sticker shock price.

I think this is the real reason for this amendment. Embarrassing drug companies they hope will put a chill on DTC for cancer drugs, biologics for arthritis, Crohn’s, and other new premium drugs. Of course, all drugs will face a guidance on how pricing needs to be discussed. Somehow FDA will make disclosure a time consuming step in a DTC ad. That will add 10-15 seconds to the ad and may make them difficult to execute. Their hope is to get drug companies to stop doing DTC.

So the good news is it will take FDA a while to study and draft guidance for disclosing price. This lag may allow the powerful advertising lobby to show how impractical this disclosure requirement will be. My guess is we may have some compromise that speaks in terms of ranges of price. That is something like “most patients will pay much less than the price listed depending on your insurance coverage.” Or, drug makers may be able to say “the average price paid by consumers is x.”

It may be illegal to require drug makers to disclose price under commercial free speech grounds. I am sure the advertising lobby will argue this inhibits commercial speech. They would have a strong case based on precedent.

My advice to the agencies is to be ready to deal with adding some price statement but I am sure it will be a few years before FDA can figure out how best to do this. They research everything they do and that will take a long time to study. DTC price disclosure sounds great but is just a bad idea that will not help patients.

Bob Ehrlich

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