Explore the potential impact of Robert Kennedy Jr.'s nomination to head HHS on the future of direct-to-consumer (DTC) pharmaceutical advertising. Understand the legal and regulatory challenges that could reshape the industry.
Explore the potential impact of Robert Kennedy Jr.'s nomination to head HHS on the future of direct-to-consumer (DTC) pharmaceutical advertising. Understand the legal and regulatory challenges that could reshape the industry.
I was watching HHS Secretary Alex Azar during the White House press briefing unveil an idea we have heard pushed before. That is, DTC advertising should disclose the price of the advertised drug. That sounds fair but is a lot more difficult to implement than any other advertised category.
Most advertised retail prices have relevance to consumers. A car advertised at MSRP will sell for somewhere between 85-100% of that price. That is true for most products that disclose prices. Health care prices are wildly variable depending on the payer. Those prices can vary by as much as 50-75%. I understand the goal of HHS. It is to give consumers an idea about how expensive a drug is before they and their physician make the decisions to use it.
In my last column on this topic, which was written last July after the American Medical Association recommended that a drug’s price be required in DTC ads, I said prescription drugs are unique in that consumers have no idea what the advertised drug costs based on the ad itself. No other category has ads where its products range from $300 a year to $100,000. Consumers who are interested in an advertised drug may be in for sticker shock and depending on coverage may be paying a high out of pocket cost. Secretary Azar thinks that the consumer deserves to know that price information in advance. The issue is how to do that in the prescription market with its myriad of discounts. What consumers want to know is what they will pay, not what their insurer will pay. Given the numerous payers, all with different formulary coverage and individual discounts, that is hard to communicate.
Clearly drugs can be broadly categorized by cost, so perhaps an ad can say in what pricing category the drug fits. Maybe there are terms HHS can come up with to give consumers an idea in which cost category the drug belongs. Even if they do, consumers care what they pay not the listed retail price. It is possible a $100,000 drug costs them less than the $3000 drug based on reimbursement.
This price disclosure motive seems to be designed to put pressure on drug makers to be embarrassed advertising high priced drugs. That may mean those $100,000 cancer drugs prefer not to advertise if they had to list a high retail price in the ad. My recommendation would be to have ads refer to a link on their website or an HHS website that can discuss price in detail. In a 60 second spot HHS can only expect a super that discloses a list price or a voice over saying what the drug may cost. That would be totally insufficient for consumers and more likely confuse them.
OPDP likely will propose research studies on how best to convey price and we can expect a guidance several years out. I do not agree with the practical value of some of their research studies but this one deserves careful study. I doubt a DTC ad is the right place to discuss price but if it is mandated by FDA then it must be done to help consumers evaluate a drug on the cost/benefit context, and not just to generate public outrage that some drugs are very expensive.