Pharma is taking its best shot to stop, or at least delay, the new rule requiring TV drug ads to include list prices.
Three pharma companies and an advertising association filed a lawsuit last week to overturn the Department of Health and Human Services rule finalized in May. Merck, Amgen, Eli Lilly and the Association of National Advertisers claim that the rule flies in the face of First Amendment rights and other familiar arguments about the list price confusing patients and the rule requiring the companies to spend more on advertising.
As a reminder, the rule would require pharma companies to include the list price in the ad of any drug advertised on TV that costs more than $35 per month or for the typical treatment course.
The industry was largely against it, with some exceptions, and enforcement would be pretty toothless. The Centers for Medicare and Medicaid Services would keep an online list of drugs and companies that violate the rule and it expects the industry to self-enforce through lawsuits.
While a decision on the lawsuit is a long way away, the plaintiffs jumped right on the opportunity to delay it. They filed a motion on Friday to delay the rule until the case is decided. Many pharma companies were concerned about the quick turnaround, which gave the industry just 60 days to begin rolling out new ads.
That meant that TV drug ads would need to include a drug’s list price beginning on July 9. If the pharma industry’s goal is to simply tie up the fate of the new rule in court, it already seems to be working.
In support of the motion, the pharma companies argued that the rule oversteps HHS’ authority to regulate advertising, violates the First Amendment and that HHS did not prove the rule would directly lower costs.
If the judge were to grant the motion to stay, that would pause implementation of the rule until at least 60 days after the case was decided, which could take months on its own. In response to the plaintiffs’ motion, HHS also urged the court to decide on an injunction as quickly as possible. The court agreed and set a hearing to decide the motion on July 2.
That’s really going down to the wire. The judge plans to make a decision by July 8, just one day before the rule would go into effect. The plaintiffs, and the rest of the pharma industry, have been preparing for the rule nonetheless. The injunction, if granted, would simply be a last-minute save.
Every Wednesday, MM&M covers health policy changes relevant to pharma and healthcare marketers. Got a tip? Contact Alison Kanski at email@example.com.