HHS Finalizes Direct-to-Consumer Ad Drug Price Transparency Rule - Patient Engagement HIT

Will Garvin, Shareholder in the firm's Life Sciences industry group, comments on HHS finalizing its direct-to-consumer ad drug price transparency rule in Patient Engagement HIT's article "HHS Finalizes Direct-to-Consumer Ad Drug Price Transparency Rule."

"Normally it's very difficult for the federal government - or any government in the United States - to force somebody to say something," William Garvin, a healthcare attorney at Buchanan Ingersoll and Rooney, said in an interview at the time of the HHS proposal. "For the government to actually compel you to speak, they have to have good reasons to do so. And the argument's going to be: is this a form of compelled speech that's inappropriate for the government to do?"

As a lawyer, Garvin can predict that HHS will argue that its proposal is appropriate because it simply asks pharmaceutical companies to disclose truthful information and that implementing the rule isn’t costly.

Furthermore, HHS may argue that DTC ad price transparency is pertinent to how CMS runs its agency. Pharmaceutical companies have opted to work within the federal systems, meaning they have agreed to play by the rules laid out by HHS and CMS, Garvin said, predicting HHS’s arguments.

"There's no teeth to the enforcement mechanism. All that CMS has said is, 'If you do not follow this rule, we're going to put your name on a list,’" Garvin added, pointing out some enforcement issues.

But Garvin rightly predicted that HHS will lean on the Lanham Act – the federal statute that calls for fair market competition – to enforce this rule.