Court rejects HHS rule to include drug prices in TV ads
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A judge in the U.S. Court of Appeals blocked HHS from implementing a rule requiring drug companies to put the manufacturer’s list price for prescription drugs or biological products to wholesalers or direct purchasers in TV commercials.
The decision Tuesday by U.S. District Judge Patricia A. Millett was the latest setback for President Donald J. Trump and his administration’s ongoing effort to lower drug prices.
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In rendering her opinion, Millett wrote that HHS “acted unreasonably” in assuming it could tie the rule to Medicare or Medicaid programs. She added that “although the Secretary’s regulatory authority is broad, it does not allow him to move the goalposts to wherever he kicks the ball.”
Robin Feldman, JD, director of the Center for Innovation at University of California Hastings, said Millett did not rule on the part of the Merck, Eli Lilly, Amgen and the Association of National Advertisers lawsuit that claimed the rule violated freedom of speech.
“Overturning the rule [on those grounds] would have been a heavier lift for the court,” Feldman told Healio Primary Care.
She and Raymond March, PhD, research fellow at the Independent Institute and director of FDAReview.org, citing the November presidential election, agreed that the Trump administration would probably not appeal Millett’s decision.
“The much more likely options are to rework the legislation using the authority of the FDA or HHS to require some system of price disclosure or Trump issuing an executive order requiring price disclosure, March said. “Trump has issued three executive orders trying to lower the price of various health care goods. Issuing another would be the quickest way to mitigate this failure and attractive during an election year.”
Feldman said it is possible “that the Trump administration could refile an advertising rule with a different agency, in a different manner.”
The AMA, the American Academy of Family Physicians and the ACP had not reacted publicly to Millett’s decision before this story’s posting. However, these societies had previously indicated that the rule was a step in the right direction to lower drug costs.