Donald J. Trump
A district judge recently blocked the HHS rule that certain drugs prices be included in TV ads, saying HHS overstepped its authority in issuing such a requirement. The rule, part of the President’s blueprint to lower drug prices and increase transparency, was scheduled to take effect this month.
“Neither the Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The Rule is therefore invalid,” District Judge Amit P. Mehta wrote in his July 8 ruling.
“No matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance,” Mehta continued.
Amgen, Merck, Eli Lilly and the Association of National Advertisers sued the Trump administration in June to invalidate the HHS rule that would have required the manufacturers of all prescription drugs covered by Medicare or Medicaid that had a list price — also known as the Wholesale Acquisition Cost — equal to or greater than $35 for a month’s supply or for the usual course of therapy to include that price in TV ads.
Neither Trump nor HHS had commented on the district judge’s ruling prior to this story’s posting.
A district judge recently nixed the HHS rule that certain drugs prices be included in TV ads, saying HHS overstepped its authority in issuing such a requirement. The rule, part of the President’s blueprint to lower drug prices and increase transparency, was scheduled to take effect this month.
The AMA, which said it had called for similar regulations before they were announced by the Trump administration, explained why the drug prices should be included in the ads.
“If permitted, this small dose of transparency will help patients have a more complete picture when faced with prescription drug ads. While current ads outline the potential benefits and side effects, a crucial factor for patients — the drug’s price — is not included. Patients, especially those who pay a drug’s list price or whose cost-sharing is based on the list price, would benefit by having another tool in their toolbox as they work with their physicians to determine their prescription drug regimens,” Patrice A. Harris, MD, AMA president, said in a statement.
Neither Trump nor HHS had commented on the district judge’s ruling prior to this story’s posting. The ACP and the American Academy of Family Physicians had also not publicly reacted to the decision, but Healio Primary Care had previously reported how these societies had thought the final rule was a step in the right direction to lower drug costs. – by Janel Miller
Reference : A copy of the district judge’s decision can be found at: https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2019cv1738-32
Disclosures: Healio Primary Care was unable to determine Mehta’s relevant financial disclosures prior to publication.
Editor's Note: This story has been updated to include new comments from AMA.