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September 15, 2023

Washington Roundup

On Tuesday September 12, the House of Representatives joined the Senate in returning to Committee business and floor voting following the August recess. The new federal fiscal year begins on October 1, 2023. 

Per the American Hospital Association,

“The Food and Drug Administration’s independent Nonprescription Drugs Advisory Committee Sept. 12, by unanimous vote, declared oral phenylephrine ineffective as a decongestant. Phenylephrine is a common active ingredient in over-the-counter medications sold under the Nyquil, Tylenol, Advil, Robitussin, Sudafed and Benadryl brands, to name a few. FDA is not bound to the committee’s recommendations, but the agency’s own analysis presented prior to the panel’s meeting concluded that oral phenylephrine formulations are safe but ineffective at standard or even higher doses. The vote paves the way for products containing oral phenylephrine potentially being pulled from shelves until reformulated versions are offered.”

Beckers Hospital Review informs us,

  • “CMS fined two more hospitals for alleged price transparency violations Sept. 5, marking the third consecutive month the agency has levied fines on noncompliant hospitals.   
  • “According to CMS’ price transparency website:
    • Washington, D.C.-based Saint Elizabeths Hospital was fined $677,440. 
    • Silver Spring, Md.-based Holy Cross Hospital was fined $325,710.
    • Additionally, CMS’ Sept. 8 update of its price transparency website included information of another hospital fined Aug. 22 that was not previously uploaded to the site. Doctors’ Center Hospital Bayamón (Puerto Rico) was fined $102,200.
  • The hospitals have 30 days from the issuance date to appeal the fines. 
  • CMS has now fined 14 hospitals for price transparency violations. To date, three hospitals have appealed their penalties and are under review, according to CMS.” 

Roll Call tells us,

  • “During the same week that naloxone — a nasal spray that reverses opioid overdoses — became available for purchase without a prescription, the nation’s top substance use officials called for greater availability and training for the drug, with five federal officials receiving training to administer it during a public demonstration at Health and Human Services headquarters Friday. 
  • * * * “While the Food and Drug Administration initially approved naloxone in 1971 as an injectable drug used in medical settings, it wasn’t until 2015 that the FDA approved a nasal spray version for prescription use. But the agency only approved the first over-the-counter versions of the drug this year. It became available without prescription this week, with Emergent BioSolutions’ 4 mg nasal spray selling for $44.99 for a two-dose product. Harm Reduction Therapeutics’s RiVive, is expected to become available in eBloomarly 2024.
  • “The price point has been a concern for some advocates who worry it could limit accessibility and use. In an interview, Rahul Gupta, director of the White House Office of National Drug Control Policy, said the administration is working to bring the price point down as part of a larger effort to reduce healthcare costs.
  • “We’re constantly working with manufacturers because we’ve got to make this accessible and affordable. So we’re on this, and we’re exploring every pathway working with HHS and our other government partners as well,” he said.