BREAKING: More than Half of the U.S. House Asks Azar to Address Drug Makers’ 340B Actions Immediately

Your 340B Report for Monday Sept. 14, 2020

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More than Half of the U.S. House Asks Azar to Address Drug Makers’ 340B Actions Immediately

More than half of the U.S. House today told U.S. Health and Human Services (HHS) Secretary Alex Azar “it is imperative that immediate action is taken to ensure covered entities continue to receive crucial 340B drug discounts.”

The bipartisan Sept. 14 letter was spearheaded by Reps. David McKinley (R-W.Va), Diana DeGette (D-Colo.), Greg Gianforte (R-Mont.), Peter Welch (D-Vt.), Dusty Johnson (R-S.D.), and Doris Matsui (D-Calif.) 340B Report will provide the tally of signers by party affiliation tomorrow.

Recent drug manufacturer actions to restrict federally required 340B drug discounts undermine the 340B program’s intended purpose, the 243 representatives said. HHS “must take immediate action to stop these companies from either denying or limiting access to 340B pricing to hospitals, health centers, and clinics participating in 340B,” they said.

The bipartisan letter is a powerful political rebuke of five drug manufacturers’ recent crackdown on 340B contract pharmacy. Manufacturers Eli Lilly and AstraZeneca have decided to stop providing reduced 340B pricing to contract pharmacies. Sanofi and Novartis are forcing covered entities to submit claims data to keep getting 340B pricing at their contract pharmacies. Merck says entities that don’t provide the data could face unspecified adverse actions. Other manufacturers, meanwhile, are soon expected to announce they will provide 340B pricing in the form of rebates, not discounts.

Health centers and other 340B providers and organizations are considering filing lawsuits in response to the manufacturers’ actions.

Manufacturers’ restrictions on 340B pricing “based on where the safety-net provider elects to have its 340B drugs shipped” violate the 340B statute and “establish a dangerous precedent for other manufacturers to follow,” the lawmakers said. Manufacturers’ demands for “extensive” claims data, they added, go “far beyond the scope of the 340B statute,” burden covered entities needlessly, and raise patient privacy issues.

“The actions of these companies violate the 340B statute and must be rejected,” the representatives wrote. “A failure to act will serve as an invitation to other manufacturers to follow suit, leading to a wholesale increase in prescription drug costs for our safety-net providers during a public health emergency. We urge you to use your authority to address these troubling actions and require these companies to comply with the law.”

Today’s bipartisan letter increases pressure on Azar to do something to stop the drug makers. The letter comes less than two weeks after House Democratic leaders of the House Energy & Commerce Committee made a similar request.  Considering this letter has Republican signatures, it may hold more weight with the Trump administration. The U.S. Health Resources and Services Administration (HRSA) told 340B Report earlier this month it is considering whether manufacturers have violated the 340B statute and whether sanctions may apply.

Last week, more than 1,100 hospitals and health systems wrote to Azar protesting the manufacturers’ actions.

“Drug manufacturers are flouting their statutory obligations by restricting access to safe, affordable medications for low-income Americans who also are among those most affected by COVID-19,” said Bruce Siegel, President and CEO of America’s Essential Hospitals. “We thank the nearly 250 House members led by Reps. McKinley, DeGette, Gianforte, Welch, Johnson, and Matsui for their swift action to urge the administration to stop big pharma’s ill-timed and illegal efforts to narrow the 340B program.”

Correction: The Sept. 14 email and web versions of this article incorrectly stated that 245 members of the U.S. House signed the letter. The actual total was 243.


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