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FDAnews Drug Daily Bulletin

HHS Delays 340B Rule Again, Indicates It May Drop It Per Trump Order

Oct. 9, 2017

HHS has once again pushed back the effective date of its final rule that would institute fines for drugmakers who overcharge for products covered by a hospital discount program.

The agency also sent strong signals that it may abandon the rule altogether to comply with the Trump administration’s directive to soften the economic impact of the Affordable Care Act.

In a notice published Sept. 29 in the Federal Register, the day before the regulation was to take effect, HHS said it is postponing the rule for the 340B discount program to July 1, 2018.

The agency published the final rule in the waning days of the Obama administration, with an original effective date of March 6. Under the new administration, the agency delayed the rule to March 21, then to April 1 and then to Oct. 1.

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