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After a defeat in federal court, the Department of Health and Human Services withdrew an advisory opinion which said drug makers participating in a controversial federal program must offer discounts through pharmacies that contract with hospitals serving low-income patients.

However, HHS simultaneously maintained the move does not have any bearing on a separate set of “violation” letters sent last month to six drug makers, which could face fines for failing to offer discounts through the 340B drug discount program for safety-net hospitals and clinics. The agency said the letters should be viewed as distinct from the opinion and that enforcement action can be pursued.


As a result, the HHS withdrawal appears to have done little to resolve a simmering dispute between drug makers and hospitals over a growing portion of medicines that are sold in the U.S. through the program.

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