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PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA v. UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES et al
Case Number:
1:13-cv-01501
Court:
Nature of Suit:
Administrative Procedure Act/Review or Appeal of Agency Decision
Judge:
Firms
Companies
Government Agencies
Sectors & Industries:
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August 27, 2014
PhRMA Must Restart Suit Over 340B Orphan Drug Rule
A Washington, D.C., federal judge on Wednesday rejected requests from Pharmaceutical Research and Manufacturers of America to invalidate a new interpretive rule involving so-called orphan drugs in the 340B drug discount program, saying the trade group must bring a new lawsuit to proceed.
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July 21, 2014
HHS Formalizes 340B Policy As Court Fight Continues
The U.S. Department of Health and Human Services on Monday released a new regulation requiring drugmakers to discount so-called orphan drugs when hospitals use them for conditions that aren't rare, hoping to skirt a recent court decision that called the 340B program policy into question.
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June 16, 2014
HHS May Dig In Heels On 340B Orphan Drug Rule
The U.S. Department of Health and Human Services on Thursday said it's looking for ways around a significant D.C. federal court defeat that restricted its ability to require drug discounts in the controversial 340B program.
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May 27, 2014
Pharma Group Beats Orphan Drug Discount Rule In 340B Fight
A D.C. federal judge voided a new requirement that drugmakers offer discounts when hospitals in the 340B drug discount program use orphan medications to treat relatively common conditions, saying Friday that federal regulators had a worthy goal but no authority for such policymaking.
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October 01, 2013
Pharma Trade Group Seeks To Stop HHS Orphan Drug Rule
A pharmaceutical trade group on Monday urged a Washington federal judge to block the U.S. Department of Health and Human Services from implementing a final rule that details how hospitals participating in the 340B drug-discount program can acquire so-called orphan drugs for cheaper prices.