PHARMACEUTICAL RESEARCH AND MANUFACTURERS OF AMERICA v. UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES et al

  1. October 14, 2015

    340B Orphan Drug Discounts Dialed Back

    The Affordable Care Act fully exempts orphan drugs from mandatory discounts under the 340B program for certain health care providers, a D.C. federal judge said Wednesday in an important victory for trade group Pharmaceutical Research and Manufacturers of America.

  2. July 06, 2015

    Life Sciences Cases To Watch In The 2nd Half Of 2015

    The pharmaceutical industry is poised for important court developments involving off-label marketing, biosimilars exclusivity, False Claims Act liability and the 340B drug-discount program. Here are four cases that attorneys will be tracking closely in the second half of 2015.

  3. July 02, 2015

    Health Cases To Watch In The 2nd Half Of 2015

    The second half of 2015 is shaping up as a potential litigation blockbuster for health care providers, as major developments loom in cases involving the False Claims Act, the future of crucial Affordable Care Act funding and the 340B drug-discount program. Here are six cases that attorneys will be watching closely.

  4. April 14, 2015

    PhRMA Presses Case For Dumping 340B Orphan Drug Rule

    Pharmaceutical Research and Manufacturers of America is once again pushing a D.C. federal court to nix a U.S. Department of Health and Human Services interpretative rule on discounts for orphan drugs under the 340B program, arguing that the rule has legally binding consequences that are ripe for judicial review.

  5. March 23, 2015

    HHS Fights Court Review In 340B Orphan Drug Row

    The U.S. Department of Health and Human Services is fighting to block court review of its policy on discounts for orphan drugs in the 340B program, telling a D.C. federal judge that judicial scrutiny is inappropriate because the policy isn't binding.

  6. February 26, 2015

    PhRMA Seeks Quick Win In 340B Orphan Drug Suit

    Pharmaceutical Research and Manufacturers of America on Wednesday urged a D.C. federal judge to ax a regulation involving discounts for orphan drugs, setting the stage for an important decision on the 340B program's future.

  7. January 28, 2015

    HHS Asks DC Court To Nix PhRMA's 340B Orphan Drug Suit

    The U.S. Department of Health and Human Services asked a D.C. federal court Tuesday to toss Pharmaceutical Research and Manufacturers of America's complaint challenging a department rule on discounting so-called orphan drugs in the 340B program, saying the interpretive rule wasn't subject to the court's review.

  8. October 09, 2014

    PhRMA Launches New Suit Over 340B Orphan Drug Rule

    Reviving a high-stakes fight, Pharmaceutical Research and Manufacturers of America on Thursday sued the U.S. Department of Health and Human Services in D.C. federal court to prevent regulators from disciplining drugmakers that sometimes withhold discounts on so-called orphan drugs in the 340B program.