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The Courts

Friday, 23 June 2017

Democrats would likely use the Supreme Court ruling against mandatory Medicaid expansion to fight federal Medicaid funding caps, a former Senate Republican staffer said, but legal scholars doubt that suit would be a good precedent to use against the caps should the GOP health reform legislation be enacted.

Monday, 19 June 2017

The U.S. Supreme Court agreed last week take up a case that will determine the constitutionality of the patent office’s inter partes review process -- an administrative procedure for challenging patents that some drug industry stakeholders have said undermines the drug pipeline and unfairly uses a lower standard for reviewing patents than that used by a district court.

Monday, 19 June 2017

In the wake of the U.S. Supreme Court's reversal of a lower court decision on patent exhaustion, which some see as partially clearing the way for drug importation, legal experts argue that the pharmaceutical industry will now turn to contract disputes over licensing to fight importation.

Tuesday, 13 June 2017

Amgen's pediatric exclusivity lawsuit against FDA was stayed after the agency agreed to reconsider its May 22 decision not to grant pediatric exclusivity to Amgen's Sensipar, a drug to treat secondary hyperparathyroidism.

Monday, 12 June 2017

NEW YORK --The Supreme Court’s decision to punt on whether the so-called biosimilar patent dance is mandatory in the highly-watched Amgen v. Sandoz case leaves the state of play filled with “uncertainty and gamesmanship,” but companies are still likely to follow the patent dance process, an attorney who represents innovator biologic companies said Monday (July 12).

Monday, 12 June 2017

The U.S. Supreme Court on Monday (June 12) issued a biosimilar-friendly ruling in the high-profile Amgen v Sandoz case involving key policies surrounding the biosimilar pathway, but one justice opined that FDA potentially could still depart from the court's interpretation as it gains more experience with the law.

Wednesday, 07 June 2017

The Center for Science in the Public Interest and the National Consumers League sued FDA Wednesday (June 7) for delaying implementation of the menu labeling rule, saying the agency's move was illegal because there was no prior notice or opportunity for stakeholder comment.

Monday, 05 June 2017

The White House Office of Management and Budget finished its review of a proposed rule to revise the contentious provision banning pre-dispute arbitration agreements for long-term care facilities Friday (June 2), coming after OMB officials met with a number of beneficiary advocacy groups last month.

Friday, 02 June 2017

FDA is being sued by a journalist for refusing to hand over documents surrounding the approval of Sarepta Therapeutics' Duchenne muscular dystrophy drug, Exondys 51, and FDA's justification for withholding the information -- that there is no “urgency to inform the public” -- comes just weeks after the agency's chief counsel publicly said FDA will increasingly face issues similar to those surrounding the controversial DMD drug approval.

Thursday, 01 June 2017

Women's advocates warn the Trump administration to be prepared for a court battle should it move forward with a draft interim final rule under review by the White House that would make it easier for employers to opt out of the Affordable Care Act's requirement to provide cost-free coverage of FDA-approved contraceptives.

Tuesday, 30 May 2017

Just one day after an FDA advisory panel urged approval of Hospira's epoetin alfa biosimilar, innovator Amgen took to the courts in an attempt to block the biosimilar from coming to market until Hospira has complied with the biosimilar pathway's notice of commercial marketing provisions.

Monday, 22 May 2017

An HHS official said the administration continues to weigh options on future payment of the Affordable Care Act's cost-sharing reductions -- even as it has agreed to continue to hold a related court case in abeyance rather than end the payments -- and suggested the issue could be resolved by passing the GOP's health care bill and reforming “Obamacare's failed funding structure.”

Monday, 22 May 2017

The Trump administration's decision to once again request a federal court put on hold the high-profile case over the Affordable Care Act's cost-sharing reductions defused an immediate threat to the payments that are viewed as key to insurers in the exchanges, but insurers say congressional action is still needed to ensure market stability.

Monday, 22 May 2017

A coalition of groups including the Center for Food Safety sued FDA Monday (May 22) in an attempt to block the voluntary generally recognized as safe (GRAS) notification system created by the agency's August 2016 final rule, which the plaintiffs say violates both the Administrative Procedure Act and the Food, Drug and Cosmetic Act, and is unconstitutional because it forecloses judicial review of GRAS determinations.

Thursday, 18 May 2017

Democratic attorneys general from more than a dozen states on Thursday asked to intervene in support of the Affordable Care Act's embattled cost-sharing reduction payments in a federal case brought by House Republicans challenging the prior administration's payment of the subsidies.

Thursday, 11 May 2017

Tucked into the FDA user fee package that cleared the Senate health committee Thursday (May 11) are technical changes to orphan drug law that one legal expert says would bolster the agency's legal stance in both current and past litigation, and effectively unravel a case that FDA lost.

Friday, 05 May 2017

Anthem is asking the Supreme Court to review a federal appeals court's decision to block the company's merger with Cigna, pointing to the dissent from one of the appeals court judges.

Monday, 01 May 2017

The White House Office of Management and Budget is reviewing a CMS proposed rule to revise a highly contentious provision on arbitration contracts that was included in updated requirements for long-term care facilities -- mainly nursing homes -- to participate in Medicare.

Friday, 28 April 2017

A federal appeals court upheld the D.C. District Court's decision to block the merger between Anthem and Cigna -- a move praised by the American Medical Association and the New York Attorney General.

Wednesday, 26 April 2017

During Wednesday (April 26)'s oral arguments in a highly watched U.S. Supreme Court case, a key government attorney shot down an idea from Supreme Court Associate Justice Stephen Breyer that FDA should weigh in through notice-and-comment rulemaking on how to interpret the biosimilar pathway before the court interprets the statute, given the complexity of the topic.