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The Courts

August 31, 2015 | Daily News

A federal circuit court judge agreed Monday (Aug. 31) to give Amarin Pharma Inc. and FDA until the end of October to come up with a settlement in a high-profile case that gave the manufacturer wide latitude to promote its triglyceride-lowering drug Vascepa off-label.

August 28, 2015 | Daily News

Lawyers on both sides of U.S. House of Representatives v. Burwell are sparring over whether federal district court Judge Rosemary Collyer should grant a motion to strike what the plaintiffs believe was an “unauthorized” response from defendants to their notice of new supplemental authority filed June 30.

August 18, 2015 | Daily News

The Pharmaceutical Care Management Association, which represents pharmacy benefit managers, is suing Arkansas in a bid to stop implementation of a law the group says would guarantee pharmacies make a profit on every generic drug they dispense.

August 14, 2015 | Daily News

Public Citizen worries that a federal district court judge's ruling last week allowing Amarin Pharma Inc. to promote its triglyceride-lowering drug Vascepa off-label will undermine FDA's regulatory authority to ensure the safety and efficacy of prescription drugs.

August 07, 2015 | Daily News

A federal district court judge ruled Friday (Aug. 7) in a closely watched off-label promotion case that Amarin Pharma Inc. can promote its drug Vascepa to health care professionals for off-label uses as long as the drug maker's statements are truthful and non-misleading.

July 08, 2015 | Daily News

NEW YORK -- U.S. District Court Judge Paul Engelmayer prodded Amarin Pharma, Inc. and FDA Tuesday (June 7) to come to terms on disclaimer language the pharmaceutical company can use if it wants to share information with doctors on off-label use of its Vascepa product, but the parties didn't budge as he heard oral arguments in Amarin’s request for a preliminary injunction shielding the company from criminal prosecution in its suit filed against the agency in May.

July 07, 2015 | Daily News

Several health and employer benefit experts have varying opinions on whether the Supreme Court decision that essentially seals the public exchanges -- and accompanying subsidies -- into the fabric of the health care systems for the foreseeable future will result in more employers opting to push workers to those exchanges.

June 26, 2015 | Daily News

The U.S. Supreme Court's decision to uphold the Obama administration's equal treatment of the Affordable Care Act's health insurance subsidies could open the door for new forms of exchanges that fall somewhere along the federal-state spectrum, according to one health care expert.

June 25, 2015 | Daily News

Legal experts are surprised by the U.S. Supreme Court's decision to avoid calling on "Chevron deference" as the test of whether Affordable Care Act tax credits are allowed in states that use the federal exchange, a move that would have created a narrower ruling and let future administrations interpret the law as they saw fit.

June 25, 2015 | Daily News

Although the U.S. Supreme Court's decision to uphold Obamacare subsidies likely averts a major GOP overhaul of the health care system, it increases the likelihood that Congress will pass a slew of bipartisan health care bills, such as the House 21st Century Cures legislation and other smaller bills, most of which affect Medicare and Medicaid, that the House Ways & Means and Senate Finance committees recently passed or are writing, health care lobbyists and consultants say.

June 25, 2015 | Daily News

Several stakeholders from all sides are pointing to various fixes to the Affordable Care Act that they still see as priorities despite the U.S. Supreme Court's decision to uphold the law's subsidies, with businesses and unions stressing a need for action on the controversial Cadillac tax and several other provisions, including easing reporting requirements and repealing the charge on private businesses used to fund the transitional reinsurance pool.

June 25, 2015 | Daily News

The president celebrated while also offering to work across the aisle on Affordable Care Act improvements, Republicans vowed to continue the repeal effort -- without a clear path forward -- and ACA supporters heaved a collective sigh of relief after the U.S. Supreme Court ruled 6-3 in favor of the administration that nearly 7 million Healthcare.gov enrollees in 34 states can keep their health insurance premium subsidies under the law as it is written.

June 25, 2015 | Daily News

The Supreme Court's decision upholding subsidies for millions of Americans maintains the status quo in the health sector, which is ultimately positive for issuers and hospitals, but will not hugely impact ratings for those sectors, several analysts, including Standard & Poor's and Fitch Ratings say.

June 22, 2015 | Daily News

The U.S. Supreme Court will hand down more decisions on Thursday and Friday this week, its website said Monday afternoon (June 22).

June 17, 2015 | Daily News

Six former HHS officials, including former Secretary Michael Leavitt, in a white paper anticipating possible rulings in the high-profile King case, said the U.S. Supreme Court potentially could side with the petitioners while demanding Congress propose a solution due to the “uniformity clause” that taxes be applied equally across the country.

June 17, 2015 | Daily News

Stakeholders on all sides of Obamacare floated post-King options this week as they braced for a highly anticipated U.S. Supreme Court ruling on whether subsidies should be pulled from federally facilitated exchanges.

June 12, 2015 | Daily News

Advocates for older Americans who are not yet eligible for Medicare say the 50- to 64-year-old population is often forgotten in the panic around King v. Burwell, though the pre-Medicare group is one that would suffer the most if the U.S. Supreme Court rules against the administration.

June 12, 2015 | Daily News

Bills that would make the small group expansion a state decision could be part of a package of tweaks to the Affordable Care Act, possibly used as a bargaining chip if the U.S. Supreme Court rules against the administration in King v. Burwell, a key stakeholder said.

June 12, 2015 | Daily News

The Goldwater Institute filed a lawsuit against FDA Tuesday (June 9) for denying its Freedom of Information Act request seeking information on the process used by the agency to authorize use of an experimental drug to treat Americans with Ebola.

June 10, 2015 | Daily News

House Ways & Means Republicans on Wednesday (June 10) pressed HHS Secretary Sylvia Burwell on whether the administration would be willing to work with Congress should the Supreme Court strike subsidies for residents in states with federally run exchanges or would only support a quick, one-line fix as suggested by the president earlier this week.