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The Courts

December 14, 2015 | Daily News

The brand-name drug lobby comes out strong in defense of Pacira Pharmaceuticals in a closely watched lawsuit challenging FDA's off-label policies, contending in an amicus brief that the agency is attempting to narrow the indication of an approved drug without going through the required regulatory process.

December 14, 2015 | Daily News

The federal district court in southern Florida ordered Apotex to provide Amgen with a 180-day notice of the first commercial marketing of its pegfilgrastim biosimilar if the product is approved, saying the notice is mandatory for all applicants regardless of whether they participated in the patent exchange provisions of the biosimilar pathway.

December 04, 2015 | Daily News

A coalition of drug and medical device makers has weighed in on the side of Pacira Pharmaceuticals in a high-profile lawsuit challenging FDA's off-label policies, arguing in an amicus brief that the agency's vague regulatory and enforcement policies on off-label communication chills constitutionally protected speech.

November 18, 2015 | Daily News

The White House Office of Management and Budget recently began reviewing a CMS notice on inpatient hospital cuts that the agency says is a response to the American Hospital Association's lawsuit over reimbursement cuts associated with the two-midnight hospital admissions policy.

November 11, 2015 | Daily News

Facing pressure from Congress and a series of competing citizen petitions, FDA is seeking public input on whether it should define the term “natural” for use on food product labels, and, if so, how to do so.

November 06, 2015 | Daily News

The Supreme Court on Friday (Nov. 6) agreed to review a consolidated version of seven similar cases from across the country, including Little Sisters of the Poor V. Burwell, that claim the administration’s accommodation allowing certain institutions an exemption from the Affordable Care Act requirements to provide contraceptives at no cost to the enrollees is overly burdensome and violates religious freedom.

November 06, 2015 | Daily News

Industry attorneys expect either Amgen or Sandoz to appeal the fractured Federal Circuit's decision concerning the biosimilar pathway's patent and marketing requirements to the Supreme Court, with one attorney saying there is "simply too much at stake here for the budding biosimilar industry."

October 30, 2015 | Daily News

Amarin Pharma Inc. and FDA asked a federal judge Friday (Oct. 30) to give them more time to reach a settlement in the off-label promotion case filed by the drug maker against the agency. In a filing with the Federal District Court for the Southern District of New York, an attorney for Amarin asked the judge to extend a stay in the case until Dec. 17.

October 30, 2015 | Daily News

FDA recently pulled from its website an off-label promotion warning letter to Pacira Pharmaceuticals Inc. that was the basis of a lawsuit against the agency, as court records indicate the two are working towards a settlement in the case filed by the company in September.

October 29, 2015 | Daily News

In the wake of a Supreme Court ruling earlier this year that providers cannot sue states over inadequate Medicaid pay rates, CMS on Thursday (Oct. 29) finalized a long-awaited rule from 2011 laying out requirements for states to provide information that would help CMS ensure changes to provider pay rates don't hurt beneficiaries' access to care.

October 23, 2015 | Daily News

Industry attorneys are heralding a recent step by FDA to quietly change the intended use regulation as a small but meaningful and long overdue action.

October 22, 2015 | Daily News

Texas, Kansas, and Louisiana are suing the federal government over an Obamacare health insurer fee levied against companies that manage state Medicaid and CHIP programs.

October 19, 2015 | Daily News

A federal judge on Monday (Oct. 19) rejected the Obama administration's request for an immediate appeal of the court's Sept. 9 decision that the House has standing to proceed with its lawsuit charging the administration illegally spent money on the Affordable Care Act's cost-sharing reduction, or CSR, program.

October 16, 2015 | Daily News

The Federal Circuit appeals court shot down requests by Amgen and Sandoz for the full court to hear a high-profile biosimilars case on the Biologic Price Competition and Innovation Act's patent dance provisions.

October 09, 2015 | Daily News

The Center for Science in the Public Interest sued FDA Thursday (Oct. 9) demanding the agency respond to the group's 2005 citizen petition calling for stricter controls over salt levels in food.

September 23, 2015 | Daily News

A federal district court has given HHS until Oct. 1 to meet with hospitals to come up with a time table to re-issue a Medicare rule that contained a controversial two-midnights hospital inpatient admissions policy in order to give hospitals more opportunity to comment, according to the American Hospital Association.

September 11, 2015 | Daily News

A number of industry stakeholders have filed briefs weighing in on appeals by Amgen and Sandoz for an en banc federal appeals court hearing of their litigation concerning the biosimilar pathway, with many fellow biosimilar companies siding with Sandoz in its push for a reversal of the court's ruling that the law's 180-day marketing notice is only effective after licensure.

September 09, 2015 | Daily News

The U.S. House of Representatives' lawsuit claiming the Obama administration illegally disbursed cost-sharing reduction payments to health insurers without congressional approval can go forward, a federal district court ruled in House v. Burwell on Wednesday (Sept. 9).

September 09, 2015 | Daily News

Pacira Pharmaceuticals Inc. filed suit against FDA in federal district court Tuesday (Sept. 8) alleging the agency has violated the Administrative Procedure Act, its own guidance and the First and Fifth Amendments by not allowing the company to promote its post-surgical analgesia product Exparel for its approved indications.

August 31, 2015 | Daily News

Sandoz pushed back against Amgen's “emergency motion” to block the biosimilar sponsor from bringing its filgrastim product Zarxio to market on Sept. 3, saying in court documents Monday (Aug. 31) that a further marketing delay would cause cancer patients significant harm.