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The Courts

October 18, 2017 | Daily News

A coalition of Democratic attorneys general are seeking a temporary restraining order that would force the administration to continue paying out the cost-sharing reduction payments, arguing the coalition is likely to succeed on the merits of their case and failure to take action would cause irreparable harm to residents.

October 17, 2017 | Daily News

The American Civil Liberties Union (ACLU) Foundation and ACLU of Hawaii Foundation, representing a medical professional and other health organizations, have sued HHS and FDA for what the plaintiffs say are inappropriate and unnecessary Risk Evaluation and Mitigation Strategies (REMS) restrictions on Danco Laboratories' Mifeprex -- also known as the “abortion pill” -- that limit patient access.

October 16, 2017 | Daily News

Watchdog group Democracy Forward sued the White House Office of Management and Budget for information on the role OMB Associate Director of Health Programs Joseph Grogan played in the delays of the Obama administration's 340B drug ceiling price and manufacturer penalty rule.

October 13, 2017 | Daily News

The suit that more than a dozen Democratic attorneys general filed Friday (Oct. 13) to block President Donald Trump from cutting off the Affordable Care Act's cost-sharing reduction payments argues that the law requires the government to pay those subsidies.

October 12, 2017 | Daily News

A federal circuit judge has reversed a lower court's recent controversial decision to order a biologic cholesterol medication to be taken off the market in response to a patent challenge.

October 11, 2017 | Daily News

Top pharmaceutical trade groups haven't yet said they will sue over California’s newly signed drug pricing law, but the generics trade group tells Inside Health Policy it is weighing its options.

October 11, 2017 | Daily News

While courts have struck down FDA's prohibition on off-label promotion based on First Amendment grounds, the agency has good standing to prohibit such actions when considering various canons of statutory construction, one law professor argues in a recently published University of Chicago Law Review article.

October 10, 2017 | Daily News

The Fourth Circuit has granted the Association for Accessible Medicines’ request to expedite appeal of a district court’s recent decision to strike down a constitutional challenge to Maryland’s first-in-the-nation generic drug price gouging law.

October 06, 2017 | Daily News

The ACLU on Friday (Oct. 6) immediately filed suit against the Trump administration for releasing interim final regulations that broaden the ability of employers to stop providing FDA-approved contraceptive coverage to workers without cost-sharing, and other groups are also exploring legal action.

September 29, 2017 | Daily News

A district court judge denied the generic drug lobby's request to block implementation of Maryland's first-in-the-nation generic drug price gouging law and dismissed a portion of the group's constitutional challenge.

September 21, 2017 | Daily News

Public Citizen sued FDA Thursday (Sept. 21) in an attempt to force the agency to take action on the advocacy group's citizen petition asking FDA to address what the group claims are life-threatening health risks with over-the-counter drugs containing benzocaine, such as infant teething products.

September 20, 2017 | Daily News

FDA is going against congressional intent and potentially running afoul of the law by quietly killing its earlier plans to implement portions of the Drug Quality and Security Act (DQSA), a drug industry attorney tells Inside Health Policy.

September 20, 2017 | Daily News

The CEO of leading compounder, Imprimis Pharmaceuticals, tells Inside Health Policy that despite allegations that it is running afoul of multiple federal laws, FDA is aware of the company's actions and almost all compounders are compounding ingredients that have not been greenlighted by FDA and face no enforcement action.

September 20, 2017 | Daily News

The United States government has once again sided with the biosimilar industry in the latest iteration of litigation surrounding the so-called patent-dance provisions of the Biologics Price Competition and Innovation Act -- arguing in a remanded portion of the highly watched Amgen v. Sandoz Supreme Court case that no additional remedies are available under state law for non-compliance with the patent dance.

September 19, 2017 | Daily News

The Center for Science in the Public Interest, National Consumers League and FDA agreed Friday (Sept. 15) to ask the United States District Court for the District of Columbia to stay the advocacy groups' menu labeling lawsuit, citing FDA Commissioner Scott Gottlieb's promise to issue new guidance on menu labeling by the end of the year and not alter the underlying rule as instrumental to reaching the agreement.

September 11, 2017 | Daily News

FDA Commissioner Scott Gottlieb hopes to bring the agency’s policies on commercial speech in line with recent industry-friendly legal precedents, the agency head signaled during a Monday (Sept. 11) speech at the 2017 RAPS Regulatory Convergence.

September 05, 2017 | Daily News

A federal district court last week agreed with the American College Of Emergency Physicians that a 2010 CMS regulation pertaining to out-of-network emergency physician payments did not adequately consider stakeholder concerns, and remanded the rule back to the administration.

August 31, 2017 | Daily News

Hoping to seize on a recent U.S. Supreme Court ruling upholding companies' ability to bring unfair competition cases based on false or misleading labeling of products regulated under the Food, Drug, and Cosmetic Act, Amarin Pharma has filed a lawsuit asking the International Trade Commission to block importation and essentially freeze U.S. inventory of certain synthetic omega-3 products being sold as dietary supplements.

August 28, 2017 | Daily News

Premera Blue Cross and LifeWise Health Plans of Washington and Oregon have entered the lawsuit fray to try to get full risk-corridor payments due from all three years of the Affordable Care Act program.

August 25, 2017 | Daily News

New York City on Friday (Aug. 25) settled a lawsuit brought by food industry groups over the cities' menu labeling law by agreeing to hold off enforcing the city's requirements until FDA's federal menu labeling rule kicks in May 2018.