Administrative Agency Constitutional Law Communications & Media

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Two Additional Challenges to the FCC’s July 2015 Declaratory Ruling and Order

As anticipated, additional parties continue to join the consolidated appeal of the FCC’s July 10, 2015 Declaratory Ruling and Order. On August 26, 2015, inc. and its wholly-owned subsidiary ExactTarget, Inc....more

Another One Bites the Dust: FDA Doesn’t Like the Fishy Smell of the Latest Court Decision on Off-Label Dissemination

In the most recent court decision, Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. August 5, 2015), a U.S. District Court granted Amarin's preliminary injunction to...more

First Amendment Protects Truthful Off-Label Speech by Drug Manufacturers

Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more

What Comes Next In Amarin Pharm v. FDA?

The Southern District of New York’s preliminary injunction in Amarin Pharm, Inc. v. FDA—prohibiting the FDA from taking action against Amarin over truthful, non-misleading “off-label” statements about its prescription drug...more

Amarin Wins Truthful Off-Label Speech Challenge

On August 7, Citing the First Amendment, a Southern District of New York court ruled that FDA cannot limit a manufacturer’s “truthful and non-misleading speech promoting off-label use” of a drug and evaluated specific...more

FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it...more

Blog: Case to Watch: Amarin Pharma v. FDA

A potentially significant case being watched by the pharmaceutical industry is Amarin Pharma, et al., v. U.S. Food and Drug Administration, et al., Civ. A. 15-cv-3588 (S.D.N.Y.). The complaint, filed in May 2015, is a “First...more

Food and Beverage News and Trends

KIND LLC faces challenges from FDA on its labeling claims. KIND LLC, a New York-based natural foods company, says it is working closely with the FDA to address issues raised by the agency in a warning letter over label...more

NLRB determines vulgar Facebook posts protected concerted activity

The National Labor Relations Board (NLRB) determined that Pier Sixty LLC, a New York catering service, violated federal labor law by firing an employee server after he posted a Facebook message protesting supervisory abuse...more

Powers of Regulators Brought Into the Spotlight by High Court Decision - Australian Communications and Media Authority v Today FM...

Recently the High Court of Australia handed down its unanimous decision in Australian Communications and Media Authority v Today FM (Sydney) Pty Ltd [2015] HCA 7 (HCA Decision) which relates to the powers of the Australian...more

FCC Should Use Scalpel, Not Ax to Preempt State Laws Limiting Muni-Broadband

On Feb. 26, the FCC plans to act to preempt state laws that retard development of municipally owned broadband networks. The breadth of the potential preemption is unclear. The decision will occur at the same meeting at which...more

Food and Beverage News and Trends

New group emerges to oppose sale of GMO foods nationwide. A new nonprofit organization, U.S. Right to Know, seeks to publicize alleged harms of GMO food and to require disclosure by manufacturers of such ingredients....more

What’s Next for the FDA’s Draft Social Media Guidances?

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more

Food and Beverage News and Trends

Vermont AG defends the state’s GMO statute. On August 8, the Vermont attorney general filed a motion to dismiss a case brought by food trade groups against the state’s newly enacted statute requiring GMO foods be...more

UPDATE: D.C. Circuit Clarifies Standard for Required Factual Disclosures

The D.C. Circuit issued its en banc opinion in American Meat Institute v. U.S. Department of Agriculture. The Court agreed with the panel's decision and specifically held that the test for assessing government mandates...more

FDA Issues Distribution of Risk Information Draft Guidance Amid Asserted Push to Release Guidance on Manufacturer Communications

The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more

FDA Issues Draft Guidance Relating to Distribution of New Risk Information for Approved Drugs and Biologics and Grants Two Citizen...

On June 6, 2014, the Food and Drug Administration (“FDA”) issued two documents that reflect the agency’s ongoing effort to clarify its regulatory approach regarding manufacturer communication of scientific and medical...more

MoFo New York Tax Insights - Volume 5, Issue 4 - April 2014

In This Issue: City ALJ Holds First Amendment Requires Exercise of Discretionary Authority for Sourcing Receipts from Providing Credit Ratings; Tribunal Affirms Partial Day Count for Statutory Residency Purposes; ALJ...more

MoFo New York Tax Insights - Volume 5, Issue 4 - April 2014

In This Issue: City ALJ Holds First Amendment Requires Exercise of Discretionary Authority for Sourcing Receipts from Providing Credit Ratings; Tribunal Affirms Partial Day Count for Statutory Residency Purposes; ALJ...more

Food Litigation Newsletter - January 23, 2014

In This Issue: - Recent Significant Developments and Rulings ..Court Denies Class Certification in Class Action Suit Against Ben & Jerry’s ..FDA Declines to Revise Policy on “Natural” Food Labels ..Court...more

FDA Refuses to Settle “All Natural” Debate

The U.S. Food and Drug Administration (FDA) has officially refused requests from several courts (discussed here and here) for a determination of whether and under what circumstances food products containing genetically...more

Fenwick Employment Brief - September 2013: EEOC Sued for Unauthorized Mass Solicitation E-mail to Company Employees

After sending 1,330 e-mails to employees of Case New Holland, Inc. and its affiliates in an alleged effort to solicit plaintiffs to commence a class action lawsuit, the federal EEOC found itself on the receiving end of a...more

Spirit Airlines v. U.S. Dep’t of Transportation

Brief Of Amici Curiae CATO Institute And The National Federation Of Independent Business Small Business Legal Center In Support...

It is axiomatic that the freedom of speech is vitally important to our democratic society and that being able to criticize the government is at the core of this freedom. Yet government officials are constantly inventing new...more

Court of Appeals Rules Employee Efforts To Take Over Editorial Control At Newspaper Unprotected By NLRA

An issue we have discussed previously is whether all employee action that is “concerted” is also protected by the NLRA. We have seen that maliciously false statements made to third parties are unprotected. But what about when...more

Court’s Ruling about Off-Label Drug Promotion Defies Reason

Last week a federal appeals court made a ruling that chips away at a fundamental aspect of the FDA's gatekeeping function with new drugs. The court tossed a conviction of a drug sales representative who was promoting drugs...more

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