Administrative Agency Constitutional Law Communications & Media

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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As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest.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

Second Circuit Holds that Criminal Penalties for Pharmaceutical Sales Representative’s Off-Label Promotion Violate the First...

On December 3, 2012, the United States Court of Appeals for the Second Circuit issued an opinion that stands to transform the regulatory landscape in which pharmaceutical and medical device companies operate. In recent...more

Second Circuit Holds Food, Drug and Cosmetic Act Does Not Prohibit Off-Label Promotion

In a significant blow to the U.S. government’s enforcement efforts against the pharmaceutical industry, a panel of the Second Circuit overturned the conviction of a pharmaceutical sales representative for conspiracy to...more

Domain Names and the First Amendment: The Latest Word

The intersection of domain names and the First Amendment is not new. Indeed, in the early days of the domain name system, courts considered the issue of whether a domain name registrar could prohibit the registration of...more

CBb 22 juni 2012, CR 2012/187 (SURFnet/OPTA) m.nt. P.M. Waszink en H.P. Wiersema

Uitspraak van het CBB in beroep en in hoger beroep. SURFnet is geen aanbieder van een openbaar elektronisch communicatienetwerk of een openbare elektronische communicatiedienst. Of sprake is van het aanbieden van een openbaar...more

POM Loses a Round in Its Advertising Dispute With FTC, But Battle Continues

POM Wonderful LLC recently received a setback in its longstanding dispute with the Federal Trade Commission. On Sept. 30, 2012, U.S. District Judge Richard Roberts in the District of Columbia dismissed the juice maker’s...more

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