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The FTC Pressures Press Interactions, Defies Commercial Speech Doctrine

On Tuesday, the FTC joined the Department of Justice and several other federal agencies in announcing numerous recent and ongoing actions against dietary supplement marketers. The FTC, in its discussions, highlighted a case...more

California Enacts Electronic Communication Privacy Statute, Connected Television Privacy Statute

The California legislature recently enacted the California Electronic Communications Privacy Act (“CalECPA”) (Senate Bill 178), which provides greater protections against governmental searches for persons’ electronic...more

Supreme Court denies cert in case involving cell location privacy rights

On July 31, 2015, Quartavious Davis petitioned for certiorari in Davis v. United States, No. 15-146 asking (1) whether the acquisition of a cell phone user’s location data from his cellular service provider constitutes a...more

California Gives the Fourth Amendment a 21st Century Makeover

The average American today generates more media than they did at any other point in history, and the ease with which our communications, photos, and videos are sent and stored digitally means most of us have more media stored...more

Risky times for some Internet lenders

A recent decision by the Minnesota Supreme Court serves as a painful reminder to Internet lenders of the perils of relying on choice-of-law provisions or arguments citing the Commerce Clause of the U.S. Constitution to avoid...more

Commerce Clause Does Not Prevent Minnesota from Regulating Internet Loans Made to State Residents, Minnesota Supreme Court Rules

The Minnesota Supreme Court has ruled that the Commerce Clause of the U.S. Constitution does not preclude Minnesota from applying its payday lending law to loans consummated in Delaware that are made to Minnesota residents...more

First Amendment Notes: Amicus Briefs In Pacira & Application of IMS v. Sorrell

Here we discuss a couple of developments involving (actually or potentially) the application of the First Amendment to the FDA’s increasingly battered prohibition against truthful promotion of off-label use....more

Updates Regarding the Pacira Pharmaceutical Inc. v. FDA Lawsuit Regarding First Amendment and Off-Label Promotion Issues

As readers of this blog know, following Amarin’s success in obtaining a preliminary injunction limiting FDA enforcement action against it for truthful, non-misleading off-label promotion of its prescription drug Vascepa,...more

Change Coming to FDA’s “Intended Use” Regulations?

Over at the Drug And Device Law Blog, our colleagues call attention to proposed changes to the “intended use” regulations for prescription drugs and devices, 21 C.F.R. §201.128 and 21 C.F.R. §804.1, somewhat hidden within a...more

FDA Regulatory and Compliance Monthly Recap — September 2015

Pacira sues FDA, alleging it illegally attempted to restrict truthful and non-misleading speech about its post-surgery pain drug Exparel - The drugmaker filed a First Amendment suit seeking an injunction to prevent the...more

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

It’s Déjà Vu All Over Again: FDA Sued Again in Off-Label Promotion Case

To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more

Arizona’s Revenge Porn Law Remains on Indefinite Hold

Earlier this year, the Arizona Legislature made major revisions to Arizona’s revenge porn law, Arizona Revised Statutes § 13-1425. Arizona is neither the first nor the only state to prohibit the unauthorized disclosure...more

First Amarin Pharm v. FDA, Now Pacira Pharm, Inc. v. FDA

The Southern District of New York certainly is becoming a hotbed for issues relating to the FDA’s ability to take enforcement action against manufacturers who promote their FDA-regulated products for uses outside the approved...more

Status Updates: Appeals court upholds anti-cyberbullying law; better marketing through neural networks; restaurant owner turns the...

Cruel intentions. Laws seeking to regulate speech on the Internet must be narrowly drafted to avoid running afoul of the First Amendment, and limiting such a law’s applicability to intentional attempts to cause damage usually...more

Batting Down Generic Plaintiffs’ Amarin Hail Mary Pass

We received a couple of odd anonymous comments to our “breaking news” post about the Amarin First Amendment victory for truthful off-label promotion. Both of them raised the same suggestion: “Does the logic of this opinion...more

Another Successful First Amendment Challenge to the Prohibition of Off-Label Promotion for FDA-Approved Drugs

The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more

Newest FDA Newsletter from AGG

Once a month, AGG’s terrific FDA team publishes a newsletter updating readers on the latest regulatory news affecting food/drug companies–including those from Ireland and Northern Ireland. The August newsletter is here and...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

One Small Step for Amarin & One Giant Leap for Pharmaceutical Companies? - Only Time Will Tell

Friday’s ruling in Amarin Pharma, Inc. v. United States Food & Drug Administration is a monumental event. It signals the dawn of a new era for prescription drug promotion....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

Practical Implications from Amarin

Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...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

Northern District of California Requires A Warrant to Access Cellphone Geographic Information

We previously reported that government access to cellphone geographic information or CSLI without a warrant has become a vigorous debate between the government, defense attorneys, and the federal bench. In a lengthy opinion,...more

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