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Pharmaceutical Industry › First Amendment › Marketing

Brownstein Hyatt Farber Schreck

The First Amendment and Direct-to-Consumer (DTC) Prescription Drug Ads

Brownstein Hyatt Farber Schreck on

Department of Health and Human Services Secretary Robert F. Kennedy, Jr. has made no secret of his disdain for television advertisements for prescription drugs. As a presidential candidate, he promised to ban those ads by...more

Ropes & Gray LLP

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

Ropes & Gray LLP on

On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

King & Spalding

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)

King & Spalding on

Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

American Conference Institute (ACI) on

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

American Conference Institute (ACI) on

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

Searcy Denney Scarola Barnhart & Shipley

Johnson & Johnson Advocate Says It Should Not Be Defendant in Baby Powder Case

Searcy Denney Scarola Barnhart & Shipley on

The Personal Care Products Council wants its name off the defendants’ list in multidistrict litigation filed in U.S. District Court in New Jersey by plaintiffs suing Johnson & Johnson over the pharmaceutical giant’s baby...more

Mintz - Health Care Viewpoints

HIPAA Marketing Rules Prompt First Amendment Challenge

Mintz - Health Care Viewpoints on

In what is believed to be the first legal challenge to the HIPAA Omnibus Rule (the “Rule”), a vendor of prescription drug adherence services is seeking an injunction to block certain provisions of the Rule related to drug...more

King & Spalding

Two New Developments in First Amendment Challenges to Off-Label Promotion: What's Next?

King & Spalding on

Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more

Sheppard Mullin Richter & Hampton LLP

Ninth Circuit Off-Label Marketing Decision Suggests More Prosecutions Will Be Coming

Sheppard Mullin Richter & Hampton LLP on

The Ninth Circuit has reopened a door for off-label marketing prosecutions, and it is important to review your compliance and risk management programs in light of this recent decision. Last December, the pharmaceutical and...more

Holland & Knight LLP

Second Circuit Vacates Pharmaceutical Misbranding Conviction on Free Speech Grounds

Holland & Knight LLP on

After two years of deliberation, the U.S. Second Circuit Court of Appeals has finally issued its decision in United States v. Caronia, holding that the government cannot prosecute pharmaceutical manufacturers or their...more

K&L Gates LLP

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

K&L Gates LLP on

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

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