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First Amendment › Pharmaceutical Industry › Commercial Speech

The First Amendment to the United States Constitution prohibits the government from making laws respecting the establishment of religion, prohibiting the free exercise of religion, abridging the freedom of speech... more +
The First Amendment to the United States Constitution prohibits the government from making laws respecting the establishment of religion, prohibiting the free exercise of religion, abridging the freedom of speech or the press, preventing citizens from peacefully assembling, or interfering with citizens' ability to petition the government for redress of their grievances. The First Amendment is one of the most sacred aspects of the American legal tradition and has spawned a vast body of jurisprudence and commentary. less -
Patrick Malone & Associates P.C. | DC Injury...

Taming Big Pharma profiteering is no snap, White House learns in dual defeats

Patrick Malone & Associates P.C. | DC Injury... on

It takes more than a lot of huffing and puffing to blow down the ever-rising high costs of prescription drugs, the Trump administration has found. Two defeats happened last week: officials were forced to pull a plan to curb...more

Holland & Knight LLP

Healthcare Law Update: July 2019

Holland & Knight LLP on

CMS Regulation - District Court Strikes Down Rule Mandating Price Disclosure in DTC Pharmaceutical Advertisements - The U.S. Department of Health and Human Services (HHS), together with the Centers for Medicare &...more

Mintz - Health Care Viewpoints

Federal Judge Strikes Down HHS Drug Pricing Disclosure Rule

Mintz - Health Care Viewpoints on

In follow-up to our previous post, the pharmaceutical industry gained a win on July 8th when a federal judge struck down the Trump administration’s rule that would have required drugmakers to include list prices for drugs in...more

Mintz - Health Care Viewpoints

Pharmaceutical Companies Object to HHS Drug Pricing Disclosure Rule

Mintz - Health Care Viewpoints on

Several parties from the pharmaceutical industry have teamed up with an advertising association to file a lawsuit against the Department of Health and Human Services (HHS) to prevent a new drug pricing disclosure rule from...more

Obermayer Rebmann Maxwell & Hippel LLP

Ads will be Required to Disclose Prices for Rx Drugs

Obermayer Rebmann Maxwell & Hippel LLP on

Ever since the FDA approved advertisements for prescription drugs on television, pharmaceutical companies have been heavily relying on them and collectively represent the third highest spender of any industry in national TV...more

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Mintz - Health Care Viewpoints on

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more

Mintz - Health Care Viewpoints

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

Mintz - Health Care Viewpoints on

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

Fish & Richardson

The First Amendment Does Not Protect All Off-Label Drug Promotion

Fish & Richardson on

FDA is considering making off-label promotion easier, consistent with recent case law. The drug and biologics industry is also proposing an ease up of FDA regulation, which would allow it to “responsibly” promote new drug...more

Mintz - Health Care Viewpoints

Five Important Themes to Watch in the Reform of FDA’s Off-Label Communications Policy

Mintz - Health Care Viewpoints on

As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more

Foley Hoag LLP

FDA and Amarin Pharma Reach Milestone Settlement Allowing Off-Label Drug Promotion

Foley Hoag LLP on

A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e.,...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

Skadden, Arps, Slate, Meagher & Flom LLP on

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

Perkins Coie

Pharma and Medical Device Industry Victory in Off-Label Marketing Decision

Perkins Coie on

The U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug,...more

Jackson Walker

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

Jackson Walker on

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

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

Holland & Knight LLP

Second Circuit Vacates Misbranding Conviction for Pharmaceutical Representative on First Amendment Grounds

Holland & Knight LLP on

In United States v. Caronia, No. 09-5006-cr, slip op. (2d Cir. Dec. 3, 2012), the U.S. Court of Appeals for the Second Circuit held that "the government cannot prosecute pharmaceutical manufacturers and their representatives...more

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