Pharmaceutical Industry Marketing

News & Analysis as of

FTC Addresses Homeopathic Drug Advertising

The Federal Trade Commission (“FTC”) recently released an enforcement policy statement regarding marketing claims for products in the over-the-counter (“OTC”) homeopathic drug market. Long permitted to fly under the FTC’s...more

Pharmaceutical Companies Face Fax Marketing TCPA Class Action

On November 11, 2016, a putative class action complaint was filed against two related pharmaceutical companies alleging violations of the Telephone Consumer Protection Act (“TCPA”). Specifically, the complaint alleges that...more

Blog: Pharmaceutical Reps Now Required to be Licensed in the City of Chicago; Includes Code of Ethics & Potential Transparency...

Earlier this week, the Chicago City Council joined other government agencies in imposing licensure and marketing requirements on pharmaceutical representatives when it unanimously approved licensing requirements for...more

FDA Launches New Webpage to Report Regulatory Misconduct

Earlier this week, the FDA launched a new webpage to simplify the process of reporting violations of the law by medical device manufacturers and individuals marketing medical devices. Unlike the MedWatch system for reporting...more

Fourth Circuit Holds False Claims Act Relators Cannot Use Facts Learned by Their Attorney in a Previous Case to Defeat the FCA’s...

Earlier this year, the Fourth Circuit held in United States ex rel. May v. Purdue Pharma L.P., 811 F.3d 636 (2016) that the a complaint that is “based on” relators’ attorney’s work on a prior dismissed FCA action triggers the...more

The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims

The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law....more

EMA Accepts Mylan and Biocon’s Application for Authorization to Market a Pegfilgrastim Biosimilar

Mylan N.V. and Biocon Ltd. recently announced that the European Medicines Agency has accepted Mylan’s Marketing Authorization Application for a proposed biosimilar version of Amgen’s Neulasta (pegfilgrastim). In Europe,...more

China Announces a Detailed Pilot Plan for the Marketing Authorization Holder System for Drugs in Selected Regions

China’s State Council announced on May 26, 2016, a detailed pilot plan for the Marketing Authorization Holder System (“MAH”) for drugs in 10 provinces in China (the “Plan”). The three-year pilot program was initiated in...more

Transparency in Drug Pricing: Issues to Consider from the Research Lab to the Consumer

Since 2014, drug pricing has grown in importance in health care policy conversations. From Gilead Sciences’s Hepatitis C treatment costing $84,000 per course of treatment to Turing Pharmaceutical’s 5,000 percent price hike of...more

Ukraine further simplifies the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or...

As we reported in our previous alert, the Cabinet of Ministers of Ukraine has recently adopted Resolution No. 312 simplifying the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or...more

Congress acts on opioid drug epidemic as judge unseals OxyContin files

Here are some developments worth watching in the nation’s battle against the epidemic of opioid drug misuse that killed 28,000 Americans in 2014 alone...more

Breaking: Third Circuit Dismisses Antitrust Suit Concerning Marketing of Lovenox

Earlier today, the Third Circuit Court of Appeals upheld the decision of the District of New Jersey trial court dismissing the antitrust claims lobbed against Sanofi-Aventis by its rival pharmaceutical company Eisai. The...more

Alert: China Piloting Drug Marketing Authorization Holder System

The Chinese central government has taken several important steps in reforming the drug approval system in China, which could have far-reaching implications for pharmaceutical companies in China as well as foreign companies...more

HIPAA Lessons from the Warner Chilcott Settlement

Last week, the US Attorney’s Office in Boston announced that drug company Warner Chilcott agreed to plead guilty to health care fraud and pay $125 million to resolve criminal and civil liability arising out of allegations...more

The Third Circuit Gives the Green Light to RICO Plaintiffs Seeking to Recover Payments for Prescription Drugs

This week, the Third Circuit altered the legal landscape for civil Racketeer Influenced and Corrupt Organizations Act (RICO) claims against pharmaceutical companies. The ruling in In re Avandia Marketing, Sales Practices &...more

United States v. Bayer: Preventing or Treating Disease Claims

In recent years, the FTC and the Center for Science in the Public Interest (“CSPI”) seem to have seen disease claims everywhere, regardless of whether the FDA has deemed the same claims appropriate, non-disease...more

Why Industry Drug-Assistance Programs Are a Sham

You probably heard about the recent price hike for a drug critical to AIDS patients when the manufacturer sold it to an evil hedge fund manager who promptly marked it up 5,000%. This prompted Los Angeles Times columnist...more

The Revolution that Wasn’t: New Jersey’s Direct-To-Consumer Exception to the Learned Intermediary Doctrine

The learned intermediary doctrine – in which a manufacturer’s duty to warn runs to the physician, not to the patient – is one of the most potent weapons in the arsenal for a pharmaceutical or medical device manufacturer faced...more

Actavis Loses Nameda® Appeal Over “Hot Documents”

The U.S. Court of Appeals for the Second Circuit’s opinion (issued May 22, 2015 with a public, redacted version available May 28, 2015), affirming the district court’s grant of a preliminary injunction in State of New York v....more

Pharmaceutical Marketing and Unfair-Trade-Practices Claims

Lawsuits against pharmaceutical companies generally center on product-liability claims. A new trend in pharma cases, however, is to include a different kind of claim: a claim for unfair trade practices....more

2014 Year in Review: OPDP Warning and Untitled Letters

In 2014, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 10 enforcement letters to pharmaceutical manufacturers. Of the 10 letters, nine were Untitled...more

FDA Clarifies Orphan Drug Exclusivity Policy Following Court Defeat

On the heels of a loss in federal court last fall, the FDA recently announced a clarification of its policy concerning orphan drug exclusivity. In short, despite a court ruling requiring the FDA to grant orphan drug...more

FDA Regulatory and Compliance Monthly Recap – November 2014

In an unusual move, the FDA takes issue with the accuracy of Sciecure’s studies in a warning letter over sales promotion material for the company’s sleeping pill - In addition to criticizing the pharmaceutical company...more

OIG Approves Manufacturer’s Direct-to-Patient Discount Sales Program

The Office of Inspector General (“OIG”) recently posted an Advisory Opinion approving a pharmaceutical manufacturer’s direct-to-patient product sales program. While this Advisory Opinion cannot be relied upon by anyone other...more

Mylan Pharms., Inc. v. FDA (N.D.W.V.)

Mylan filed a complaint on April 25, 2014, challenging a letter decision by the FDA, addressing the marketing exclusivity eligibility of celecoxib Abbreviated New Drug Application applicants. Mylan then filed a motion for...more

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