Legal

Judge puts freeze on Merz bid to challenge Botox

March 07, 2012

US District Court Judge Andrew Guilford slammed the breaks on Merz's foray into a market dominated by Botox, siding with Allergan in a case about stealing intellectual property and poaching sales reps.
 

DOJ hit pharmas for $2.2 billion in 2011 False Claims Act cases

December 20, 2011

Pharmas shelled out $2.2 billion in False Claims Act fines and settlements with the Justice Department this year as the feds' healthcare fraud haul hit an all-time high.
 

Merck v. Merck Facebook fracas a "tempest in a teapot" says US firm

November 29, 2011

Facebook shut down Facebook.com/Merck after Merck KGaA announced plans to take legal action "based on the apparent takeover of its Facebook page" by its US cousin, Merck & Co.
 

Amylin, parting ways with Lilly, plans for extra sales reps

November 08, 2011

Amylin said it will hire 365 sales reps to make up for Eli Lilly's departure from commercial activities, once the firm takes full control of the exenatide diabetes franchise in the US this month.
 

GSK hopes $3-bil. off-label settlement will end legal woes

November 07, 2011

GlaxoSmithKline's deal to resolve multiple US investigations into its sales and marketing practices—one of the largest settlements by a pharma company—aims to patch up several long-running legal disputes.
 

Par Pharma suit could set up off-label court showdown

October 18, 2011

Par Pharmaceutical last week asked a federal court to tell the FDA to back off and allow the company to detail docs about using its Megace ES to treat AIDS-related wasting.
 

Feds subpoena Merck on marketing of hepatitis, cancer drugs

August 08, 2011

Merck said it received a subpoena related to marketing and selling activities with respect to three drugs: Temodar, PegIntron and Intron A.
 

Pharmas ask FDA for guidelines on off-label info

July 06, 2011

Seven large pharmas filed a citizen petition with FDA asking for guidance on communication about off-label uses for products.
 

Supremes strike down Vermont data law

June 23, 2011

The Supreme Court came down on the side of data firms, overturning a Vermont law banning the sale of prescription data to pharmas because it violates First Amendment speech protections.
 

Data firms get a little help from their friends in Supreme Court case

April 04, 2011

The data mining firms fighting for their right to sell physician data got an assist as a host of big names, including a pair of former Health and Human Services secretaries, filed 16 supportive amicus briefs with the Supreme Court.
 

Off-label marketing offenses cost Elan $203 million

March 01, 2011

Elan Pharmaceuticals pleaded guilty today to a misdemeanor violation for illegally promoting epilepsy drug Zonegran.
 

Supreme Court to weigh prescriber data ban

January 11, 2011

After shrugging at a similar plea for a hearing in July of 2009, the Supreme Court has decided to weigh in on the legality of selling prescriber data - or information that details the prescribing habits of physicians - to drug marketers.
 

FTC actions in Watson case come under Senate scrutiny

June 10, 2010

Two senators grilled the chairman of the Federal Trade Commission (FTC) yesterday over allegations made by Watson Pharmaceuticals that the agency used its subpoena power and access to confidential information to force the company into a business deal with a rival generics firm.
 

Watson: FTC abused power in trying to 'engineer' entry of generic Provigil

May 27, 2010

The FTC, which opposes reverse-payment patent settlements but has failed to muffle them via the courts or healthcare reform legislation, is now trying some new tactics: harassment, use of privileged information and attempting to force a pharma company to partner with another firm against its will.
 

AstraZeneca settles Seroquel off-label suit for $520m, CIA

April 27, 2010

AstraZeneca agreed to pay $520 million and enter a five-year Corporate Integrity Agreement to settle a federal case against the company for off-label marketing of Seroquel, the Departments of Justice and Health and Human Services' Healthcare Enforcement Action Team announced.
 

New Jersey's tough new conflict regs face uncertain future

December 07, 2009

Conflict-of-interest rules announced by New Jersey's Division of Consumer Affairs last week would seem to have mixed prospects under an incoming Republican administration.
 

Senate health bill pharma-friendly on biologics, price controls

November 19, 2009

The Senate health reform bill would maintain the ban on price controls in the Medicare prescription drug benefit and establish a 12-year data exclusivity period for biologics.
 

Industry coalition goads DDMAC on sponsored links

May 27, 2009

An ad hoc coalition, spearheaded by industry veteran Arnold Friede, is formulating a proposal to challenge recent DDMAC actions it considers misguided.
 

Iowa Senate passes harsh gifts, data ban bill

March 20, 2009

Iowa's state Senate passed a healthcare bill containing some of the toughest restrictions on drug company contacts with physicians yet.
 

Supremes deny Wyeth in pre-emption bid

March 04, 2009

The Supreme Court struck a blow to FDA pre-emption of state laws with a 6-3 decision in Wyeth v. Levine finding the company liable for a failure-to-warn claim under Vermont state law.
 

DOJ: Forest promoted Celexa and Lexapro off-label

February 26, 2009

The Department of Justice is suing Forest Laboratories over the alleged promotion of Celexa and Lexapro off-label, for pediatric use. Forest also paid kickbacks to physicians, the DOJ said.
 

Bayer runs "corrective" Yaz ad, agrees to preclearance

February 11, 2009

Bayer is shelling out $20 million to air a rare remedial TV ad campaign for its Yaz birth control pill as part of a settlement with FDA and 27 states over charges of deceptive advertising. Bayer also agreed to submit all ads to FDA for preclearance for the next six years.
 

Troubled KV cuts 700 jobs amid suspension

February 09, 2009

KV Pharmaceutical Company said it is eliminating 700 jobs as part of a cost-cutting program following a suspension of manufacturing and product recalls resulting from an FDA investigation.
 

Sunshine bill is back with sharper teeth

January 22, 2009

Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI) reintroduced their Physician Payments Sunshine Act, which would require that manufacturers and group purchasing organizations disclose payments to physicians of $100 or more.
 

Lilly enters CIA as part of $1.4 billion settlement

January 15, 2009

As part of its $1.415 billion settlement for off-label marketing of Zyprexa, Eli Lilly & Co. will enter a Corporate Integrity Agreement with the HHS Office of Inspector General.
 

FDA OKs distribution of journal articles on off-label uses

January 12, 2009

Drug company reps can distribute -- but not discuss -- reprints of journal articles on off-label uses for drugs, according to an FDA guidance posted today.
 

IMS, SDI request a rehearing on NH data ban

December 18, 2008

A motion to challenge New Hampshire's law banning the commercial use of prescriber-identifiable data has been filed by research companies IMS Health and SDI.
 

Grassley questions Prempro ghostwriting practices

December 12, 2008

Sen. Chuck Grassley (R-IA) today sent letters to Wyeth and a third party regarding Prempro-related journal articles, and specifically the use of ghostwriters, the New York Times reported.
 

PhRMA tweaks DTC guidelines

December 10, 2008

Print and TV ads for ED drugs should appear only in programs or publications with an adult audience of 90% or more under revised PhRMA consumer advertising guidelines -- in the original version, released in August 2005, the baseline was 80% -- and signatory company CEOs and chief compliance officers must sign an annual certification stating that they have policies and procedures in place to foster compliance with the principles.
 

Prescription Project: VNRs on YouTube are ads, must include warnings

December 04, 2008

Drug industry watchdog The Prescription Project called on FDA to take action against video news releases and B-roll for Abbott, Medtronic and Stryker medical devices appearing on YouTube, and said the agency should issue guidance for online ads.
 

Video Exclusive

Web Exclusives

Five industry experts advise specialty pharma company on digital strategy

April 20, 2012

Specialty pharma company POZEN assembled a crack team of experts to help shape its digital strategy. Not only did POZEN share with us the text from their contributions, but you can watch exclusive video clips of their valuable perspectives right here.
 

MM&M Awards 2011 HIghlights

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