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 Legal

Novartis sued for alleged speaker-program abuse

April 29, 2013

The Swiss drug maker is defending itself against two civil fraud lawsuits filed within a week of each other.
 

Myriad decision could be a drag on personalized medicine R&D

April 15, 2013

After a skeptical Supreme Court hearing, diagnostics and biopharma patent lawyers are sweating the outcome of Association for Molecular Pathology vs. Myriad Genetics, in which the Court could decide whether or not swatches of genes are patentable.
 

Court could punt "Pay for Delay" back to Congress

March 25, 2013

Eight members of the Supreme Court heard testimony in the case of FTC v. Actavis this morning, and the fate of so-called "pay for delay" settlements hangs in the balance.
 

Amgen pleads guilty, takes CIA in $762 million False Claims Act case

December 20, 2012

Amgen "marketed the spread" between the price practices pay for Aranesp and that patients pay as a means of driving sales—to the point of having speakers tell docs that they could make a million more each year by prescribing the Amgen anemia drug over its competitor, Procrit.
 

FDA regulatory policy chief to take on compounding question

December 19, 2012

FDA's Jane Axelrad is leaving the Office of Regulatory Policy to head the agency's compounding policy rethink.
 

Court says off-label decision against Jazz rep ran afoul of free speech protections

December 03, 2012

A federal appeals court has overturned the conviction of a drug rep for detailing a drug off-label on First Amendment grounds, ordering the lower court to retry the case.
 

For Forest, one Bystolic test down, six to go

October 29, 2012

Forest Labs may have settled a patent challenge from generics maker Hetero, but the drugmaker has yet to come to terms with six others.
 

Pharma execs: MLR teams are friendlier on digital

October 22, 2012

Pharma's med/legal/regulatory (MLR) teams, managers of risk and so often the scapegoats for creating roadblocks to digital innovation, were discussed in a much friendlier light by digital marketers at last week's ExL Digital Pharma East conference in Philadelphia.
 

Hologic, seeking rights to Makena, trades barbs with KV

September 24, 2012

Hologic alleges KV has botched the marketing and wants rights to the drug. KV disagrees.
 

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.
 
  

Web Exclusive

Angelina Jolie's fearless but flawed message

Paul Oestreicher, Ph.D. May 17, 2013

Angelina Jolie's story raises important questions about education, outreach and access—but her nod to holistic treatments is less helpful
 

Podcasts

How to engage even the busiest physicians

March 04, 2013

Sponsored by TRUE Health + Wellness. The increasingly demanding schedules of healthcare professionals continue to narrow the window of opportunity for pharma sales teams, and, as a result, marketers are focusing more on non-personal promotion. However, there's a lot more to it than simply bombarding physicians with brand messages, as Anne Stroup, Managing Director at TRUE Health + Wellness, explains to MM&M's James Chase in this special podcast presentation.
 

2013 Hall of Fame Inductees

An entertaining look at the extraordinary lives and careers of the Medical Advertising Hall of Fame's 2013 inductees: Peter Frishauf, Dorothy Philips and David Labson. Clips produced by JUICE Pharma. 

Slideshows

MAHF 2013: Honors Class

A gallery of images from the 2013 Medical Advertising Hall of Fame induction dinner
 
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