Legal

FTC actions in Watson case come under Senate scrutiny

Marc Iskowitz 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

Marc Iskowitz 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

Matthew Arnold 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

Marc Iskowitz 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

Matthew Arnold 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

Ben Comer 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

Matthew Arnold 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

Matthew Arnold 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

Ben Comer 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

Matthew Arnold 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

Matthew Arnold 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

Matthew Arnold 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

Matthew Arnold 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

Matthew Arnold 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

Ben Comer 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

Ben Comer 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

Matthew Arnold 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

Matthew Arnold 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.

Congress to investigate FDA's medical device approval process

Ben Comer November 17, 2008

Reps. John Dingell (D-MI) and Bart Stupak (D-MI) have launched an investigation into the FDA's process for reviewing medical devices, following an accusatory letter from FDA scientists and physicians.

FDA public relations contract scrutinized by Congress

Ben Comer November 13, 2008

Senators Mike Enzi (R-WY) and Tom Coburn (R-OK) are requesting information on the FDA's contract process, specifically with respect to a no-bid public relations campaign contract.

DoJ recovered $694.5 million from drug and device manufacturers in 2008

Ben Comer November 11, 2008

The Department of Justice (DoJ) recovered a total of $694.5 million in settlements from a device manufacturer and two pharmaceutical companies during FY 2008.

Lilly settlement with states demands even greater transparency

Matthew Arnold October 09, 2008

Eli Lilly & Co.'s $62 million settlement with 32 states and the District of Columbia over off-label Zyprexa marketing comes with an agreement requiring, among other things, that the company furnish those state AGs with a list of all healthcare professionals paid more than $100 for promotional speaking and consulting in the US.

ACCME proposals imperil CME, critics say

Matthew Arnold September 15, 2008

As ACCME's public comment period on a proposed restructuring of the CME funding structure drew to a close, industry groups blasted the accrediting body for what they see as an overreaction imperiling medical education.

Obama win could spark regulatory frenzy, says ex-FDA chief counsel

Anthony Vecchione September 09, 2008

What impact will the presidential election have on advertising regulation? That's the question that Richard Cooper posed to attendees at the Food and Drug Law Institute's 20th annual Advertising & Promotion Conference in Washington, DC.

Amgen to unbundle anemia medications

Ben Comer August 29, 2008

Amgen announced plans to restructure its sales practices for Aranesp, a anemia drug used primarily for chemotherapy patients

FDA cracks down on conflicts of interest in committees

Ben Comer August 04, 2008

New documents released by the FDA seek to limit conflicts of interest among advisory committee members and provide greater transparency.

FDA oversight limited on off-label promotion

Ben Comer July 29, 2008

A new GAO report finds the FDA incapable of reviewing all drug advertising -- including the identification of off-label promotions -- due to the quantity of submissions and the variety of materials.

Massachusetts dumps gift ban, punts on data

Matthew Arnold July 16, 2008

Massachusetts lawmakers trashed a proposed gift ban hotly contested by biotechs, a key industry in the state, and put off the effective date of a provision banning commercial use of prescriber data.