Dover – In his weekly message, the Governor talks about the unofficial end of summer – Labor Day weekend.

“The Labor Day holiday began with the labor movement in the late 1800’s, the strong backs upon which our nation was built and the trades that still keep us moving today,” said Governor Jack Markell.  “It honors our country’s core values – the hard work it takes to get ahead, the perseverance to do so and the responsibility that comes with economic gains.”

At noon every Friday, the Governor’s office releases a new Weekly Message in video, audio, and transcript form.  The message is available on:

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Delaware.Gov: http://governor.delaware.gov/information/podcast_video.shtml
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Governor’s Weekly Message Transcript:  Labor Day – Working For Our Future

This week, we mark the unofficial end of summer – Labor Day weekend – with most people wondering where the summertime went.  I hope this message finds you enjoying family and friends or taking a break from your traditional “work.”

The Labor Day holiday began with the labor movement in the late 1800’s, the strong backs upon which our nation was built and the trades that still keep us moving today.  It honors our country’s core values – the hard work it takes to get ahead, the perseverance to do so and the responsibility that comes with economic gains.

Every day, men and women continue to build and grow our great nation by the contributions they make at work.  We’re doing everything we can at the state level to keep people working and create new opportunities in this changing world.

A recent report by the Center for American Progress tells us other countries, through grit, determination and dire necessity are making the political commitments and financial investments to improve and modernize – and the best of them are catching up to us.   That’s why it’s important we strengthen American competitiveness in an increasingly global market.

It’s stunning to think that in five years, India, for instance, will graduate 20 million people from high school, or five times as many as in the United States.  By 2030, China will have 200 million college graduates, more than the entire U.S. workforce.  We know the next generation can be equally equipped with the skills and knowledge to keep us strong.

Our children will face a much more competitive world in the years ahead.  That’s why we have some incredible work in education underway in Delaware. This school year, we want to prepare our children to have the best shot at the labor market of the future, as we celebrate this Labor Day and work together to keep Delaware moving forward.

DOVER – The Delaware Office of Management and Budget today announced that it will hold public hearings in September and October in all three counties as part of Governor Markell’s effort to improve Delaware’s regulatory climate and to streamline or eliminate unnecessary regulations.

The agency’s public hearings are being conducted in connection with Governor Markell’s Executive Order No. 36, a statewide review by all agencies to identify and remove regulatory hurdles. The agency’s hearings are scheduled for:

• Thursday, September 27 at 6 p.m. at Sussex Central High School, 26026 Patriots Way, Georgetown
• Thursday, October 4  at 6 p.m. at the University of Delaware Paradee Center, 69 Transportation Circle, Dover
• Thursday, October 11, at 6 p.m. at the James Gilliam Conference Center, 77 Reads Way, New Castle

Executive Order 36 provides an opportunity for state agencies to review regulations on their books, and streamline or eliminate those that are outdated, inconsistent or no longer serve their intended purpose. After formal comment, OMB will consider the input received and change or remove regulations accordingly. The Governor will submit a report to the General Assembly detailing the regulatory changes in all state agencies in June 2013.

In addition to participating in the public hearings, members of the public are also encouraged to submit comments in writing. Comments may be submitted via an online submission form located here. Comments will be accepted through December 1.

Delaware consumers estimated to receive over $235,000 in total compensation

Wilmington — Attorney General Beau Biden, along with 54 other state attorneys general, announced today that they have reached an antitrust settlement with three of the nation’s largest book publishers.  Hachette Book Group, Inc., HarperCollins Publishers L.L.C. and Simon & Schuster Inc. will pay more than $69 million to consumers to resolve the states’ antitrust claims of an alleged unlawful conspiracy to fix the prices of electronic books (E-books).  The publishers have also agreed to follow a court order designed to reestablish price competition in the retail market for E-books. 

The settlement agreement occurred in conjunction with a civil lawsuit filed by the states today in US District Court against Hachette, HarperCollins, and Simon & Schuster.  In the lawsuit, the states allege that the three settling publishers and others, including non-settling publishers Macmillan and Penguin (collectively, the “Agency Five” publishers), “conspired and agreed to increase retail E-book prices for all consumers” and “agreed to eliminate E-book retail price competition between E-book outlets, such that retail prices to consumers would be the same regardless of the outlet patronized by the consumer.” 

“Competition lowers prices for consumers, but in this case, the publishers’ collusive actions denied consumers that benefit,” Attorney General Beau Biden said.  “This settlement with three of those publishers begins the process of helping consumers harmed by the publishers’ scheme.”   

The lawsuit and related settlement stem from a two-year antitrust investigation conducted jointly by the Connecticut and Texas Attorneys General and U.S. Department of Justice’s Antitrust Division. That investigation developed evidence that the Agency Five conspired to end E-Book retailers’ freedom to compete on price.  Once they took control of pricing, the publishers substantially increased the prices consumers paid for E-Books. This action resulted in consumers paying millions of dollars more for their e-books.

Under the proposed settlement agreement, which must be approved by the court, Hachette, HarperCollins and Simon & Schuster will compensate consumers who purchased E-books from any of the Agency Five between April 1, 2010 and May 21, 2012.  Delaware consumers are estimated to receive over $235,000 in total compensation. The settling defendants will also pay approximately $7.5 million to the states for fees and costs.

Delaware continues to seek compensation for consumers who have purchased E-books from other participants in the conspiracy.  Biden’s office has joined with other states in a separate lawsuit against E-book publishers Macmillan and Penguin and E-book seller Apple, with a trial date set for early June 2013.

Record setting payment includes $4.2 million to fund Delaware Consumer Protection Efforts

Wilmington – In the largest multi-state consumer protection settlement with a pharmaceutical company, Attorney General Beau Biden announced today that he and 35 other Attorneys General have reached a record $181 million dollar settlement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson and Johnson.  The Attorneys General allege that Janssen improperly marketed the antipsychotic drugs Risperdal, Risperdal Consta, Risperdal M-Tab and Invega.

“Marketing drugs for uses that are not FDA approved is an unacceptable threat to the health and wellbeing of Delawareans,” Biden said.  “The changes we have secured to this company’s marketing practices, along with the significant financial impact, will help protect the public.”

Today’s settlement was reached in connection with a civil lawsuit Biden’s office filed today in New Castle County Superior Court.  The suit, filed after an extensive four-year investigation led by the State of Florida, alleges that Janssen engaged in unfair and deceptive practices when it marketed Risperdal for unapproved or off-label uses.  Although physicians may prescribe drugs for off-label uses, federal law prohibits pharmaceutical manufacturers from promoting their products for these purposes.  The states’ suit alleges that Janssen promoted Risperdal, among a class of drugs known as atypical or second-generation antipsychotics, for off-label uses to both geriatric and pediatric populations, targeting patients with Alzheimer’s disease, dementia, depression, and anxiety, when these uses were not FDA-approved and for which Janssen had not established that Risperdal was safe and effective. 

Under the terms of the settlement reached today, Janssen will pay $4.2 million to the Delaware Attorney General’s Consumer Protection Fund.  It is also required to change how it promotes and markets its atypical antipsychotics and refrain from false, misleading or deceptive promotion of the drugs.  In addition to the record setting payment, the settlement restricts Janssen from promoting its atypical antipsychotic drugs for “off-label” uses not approved by the U.S. Food and Drug Administration (“FDA”).  Additionally, for five years, Janssen:

•           Must clearly and conspicuously disclose, in promotional materials for atypical antipsychotic products, the specific risks identified in the black-box warning on its product labels;

•           Must present information about effectiveness and risk in a balanced manner in its promotional materials;

•           Shall not promote its atypical antipsychotics using selected symptoms of the FDA-approved diagnoses unless certain disclosures are made regarding the approved diagnoses;

•           Shall require its scientifically trained personnel, rather than sales and marketing personnel, to develop the medical content of scientific communications to address requests for information from health care providers regarding Janssen’s atypical antipsychotics;

•           Must refrain from  providing samples of its atypical antipsychotics to health care providers whose clinical practices are inconsistent with the FDA-approved labeling of those atypical antipsychotics;

•           Must not use grants to promote its atypical antipsychotics nor condition medical education funding on Janssen’s approval of speakers or program content;

•           Must contractually require medical education providers to disclose Janssen’s financial support of their programs and any financial relationship with faculty and speakers; and

•           Must have policies in place to ensure that financial incentives are not given to marketing and sales personnel that encourage or reward off-label marketing.

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