Wilmington – Delaware Attorney General Beau Biden announced Thursday that Shire Pharmaceuticals will pay Delaware $137,000 as part of a national settlement with state and federal governments to resolve allegations that the company improperly marketed its drugs for off-label uses.

The entire settlement totals $56.5 million for Delaware, the federal government and many other states. The agreement settles charges that Shire, a Pennsylvania-based company, launched marketing campaigns for Adderal XR, Vyvanse, Daytrona, Lialda and Pentasa, promoting the drugs for uses for which they had not received Food and Drug Administration approval. Delaware’s $137,000 payment will go to Delaware’s Division of Medicaid and Medical Assistance, as reimbursement for previous Medicaid expenses that were incurred as a result of the drugs being used for off-label purposes.

“The misuse of prescription medication is a major public safety issue,” Biden said. “Pharmaceutical companies have a responsibility to market their drugs only for uses that have been approved by the FDA, and will be accountable when they attempt to sell their drugs for unapproved uses.”

Adderrall XR, Vyvanse and Daytrona are approved by the United States Food and Drug Administration (FDA) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Lialda and Pentasa are approved for the treatment of mildly to moderately active ulcerative colitis. Specifically, according to the settlement, Shire is accused of:

• Promoting Adderall XR as clinically superior to other ADHD drugs despite a lack of clinical data to support such claims and for the treatment of Conduct Disorder, an indication not approved by the FDA;
• Promoting Vyvanse as preventing certain negative consequences of ADHD and as less abuseble than Adderrall XR or other ADHD medications despite a lack of clinical data to support such claims;
• Promoting Daytrona as less abuseable than pill-based medications despite a lack of clinical data to support such claims; and that Daytrona, a patch applied product, demonstrated difficulty in sticking to the patient’s body, making it therapeutically less effective;
• Promoting Lialda for the prevention of colorectal cancer, an indication not approved by the FDA and marketed Lialda as having greater efficacy than other medications, despite a lack of clinical data sufficient to support such a claim;
• Promoting Pentasa for the treatment of indeterminate colitis and Crohn’s Disease, indications for which it had not been approved by the FDA.

As a condition for the settlement, Shire has entered into a Corporate Integrity Agreement (CIA) with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.

The settlement resulted from two qui tam lawsuits originally filed by whistleblowers in the United States District Courts for the Eastern District of Pennsylvania and the Northern District of Illinois under the federal False Claims Act and various state false claims statutes.

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Group will provide important perspective on needs of City youth and the schools they attend

Wilmington, DE – Following through on a recommendation earlier this month from city legislators in the General Assembly, Governor Markell issued an Executive Order today to bring together community leaders, parents, teachers, and others active in Wilmington education to provide suggestions and feedback on ways to improve educational opportunities for city youth.

E.O. 46 establishes the City of Wilmington Education Advisory Group, which will be comprised of at least 15 members appointed by the Governor in consultation with elected representatives from the city. The group, which is the result of a conversation the Governor had with Representative Charles Potter (D-Wilmington North), Representative Stephanie T. Bolden (D-Wilmington East), Representative James “J.J.” Johnson (D-New Castle), and Senator Margaret Rose Henry (D-Wilmington East), will offer input to the Governor and the Department of Education. Members are tasked with addressing educational outcomes, community involvement and family engagement in schools, social services and access to extracurricular activities.

“While we have seen improvements in college attendance and dropout rates, as well as increases in students who meet their individual growth goals throughout the state, we have not seen enough progress in schools serving our highest-need youth in Wilmington,” said Governor Markell. “We must not accept a status quo in which students in our most disadvantaged communities fall further and further behind each year.

“Working with community leaders, activists, parents, teachers, and family members is essential to combating the inequalities that plague many City schools. I thank Senator Henry, Representative Potter, Representative Bolden, and Representative Johnson who suggested that I create this advisory group, and I look forward to working with this group to give Wilmington children the quality education that every Delaware child deserves.”

The perspective of the task force would complement increased funding available to help turn around the six lowest performing schools in the state, all located in the City of Wilmington. The Governor recently announced an initiative that would invest about $6 million in additional funding in these “Priority Schools,” while ensuring the schools have outstanding leadership and increased flexibility to implement proven strategies to help disadvantaged students, and holding them accountable for making improvements. In addition, the Children’s Department has won a $4 million federal grant to support the social and emotional development of young children in some of these same communities.

“I have been approached by parents of students and other city residents who care deeply about the education our children receive and who can offer valuable insights to improve opportunities for our children,” said Rep. Potter. “I appreciate the Governor’s support of giving the community a stronger voice in their children’s education and thank him for working over the past few weeks to quickly establish this advisory group.”

“Too many of the children in our city communities are not getting the education they need,” said Sen. Henry. “We need to see more progress for our children, especially at our schools that struggle the most. And we will only make things better if we give the people who live in the communities the chance to communicate their concerns and suggestions. I applaud the creation of this advisory group and look forward to the members of our community finally having an effective way to make themselves heard.”

The Governor announced that the group will be chaired by Dr. Tony Allen, founding President of the Metropolitan Wilmington Urban League and a strong advocate for underprivileged children in Wilmington and a longtime Wilmington resident who has helped lead Bank of America’s community service efforts during his many years at the company. In 2012, Allen co-orchestrated the donation of a 450,000 square-foot Bank of America building to the Longwood Foundation to build a campus of schools designed to eliminate the achievement gap for 2,500 inner-city children.

“While I am humbled to accept the role, doing nothing is simply not an option,” said Allen.  “Our City – and our state – cannot afford one more generation of underprepared young citizens without the skills to meet the challenges of the digital age and no incentive to succeed.  The notion that these kids are un-teachable because of where they come from is wrong.  It has already been proven that where ever public officials, school leaders and citizens have the will and the commitment to help those children succeed; they have, in fact, succeeded.  We should set the standard. ”

Visitors will have a unique opportunity to learn about the volatile, behind-the-scenes events that culminated in the creation of the recorded-music industry during the program “Pioneers in the Music Industry: Emile Berliner” that will take place at 2:30 p.m. on Saturday, Oct. 4, 2014 at the Johnson Victrola Museum, located at 375 S. New St. in Dover, Del. Admission is free and open to the public. For additional information, call 302-744-5055.

Oliver Berliner, Emile Berliner’s only descendent who has worked in the music business, will make a rare appearance as guest speaker for the program which honors his grandfather, inventor of the microphone and the disc-record player, which he named the gramophone, but which Americans call the phonograph. Emile Berliner is the recipient of two Grammy Awards: a Trustees Award in 1987 and a Technical Award in 2014.

Like his grandfather, Oliver’s interests are in both engineering and artistic endeavors. He holds two patents; has created broadcast products that were mass-produced by Panasonic, Electrohome, Leader Instruments and Hitachi; has authored two books; and has published over 200 articles on music, audio and video.

He is also a leading publisher of Cuban music, controlling among other hits, the world’s two most famous “chachachas” which have appeared in countless television shows, movies, radio and television commercials. During his Johnson Victrola Museum talk, Berliner will reveal music business secrets for which even historians and scholars are unaware.

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Contact:
Jim Yurasek
Delaware Division of Historical and Cultural Affairs
Phone:  302-736-7413
E-mail:  Jim.Yurasek@delaware.gov
Web:   http://history.delaware.gov

For Immediate Release:

The Institute of Museum and Library Services (IMLS) recently interviewed State Librarian, Dr. Annie Norman, about how the needs of library users are changing and evolving. It’s an interesting topic and a worthwhile read. Thanks for the support IMLS!

Cheswold, DE – Joined by members of the General Assembly and volunteer firefighters at Cheswold Volunteer Fire Company today to recognize Delawareans who provide life support services, Governor Markell signed into law three bills to help ensure volunteer ambulance and fire companies have the financial support to continue to serve the state to the best of their abilities.

The legislation addresses findings of the Ambulance and EMS Funding Task Force that was created in 2013 and examined the outlook of emergency services in Delaware, finding that “the public may begin to see diminished ambulance service in as little as 8 to 12 months, if steps are not taken promptly to meet the funding need.”

“No one wants to think about being in a situation that requires help from our emergency responders, but we have a responsibility to ensure Delawareans have access to ambulance and EMS life support services,” said Governor Markell. “Today, we take an important step forward in sustaining our volunteer ambulance and fire companies.”

The bills signed included:

• Senate Bill 207, sponsored by Senator Bruce Ennis (D-Smyrna), requires that Delaware health insurance policies cover the cost of every ambulance run and the basic life support provided by a volunteer ambulance company.
• House Bill 315, sponsored by Representative William Carson (D-Smyrna), establishes a Volunteer Ambulance Company Fund, administered by the State Fire Prevention Commission and funded through a $10 assessment on all motor vehicle violations under Title 21 of the Delaware Code.
• House Bill 317, also sponsored by Rep. Carson, increases from 0.15% to 0.21% the share of the gross premium tax already paid by health insurance companies to be distributed to volunteer fire companies.

“Our emergency services needed help, so the Delaware Volunteer Firefighters Association and we in the General Assembly teamed together and got the job done,” said Rep. Carson, a past chief of Citizens Hose Co. in Smyrna. “These men and women come to our aid whenever they are called, and it was our duty to help them when they needed it most.”

In addition to being the lead sponsor of one of the bills, Sen. Ennis was co-chairman of the Ambulance and EMS Funding Task Force which specifically found a statewide $8.6 million operating deficit for EMS companies and Ennis said the new laws will help tackle those challenges.

“We didn’t get everything we wanted, but we are taking a good first step that I think will help end that deficit,” Ennis said. “I think this is really going to help our emergency medical service.”

Photos from the bill signings