Forest Pharmaceuticals pays $313 million in settlement deal
SILVER SPRING, Md. Drug maker Forest Pharmaceuticals will pay more than $300 million to the federal government as part of a plea agreement over alleged improper drug distribution and obstructing a Food and Drug Administration inspection.
The FDA said Wednesday that Forest Pharmaceuticals, a subsidiary of New York-based Forest Labs, had entered a plea agreement whereby it would accept criminal responsibility for distribution of an unapproved drug, distribution of a misbranded drug and obstruction of an FDA inspection. The total payment of $313 million includes $164 million in criminal penalties.
One charge centered around the marketing of Levothroid (levothyroxine sodium), an unapproved drug used to treat hypothyroidism. A 1997 Federal Register notice announced that Levothroid is a “new drug,” and that manufacturers who wish to continue marketing it would have to obtain approval from the FDA by August 2000.
The company also is charged with alleged off-label promotion of the antidepressant Celexa (citalopram) for use in children; the drug is only approved for use in adults. The charge of obstructing an FDA inspection relates to an alleged 2003 incident in which Forest employees made false statements to the agency.
“We are pleased to bring closure to this long-running investigation,” Forest chairman and CEO Howard Solomon said. “We remain dedicated to ensuring that we operate in full compliance with all laws and regulations and that our employees uphold the highest principles of integrity, honesty and ethics.”
Big Y, pharmacy school open consultation and wellness center
SPRINGFIELD, Mass. Big Y Foods and Western New England College School of Pharmacy have teamed up to develop a faculty pharmacist-run, patient-centered consultation and wellness center inside the Big Y World Class Market here.
The facility is the first one to be located in a supermarket. Patients will be able to make an appointment with a pharmacist who will work with the individual and his or her physician to optimize that individual’s care. The grand opening event took place on Sept. 10.
The goal: to decrease visits to the emergency room and the number of hospital re-admissions by collaborating with physicians on patient care. Free services offered at the new consultation and wellness center include education and training programs, blood-glucose evaluations, individualized patient care plans and medication review. Kam Capoccia, clinical associate professor at the Western New England College School of Pharmacy, will supervise the center.
"There are changes taking place within the practice of pharmacy that make opportunities such as this more beneficial than ever to patient care," stated Evan Robinson, dean of the Western New England College School of Pharmacy. "To accomplish something like this, it was imperative to find a collaborate who shared our belief in the pharmacist-as-educator model, and to that end, we are thrilled to be working with Big Y."
H.D. Smith signs prime vendor agreement with U.S.-based Nigerian pharmacy group
CINCINNATI and SPRINGFIELD, Ill. A large group of Nigerian-owned independent retailers has struck a new, three-year prime vendor agreement with H.D. Smith, a leading national pharmaceutical wholesaler.
H.D. Smith and the Nigerian Association of Pharmacists and Pharmaceutical Scientists in America said the deal would bolster both groups. Under terms of the contract, H.D. Smith will become the primary supplier of pharmaceutical products for the more than 100 U.S. pharmacies that are NAPPSA members. The supply agreement begins immediately and extends through June 30, 2013.
“We are excited and proud of this accomplishment, and hope it is only the beginning of more to come,” said NAPPSA Nnodum Iheme. “Since success breeds success, we anticipate more Nigerian-owned pharmacies to join or partner with NAPPSA.”
H.D. Smith chairman and CEO Dale Smith also expressed satisfaction with the agreement. “The decision to select a primary vendor does not come lightly and demands close inspection of services, programs and reputation,” Smith said. “We seek to enhance NAPPSA members’ success.”
NAPPSA is an umbrella organization of Nigerian pharmacists, pharmaceutical scientists, allied scientists and academics in the Americas. “Among other objectives, NAPPSA fosters cooperative efforts among relevant educational, research, industrial, commercial and governmental entities; propagates critical information in the medical, biological, pharmaceutical and related healthcare-technology fields, for the optimization of health outcomes,” the group noted in a statement.
H.D. Smith markets itself as “the largest privately held national full-line, full-service wholesaler that provides a complete line of pharmaceuticals, OTCs, HBAs, home healthcare products, durable medical equipment, seasonal merchandise and a wide array of marketing programs to retail pharmacies, regional chains and health systems.”