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.”
Study: Smoking cessation can provide health, economic benefits to Calif., nation
SACRAMENTO, Calif. A new study released Wednesday by the American Lung Association, and conducted by researchers at Penn State University, found that helping smokers quit not only saves lives but also offers favorable economic benefits to California and the nation.
“Smoking Cessation: The Economic Benefits” provides a nationwide cost-benefit analysis that compares the societal costs of smoking with the economic benefits of states providing cessation coverage.
There are an estimated 3.8 million people who smoke in California, and the study found that smoking results in costs to the California economy of more than $26 billion. This includes workplace productivity losses of nearly $6 billion, costs of premature death at more than $9 billion and direct medical expenditures of $11 billion.
The Penn State study also calculated the combined medical and premature death costs and workplace productivity losses per pack of cigarettes. The study showed that while the statewide average retail pack of cigarettes in California is $5.17, the true cost of a pack of cigarettes when considering healthcare impacts and workplace productivity losses is $27.07 per pack, a third higher than the $18.05 national average.
The American Lung Association study found that smoking cessation provided a tremendous return on investment for states. For every dollar spent on helping smokers quit, states will see, on average, a return of $1.26. However, the return on investment for California is among the highest in the country at $1.40. Comparative data for all states can be found at LungUSA.org/stop-smoking/tobacco-control-advocacy/reports-resources/cessation-economic-benefits/ .
The study came at an important time, as smoking-cessation provisions are being implemented at the federal level and in California as Senate Bill 220 is awaiting action by Gov. Arnold Schwarzenegger. Sponsored by the American Lung Association in California, the Cancer Society and the Heart Association, SB 220 would require all health plans and insurers to provide coverage of treatments to help people who smoke to quit smoking. If signed into law, SB 220 would represent the most comprehensive smoking-cessation benefits policy in the nation.
“Gov. Schwarzenegger has the opportunity to make a long-lasting difference in the health and lives of future generations of Californians, and we urge him to do so by signing SB 220 into law,” stated Jane Warner, president and CEO of the American Lung Association in California.
Some of the highest rates of smoking are found among people enrolled in Medicaid, the American Lung Association added. The American Lung Association urged California and every state in the nation to provide all Medicaid recipients and state employees with comprehensive, easily accessible tobacco-cessation benefits. A comprehensive cessation benefit includes all seven medications and three types of counseling recommended by the U.S. Public Health Service for tobacco cessation. Only six states now provide comprehensive coverage for Medicaid recipients: Indiana, Massachusetts, Minnesota, Nevada, Oregon and Pennsylvania.
The American Lung Association also recommends that private insurance plans and employers offer comprehensive cessation coverage, and encourages states to require them to cover these treatments. Only seven states have such requirements now: Colorado, Maryland, New Jersey, New Mexico, North Dakota, Oregon and Rhode Island.
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.”