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.”
NACDS cautions Congress on expanding Medicare’s DME bidding program
ALEXANDRIA, Va. The National Association of Chain Drug Stores on Wednesday issued a statement to the House of Representatives’ Committee on Energy and Commerce Subcommittee on Health, which held a hearing earlier in the morning on the implications for quality, cost and access to Medicare’s competitive bidding program for durable medical equipment.
NACDS recommended to the subcommittee that the Centers for Medicare and Medicaid Services delay expansion of the competitive bidding program until the impact of the program on Medicare beneficiaries’ access to healthcare services and supplies is fully analyzed. In particular, NACDS urged caution in expanding the program to include retail pharmacies and diabetic testing supplies.
“To ensure that community pharmacists continue to play a role in providing quality healthcare services and decreasing medical costs, it is vital that Medicare beneficiaries have continued access to medications and supplies through community retail pharmacies,” NACDS stated. “Pharmacists play a key role in ensuring patients use their supplies in the most proper and meaningful way. Including retail pharmacies in the competitive bidding program will limit the number of options available to beneficiaries. … Beneficiaries should have the continued ability to obtain their medical supplies from pharmacies with which they have a long-standing relationship,” the statement read.
In related news, the National Community Pharmacists Association, the lobbying group which represents the nation’s independent pharmacies, offered three legislative recommendations to the House subcommittee, which included the passage of H.R. 5235 — the Medicare Access to Diabetes Supplies Act — which would preserve seniors’ access to diabetes supplies at community pharmacies by exempting such businesses from the first round of the competitive bidding program. NCPA also added that:
- Congress must introduce and pass legislation that exempts community pharmacies from any pricing resulting from competitive bidding. Otherwise, pharmacies might be forced to ”terminate sales of diabetes testing supplies and hinder beneficiary access if the prices established under such a program are applied to the community pharmacy market” in the future; and
- In enacting legislation to address the points above, Congress also should clarify the ability of community pharmacists to deliver these products to homebound seniors and, on a temporary basis, to “snow bird” seniors who spend colder months in warmer climates. CMS’ proposed present definition in this instance of “mail order” as “any item…shipped or delivered to the beneficiaries’ home regardless of the method of delivery,” would block community pharmacies from providing these patient services.
NCPA noted that it has constructively worked with CMS ever since the CBP program was announced and that such efforts will continue.
Thompson Brands’ Adora supplement arrives at retail
MERIDEN, Conn. Thompson Brands on Wednesday launched its Adora calcium and vitamin D supplement, an all-natural chocolate that is 30 calories per serving.
"After a great deal of research, we have perfected the formula for a delicious-tasting calcium and vitamin D supplement that is made from all-natural premium chocolate," stated Gene Dunkin, CEO of Thompson Brands. "This was not an easy task, considering the delicate balance between the calcium mineral’s inherent chalkiness, the recommended daily dosage in each serving size and the creamy texture and rich flavor we were trying to achieve."
Each chocolate Adora disk provides up to 50% of the daily value of calcium plus vitamin D3 and magnesium for optimal absorption. Adora calcium and vitamin D supplement is available in milk chocolate and dark chocolate flavors and can be found nationally at CVS/pharmacy stores, Whole Foods and other retailers for a suggested retail price of $9.99.