Rite Aid to pay $5 million in violations to settle allegations
WASHINGTON Rite Aid has agreed to pay $5 million in civil penalties to settle allegations of violations of the Controlled Substances Act, the Department of Justice announced Monday.
According to information contained in the agreement, the Drug Enforcement Agency conducted an investigation of 53 separate Rite Aid locations starting in 2004. The DEA charged that Rite Aid violated the CSA, alleging the following:
• At pharmacies in Kentucky and New York, Rite Aid knowingly filled prescriptions for controlled substances that were not issued for a legitimate medical purpose pursuant to a valid physician-patient relationship;
• At five pharmacies in Maryland, four pharmacies in New York and 13 pharmacies in California, Rite Aid failed to notify the DEA in a timely manner of significant thefts and losses of controlled substances;
• At pharmacies in California, Pennsylvania and Maryland, Rite Aid either failed to maintain or failed to furnish to the DEA upon request records that are required to be kept under the CSA for a period of two years;
• At 53 pharmacies in eight states, Rite Aid failed to properly execute DEA forms used to ensure that the amount of Schedule II drugs ordered by Rite Aid were actually received.
In addition to the $5 million penalty, Rite Aid agreed to a compliance plan with the U.S. Drug Enforcement Administration to ensure compliance with all requirements of the CSA and applicable DEA regulations and to prevent diversion of controlled substances. The compliance plan also requires Rite Aid to implement a pseudoephedrine and ephedrine tracking system in each of its 4,915 stores that is designed to prevent the abuse of pseudoephedrine and ephedrine products.
“Congress regulates prescription medications because of their powerful and potentially harmful effects,” said Deputy Attorney General Mark Filip. “Today’s settlement will help to curb illegal access to these dangerous drugs that can often be abused.”
“This settlement demonstrates the important responsibilities all pharmacies have to prevent dangerous drugs from being diverted from their intended use,” commented DEA acting administrator Michele Leonhart.
The settlement agreement is neither an admission of liability by Rite Aid nor a concession by the United States that its claims are not well founded.
GSK completes acquisition of Stiefel
LONDON A drug maker has announced it has completed the acquisition of a company specializing in skin care.
GlaxoSmithKline announced that it has completed its acquisition of Stiefel Labs. GSK has acquired the total share capital of Stiefel for a cash consideration of $2.9 billion. GSK also assumed $0.4 billion of net debt. Under the terms of the agreement, GSK may be obligated to make additional cash payments of up to $0.3 billion depending on the future performance of the business. The new dermatology business unit within GSK will operate under the name Stiefel, a GSK company.
“The Stiefel acquisition demonstrates how we are implementing our strategy to grow and diversify our business through targeted acquisitions,” Deirdre Connelly, president North American Pharmaceuticals at GSK. “We now have established a new world-leading, specialist dermatology business that will immediately generate new revenue flows to GSK.”
Charles Stiefel, Chairman of Stiefel, said, “As part of GSK, we are stronger, more competitive and continue to be a driving force in dermatology around the world. We are excited to combine GSK’s prescription dermatology products, such as Bactroban, Cutivate and Altabax, with Stiefel’s portfolio, including brands such as Duac, Olux E and Soriatane. This combined portfolio, together with our specialty sales force and GSK’s global presence, positions GSK’s dermatology business for significant growth.”
Sales of Stiefel’s products for 2008 were approximately $900 million and sales of GSK’s prescription dermatology products were approximately $550 million. The combined pro forma revenues of approximately $1.5 billion, represent an 8% share of the global prescription dermatology market.
Stiefel is committed to improving and developing new treatments and has a robust development pipeline, with more than 15 projects in late-stage development across a wide variety of such dermatological conditions as acne, dermatoses and fungal infection. The business unit also has access to significant innovative and proprietary formulation technologies.
Trial for MS drug should continue, company’s DSMB says
EDMONTON, Alberta An independent data safety monitoring board has recommended that a phase 3 trial for a multiple sclerosis drug continue.
BioMS Medical Corp. announced Tuesday that the DSMB for its pivotal phase 3 trial of the drug dirucotide in patients with secondary progressive MS has completed its safety analysis and recommended the continuation. This was the fourth of several regularly scheduled reviews by the DSMB, BioMS said.
The study is a randomized, double-blind study that has completed recruitment of more than 500 patients at 67 clinical sites who will receive either dirucotide or placebo intravenously every six months for the next two years.