Merck, Schering-Plough announce settlement, close of investigation of anti-cholesterol drugs, related trial
WHITEHOUSE STATION, N.J. Two drug makers and their joint venture announced that they settled with a group of attorneys general from 35 states and the District of Columbia investigating whether they violated consumer protection laws with regard to two anti-cholesterol drugs and a related clinical trial.
Merck & Co. and Schering-Plough Corp., as well as joint venture Merck/Schering-Plough Pharmaceuticals, said Wednesday that they had reached the settlement in connection with the drugs Vytorin (ezetimibe and simvastatin) and Zetia (ezetimibe) or ENHANCE, a clinical trial comparing the drugs.
As part of the resolution, the companies have agreed to reimburse the investigative costs, which total $5.4 million, but they are not required to make any other payment. They have also agreed to comply with the Food, Drug and Cosmetic Act, the U.S. Food and Drug Administration Amendments Act and other laws requiring truth in marketing.
“Today’s agreement is consistent with our belief that the companies conducted the ENHANCE trial in good faith and that their promotion of Vytorin and Zetia was in compliance with the law,” Merck EVP and general counsel Bruce Kuhlik said in a statement.
Experts discuss medication adherence
WASHINGTON Poor adherence to medication regimens could counteract the benefits of healthcare reform, a panel of experts concluded Wednesday.
The panel — which brings together experts from GlaxoSmithKline, the National Association of Chain Drug Stores Foundation, the National Consumer’s League and the Pharmaceutical Research and Manufacturers of America — hopes to open a dialogue about medication adherence with between experts from the health, medical, insurance, business, employer, academic and government sectors.
“To date, medication adherence hasn’t been a prominent part of the debate,” conference moderator and founding editor of the journal Health Affairs John Iglehart said in a statement. “But no matter what shape health reform takes, it will ultimately be more successful if it supports the education and motivation of patients to properly follow their medication regimens.”
Participants in the panel will receive briefings on two new research efforts on medication adherence conducted by Avalere Health and the RAND Corp., respectively, using findings from the studies to guide the creation of policy and public education recommendations.
As many as 80% of patients may not be adhering to their medication regimens, according to research, resulting in adverse consequences and draining $100 billion to $300 billion from the healthcare system every year.
MiddleBrook Pharmaceuticals develops copay program for Moxatag
WESTLAKE, Texas A company making a long-acting formulation of a common antibiotic has announced a program to minimize the drug’s cost to consumers.
MiddleBrook Pharmaceuticals announced Wednesday a $20 maximum copay program for Moxatag (amoxicillin) extended-release tablets in the 775 mg strength, designed to keep the drug’s cost to patients at $20 or less. The company said it will field 300 representatives and district managers to begin supplying physicians with voucher cards for the program.
“In this tough economy, we recognize the need to improve Moxatag’s affordability to the patient,” MiddleBrook president and CEO John Thievon said in a statement. “This $20 maximum copay program will replace our current $15 point-of-sale copay check program, which has been in place since Moxatag’s launch.”