Should generic drug makers be required to update their drug labels about safety concerns before FDA reviews the change? Should this be done even if the information differs from the brand name drug labels temporarily?
As healthcare facilities across the nation deal with shortages of certain drugs, including generics, pharmacists and pharmacy managers are tasked with the daily monitoring of drug supplies and increased communications with other healthcare professionals such as nurses and physicians.
FDA approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules, Ivax Pharmaceuticals, Inc., a subsidiary of Teva Pharmaceuticals USA) to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older. Esomeprazole is a proton pump inhibitor that reduces the amount of acid in the stomach.
While hepatitis C drugs Solvani, Harvoni, and Viekira Pak have been in the news recently because of their high price tag, and Express Scripts’ and CVS Health’s exclusive agreements with the drugmakers, they are not the only culprits in soaring drug costs.
There is plenty of activity already in the hepatitis C market as competition has arrived for 2015, including CVS Health versus Express Scripts and Gilead Sciences versus AbbVie, over FDA-approved hepatitis C treatments. This will have implications for retail prescriptions as well as continuity-of-care programs within non-Medicare accountable care organizations (ACOs) and health systems.
FDA recently raised concerns that two generic versions of Concerta (methylphenidate hydrochloride extended-release tablets; Janssen Pharmaceuticals) may not be therapeutically equivalent to the brand-name drug.