FDA Sends Warning to Merck
The U.S. Food and Drug Administration sent a warning letter to drug maker Merck, because the company failed to meet the deadline for completing a postmarketing study of sitagliptin (Januvia) and sitagliptin/metformin (Janumet). As a result, the agency wrote Merck, “your product is considered misbranded.” Merck had committed to conducting a 3-month pancreatic safety study in rodents to assess the risk of acute pancreatitis associated with sitagliptin. “Failure to promptly correct this violation may result in regulatory action by the FDA without further notice,” the agency wrote in its warning letter. Such actions could include civil financial penalties, and additional penalties if the violation is not corrected, the agency warned. In a statement, Merck officials said they would submit the final protocol for the rodent study within 30 days of the warning letter, and will start the study within 6 months.
ADA Applauds Funding
The Centers for Disease Control and Prevention received $10 million in funding from the U.S. Department of Health and Human Services for Fiscal Year 2012 to administer the National Diabetes Prevention Program, a national network of lifestyle intervention programs based on Diabetes Prevention Program clinical trial. In a statement, the American Diabetes Association applauded the funding. “Expansion of the National Diabetes Prevention Program will allow more Americans with prediabetes to participate in a proven program to lower their risk for type 2 diabetes and its dangerous complications,” said L. Hunter Limbaugh, Chair of the Board of the ADA, in a statement. But they expressed concern about President Obama's Fiscal Year 2013 budget. “The Association is concerned that the Administration's Budget does not provide adequate resources to continue the nation's investment in diabetes prevention and research at National Institutes of Health and the [CDC], both of which are critically important to addressing the diabetes epidemic.
Entity Promotes Collaborative Care
Six national health profession organizations have created the Interprofessional Education Collaborative, or IPEC, in an effort to create a more collaborative and patient-centered care environment. The stand-alone collaborative aims to advance interprofessional education around the nation, and is planning to share information on best practices and collaborative practice innovation. “Better patient care depends on all members of the health care team understanding each other's roles and knowing how to work together effectively,” said Dr. Darrell G. Kirch, president and CEO of Association of American Medical Colleges, one of the founding members of IPEC, in a statement.
Health IT Progress Report
At least 2,000 hospitals and 41,000 physicians have received $3.1 billion in incentive payments from the Health and Human Services department for certifying meaningful use of health information technology, the department said in a report. The American Hospital Association surveyed its members and found that 35% of hospitals were using electronic health records in 2011, up from 16% in 2009. Seven states had a significantly higher level of adoption, compared with the national average, of at least a basic electronic health record: Florida, Illinois, Massachusetts, Minnesota, Missouri, Virginia, and Wisconsin. The Centers for Medicare and Medicaid Services had compiled data showing that enrollment in incentive programs is increasing. In January, the agency provided $519 million to eligible providers.