• The FDA submitted a draft guidance to the Office of Budget and Management on implementation of required label changes based on new safety information available for drugs and biologics post-approval. Under the draft guidance, application holders can expect a notification letter from the FDA, to which they must then respond with submission of a labeling supplement, or a statement explaining why a labeling change is not necessary. The applicants should also post the new labeling on their websites within 10 calendar days of approval. The FDA said that about 197 companies will update their labels each year, at a cost of about 4 hours' time in preparation.

• The Patient-Centered Outcomes Research Institute (PCORI) will award $12 million in funding through 14 contracts for studies addressing knowledge gaps in comparative clinical effectiveness research. The PCORI's goals are to build data infrastructure, improve analytic methods and train researchers and patients. The current funding announcement is the first of many future awards PCORI plans to issue in the future.

• The SEC has collected more than 3,000 whistleblower tips from 50 states and 49 countries in the first year of the Dodd Frank Whistleblower Program, according to a report on the program released Friday. The most common complaints had to do with corporate disclosures and financials, fraud, and manipulation. The program resulted in 143 enforcement judgments and orders in 2012 eligible for a whistleblower award. The SEC made its first award to a whistleblower, in the amount of 30 percent of the amount collected in in its enforcement action.

• The American Medical Association adopted new advocacy agendas including next-generation sequencing technologies; hepatitis C virus education, prevention, screening and treatment; workplace violence; gene therapy; vaccination for whooping cough; and caring for Medicare and Medicaid patients.

• The Government Accountability Office (GAO) issued a report on high-cost Medicare Part B drugs, finding that in 2010, the 55 highest-expenditure drugs represented $16.9 billion in spending, or about 85 percent of Medicare's spending on all part B drugs. The five drugs with the largest increase in cost from 2008 to 2010 also had the largest increase in beneficiaries. Medicare Part B covers a wide range of drugs and biologics prescribed by physicians at a rate of 80 percent, with the remaining 20 percent paid by the beneficiary or supplemental coverage. Congress requested the report in order to determine which Part B drugs had the highest expenditures and the trends driving those expenditures, and to gauge nationwide spending levels for the overall population for those drugs and Medicare's percentage of total U.S. spending.