The New Jersey Department of Human Services ("Department") has sent letters to numerous pharmaceutical manufacturers demanding rebate payments under the Work First New Jersey General Public Assistance/Medicare Part D Wraparound Drug Rebate Program ("GA Rebate Program"). The Department is seeking to collect payments from manufacturers that have chosen not to participate in the GA Rebate Program and thus never entered into a GA Rebate Program agreement with the Department ("Rebate Agreement"). In addition, for some manufacturers that have entered into Rebate Agreements, the Department is now seeking payments for time periods prior to the effective dates of those Rebate Agreements.… Continue Reading
On January 19, 2011, FDA announced its long-awaited plans for revising the premarket notification (510(k)) process for medical devices to address the concerns that have been raised about the process by industry, consumers and Center for Devices and Radiological Health (CDRH) staff regarding the lack of predictability, consistency, transparency of the process, the inadequacy of the process to ensure the safety and effectiveness of products, and the lack of flexibility of the process to address changing technology and complexity. In 2009, CDRH established working groups to address these concerns. In August 2010, these working groups issued recommendations, which FDA analyzed and addressed as part of the announcement. FDA also sought public input and comments.… Continue Reading
FDA has issued a press release on its plan to reform the 510(k) medical device review process, outlining changes it intends to implement during 2011 including streamlining the "de novo" review process for certain innovative, lower-risk medical devices; clarifying when clinical data should be submitted in a premarket submission; and "establishing a new Center Science Council of senior FDA experts to assure timely and consistent science-based decision making." Undoubtedly there will be much more on this in the coming weeks and months.… Continue Reading
On January 14, 2011, the Internal Revenue Service ("IRS") issued Notice 2011-9 (the "Notice"), which extended the filing date for reporting on Form 8947 a covered entity's 2009 sales of branded prescription drugs under the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the "Affordable Care Act" or the "ACA"). The filing date for Form 8947 with respect to 2009 sales of branded prescription drugs was extended from January 20, 2011 to February 11, 2011. In addition, in response to numerous comments received by the IRS, the Notice made certain changes to Notice 2010-71, 2010-50 IRB (the "Initial Notice"), primarily with respect to the information requested from covered entities.… Continue Reading