This post was also written by Lorraine Mullings Campos. On March 17, 2009, the Department of Defense (DoD) issued a final rule to implement a provision of the 2008 National Defense Authorization Act (NDAA). In the final rule, the DoD takes the position that the NDAA requires pharmaceutical manufacturers to provide discounted drug prices based on … Continue Reading
Recent posts on www.lifescienceslegalupdate.com include:
"TRICARE Retail Pharmacy Program Subject To Federal Ceiling Prices Under New DoD Rule" discussing Department of Defense final rule to implement a provision of the 2008 National Defense Authorization Act.
View the entire entry:
https://www.lifescienceslegalupdate.com/2009/03/articles/regulatory-developments/tricare-retail-pharmacy-program-subject-to-federal-ceiling-prices-under-new-dod-rule/
...and "FCC Allocates More Spectrum to Wireless Medical Devices and Proposes Even More Spectrum for Implanted Neuromuscular Stimulators" which discusses the Federal Communications Commission's recently released Order allocating 2 MHz of new spectrum for advanced wireless implanted devices, which may enable the certification of new devices. The FCC also seeks comment on a proposal to allocate up to 20 MHz of spectrum for implanted neuromuscular micro stimulators.… Continue Reading
At the 2nd Session of the 11th National People's Congress (NPC) convened on March 5, 2009, China' Premier Wen Jiabao confirmed the major contents of the healthcare reform in the 2009 Government Work Report. On January 21, 2009, the State Council approved the Opinions on Advancing Healthcare Reform and the Implementation Plan on Advancing Healthcare Reform 2009-2011 in principle. The opinions and the plan are expected to be published after the NPC session, with the Government Work Report representing the first government document that confirms work focuses in the coming healthcare reform program.
According to the Work Report, the Chinese government will spend US$124 billion (850 billion RMB) on healthcare reform between 2009 and 2011, including 331.8 billion RMB from the central government. The funds will be used in five primary areas 1) medical insurance, 2) essential medications, 3) basic healthcare service systems, 4) equal access to basic public health services, and 5) reform of public hospitals.… Continue Reading
On March 11, 2009, the Massachusetts Department of Public Health (the "Department") released final regulations that impose restrictions on pharmaceutical and medical device manufacturers' sales and marketing activities. The final regulations--which implement section 14 of the Massachusetts Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care (the "Act")-- also require companies to file annual disclosures of all fees, payments and economic benefits paid to health care professionals that total $50 or more.
Massachusetts now joins seven other jurisdictions that have issued similar requirements. Currently, California and Nevada both require manufacturers to adhere to restrictions on marketing activities, and the District of Columbia, Maine, Minnesota, Vermont and West Virginia all mandate periodic disclosures of payments and other economic benefits to health care professionals. Massachusetts, however, has the broadest regulations in two regards. First, Massachusetts is the only state to include both a marketing code of conduct that is specifically enumerated in detail in the regulations as well as annual financial disclosure obligations. Other jurisdictions require adherence to a marketing code or disclosure, but not both. Second, Massachusetts is the first state to require financial disclosure from medical device companies. Financial disclosure requirements in other states currently only apply to pharmaceutical companies.… Continue Reading
On February 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the "ARRA"). The sweeping $790 billion economic stimulus package includes a number of health care policy provisions. Reed Smith's Health Care Memorandum summarizes the major health policy provisions of the Act.… Continue Reading
The Supreme Court had held action on a petition in Colacicco v. Apotex, Inc., No. 08-437, an implied preemption decision out of the Third Circuit involving an anti-depressant, pending the outcome of Wyeth. The docket now reflects that the case has been distributed for the Court’s March 6, 2009 conference. The most likely outcome is that … Continue Reading
Today the Supreme Court affirmed (http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf) Wyeth v. Levine, as reported by Drug and Device Law.… Continue Reading
This morning, March 3, 2009, the California Supreme Court heard argument in In re Tobacco II Cases, a case that will shape how parties litigate California Unfair Competition Law ("UCL") claims. At issue is the viability of UCL actions that seek to certify a class despite the fact that not all putative plaintiffs suffered injury as a result of a defendant's allegedly unfair practice. Since California's infamous UCL (also known as Bus. & Prof. Code, § 17200 et seq.) is often used to add broad "consumer fraud" claims to product liability lawsuits against the life sciences industry (as well as many other industries), the outcome of In re Tobacco II is garnering considerable attention.… Continue Reading
On Feb. 17, 2009, President Obama signed into law H.R. 1, the American Recovery and Reinvestment Act (the "ARRA").1 This memorandum outlines significant changes and additions to the landscape of federal privacy and security law set forth in Subtitle D of the ARRA. In general, the privacy and security portions of the ARRA become effective 12 months after the enactment of the ARRA, which is approximately February 2010. It is also important to note that the ARRA directs the Secretary of the U.S. Department of Health & Human Services ("HHS") to amend the HIPAA Privacy and Security Rules to implement the legislative changes. As such, the effective dates associated with the rulemaking process will vary.… Continue Reading
