On June 9, 2009, Vermont's governor signed S. 48, a new law that revises the state's current pharmaceutical marketing disclosure requirements. The new statute expands the application of Vermont's current requirement that pharmaceutical manufacturers annually disclose certain expenditures made in connection to interactions with Vermont health care professionals. Under the new law, the disclosure requirement now also applies to medical device companies. Further, the new law adds a ban on certain items and expenditures that was not included in the previous version. Notably, this gift ban goes into effect July 1, 2009...… 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
This post was also written by Matt Wetzel. On Nov. 10, 2008, a bill was introduced in the Texas Senate that would require drug companies to provide annual disclosures of gifts, payments and other economic benefits to health care providers. If passed, Texas would join the ranks of other jurisdictions (the District of Columbia, Maine, … Continue Reading
In early 2008, the District of Columbia City Council passed the SafeRX Amendment Act (the "Act"), introduced by Council Member David Catania. The Act requires pharmaceutical "detailers," which includes both employees and independent contractors of pharmaceutical manufacturers, to be licensed by the District of Columbia Board of Pharmacy (the "Board") by April 1, 2009. Pursuant to the Act and regulations issued by the Board Aug. 29, 2008, once a pharmaceutical detailer has been licensed by the Board, he or she must, among other things, (1) comply with the PhRMA Code on Interactions with Healthcare Professionals ("the PhRMA Code"), as well as additional requirements; (2) earn continuing education credits; and (3) follow stringent document retention requirements. This Client Alert summarizes the Act and the Board's regulations, and includes a list of considerations for manufacturers whose employees and independent contractors must be licensed to work in the District of Columbia. Read the full alert here: [https://www.lifescienceslegalupdate.com/wp-content/uploads/sites/500/2015/05/alert08186_lshi.pdf]
Check out our most recent posts at https://www.lifescienceslegalupdate.com, including another post written today, "Wisconsin Medical Society's Physician Gift Ban".… Continue Reading
This post was written by Matthew E. Wetzel. On Oct. 11, 2008, the Wisconsin Medical Society (WMS)–an association of more than 11,000 medical doctors in the state of Wisconsin–implemented a full ban on gifts to physicians. Specifically, the WMS policy prohibits physicians from accepting gifts from any provider of products that they prescribe to their … Continue Reading
A recent Virginia federal court decision demonstrates the powerful effect of the Riegel v. Medtronic precedent in product liability cases where PMA-devices are subject to claims-sounding in negligence or breach of duty related to the design, manufacturing, and labeling of the device. According to this court, however, the preemption defense of Riegel reaches only those allegations … Continue Reading
This post was written by Christine E. Bloomquist, Gina M. Cavalier, and Matthew E. Wetzel. INTRODUCTION On July 10, 2008, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) issued a revised Code on Interactions with Healthcare Professionals (“HCPs”) (the “PhRMA Code”). The revised PhRMA Code, which becomes effective January 2009, contains several key changes that will impact significantly … Continue Reading
