January 31, 2010
by Amy Dow, Leah Kendall and Lee Rosebush
The U.S. Food and Drug Administration (“FDA”) continues to focus on clinical research activities. In this regard, FDA recently has taken two additional actions to regulate the conduct of clinical trials: (1) publishing a proposed rule updating informed consent regulations; and (2) issuing a draft guidance addressing Institutional Review Board (“IRB”) continuing review requirements. This Client Alert provides a high level summary of these recent FDA regulatory developments in the clinical research area.
January 28, 2010
by Sarah Giesting and Wendy Goldstein
On January 19, 2010, New York Governor David Paterson introduced Senate Bill 6608[i]as part of the 2010-11 New York State Executive Budget. Included in Senate Bill 6608 is a provision to add Section 279, “Interactions Between Pharmaceutical Companies and Health Care Professionals,” to the Public Health Law (“Section 279“). Similar bills are pending in the New York Senate and General Assembly.[ii]
If enacted, Section 279, like other current state marketing laws[iii] and industry codes,[iv]provides a code of conduct applicable to “all companies that sell or market prescription drugs, biologics or medical devices in the state” (“Pharmaceutical Company“).[v]Notably, Section 279 would be the first state law also to provide a code of conduct applicable to health care professionals (“HCP“) practicing in the state to whom such drugs, biologics or medical devices are sold or marketed.
January 26, 2010
On January 14, 2010, acting Governor Steven M. Sweeney signed into law the New Jersey Emergency Responders Employment Protection Act. The Act prohibits employers from terminating, dismissing or suspending an employee who fails to report for work because he or she is serving as a “volunteer emergency responder” who is either: (1) actively engaged in responding to an emergency alarm; or (2) volunteering as an emergency responder during a state of emergency declared by the President of the United States or the Governor of the State of New Jersey. The Act will take effect on April 1, 2010.
January 7, 2010
I just read a new press release by the National Association for Law Placement (NALP) that I would like to share with you. Entitled “Most Lawyers Working Part-time Are Women – Overall Number of Lawyers Working Part-time Remains Small,” the release highlighted statistics featured in the 2009-2010 edition of the NALP Directory of Legal Employers. NALP discovered that 5.9 percent of lawyers worked part-time in 2009, up from 5.6 percent in 2008. This information was based on data from 1,475 individual law offices and firms and more than 140,000 lawyers. (By the way, the percentage of part-time lawyers is far below the percentage of part-time employed individuals in the U.S. workforce as a whole, which was estimated to be nearly 14 percent in 2008.)