Category: Healthcare

21st Century Cures Act Lands in Federal Budget Blueprint

President Trump’s proposed FY 2018 Budget (a/k/a the “skinny budget”) presented a departure from his predecessor’s proposed annual budgets – namely a $54 billion increase in defense and military spending paired with corresponding cuts to virtually every other federal department. But one area President Trump did not cut was the implementation of the 21st Century Cures Act (the “Cures Act”), which also happens to be one of the last bills signed into law by then-President Obama. The FY 2018 budget blueprint proposes to appropriate $1.1 billion towards the Cures Act’s implementation in the upcoming fiscal year. The Cures Act strives to expedite the discovery, development, and delivery of new treatments and cures. Those in the medical, biotechnology, and pharmaceutical industry should look to the Cures Act as the potential game-changer that the bipartisan sponsors of the law hoped it would be. Not only does the Cures Act provide the National Institute of Health with significant new funds to speed up research into diseases like cancer and Alzheimer’s, but it also attempts to speed up the process by which new treatments are reviewed and approved by the FDA. The Cures Act also focuses on changes to the treatment of mental health and...

Sufferers of PTSD Gain Access to Medicinal Marijuana

On September 14, 2016, New Jersey amended its medicinal marijuana law to add post-traumatic stress disorder (‘PTSD’) as a qualifying condition, permitting PTSD sufferers to gain access to this unconventional therapy for the first time. Some background — In 2009, New Jersey became the 14th state to allow access to medicinal marijuana. Over the past seven years, 11 additional states have expanded their laws to allow access to medical marijuana. In New Jersey, the original law provided access to medical marijuana for the following conditions: Amyotrophic lateral sclerosis; Multiple sclerosis; Terminal cancer; Muscular dystrophy; Inflammatory bowel disease, including Crohn’s disease; Terminal illness, if the physician has determined a prognosis of less than 12 months of life; Seizure disorder, including epilepsy; Intractable skeletal muscular spasticity; Glaucoma; Positive status for human immunodeficiency virus; Acquired immune deficiency syndrome; and Cancer. Under the amended law signed by Governor Christie, a patient with PTSD would be eligible for medicinal marijuana if she has been unsuccessful alleviating her symptoms with conventional medical therapy. Additionally, the patient would have to obtain certification of her condition from a physician with whom she has a “bona fide physician-patient relationship.” Several other recent developments on this issue merit a brief...

Legislative Fixes to Keep Pharmaceutical Companies in NJ

In recent years, New Jersey has — at times — been deemed a “Judicial Hell Hole” by the American Tort Reform Association. The expense of defending thousands of mass tort products liability cases in New Jersey, as well as other costs of doing business in New Jersey, have resulted in some pharmaceutical companies relocating out of state. To halt the trend of businesses leaving New Jersey, the legislature could consider the following three actions to incentivize New Jersey companies to remain in-state. Provide an absolute defense to pharmaceutical companies sued for a failure to warn claim if the warning was approved by the Food and Drug Administration (“FDA”). Michigan has adopted, MCL 600.2946(5), which, subject to two exceptions, establishes an absolute defense for drug manufacturers and sellers in a products liability action, where the drugs complied with FDA standards and labeling. In New Jersey, a bill similar to MCL has been introduced. While N.J.S. 2A:58C-4 of the New Jersey Products Liability Act (“NJPLA”) provides for a rebuttable presumption of adequacy with respect to a drug label where the drug is approved by the FDA, an absolute defense in these circumstances would be more appropriate. The pharmaceutical industry is among the most...

New Jersey Moves Forward with Attempts to Regulate E-Cigarettes

On May 16, the New Jersey Senate Health, Human Services and Senior Citizens Committee heard more than three hours of testimony from a variety of groups on a bill — S.298, introduced by Senator Joe Vitale — that would prohibit the sale of flavored electronic cigarettes. New Jersey banned the sale of flavored traditional cigarettes in 2008 because of concerns regarding their attractiveness to children. The sponsor believes that the same concerns apply to electronic cigarettes today, making this legislation necessary to create uniformity in the state’s public health laws, all of which are designed to keep children from starting a smoking habit. Opponents contend that this bill would reduce adults’ access to a product that has enabled many tobacco-addicted people to quit smoking. According to NCSL, 48 states and two territories currently prohibit sales of electronic cigarette products to minors. (Michigan and Pennsylvania still permit the sale of electronic cigarette products to minors.) In 2010, New Jersey was one of the first states to include electronic cigarettes among other tobacco items that would not be sold to minors when it expanded the New Jersey Smoke-Free Air Act. S.298 was released from committee by a vote of 6-2 and now...