Cosmetic Regulation in the U.S.: Is the FDA doing enough?
The Food and Drug Administration (FDA) has had authority over cosmetics since the passing of the Food, Drug, and Cosmetic Act (FDCA) in 1938. However, this authority is based only in regulatory power, not approval power. The FDCA does not require cosmetics to acquire pre-market approval, except for cosmetics that have color […]
The FDA and Insulin: Biologic and Biosimilar Pricing
The United States is the most expensive market for biologic drugs, including insulin, despite initiatives devised by the Food and Drug Administration (FDA) and the Affordable Care Act. For more than a decade, the biosimilars market in the US has lagged behind the European market, whose medicines are as much […]
Blockchain’s Promise for the Future of Healthcare
In the winter of 2017, the world was captivated by the rise and fall of Bitcoin. Every night during its historic rise, local news ran rags-to-riches stories of basement investors who had cashed out at the right time. Every day, bloggers, tech journalists, and finance journalists tried to diagnose the […]
From Counsel to Counselor: A Brief Overview of the Legal Profession’s Relationship with Mental Health
People joke that being an attorney sucks the life out of you. And frankly, it does. There is a high mental and emotional toll on legal professionals. A 2016 survey from the American Bar Associationfound that “21-36% of lawyers qualify as problem drinkers, approximately 28 percent of lawyers are struggling with […]
Does a New Round of Pharmaceutical Deal-Making Invite Regulatory Scrutiny?
On January 3rd, Bristol-Myers Squibb Co. agreed to purchase Celgene Corp. for approximately $74 billion. Once the deal closes, it will be the largest pharmaceutical acquisition in history. The acquisition is driven by Bristol-Myers’ expansion into immuno-oncology drug manufacturing and the potential to leverage Celgene’s research pipeline to boost Bristol-Myer’s […]