In early August 2018, the Food and Drug Administration (“FDA”) announced the availability for guidance in Clinical Research projects relating to expansion cohorts used in first-in-human (“FIH”) clinical trials that are used to expedite the development of Oncology Drugs and Biologics. The guidance is directed towards clinical sponsors in their design and conduct of FIH clinical trials intended to expedite the development of cancer drugs, including biological products that use multiple expansion cohort study designs. These studies typically employ multiple, concurrently accruing, patient cohorts, which use individual cohorts that assess the different aspects of the safety, pharmacokinetics, and antitumor activity of the drug. The FDA provides guidance for (1) the characteristics of drug product best suited for consideration for development under a multiple cohort study; (2) information to include in investigational new drug application submissions to justify the design of multiple expansion cohorts; (3) when to interact with FDA on planning and conduct of multiple expansion cohort studies; and (4) safeguards to protect patients enrolled in FIH expansion cohort studies.
One month after the largest health care fraud enforcement action was taken, the Assistant Attorney General, Brian A. Benczkowski, of the Justice Department’s Criminal Division, announced the addition of the Newark/Philadelphia Regional Medicare Strike Force. The newly added 11th Medicare Strike Force will largely focus on healthcare fraud that is contributing to the opioid epidemic.
Drug companies need to fund the research and development necessary to create better products. This means that pharmaceutical companies have fought for years to maintain control over the prices of said drugs. But this standard is being challenged with a new bill that was introduced to the House of Representatives on June 25, 2018.
In January 2018, Warren Buffet, Jamie Dimon, and Jeff Bezos announced that Berkshire Hathaway, JP Morgan Chase, and Amazon would partner together to form a non-profit company aimed at improving the United State healthcare system and combating ever-increasing costs. The idea for the project came about from the ongoing discussion between the three CEOs regarding providing healthcare for their, collectively, approximately 840,000 employees. Even though details are scarce, given the importance of the issue and the prominent names attached to this project, the press, the public, and the market have reacted accordingly. In other words, people are scrambling to figure out what this might mean for their companies and our healthcare system as a whole.
In April 2013, members of the Federation of State Medical Boards (FSMB) and the Council of State Governments (CSG) embarked on a venture to create the Interstate Medical Licensure Compact (the Compact or IMLC), a voluntary, expedited pathway to licensure for qualified physicians who wish to practice medicine in multiple states. On April 20, 2017, the Interstate Medical Licensure Compact Commission, (IMLCC) issued its first Interstate Medical License to a Wisconsin physician who applied to practice in Colorado, setting a groundbreaking precedent in medical licensure portability. While the IMLC is a great first step toward increasing access to healthcare by expanding licensure portability, this initiative faces multiple regulatory hurdles.
Connie Zhang Associate Editor Loyola University Chicago School of Law, JD 2018 Your healthcare may come from an accountable care organization, and you may not even know it. That could soon change now that the IRS has denied one commercial accountable care organization (ACO) the tax-exempt status granted to most nonprofit health care providers. …