Policies & Guidelines

The Impact of Policy and Politics on Health and Drug Pricing

Jessica Miller

December 2016, Vol 7, No 11 - Health Policy

Washington, DC—A panel discussion on health and drug politics took place at the Sixth Annual Conference of the Association for Value-Based Cancer Care. The expert panel included Kavita Patel, MD, Johns Hopkins Medicine, Baltimore; Dan Todd, Principal of Todd Strategy, Washington, DC; and Liz Fowler, Vice President, Global Health Policy, Johnson & Johnson. The panel discussed what is working in healthcare, what is not, and where cancer care fits into it all. [ Read More ]

Increase in Drug Spending Largely Attributed to Rebates Pocketed by Pharmacy Benefit Managers

Robert Goldberg, PhD

September 2016, Vol 7, No 8 - Patient Advocacy

Total drug spending in the United States, based on invoice prices, reached $425 billion in 2015, according to the IMS Institute for Healthcare Informatics report, “Medicines Use and Spending in the U.S.: A Review of 2015 and Outlook to 2020.” When adjusted for net price spending, $310 billion went to drug and biotech companies, but where the other $115 billion went is often omitted from media coverage. [ Read More ]

FDA Advisors Vote Against Duchenne Muscular Dystrophy Drug, Reject Value of Hope for Patients

Robert Goldberg, PhD

July 2016, Vol 7, No 6 - Patient Advocacy

On April 25, 2016, an FDA advisory committee voted not to recommend the approval of eteplirsen, an experimental drug that targets one of many genetic mutations causing Duchenne muscular dystrophy (DMD), a deadly degenerative disease that has no cure. After agreeing to study the real-world effects of eteplir­sen, the FDA advisory committee rejected findings that patients who have been taking eteplirsen since 2011 were still able to walk because the clinical data did not meet the FDA requirements for a well-controlled study. [ Read More ]

FDA Streamlines Expanded Access Application for Patients to Get Investigational Drugs

Nick Bryant

July 2016, Vol 7, No 6 - Health Policy

The Individual Patient Expanded Access Application, which is designed to streamline the application procedure for individual patients who apply for expanded access to investigational therapeutics, including expanded access to drugs that are not in clinical trials, was recently updated by the FDA. Form FDA 3926 authorizes expanded access to investigational drugs for patients with serious or life-threatening conditions who have no therapeutic options. [ Read More ]