Missed last week and sorry about that and this week’s roundup is a day late. It has been a busy Fall and even yesterday was a travel day. I can barely keep up with how quickly the year is passing.
And in health care, there has been a great deal of news, some of it not very good. Let’s try to focus today on a few of the more positive developments from our friends at FDA.
- Two Approvals for Idiopathic Pulmonary Fibrosis – On the same day, FDA announced the approval of two new treatments for Idiopathic Pulmonary Fibrosis, a condition that causes gradual scarring of the lungs and can result in the need for transplant. Both products had fast track, priority review, breakthrough and orphan product designations. (You can see the differences between the first three of those here.) The first announcement from FDA was about Esbriet (perfenidone) and the second was for a drug named Ofev (nintedanib) is a kinase inhibitor.
- FDA Approves Labeling for XR Abuse Deterrent Opioid – An extended release opioid analgesic – Embeda – got the ok for approved new labeling this week and is the third such product approved under the FDA’s 2013 draft guidance “Abuse Deterrent Opioids – Evaluation and Labeling.” The label reflects that fact that the product has properties that are expected to reduce the possibility of oral abuse when crushed, though there are not properties that would prevent abuse altogether.
- Legislation Introduced on Prescription Drug and Heroin Addiction – On a related note, Senator Edward Markey of Massachusetts announced that he was releasing a report this week to address addiction issues related to both prescription drug products and heroin. The report contains policy recommendations that address a number of issues associated with addiction and abuse under three primary categories including in part: Prevention – increasing awareness, research on tamper-proof design, tracking prescriptions, proper disposal; Enforcement – strengthening courts, improving treatment in prisons and ensuring medical coverage upon re-entry after discharge; and Treatment – improving access to dependence treatment and evidence based treatments, increasing capacity, reducing insurance barriers, and improving care.
That’s it for me this week. Have a good weekend everyone.
Photo Credit: Anne Becker