The Official Medicare Set Aside Blog And Information Resource

FDA Takes Interest in Compounding Medications; Does this Mean Compounded Medications Will be Included in WCMSAs in the Future?

FDA, MSAs, Rx/Pharmacy on April 10, 2019
Posted by Jean S. Goldstein, JD

Last week the Food and Drug Administration’s (FDA) Commissioner, Scott Gottlieb, M.D. and Deputy Commissioner, Anna Abram issued a statement on new 2019 efforts to improve the quality of compounded drugs.  The statement can be found here.  Interestingly in 2018, the FDA also announced a new and expanded compounded research project, for which the FDA announced […] Continue

FDA Approves Esketamine Nasal Spray (Spravato™) for Treatment-Resistant Depression

FDA, MSAs, Rx/Pharmacy on March 13, 2019
Posted by Leah King, PharmD, JD, Pharmacy Consultant

Earlier this month, the Food and Drug Administration (FDA) approved esketamine nasal spray, which will be marketed by Johnson & Johnson (J&J) under the trade name of Spravato™. Spravato is approved for use in conjunction with an oral antidepressant for treatment-resistant depression. The term “treatment-resistant” refers to those patients who have failed to achieve relief […] Continue

Osteoarthritis Drug Receives Fast Track Designation from FDA

FDA, MSAs, Rx/Pharmacy on February 21, 2019
Posted by Leah King, PharmD, JD and Marilyn J. Larrimer, RN, BSN, JD

In late November 2018, the FDA announced that it was granting Fast Track designation to an investigational drug for the treatment of osteoarthritis (OA). The drug, developed by Galapagos, is known by its identifier GLPG1972/S201086.  This drug is one to watch, since it has a novel mechanism of action for this therapeutic category. GLPG1972/S201086 is […] Continue

The Opioid Crisis: What is the Government Doing About It? Part 4 – Increasing the Availability of Overdose-Reversing Drugs

FDA, Opioids, Rx/Pharmacy on December 17, 2018
Posted by Complex Claims Division

This blog series is devoted to better understanding the efforts our Federal government is undertaking to combat the opioid epidemic in America. Earlier this year, the Department of Health and Human Services (HHS) announced a five-part strategy that will be utilized to combat the opioid epidemic. In previous posts, we have focused on the first […] Continue

FDA Awards Six-Month Patent Extension for Lyrica

FDA, MSP News, Rx/Pharmacy on November 30, 2018
Posted by Complex Claims Division

You may recall our earlier blog this week about Lyrica in the News.  Once again, the spotlight is on Lyrica.  First, after Pfizer was awarded a six-month patent extension based on a new pediatric indication for the drug.  Earlier this month, the Supreme Court in the United Kingdom ruled against Pfizer in a longstanding patent […] Continue