FDA Drug Shortages and Supply Chain Updates

Updated April 9, 2020

MIDAZOLAM SHORTAGE IN THE UNITED STATES: As you may have heard reported in the news, some hospitals are reporting a shortage of generic midazolam that is being used with ventilator treatment. The Dravet Syndrome Foundation reached out to UCB, which confirmed this issue does not impact their product and there is no shortage of NAYZILAM (nasal midazolam). The shortage is not related to the midazolam used in NAYZILAM. UCB remains very confident in their supply chain and, in fact, they restocked the national supply of NAYZILAM last week.

Here are some additional resources that may help patients:

Updated April 1, 2020

The Congressional COVID-19 Relief and Support Package includes $80 million for the Food and Drug Administration to continue efforts related to shortages of critical medicines, enforcement work on counterfeit and misbranded products, emergency use authorizations and pre and post market work on medical countermeasures, therapies, vaccines, and research.

Updated March 26, 2020

The TSC Alliance has learned some individuals and families are experiencing delivery delays in receiving Afinitor® from Briova/Optum Specialty Pharmacy.  Please know we are working behind the scenes to help remedy this issue.  If you are experiencing these challenges and utilize Afinitrac, contact their Patient Support Line at 888-669-6682 (Monday to Friday 8:30 a.m. to 5 p.m. ET) to get help navigating any delivery delays.

UPDATE: Afinitrac will be ending on June 30, 2022. Novartis will continue to provide financial assistance through Patient Assistance Now Oncology (PANO), which is the patient assistance arm of Novartis Oncology.  For requests or questions, caregivers and individuals with TSC can reach PANO at 800-282-7630 or visiting patient.novartisoncology.com.  The main differences between Afinitrac and PANO is there will no longer be patient education on Afinitor, the patient care team is replaced by case managers at PANO, and 1 free trial (14 days) is offered while insurance companies are evaluating prior authorization.  Anything beyond 14 days is evaluated on a case by case basis.  They will continue to offer co-pay and other forms of assistance through PANO.

Updated March 25, 2020

The TSC Alliance is not aware of any current seizure medication shortages caused by COVID-19.  Refer to the FDA Drug Shortage website for current information.