AARDA Statement on HHS Decision to Delay Implementation of Rebate RuleJanuary 29, 2021
“Coronavirus Aid, Relief, and Economic Security Act” (CARES) Act
As the production for COVID-19 vaccinations increases due to multiple FDA approved vaccines on the market, it is critical that we ensure patients living with autoimmune diseases still have access to the life-saving treatments for their medical conditions. For patients with autoimmune disease and other serious illness, drug shortages are an issue facing them at such a critical time due to production orders related to Operation Life Speed.
COVID-19 vaccines are a top priority for all Americans, including those living with autoimmune disease, but this production should not cost those living with serious illness their life-saving treatment. Unless the FDA chooses to use its discretionary authority to prevent drug shortages under the CARES Act, patients with complex conditions may lose access to needed therapies.
The “Coronavirus Aid, Relief, and Economic Security Act” (CARES) Act includes provisions that specifically provide FDA with new authorities to address potential drug shortages without impacting the rollout of COVID-19 vaccines.
How this affects patients:
- “Just this last week during the two snowstorms Texas had, my Xolair injection appointment for severe asthma was delayed by a week due to extremely unsafe road conditions. Thankfully, no emergencies for asthma came up, but it was very unnerving to know that it could at any time and if it had, I might have needed to go to the ER and risk potential COVID-19 exposure.
If my anxiety or depression or chronic pain medication been delayed, that would certainly go badly. My medications keep those conditions and symptoms at bay, however withdrawal from those medications can cause arthritis pain to come back more severe than before, with my anxiety or depression medication it can cause serotonin syndrome which could land me in the ER, cause me to have much worse symptoms come all at once and completely overwhelm me.
Were my rescue inhaler or nebulizer solution be delayed and I had an attack, I wouldn’t have the medications at home I need to take care of the attack myself and require going to the ER, which is a huge medical bill and I could end up on a ventilator, something that could have been avoided and risks COVID-19 exposure, and that could end up going horribly as I have a lifetime of lung damage from asthma and am immunocompromised by my arthritis medications, that can take a long time to leave the system.
If my medicated eye drops were delayed, my symptoms of dry eye would return rapidly and interact with a genetic eye disease I have that can cause corneal abrasions and ulcers that can lead to temporary blindness and possibly cause permanent vision damage. I would also end up with horrendous pain that can’t be controlled and a high infection risk to my eyes, and an infection could cause me to lose my vision or an eye, even end up leading to a brain infection.” – Savanna Braun, Houston, Texas (Twitter: @SavannaBraun Instagram: @SavannaBraun, @PsoriaticAsthmatic) Diagnoses: Severe Allergic and Eosinophilic Asthma, Psoriatic Arthritis, Plaque and Inverse Psoriasis, Corneal Dystrophy, Sjögren’s dry eye disease, Major Depressive Disorder, and General Anxiety Disorder.
- “It took years to reach remission for Crohn’s and Psoriatic Arthritis. As I approach month 5 of pregnancy, it is now more important than ever to maintain my doctor’s prescribed treatment schedule.” – Jamie Holland