In recent months, many rheumatologists and rheumatology professionals have noted issues related to obtaining supplies of injectable and oral methotrexate for their patients with rheumatoid arthritis (RA). A conventional synthetic disease-modifying anti-rheumatic drug (csDMARD), methotrexate is available as both oral tablets and as a subcutaneous injection for the treatment of RA and other autoimmune diseases.1…
Mitigating Drug Shortages: FDA Officials Say Communication Is Crucial
PHILADELPHIA—The most vital component of avoiding drug shortages is early communication, officials from the U.S. Food & Drug Administration (FDA) said in a session at ACR Convergence 2022 in November. “Early notification is key in order to prevent and mitigate shortages,” said Hyun Son, PharmD, a member of the Drug Shortage Staff with the FDA…
American Medical Association House of Delegates Meets In-Person; ACR Successfully Advances New Policies
The ACR’s resolution addressing inappropriate Medicare Administrative Contractor policy processes was adopted, and two co-led resolutions on ARPA-H funding and saline shortages also passed the policy-making body.
ACR Delegation Asks AMA to Address Issues Impacting Rheumatology
After two years of special virtual sessions, the AMA House of Delegates will reconvene in person June 10–15. ACR representatives will focus on Medicare physician payment system reform, national drug shortages, funding the new Advanced Research Projects Agency for Health and more.
ACR Guidance on Tocilizumab Allocation During Shortage
In June, the U.S. Food & Drug Administration (FDA) issued an emergency use authorization (EUA) for tocilizumab (Actemra) for treatment of hospitalized COVID-19 adults and children who are receiving systemic corticosteroids and supplemental oxygen. Since this announcement, the tocilizumab manufacturer, Genentech, has not been able to produce enough product to meet the higher demand. The…
ACR Update on Tocilizumab Shortages
ATLANTA—The ACR is actively engaged with the U.S. Food & Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) drug shortage team as they work with the manufacturer to resolve current shortages of tocilizumab (Actemra). Demand for tocilizumab has outpaced supply, with demand increasing after the FDA’s June 24 Emergency Use Authorization (EUA) for…
U.S. FDA Says HCQ & Other Malaria Drugs in Shortage as COVID-19 Drives Up Demand
April 1 (Reuters)—The U.S. Food and Drug Administration (FDA) said malaria drugs hydroxychloroquine and related chloroquine are in shortage due to a surge in demand because of the coronavirus pandemic. The drugs, which have been tried with some success to treat the illness caused by the virus, were added to the agency’s website that lists…
Old Drug, New Interest: COVID-19 Spurs Hydroxychloroquine Supply Concerns for Rheumatic Disease Patients
After a study investigated if hydroxycholoroquine (HCQ) benefits COVID-19 patients, the drug—used to treat SLE and RA patients—began running out in pharmacies around the U.S. ACR leaders have asked the FDA to increase monitoring of the HCQ supply…
CVS to Prevent Stockpiling of Malaria Drug Amid COVID-19
March 25 (Reuters)—CVS Health said on Wednesday its pharmacy benefit management (PBM) unit was laying out measures to prevent the stockpiling of malaria drug, hydroxychloroquine, which is being tested as a potential treatment for the coronavirus. The company said it was also setting up limits on the use of azithromycin, a protease inhibitor and albuterol…
Not-for-Profit to Offer 20 Generic Drugs in 2019 to Alleviate Shortages
(Reuters)—A new not-for-profit supplier of generic drugs formed by a consortium of hospitals systems said it expects this year to be able to provide about 20 products to alleviate shortages of medicines used during surgeries and to treat life-threatening conditions, such as septic shock. Since the start-up of Civica Rx spearheaded by Intermountain Healthcare was…