Drug Shortages Continue to Make Headlines
Drug shortages are not resolving, and the FDA expects an increase in demand-related shortages.
Within the past few weeks, the FDA reported demand-related shortages for the antibiotic amoxicillin due to a spike in respiratory infections.
Adderall, used to treat ADHD, has also been in shortage for months. Shortages for this drug can be more difficult to combat because it is classified as a Class 2 controlled substance, which means companies are limited on how much they can make. Demand has also bolstered shortages, driven by increased awareness of the condition and emergence of telehealth services.
When surges in demand occur, manufacturers are unequipped to immediately respond with increased capacity. Mark Cuban’s Cost Plus Drugs is taking a proactive approach in addressing the supply chain issues. The company recently opened a robotics-driven manufacturing site in Texas. The advanced technology at the site is equipped to rapidly respond and address drug shortages in hospitals.
Legislative Updates to Prescription Drug Transparency
Section 204 of the Consolidated Appropriations Act (CAA) established new transparency reporting requirements for prescription drug data collection (RxDC). Enforcement of the RxDC reports were scheduled to go [?] into effect on December 27, 2022. However, days before the enforcement date, the U.S. Departments of Labor, Health and Human Services, and Treasury (collectively, the Departments) released an FAQ with additional updates for the 2020 and 2021 data, including:
- The Departments will not take enforcement action against any plan or issuer that makes a “good faith, reasonable interpretation” of the requirements and RxDC reporting instructions for the 2020 and 2021 submissions.
- A non-enforcement grace period is being provided through January 31, 2023, which means plans and issuers will not be considered out of compliance if the data is submitted by January 31.
As we move into 2023, employers are focused on applying lessons learned from the first round of submissions and remaining compliant with the reporting requirements. All subsequent RxDC reports are due June 1st of the following year. Additional clarifying guidance from the Departments is expected to be released prior to the next reporting deadline on June 1, 2023.
Contact us to learn more about how drug shortages and prescription drug transparency legislation may or may not affect you and your business.
- “Drug shortages aren’t going away any time soon, supply chain expert warns,” Fierce Pharma, accessed January 23, 2023, https://www.fiercepharma.com/manufacturing/drug-shortages-arent-going-away-any-time-soon-supply-chain-expert-warns
- “After Adderall, common antibiotic amoxicillin runs into shortage amid demand spikes and manufacturing woes,” Fierce Pharma, accessed January 23, 2023, https://www.fiercepharma.com/manufacturing/after-adderall-common-antibiotic-amoxicillin-runs-shortage-amid-demand-spikes-and
- “Mark Cuban in talks with hospitals to solve drug shortages,” Becker’s Healthcare, accessed January 23, 2023, https://www.beckershospitalreview.com/pharmacy/mark-cuban-in-talks-with-hospitals-to-solve-drug-shortages
- “AFFORDABLE CARE ACT AND CONSOLIDATED APPROPRIATIONS ACT, 2021 IMPLEMENTATION PART 56,” CMS, accessed January 23, 2023, https://www.cms.gov/files/document/aca-part-56.pdf