Akorn Bankruptcy, Shortages Are Disrupting Patient Access to Generic Medications

FDA representatives and others have appeared before Congress to express concerns about severe financial strains plaguing the generics industry that have resulted in unprecedented drug shortages and supply chain disruptions.^1,2

Empty pill bottle | Image credit: Yuriy Redkin- stock.adobe.com

Generic drugs account for approximately 90% of US drug prescriptions, and the shortage has affected access to a range of therapeutics, including drugs such as amoxicillin and chemotherapies for ovarian and bladder cancers.¹

The recent shutdown of Akorn Pharmaceuticals is a case in point. Akorn was an Illinois-based generic pharmaceutical manufacturer that voluntarily recalled 70 generic medications after filing for bankruptcy.²

According to a June 2023 Akorn news release, the large-scale generics manufacturer urged distributors to remove their products from the market, effective immediately.² Akorn’s generics lineup included products for nonsevere conditions such as hair care, but they also made lifesaving antiseizure medicines, antipoison medicine, and albuterol cylinders.²

Separately, India-based Intas Pharmaceuticals—one of the primary manufacturers of 3 major chemotherapy drugs (methotrexate, carboplatin, and cisplatin)—was forced to suspend manufacturing when the FDA discovered a “truck full of” plastic bags with torn quality control records of products headed to US markets. The FDA issued a report about the incident in December 2022.³

Despite multiple efforts to improve supply, there is still little to no supply of these primary chemotherapy drugs, according to the Society of Gynecologic Oncology.⁴ The American Cancer Society warned that the delays could result in worse patient outcomes.⁵

“A shortage of certain cancer drugs has become a serious and lifethreatening issue for cancer patients across the country,” Karen E. Knudsen, MBA, PhD, CEO of the American Cancer Society and American Cancer Society Cancer Action Network, said in a news release.⁵ “The American Cancer Society...and its advocacy affiliate, the American Cancer Society Cancer Action Network...have heard from patients and practitioners who are directly experiencing the impact of these shortages.”

Alongside the FDA, generic drug makers, supply-chain experts, and patient advocates have also appeared before Congress to discuss solutions for the disrupted pharmaceutical supply chain.¹ Laura Bray, founder of the nonprofit Angels for Change, in an appearance before the Energy & Commerce Committee, Oversight & Investigations Subcommittee, recommended a drug exchange—which would improve access to medications for individuals and facilities who need it—and an increase in small-batch medicine production.⁶

In the meantime, experts recommend that patients work with their pharmacist to learn about similar available generics.² Pharmacists may be able to offer alternative suppliers or products, helping patients remain adherent. When that is not possible, patients should contact their health care provider to get a new prescription for an alternative drug.⁷

References

1. Rapoza K. House committee holds hearing on drug shortages. Coalition for a Prosperous America. May 12, 2023. Accessed June 8, 2023. https://prosperousamerica.org/house-committee-holds-hearing-on-drug-shortages/
2. Akorn issues voluntary nationwide recall of various human and animal drug products within expiry due to company shutdown. News release. Akorn Inc. April 26, 2023. Accessed June 8, 2023. https://www.prnewswire.com/news-releases/akorn-issues-voluntary-nationwide-recall-of- various-human-and-animal-drug-products-within-expiry-due-to- company-shutdown-301808215.html
3. Food and Drug Administration. Compliance record: Intas Pharmaceuticals. December 2, 2022. Accessed June 8, 2023. https://www.fda.gov/media/164602/download
4. SGO statement: Carboplatin and cisplatin shortages. News release. Society of Gynecologic Oncology. April 21, 2023. Accessed June 8, 2023. https://www.sgo.org/news/drugshortage/
5. Nationwide drug shortage could cause disruptions for cancer patients in active treatment. News release. American Cancer Society. May 12, 2023. Accessed June 8, 2023. https://pressroom.cancer.org/releases?item=1217
6. Examining the root causes of drug shortages: challenges in pharmaceutical drug supply chains. Angels for Change. May 11, 2023. Accessed June 8, 2023. https://d1dth6e84htgma.cloudfront.net/5_11_23_Bray_Testimony_1616f-411cf.pdf?updated_at=2023-05-11T16:33:13.037Z
7. Hui A. Recall pulls 70 generic drugs from the market—what to do if your medication is one of them. Verywell Health. May 3, 2023. Accessed June 8, 2023. https://www.verywellhealth.com/akorn-pharmaceutical-company-recalls-over-70-generic-drugs-7487962#:~:text=If%20any%20of%20your%20medications,to%20discuss%20other%20medication%20options