Akorn bankruptcy, shortages are cutting off patient access to generics

Representatives from the FDA and others appeared before Congress to express concern about severe financial strains plaguing the generic drug industry that have led to unprecedented drug shortages and supply chain disruptions.^1.2

Empty Pill Bottle | Image credit: Yuriy Redkin-stock.adobe.com

Generics account for about 90 percent of drug prescriptions in the United States, and shortages have impacted access to a range of therapies, including drugs such as amoxicillin and chemotherapy for ovarian and bladder cancer.¹

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

According to a June 2023 press release from Akorn, the large-scale generics maker has urged distributors to remove their products from the market, effective immediately.² Akorns’ range of generics included products for minor conditions such as hair care, but it also produced life-saving anticonvulsant medicines, anti-venom drugs and albuterol cylinders.²

Separately, India-based Intas Pharmaceuticals, a leading manufacturer of 3 major chemotherapy drugs (methotrexate, carboplatin and cisplatin) was forced to suspend production when the FDA discovered a truck full of plastic bags with torn control records quality products directed to US markets . The FDA released a report on the incident in December 2022.³

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

Karen E. Knudsen, MBA, PhD, CEO of the American Cancer Society and the American Cancer Society Cancer Action Network, said in a press release that shortages of some cancer drugs have become a serious and life-threatening problem. of cancer across the country.⁵ The American Cancer Society…and its advocacy affiliate, the American Cancer Society Cancer Action Network…have heard of patients and professionals who are experiencing first-hand the impact of these deficiencies.

In addition to the FDA, generic drug manufacturers, supply chain experts and patient advocates also showed up in Congress to discuss solutions to the disrupted pharmaceutical supply chain.¹ Laura Bray, founder of the non-profit Angels for Change, in an appearance before the Committee on Energy and Commerce, the subcommittee on oversight and investigations, recommended a drug swap that would improve access to medicines for the people and facilities that need them and an increase in the production of medicines in small batches.⁶

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

References

1. The Rapoza K. House Committee holds a hearing on the drug shortage. 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 pharmaceutical products by deadline due to company closure. Press 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- in-deadline-for-company-closure-301808215.html
3. Food and pharmaceutical administration. Compliance Registry: Intas Pharmaceuticals. December 2, 2022. Accessed June 8, 2023. https://www.fda.gov/media/164602/download
4. SGO Statement: Carboplatin and Cisplatin Deficiency. Press release. Society of Gynecological Oncology. April 21, 2023. Accessed June 8, 2023. https://www.sgo.org/news/drugshortage/
5. Nationwide drug shortages could cause interruptions for cancer patients in active treatment. Press 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 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 recalls 70 generic drugs: what to do if your drug is one of them. Very good Cheers. 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% 20drugs,to%20discuss%20others%20drugs%20options