U.S. Pharma Giant's Part in Skyrocketing Drug Shortage: A Crisis Unfolds

US: Medical clinics around the country felt the effect of Akorn Drugs shutting its entryways in February When the pharmaceutical company based in Lake Forest, Illinois closed its doors, it led to the withdrawal of 75 generic medications it had produced from the market. In certain instances, the business served as the only product supplier.

The closure coincides with an ongoing drug supply situation in the United States, which it also made worse. Akorn's bankruptcy and subsequent closure are a part of a larger catastrophe brought on by fewer American manufacturers of less expensive generic drugs, slim profit margins for the companies that remain in business, and an excessively convoluted global supply chain that could leave patients in need of life-saving drugs for months or even years to come.

According to a report released in March by the Senate Committee on Homeland Security and Governmental Affairs, the number of new medicine shortages climbed by about 30% between 2021 and 2022, affecting 295 goods at the end of the previous year. Drug shortages are harming patients in intensive care units or emergency rooms who require specific generic intravenous pharmaceuticals, which are in short supply, as well as cancer patients who are in urgent need of chemotherapy therapies.

As a result, there are more shortages, as of June, there were more than 300 active drug shortages, the largest in over a decade. Drug supply issues are nothing new. As of late, both locally and universally, there have been deficiencies of certain drugs, including those used to treat malignant growth, coronary illness, and ADHD. Especially defenseless is the stock of conventional meds. Due to fierce competition and diminishing revenues, businesses like Akorn have been compelled to reduce expenses and lay off employees to survive.

The closure of Akorn signifies a significant reduction in America's manufacturing capabilities, occurring concurrently with other generic drug manufacturers struggling to maintain their operations Americans depend widely on conventional drugs. However, only around 20% of prescription expenditures in the United States are spent on generic medications, which are offered at extremely inexpensive prices. In spite of the enormous interest in the items, nonexclusive drugmakers don't rake in tons of cash on the grounds that the medications are so economical.

The number of generic pharmaceuticals produced in the United States has decreased during the past ten years. 2013 to 2019, there were 118 registered U.S. facilities producing active pharmaceutical ingredients, a decrease of roughly 10%. 2014 was the only year in which this figure increased.

One of two U.S. providers of liquid albuterol, a crucial drug used by hospitals to treat asthma and RSV in children, Akorn shut down after declaring bankruptcy. Mohammed Kabir, who held the position of Director of Formulation Development at Akorn before its shutdown, stated that it was one of the company's most sought-after products. Other generic manufacturers try to fill the void left by Akorn's shutdown, all its medications are either in low supply or experiencing supply issues. Surprisingly more terrible, after Akorn's conclusion, it couldn't supervise the quality and wellbeing of a large number of the drugs it had previously offered to drug stores, emergency clinics, and online clients the nation over. The FDA announced that Akorn was reviewing drugs that had been dispersed toward the beginning of May.

Pharmacy staff at the Mayo Clinic hurried to switch manufacturers or find a means to obtain drugs that only Akorn supplied. The clinic was also required to notify physicians and patients of the recall and dispose of any leftover Akorn items. It's undoubtedly a difficult scenario, according to Eric Tichy, board chair of the End Drug Shortages Alliance and division chief of pharmacy supply solutions for the Mayo Clinic in Rochester, Minnesota. The incident increased work for our staff and caused patients' worry. Generic medications are often available on the market after a pharmaceutical patent expires at a cheaper cost than the brand-name medication.

FDA Commissioner Robert Califf stated that the system's economics were the primary issue. He asserted that generic drug producers are not shielded by patents that give brand-name drug corporations the right to sell medicines exclusively for a predetermined amount of time. Companies must get compensation that will allow them to continue operating and manufacture generic pharmaceuticals in the United States. As more U.S. enterprises fail, the industry's current issues are certain to worsen.

Pennsylvania-based Lannett Co., a producer of generic medications, declared in May that it would file for Chapter 11 bankruptcy, while it intended to carry on with business as usual during the process of reorganization. The same month, Teva Pharmaceuticals, a significant generic medication manufacturer with headquarters in Israel, said in a statement that it was scaling back production of its generic drugs. Aurobindo Pharma, an Indian company, stated early in 2017 that it would close its New Jersey-based U.S. generic manufacturing facility.

The financial model of the generic medicine sector has proven unsustainable for many manufacturers. A third of generic medication companies make money, a third break even, and a third lose money.

The U.S. already depends heavily on foreign pharmaceutical manufacturers. According to the FDA, 78% of suppliers of active pharmaceutical ingredients were in China, India, and the European Union in 2021. The United States will be even more reliant on foreign production because of the shutdown of Akorn.

Foreign vendors frequently fall short of the strict FDA requirements for generic pharmaceuticals. In addition, investigators may rely on the facility to provide translation services during FDA trips to international facilities, which raises questions about whether the agency is receiving all the information necessary to properly analyze the quality of the products.

Except for a few manufacturing facilities, all foreign output in China and India has surpassed that in North America, according to David Gortler, a former science policy adviser at the FDA and an authority on FDA regulation. Unfortunately, lesser costs are frequently associated with subpar workmanship.

Intas Pharmaceuticals, an Indian manufacturer of generic medications, ceased production in December because of multiple quality issues identified during a previous FDA inspection. Cisplatin, a chemotherapy medicine used to treat several cancers, including testicular, lung, bladder, cervical, and ovarian cancers, was severely in short supply because of the ban. The shift toward increasing medication production overseas is a big issue of national security, particularly given the current condition of world conflict.

There are no easy solutions. Drug corporations are not obligated to reveal precisely which vendors are producing each product in addition to the location. As a result, it is particularly challenging for the FDA to identify products that are manufactured abroad. The American government may take to support local generic medication manufacturers in a report released in June.

They included offering incentives for hospitals to buy generic drug supplies at set costs for several years, giving generic drugmakers a consistent source of income. Additionally, the government could give funds to generic producers so they could modernize their production facilities and construct brand-new ones with a larger capacity.

The actions also included encouraging the use of new generics and ensuring that Medicare drug plans covered them. It's challenging for new producers to enter the highly regulated, intricate field of generic medicine manufacturing right away. This implies that individuals who require the medications will not receive them. The market already has a shortage of supply.