In a startling revelation,FDA inspectors have uncovered a troubling pattern of document shredding at a prominent pharmaceutical plant in India that supplies over half of the US’s generic cisplatin and carboplatin. These affordable drugs are vital in treating up to 500,000 new cancer cases annually.
Now, seven months later, the consequences are unimaginable. Medical professionals and patients across the nation now confront the grim reality of untested rationing plans for life-saving treatments, including breast, cervical, bladder, ovarian, lung, testicular, and other forms of cancer. Tragically, this could lead to preventable fatalities.
The shortage of medications extend well beyond cancer treatments, encompassing drugs medications for ADHD, blood thinners, antibiotics, and more. While supply chain disruptions resulting from the COVID-19 pandemic and inadequate FDA oversight contribute to the problem, experts agree that the root cause lies in the inherent weakness of the generic drug industry.
The majority of vital medications are manufactured overseas, often at a loss or with meager profits. Domestic manufacturers prioritize high-priced drugs with large profit margins, leaving little incentive to produce affordable generics.
The problem is not new and frustrates clinicians who witness the dire consequences firsthand. President Joe Biden, touched personally by cancer and striving for breakthrough cures through the Cancer Moonshot initiative, must also prioritize addressing the pressing needs of countless patients who are unable to access drugs like cisplatin – a medication approved by the FDA in 1978 and available for as little as $6 per dose.
According to Mark Ratain, an oncologist and pharmacologist at the University of Chicago, “It’s just insane, your roof is caving in, but you want to build a basketball court in the backyard because your wife is pregnant with twin boys, and you want them to be NBA stars when they grow up?”
“It’s just a travesty that this is the level of healthcare in the United States of America right now,” expressed Dr. Stephen Divers, an oncologist in Hot Springs, Arkansas. Due to the scarcity of crucial medications, Dr. Divers has been compelled to postpone or alter treatments for numerous patients battling bladder, breast, and ovarian cancer.
Alarming survey results released on June 7 reveal that 93% of academic cancer centers are struggling to procure enough carboplatin, while 70% are facing shortages of cisplatin.
“All day, in between patients, we hold staff meetings trying to figure this out. It’s the most nauseous I’ve ever felt. Our office stayed open during COVID; we never had to stop treating patients. We got them vaccinated, kept them safe, and now I can’t get them a $10 drug,” says Dr. Bonny Moore, an oncologist in Fredericksburg, Virginia.
Generics Manufacturers Exit the Market
The current shortages of generic drugs can be attributed to a clear set of causes. Rapidly declining wholesale prices, driven by the relentless pursuit of cost reductions by consumers and intermediaries involved in the procurement and distribution of generics, have had a significant impact.
Research conducted by Anthony Sardella, a respected business professor at Washington University in St. Louis, reveals that the average net price of generic drugs has plummeted by over 50% from 2016 to 2022.
This race to secure contracts with major buyers, such as Vizient and Premier, has put generics manufacturers in a difficult position. Their profits dwindle as they compete for sales, forcing some companies out of business.
Akorn, a well-known producer of 75 common generics, filed for bankruptcy and closed in February. Similarly, Teva, a major player in the generics industry with a portfolio of 3,600 medicines, shifted its focus to brand-name drugs and “high-value generics” to stay afloat. Lannett Co., with approximately 120 generics in its offering, recently announced a Chapter 11 reorganization as its revenue continued to decline.
These struggles extend beyond individual companies as others are in trouble too, as highlighted by David Gaugh, the interim CEO of the Association for Accessible Medicines (AAM), the leading trade group for generics.
Previously, around one-third of the drugs produced in the generics industry resulted in financial losses, but now that number has risen to half. This reality has created a problem where if a company stops producing a drug, others do not necessarily step up to fill the gap.
Fresenius Kabi and Pfizer have announced heightened production of carboplatin since March; nevertheless, further efforts are required to alleviate the scarcity. To address the shortage, the FDA has granted emergency authorization for Chinese-made cisplatin to be introduced into the US market, although the immediate impact is still unclear.
Both cisplatin and carboplatin are produced in specialized facilities under strict sterile conditions. Expanding or changing production lines requires FDA approval, which can be a lengthy process. With the demand for cheaper drugs pushing production overseas, it becomes more challenging for the FDA to monitor quality standards.
The inspection of the Intas plant in India is relatively rare, as the FDA reportedly inspects only 3% of drug production sites for the US market in the country. Additionally, numerous drug prescriptions in the US are filled by companies that have previously received FDA warning letters. Moreover, the pharmaceutical industry is experiencing the highest level of product recalls in 18 years, highlighting the fragile supply conditions.
Intas recently decided to voluntarily close its plant in Ahmedabad following an inspection by the FDA. The inspection report that was released in January revealed some shocking findings. Accord Healthcare, the US subsidiary of Intas, announced in mid-June that there was no set date for the resumption of production.
The prices of carboplatin, cisplatin, and other drugs have significantly increased on the gray market. Speculators are exploiting these shortages by selling medicine at inflated prices. According to Moore’s clinic pharmacist, Richard Scanlon, a bottle of carboplatin that usually costs $30 was going around for $185 in early May, and a week later, the price jumped to $345.
Is Government Intervention Necessary?
Despite efforts to address the drug shortage issue, progress has been disappointingly slow. The 2020 CARES Act granted the FDA the authority to require companies to develop contingency plans to respond to shortages, but these measures have yet to be enforced.
As a result, companies like Accord and others lacked response plans when Intas’ plant shut down, posing a threat to the US supply of cisplatin and carboplatin. Soumi Saha, Senior Vice President of Government Affairs for Premier, an organization that facilitates drug purchases for hospitals and health systems, acknowledged the risk but chose not to incite panic by issuing an immediate alarm.
However, discussions are underway to find long-term solutions. One proposal is to provide government subsidies to ensure US generic medicine plants operate at full capacity. Currently, these plants are only operating at half their potential. By incentivizing federal agencies like the Centers for Medicare & Medicaid Services (CMS) to pay more for drugs that are produced safely and efficiently, it can establish a more stable supply chain.
Allan Coukell, Senior Vice President of Public Policy at Civica Rx, expressed that, “at a certain point, the system needs to recognize there’s a high cost to low-cost drugs.” In line with this commitment, Coukell added that the company is actively constructing a state-of-the-art factory worth $140 million in Petersburg, Virginia.
Time is of the essence. The discrepancy between expensive brand-name cancer drugs and the affordable, time-tested generics must be urgently addressed to ensure the lives of countless patients are not needlessly lost.