Most people have never heard of the drugs on the FDA’s critical shortages list. Epinephrine is one of them. Some types of epinephrine have been in short supply for 12 years, based on Qyobo data.
Epinephrine, also known as adrenaline, is a neurotransmitter and a hormone. It’s used as a medication to treat many life-threatening conditions such as heart attacks and treating anaphylaxis.
One of the brands in short supply, Amphastar Pharmaceuticals gets its API from its China-based subsidiary Amphastar Nanjing Pharmaceuticals Inc. Their API is turned into finished drugs at a company called International Medication Systems in California.
Another epinephrine producer, Hospira Inc. (now owned by Pfizer), had a facility in North Rocky Mountain, NC damaged by a tornado last year, so that is the likely reason for their shortages.
Another drug, Cefotaxime sodium, has been in short supply for 9 years. There are roughly six labs selling this antibacterial drug used to treat patients coming out of surgery, but three of the labs do not have the product readily available, according to Qyobo.
Of the three labs, Hikma Pharmaceuticals, is the one facing supply constraints due to its subsidiary laboratory in Portugal, Qyobo said. It is unclear exactly why Hikma is having trouble getting this drug to market.
Some drugs are in even worse shape. There are few producers and supply is hard to find.
Triamcinolone hexacetonide has been in short supply for over three years and is almost impossible to source. According to Qyobo, all the labs that make this for the U.S. market are not able to meet demand. Triamcinolone hexacetonide is a corticosteroid hormone used to treat various conditions such as allergies, arthritis, and cancers.
Estramustin phosphate sodium has been in short supply for just over a year, but like the above steroid, very few labs make this. All of them are out of stock at this time. The drug is sold under the brand names Emcyt and Estracyt and is a dual estrogen and chemotherapy medication used to treat prostate cancer.
The American Cancer Society estimated that there will be around 1.93 million cancer patients in the U.S. by the start of 2024, a 28% increase over a 13-year period. But that’s over more than a decade. One would think that the pharmaceutical industry would have prepared for that growth along time ago. Is it true that they were all caught flat-footed by a roughly 2% demand increase every year for 10 years? It seems other factors are more likely to blame for the shortages.
Drug Shortages Increase Odds Of Patient Death; More Than Half of Drugs In Short Supply For Over 12 Months.
Drug shortages are becoming commonplace in the U.S. Data from a new pharmaceutical industry tracking firm, Qyobo, shows hundreds of drugs are still in short supply – some well over a year — and our dependence on imports grows, including from labs on the receiving end of lackluster FDA inspections.
In some cases, when imported life-saving drugs are unavailable, patients die.
In December, a 60-year old Wisconsin high school football coach named Jeff Bolle died of bile duct cancer after roughly a year on chemotherapy. With two rounds of chemo remaining, Bolle’s doctors were forced to stop treatment in May 2023 due to shortages of cisplatin, one of numerous chemotherapy drugs in short supply, according to the FDA. The drug has been in short supply since February 2023.
As a result, Bolle’s cancer was left untreated for a few months and by September 2023 he had deteriorated sharply. The shortage of cisplatin, and the lack of any alternatives for his needs, ultimately led to Bolle’s death, his wife told the TODAY show in April.
The FDA gave emergency authorization to China-based Qilu Pharmaceutical Co. this winter for temporary import. Even more concerning, the FDA allowed for India’s notorious Intas Pharmaceuticals Limited to export cisplatin made in labs that were banned from exporting that very drug to the United States in November 2023, rendering the FDA’s so-called Import Alert impotent.
200 Drugs In Short Supply; 58% In Shortage For Over A Year
As of June, the U.S. has 232 drugs in short supply; some of them critical, some of them basic medications like those used in IV solution bags in hospital settings. Of that number, 58% of them have faced supply problems for a year or more, with 31% in short supply for 1-3 years, based on drug shortage analysis provided by Qyobo.
Nearly all of those drugs are imported generic medications. The U.S. imports around 80% of its generic drugs. Pharmaceuticals are a top three source of the U.S. trade deficit.
The U.S. has long since outsourced its generic drug-making manufacturing to labs overseas. The simpler the drug, the more likely it is sourced from abroad. Some of those drugs are critical, and without them, doctors are forced to skimp on potentially life-altering prescriptions. Both the House and Senate have had numerous hearings on this issue, with doctors discussing what drug shortages meant to them and their patients.
According to Qyobo, which sources data from the FDA and the pharmaceutical companies themselves, demand increase is the main driver of the shortage. Some 46% of shortages were blamed on uptake from patients, with the next known reason cited being shortage of active pharmaceutical ingredients (API).
CPA chief economist Jeff Ferry disagrees. “The fundamental driver of the widespread shortage of generic medicines, which the American Society of Hospital Pharmacists data shows is getting worse all the time, is that generic drugs are too cheap,” Ferry said. “The obsession of hospitals and other buyers with low prices has forced almost all U.S.-based producers out of the generic business, and is pressuring even the Indian producers of generics, who simply stop producing certain drugs if they can’t make a profit. For many life-critical drugs there are only one or two producers located far away in India and almost impossible for the U.S. to control their quality. As a result we are dependent on an unreliable, dangerously accident-prone India-China supply chain, and the FDA sits on the sidelines as an impotent observer, begging companies to produce drugs because American patients need them.”
Two Drugs. Nine-Plus Years In Shortage.
Most people have never heard of the drugs on the FDA’s critical shortages list. Epinephrine is one of them. Some types of epinephrine have been in short supply for 12 years, based on Qyobo data.
Epinephrine, also known as adrenaline, is a neurotransmitter and a hormone. It’s used as a medication to treat many life-threatening conditions such as heart attacks and treating anaphylaxis.
One of the brands in short supply, Amphastar Pharmaceuticals gets its API from its China-based subsidiary Amphastar Nanjing Pharmaceuticals Inc. Their API is turned into finished drugs at a company called International Medication Systems in California.
Another epinephrine producer, Hospira Inc. (now owned by Pfizer), had a facility in North Rocky Mountain, NC damaged by a tornado last year, so that is the likely reason for their shortages.
Another drug, Cefotaxime sodium, has been in short supply for 9 years. There are roughly six labs selling this antibacterial drug used to treat patients coming out of surgery, but three of the labs do not have the product readily available, according to Qyobo.
Of the three labs, Hikma Pharmaceuticals, is the one facing supply constraints due to its subsidiary laboratory in Portugal, Qyobo said. It is unclear exactly why Hikma is having trouble getting this drug to market.
Some drugs are in even worse shape. There are few producers and supply is hard to find.
Triamcinolone hexacetonide has been in short supply for over three years and is almost impossible to source. According to Qyobo, all the labs that make this for the U.S. market are not able to meet demand. Triamcinolone hexacetonide is a corticosteroid hormone used to treat various conditions such as allergies, arthritis, and cancers.
Estramustin phosphate sodium has been in short supply for just over a year, but like the above steroid, very few labs make this. All of them are out of stock at this time. The drug is sold under the brand names Emcyt and Estracyt and is a dual estrogen and chemotherapy medication used to treat prostate cancer.
The American Cancer Society estimated that there will be around 1.93 million cancer patients in the U.S. by the start of 2024, a 28% increase over a 13-year period. But that’s over more than a decade. One would think that the pharmaceutical industry would have prepared for that growth along time ago. Is it true that they were all caught flat-footed by a roughly 2% demand increase every year for 10 years? It seems other factors are more likely to blame for the shortages.
Earlier this month, Indian pharmaceutical giant Sun Pharmaceuticals received a Warning Letter from the FDA following a lab visit in December. The Warning Letter has not yet been published.
In the meantime, whatever it is that Sun Pharma was exporting from that facility is still being allowed into the United States. Sun Pharmaceuticals received a Warning Letter in 2023, as well.
Most of generic drug recalls are from foreign labs. Recalls also lead to shortages.
In a House Health Subcommittee meeting in May, Ranking Member Anna Eshoo said Congress has done nothing to address the drug shortages issue. While it’s true the House has yet to pass any legislation, Rep. Claudia Tenney (R-NY-24) has introduced the PILLS Act, which CPA strongly supports.
The PILLS Act would incentivize the strategic reshoring of U.S. domestic production of generic medicines with a domestic production-based tax credit, domestic content bonus credit, and an investment tax credit. Importantly, the PILLS Act would address the national health care crisis due to ongoing, and worsening, shortages of essential lifesaving generic drugs—a crisis that has been exacerbated by decades of offshoring our nation’s generic drug manufacturing capacity and a growing dependence on foreign manufacturers and supply chains.
In a recent op-ed in The Washington Times, CPA’s Senior Vice President Nick Iacovella writes that addressing “the drug crisis requires a comprehensive approach that includes rebuilding domestic production, reforming the FDA, and addressing the economics of the generic drug industry. By taking these steps, the U.S. can secure its drug supply chains and ensure that patients have access to safe, high-quality medications.”
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