Life Extension Magazine®

Drug Shortages

Persistent drug shortages in the United States are adversely affecting patients.

Cancer is expected to claim 618,000 American lives in 2025, with increasing malignancies occurring in younger people.¹

This equates to more than 1,600 cancer-related deaths each day.

Despite advances in cancer treatment (and early detection) leading to lower overall cancer death rates, the number of new cancer cases continues to rise.¹

This increase is attributed to the aging and growth of the population and a rise in the diagnoses of common cancers, including breast, prostate, endometrial/uterine, pancreatic, kidney, colo-rectal, and melanoma.²

Persistent drug shortages in the United States have affected thousands of cancer patients, who face delayed or canceled chemotherapy appointments.^3,4Most cancers don’t “wait” before invading and metastasizing into vital organs.

In a 2023 report, more than 90% of the largest U.S. cancer centers reported shortages of chemo drugs.⁵

The National Cancer Institute reported that at least 174 of its 608 clinical trials may be affected by these drug shortages. This did not include other clinical trials that need these drugs for studies that researchers would like to start but can’t.⁶

A 2024 survey of U.S. cancer centers shows that many continue to face drug shortages, often requiring mitigation strategies to treat patients.⁷

Among 28 cancer centers across the country, 89% reported that at least one drug was in short supply.⁸

These shortages aren’t just bad for today’s patients. The delays impacting cancer research will invariably be felt for years to come.

FDA Advises Against Offshore Drugs

The FDA has repeatedly warned Americans about the purported dangers of purchasing prescription drugs from offshore pharmacies.

Yet most of the active ingredients in prescription drugs sold in the United States are synthesized in offshore countries as follows:

According to the FDA, in 2019 approximately 72% of active pharmaceutical ingredient manufacturers supplying the U.S. market were located outside the United States.⁹
In a 2016 report the Government Accountability Office indicated that nearly 80% of the active ingredients used in drugs consumed in the U.S. are manufactured abroad.¹⁰
The Pharmaceutical Research and Manufacturers Association has reported similar figures, emphasizing that the U.S. pharmaceutical supply chain is heavily integrated with global manufacturers.¹¹

In 2022, the FDA inspected only 6% of nearly 3,000 foreign facilities, many that produce active ingredients for the U.S. generic drug market.^12,13

Consumers are warned not to purchase lower-priced drugs from Canada,^14-16 but drugs sold in Canada are often the same as those sold in American pharmacies. There is scant FDA oversight of the synthesizing companies that manufacture the active ingredients in your prescription drugs.

A group like Underwriters Laboratories could do independent inspections to certify more offshore synthesizing labs that adhere to good manufacturing practices…and identify ones that don’t.¹⁷

More Generic Competition = Lower Consumer Prices

According to a report generated by the FDA, a single generic version of an off-patent drug reduces the price of a branded drug by 31%-39%. With two competitors, the price drops by 44%-54%.

With four generic versions the consumer price drop is 73%-79%. With six or more versions, there can be price reductions of 95% and greater compared to the previously branded drug.¹⁸

Even at these steep lower prices, making generics could still be profitable if it were not for the high costs and uncertainties involved in gaining/maintaining regulatory approvals.

What’s happened in some cases is that as profit margins decline in response to generic competition, companies stop making the drug or engage in colluding to create an artificial shortage or engage in price-fixing that drives consumer prices upward.^19-21

In addition to ongoing shortages and unpredictable pricing, U.S. consumers still overpay for many of their generic drugs.²²

My solution is a parallel free market whereby companies would stake their reputations on making quality generic drugs without excess regulatory oversight.

Physicians and patients would in many cases quickly identify ineffective generics, such as an anti-hypertension drug that no longer controls blood pressure the same way. Independent groups like Underwriter Labs could also spot bad actors.

FDA Charges Generic Drug “User Fees”

The FDA began charging user fees for new drug applications in 1992 with the enactment of the Prescription Drug User Fee Act. The goal of this legislation was to accelerate the review of new drug applications by providing the FDA with additional funding.²³

Pharmaceutical companies would pay fees when submitting New Drug Applications, enabling the FDA to hire more reviewers and support staff, thereby reducing review times, and speeding up the introduction of new drugs to the market.

In 2012, Congress authorized the Generic Drug User Fee Amendments that extended the user fee system to generic drug manufacturers.²⁴

Under this 2012 amended Act, generic drug companies must pay an application fee when submitting an Abbreviated New Drug Application, an annual facility fee, and comply with other regulatory requirements. The application fee for a generic drug was $252,453 in 2024,²⁵ and will increase to $321,920 in 2025.²⁶

In 2025, manufacturing facilities in the U.S. must pay an annual fee of $41,000. Facilities outside the U.S. pay a higher fee of $56,000 which is $15,000 higher than for domestic ones.²⁶

Failure to pay the FDA’s annual facility fee means the company’s generic drugs are no longer considered FDA-approved and cannot be marketed.

While these fees are intended to fund the FDA’s ability to efficiently review generic drugs and ensure safety and quality, the costs of compliance—along with other factors such as market size, competition, and legal expenses—can lead some companies to discontinue products or not file applications.

This, in turn, contributes to drug shortages, despite the FDA’s stated goal of increasing competition through initiatives like the Drug Competition Action Plan.

Pharma Companies Pay Huge Price-Fixing Penalties

In August 2023, two drug companies pleaded guilty to price-fixing of generic drugs and collectively paid over $280 million in criminal penalties.¹⁹

In October 2021, three generic pharma companies paid $447 million in civil penalties that included illegal price-fixing of various generic drugs.²¹

I suspect this happens more often than the price-fixing violations that are ever uncovered.

Persistent Drug Unavailability

In the first quarter of 2024, a pharmacists’ association (American Society of Health-System Pharmacists) in conjunction with the University of Utah Drug Information Service, reported a record 323 active drug shortages. This surpasses the previous high of 320 shortages recorded in 2014.^27,28

The shortages affect a wide range of medications, including generic sterile injectables and emergency meds. Some of the critically short drugs are essential chemotherapy drugs for treating various cancers.

And with successes in combining immune checkpoint inhibitor drugs with chemo and radiation for certain cancers, significant numbers of lives may be prematurely ending.

Causes behind these shortages are multifaceted, including manufacturing and quality control issues, supply chain disruptions, and increased demand for certain medications.^28,29

Government agencies blame pharma companies and pharma blames incompetent regulatory oversight and vice versa.³⁰

Potential solutions by a panel of experts from Johns Hopkins University have been discussed, including increasing domestic drug manufacturing capacity, creating stockpiles of critical medications, and/or fostering public-private partnerships to ensure a more resilient supply chain.³⁰ Much of this requires more governmental intervention, which I argue is an underlying cause of the shortages.

I contend these shortages would not occur in a free-market environment. It is excess regulation that creates barriers that limit competition, whereby some generic drugs remain overpriced and in short supply.

Real World Solutions

The pharmaceutical industry is highly regulated by state and federal governments, creating challenges for drug approval and production.

Streamlining the FDA’s approval process for generics and incentivizing domestic production could help reduce shortages and lower drug prices.

Such reforms would make it easier for manufacturers to bring affordable medications to market, especially when current regulatory hurdles contribute to delays.

How the Government is Addressing this Problem

The U.S. faces ongoing challenges with prescription drug shortages, affecting a wide range of critical medications.

The government’s solutions are summarized below:³¹

Efforts are being made at various levels to address these issues, but resolving them will require comprehensive and coordinated actions involving policy changes, improved manufacturing practices, and enhanced supply chain management.

The U.S. Department of Health and Human Services and other agencies have proposed several policy solutions to address these shortages.

These include diversifying manufacturing sites, increasing inventories of critical medications, developing a rating system for quality management in drug production, and enhancing transparency in the drug supply chain.

There have been calls for legislative action to address the root causes of drug shortages. Recommendations include enacting laws to support domestic manufacturing of essential drugs, improving the inspection processes for drug manufacturing facilities, and creating stockpiles of critical medications.

What if instead of the above multi-governmental actions that may worsen the problem, they allow a parallel free market and watch drug shortages disappear while consumer prices plummet.

One proposed solution is creating a parallel system where consumers, doctors, and hospitals can access essential medications through alternative sources. For example, pharmacy chains like Walgreens and CVS could manufacture their own private-label generics, bypassing certain regulatory barriers.

Independent groups like Underwriters Laboratories (UL) could verify bioequivalence, while the FDA would still oversee quality control and safety inspections. This would give consumers the choice between expensive FDA-approved drugs and more affordable generics, especially during shortages.

Sterile injectable drugs, often in short supply, could be produced by domestic compounding pharmacies with stricter quality control but fewer regulatory burdens. These pharmacies already supply hospitals, and expanding their role could help address shortages without excessive user fees. Reducing regulatory inefficiencies and costs would improve drug availability and affordability.

For more insights into how the current regulatory system impacts healthcare and the economy, readers can access at no charge, a book I authored years ago called Pharmocracy II at: LifeExtension.com/pharm

If you have any questions on the scientific content of this article, please call a Life Extension Wellness Specialist at 1-866-864-3027.