Patent Profiteering: Unveiling the Truth Behind Skyrocketing Prescription Drug Prices and Denied Healthcare Access

 

The soaring costs of prescription drugs in the United States have become a crisis of epic proportions, driven by a combination of corporate greed and regulatory barriers that deny Americans access to affordable healthcare. At the heart of this crisis lies the insidious practice of "evergreening" in the pharmaceutical industry, where brand-name drug companies exploit patent loopholes to extend market exclusivity and inflate prices. Compounding this injustice is the role of regulatory agencies like the FDA, whose policies further restrict access to affordable medications from other countries, leaving patients stranded in a system that prioritizes profits over health.

What is Evergreening?

Evergreening, a deceptive tactic where brand-name drug companies make minor modifications to existing drugs to extend market exclusivity, has had devastating consequences for patients across the United States. A recent study published in the Journal of Law and the Biosciences revealed that a staggering 78% of drugs associated with new patents between 2005 and 2015 were not innovative breakthroughs but rather repackaged versions of existing medications. This manipulation of the patent system has allowed pharmaceutical giants to maintain their stranglehold on the market, driving prices to exorbitant levels while stifling competition and innovation.

Mebendazole & Roundworms 

One egregious example of this exploitation is seen in the case of mebendazole where Emverm is the only FDA approved drug for roundworms. These parasites are contagious and can spread via contaminated soil, food and water especially when traveling abroad to warmer climates with poor sanitation. Additionally, if one person contracts roundworms it is recommended other household members get treatment at the same time to prevent a reinfection cycle. In humans, these parasites migrate to critical organs and if left untreated, can incite Visceral Larval Migrans (VLM) and Ocular Larval Migrans (OLM), wreaking havoc on the liver, lungs, brain, and eyes.  The landscape changed dramatically in 2016 when Impax Laboratories monopolized the market on mebendazole in the US; effectively squashing affordable generics.

Timeline: Monopolies and Skyrocketing prices

-       1974: mebendazole is approved for use in the United States

-       2010: A generic version of mebendazole was widely available and sold for around $6 per pill.

-       2013: Amedra Pharmaceuticals bought the marketing rights to mebendazole.

-       2015: Impax Laboratories acquired all the rights to the mebendazole drug from Amedra Pharmaceuticals.

-       2016: The FDA approved a chewable tablet formulation of mebendazole called Emverm for the treatment of pinworm, whipworm, roundworm, and hookworm infections, which is currently the only FDA approved drug for roundworms.

-       2017: The brand-name Emverm version was priced at $500-$600 per pill. Once Impax gained control of the mebendazole drug, they were able to discontinue the generic versions and transition the market to their higher-priced brand-name Emverm product.

-       2018: Impax Laboratories merged with Amneal Pharmaceuticals 

-       2019: The average price per prescription of mebendazole was $2853

-       2024: Emverm is classified as a tier 3 formulary by major insurance companies, which is the only FDA approved drug for roundworms in the US. The current price is around $700 a pill, and 6 pills are needed for treatment of roundworms, totaling $4200 for treatment. Being a tier 3 formulary it is either not covered or partially covered by insurance

The FDA roadblock

The FDA exacerbates this crisis by imposing arbitrary restrictions that prevent U.S. citizens from accessing regulated medications from countries with comparable regulatory oversight, such as the United Kingdom. Despite acknowledging the regulatory equivalence of 25 countries, including Australia, Canada, New Zealand, and the UK, the FDA continues to bar Americans from purchasing prescription drugs from these nations. This begs the question: Why is the FDA limiting access to affordable healthcare when a prescription treatment like Ovex is widely available for less than $15 in the UK?

As patients suffer, pharmaceutical companies rake in record profits, shielded from competition and accountability by regulatory barriers and patent loopholes. It is time for policymakers to take decisive action to dismantle the monopolies that drive up drug prices and ensure that every American has access to affordable medications.

 

Sources & Additional Reading 

-       https://www.health.pa.gov/topics/Documents/Diseases%20and%20Conditions/Toxocariasis.pdf

-       https://www.news4jax.com/consumer/2017/02/14/pinworm-prescription-jumps-from-3-to-up-to-600-a-pill/

-       https://academic.oup.com/jlb/article/5/3/590/5232981?login=false

-       https://www.ncbi.nlm.nih.gov/books/NBK547885/

-       https://www.ajtmh.org/view/journals/tpmd/104/5/article-p1851.xml

-       https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2781194

-       https://www.drugs.com/history/emverm.html

-       https://blog.petrieflom.law.harvard.edu/2018/10/17/the-rotten-u-s-antiparasitic-drug-market/

-       https://www.health.pa.gov/topics/Documents/Diseases%20and%20Conditions/Toxocariasis.pdf#:~:text=An%20estimated%2010%2C000%20cases%20of%20Toxocara%20infections,clinical%20signs%20of%20a%20Roundworm%20infection%20in

-       https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8849283/

-       https://www.fda.gov/industry/import-basics/personal-importation

-       https://www.medicines.org.uk/emc/product/1766/pil#gref