The Proposed Affordable Drug Manufacturing Act

Submitted by Paige Organick
Illustrations by Kevin Shaw

Senator Warren and Representative Schakowsky introduced the Affordable Drug Manufacturing Act in December of 2018. This act would require Health and Human Services to publicly manufacture generic drugs if one of the following conditions are met:

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  • Two or fewer companies produce the drug
  • There is a drug shortage
  • The price of a drug has created a barrier to patient access.

Should it pass, this bill would be consequential. Currently, 40% of generic medicines are made by just one drug maker. Monopolies like this contribute to soaring drug prices that exclude patients who fill nine out of every ten prescriptions with generics.1 By breaking the generics monopoly and promoting competition, the act’s intent is to improve the affordability of medicines for most patients, even those still under patent protection.

Out-of-pocket costs are important in making treatment decisions for at least 80% of patients.2 By addressing the financial burden of treatments, this bill could support what we at the KER Unit call “minimally disruptive medicine”. Faced with expensive medications, patients, especially those with multiple chronic conditions must choose between buying groceries, paying rent, and purchasing their medications. When they skip their medications, healthcare labels these patients as “noncompliant”. These “noncompliant” patients must then cope with preventable symptoms and complications, the care these require in turn and their costs, and the judgment often dished to them by those who blame them for not taking personal responsibility for their care.

This act, along with other proposals including the Preserve Access to Affordable Generics and Biosimilars Act, are unlikely to pass for many reasons, including the substantial campaign contributions that pharma makes to regulators.3 Yet, these initiatives may slowly erode the fabricated consensus that market forces alone can solve the problem of drug affordability, and re-energize the role that regulation can play in creating affordable healthcare.

1 Why pharma companies are bowing out of generics”. Dan Gorenstein. Marketplace on NPR.

2 “Talking About Costs of Care During Shared Decision Making – Part One: The Problem”. Alan Balch. Journal of Clinical Pathways.

3 “Database Details Drugmakers’ Contributions to Congress”. Emmarie Huetteman and Sydney Lupkin. CNN News.

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