December 05, 2023

Senator Warren, Representative Schakowsky Reintroduce Bicameral Affordable Drug Manufacturing Act

Legislation Would Increase Public Manufacturing of Generic Drugs, Lowering Drug Prices and Improving Competition Senator Warren Highlighted Legislation at Senate Finance Committee Hearing on Drug Shortages

Bill Text (PDF) | One-Pager (PDF)

Washington, D.C. – U.S. Senator Elizabeth Warren (D-Mass.) and Representative Jan Schakowsky (D-Ill.) reintroduced the Affordable Drug Manufacturing Act, bicameral legislation to address the skyrocketing price of prescription drugs and increase competition in the generic pharmaceutical market by establishing an Office of Drug Manufacturing within the Department of Health and Human Services (HHS) tasked with manufacturing select generic drugs and offering them to consumers at a fair price that guarantees affordable patient access.

“Public manufacturing presents a powerful opportunity to resolve drug shortages, secure the pharmaceutical supply chain, and ensure generic drugs are accessible and affordable for patients.” said Senator Elizabeth Warren. “Our Affordable Drug Manufacturing Act will fix the failures in the generic drug market, introduce more competition, and lower drug prices for consumers.”

“Thanks to the passage of the Inflation Reduction Act, millions of Medicare beneficiaries will soon begin to see their prescription drug costs lowered. While this is a historic achievement, more must be done to help lower prices and increase competition in the commercial pharmaceutical market,” said Congresswoman Jan Schakowsky. “That is why I am proud to reintroduce the Affordable Drug Manufacturing Act with my friend Senator Elizabeth Warren, which would establish an Office of Drug Manufacturing within the Department of Health and Human Services responsible for manufacturing generic drugs, lowering prices, increasing competition, and addressing drug shortages. The five largest pharmaceutical companies raked in nearly $80 billion in profits last year, while many Americans struggled to afford their lifesaving medications. It is time for Big Pharma to face real, honest competition that will lower drug prices for people across the United States."

The Affordable Drug Manufacturing Act would:

  • Establish an Office of Drug Manufacturing within HHS charged with increasing competition, addressing shortages in the market for prescription drugs, and ensuring drugs are available at a fair price;
  • Authorize the Office to manufacture generic drugs under one of the following key conditions:
    • No company is marketing the drug,
    • Three or fewer companies are marketing the drug, and the price has spiked;
    • Three or fewer companies are marketing the drug, and the drug is in shortage; or
    • Three or fewer companies are marketing the drug, the price is a barrier to patient access, and the drug is listed as an “essential medicine” by the World Health Organization
  • Authorize the Office to manufacture any drug that the federal government has licensed, including under existing compulsory licensing authorities;
  • Allow the government to sell publicly-manufactured drugs at a fair price that covers manufacturing costs while ensuring patients have access to these drugs;
  • Require the Office to begin public production of insulin, asthma and chronic obstructive pulmonary disease inhalers, naloxone, epinephrine auto-injectors, and antibiotics within one year;
  • Improve the ability of new companies to enter the generic drug market by authorizing the public manufacturing of active pharmaceutical ingredients;
  • Require the Office to offer to sell the rights to publicly-manufactured drugs to manufacturers who commit to keep the drug on the market at a fair price, but to resume production if a manufacturer violates these commitments.

The legislation is also co-sponsored by Senator Jeff Merkley (D-Ore.) and Representatives Barbara Lee (D-Calif.), Pramila Jayapal (D-Wash.), Eleanor Holmes Norton (D-D.C.), Jonathan Jackson (D-Ill.), Sheila Cherfilus-McCormick (D-Fla.), Danny Davis (D-Ill.), and Jesús "Chuy" García (D-Ill.).

The Affordable Drug Manufacturing Act – first introduced in 2018 – is endorsed by Public Citizen, Social Security Works, Indivisible, CREDO, Center for Medicare Advocacy, American Federation of Teachers, Knowledge Ecology International, Action Center on Race and the Economy, Business for Medicare for All, Physicians for a National Health Program, MomsRising, Families USA, Alliance for Retired Americans, AFSCME, AIDS Healthcare Foundation, and People’s Action.

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