Senator Warren Introduces Legislation to Create Government Generic Drug Maker

Senator Elizabeth Warren, D-Massachusetts, has introduced a bill in the Senate that would create an Office of Drug Manufacturing within HHS. Simultaneously, Representative Jan Schakowsky, D-Illinois, introduced an identical bill in the House of Representatives.

Warren’s bill, dubbed the Affordable Drug Manufacturing Act, would require HHS to publicly manufacture generic drugs “in cases where the market has failed,” and “[strengthen] the market for the long term by jump-starting competition.”

Specifically, the office would be authorized to manufacture a generic drug in a case in which no company is currently manufacturing the product; a case in which only 1 or 2 companies produce the drug, and the price has spiked or the drug is in shortage; or a case in which only 1 or 2 companies produce the drug, the price has created a barrier to patient access, and the World Health Organization has designated the medication as an essential medicine.

“In market after market, competition is dying as a handful of giant companies spend millions to rig the rules, insulate themselves from accountability, and line their pockets at the expense of American families,” said Warren in a statement. “The solution here is not to replace markets, but to fix them. The Affordable Drug Manufacturing Act will introduce more competition into the prescription drug market and bring down prices for consumers.”

The price of insulin has entered the spotlight recently as it is becoming increasingly less affordable, particularly for young adults. Since 2012, the price has more than doubled in the United States. The bill would attempt to address this by requiring the office to begin public production of insulin within 1 year.

Within 1 year of the bill’s enactment, the office will be required to manufacture at least 15 applicable drugs. Additionally, no later than 3 years after the bill is enacted, the office will be required to manufacture or enter into contracts with entities for the manufacturing of at least 25 applicable products.

The introduction of the bill comes on the heels of a letter sent by Warren to Republican colleagues calling for hearings on the recent reports of alleged price-fixing by generic manufacturers in the start of January 2019.