Drugs

Warren Introduces Government Drug Manufacturing Bill

Sen. Elizabeth Warren (D-MA) introduced at the end of 2018 the Affordable Drug Manufacturing Act that would authorize HHS to manufacture select generic drugs and offer them to consumers at a fair price, guaranteeing affordable patient access. Rep. Jan Schakowsky (D-IL) was to introduce companion legislation in the House.

The bill is intended to address the high price of prescription drugs, Warren says. In a statement, she says the generic drug market “is plagued by numerous market failures. Forty percent of generic drugs are now made by a single manufacturer, and a majority are made by only one or two companies. Industry consolidation harms consumers by allowing drug makers to jack up prices.”

Warren says that public manufacturing of pharmaceuticals will “lower drug prices for millions while improving competition.”

The bill would create an Office of Drug Manufacturing in HHS and authorize it to manufacture generic drugs under key conditions where competition is lacking. The conditions would be that no company is manufacturing the drug; only one or two companies produced the drug and the price has spiked or the drug is in shortage; and only one or two companies produce the drug, price is a barrier to patient access, and the drug is listed by the World Health Organization as an “essential medicine.”

The Office of Drug Manufacturing would also be authorized to manufacture any drug that the federal government has licensed, including under existing compulsory licensing authorities.

The government would be allowed to sell publicly-manufactured drugs at a fair price that covers manufacturing costs while ensuring that patients have access to the drugs. It would also be required to begin public production on insulin within one year.

Warren says the bill would improve the ability of new companies to enter the generic drug market by authorizing the public manufacturing of active pharmaceutical ingredients.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome