Drugs

Bill to Establish HHS Generic Drug Manufacturer

Sen. Elizabeth Warren (D-MA) and Rep. Jan Schakowsky (D-IL) reintroduced 12/5 their Affordable Drug Manufacturing Act to authorize generic drug manufacturing in HHS. A statement from Warren says the bill would address the skyrocketing cost of prescription drugs and increase competition in the generic drug market by establishing an Office of Drug Manufacturing in the department. The unit would be charged with manufacturing select generic drugs and offering them to consumers at a fair price that guarantees affordable generic access, she says.

A one-page outline of the bill says it would:

establish the HHS Office of Drug Manufacturing to lower prices, increase competition, and address shortages in the market for prescription drugs;
authorize the new office to manufacture generic drugs under one of these conditions: (1) no company is marketing the drug; (2) three or fewer companies are marketing the drug and the price has spiked; (3) three or fewer companies are marketing the drug and the drug is in shortage; or (4) three or fewer companies are marketing the drug, the price is a barrier to patient access, and the drug is listed as an “essential medication” 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 manufactured drugs at a fair price that covers manufacturing costs while ensuring patients have access to the drugs;
require the office to begin production of insulin, asthma and chronic obstructive pulmonary disease inhalers, naloxone, epinephrine auto-injectors, and antibiotics within one year; and
require the office to offer to sell the rights to manufactured drugs to manufacturers who commit to keeping the drug on the market at a fair price, but authorize the office to resume production if a manufacturer violates its commitment.

The legislation is co-sponsored by Sen. Jeff Merkley (D-OR) and Reps. Barbara Lee (D-CA), Pramila Jayapal (D-WA), Eleanor Holmes Norton (D-D.C.), Jonathan Jackson (D-IL), Sheila Cherfilus-McCormick (D-FL), Danny Davis (D-IL), and Jesús Garcia (D-IL).

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