FDA Targets Insulin for Increased Competition to Lower Prices

(Bloomberg) -- The Food and Drug Administration will add insulin, a life-saving drug used by millions of diabetics, to its campaign to add generic competitors to brand-name products the agency believes are part of the U.S.’s medical cost problem.

One tool in the FDA’s effort is an agency-curated list of drugs that have lost their monopoly protections after their patents expired but that still lack a cheap generic version. The list is meant to highlight opportunities for manufacturers of generics, and the FDA has said it will expedite review of any application for a product on the list.

“It’s important that we provide tools and resources to help companies to identify products on the market that lack competition,” FDA Commissioner Scott Gottlieb said in a statement Friday.

About 30 million Americans had diabetes in 2015, and the disease is the seventh-leading cause of death in the U.S., according to the Centers for Disease Control and Prevention.

It’s also one of the drug industry’s biggest markets. Annual insulin sales worldwide exceed $20 billion and the price of the drugs, which help diabetics control their blood sugar, has risen more then 270 percent over the past decade.

For example, Eli Lilly & Co.’s best-selling insulin Humalog cost $21 a vial when it was introduced in 1996, and now sells for $275 a vial. Last year, it brought in $2.77 billion for the company.

Earlier this month the FDA approved Sanofi’s Admelog, which is similar to Humalog. While Sanofi has declined to say what Admelog will cost, health insurers and drug plans have been able to win steep discounts for diabetes products when there are similar, competing therapies.

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