FDA Encourages Cheaper Generics Of Pricey Medications

President Donald Trump’s top health advisers announced a push to cut health costs by bringing more cutting-edge generic drugs to market in a press conference on Wednesday.

The Food and Drug Administration (FDA) will eliminate bureaucratic hurdles that protect monopolies on biologics, which include many of the world’s priciest drugs, the agency announced.

Biologics, medications sourced from living organisms, represent breakthrough biotechnology, FDA Commissioner Marty Makary said. He added that the price tags can reach into the millions for a single course of the therapy and that patients without insurance or high deductibles experiencing sticker shock may never pick up prescriptions or ration doses.

The new actions are aimed at encouraging the development of biosimilars — generic versions of biologic drugs.

“In the pharmaceutical industry, we do not have competitive markets. We’re not allowed to talk about it. It’s a sacred cow,” said Makary.

Despite the wonkiness of the policy, the health chiefs cast the move as an issue relevant to the pocketbooks of everyday Americans.

“We’re replacing bureaucracy with science, we’re replacing monopolies with competition and we’re replacing despair with hope,” Kennedy said.

The high prices of these drugs can drive billions in costs to federal health programs, with biologic medications making up only 5% of prescriptions in the U.S. but 51% of total drug spending, according to HHS. In recent years, FDA approval of expensive biologics has triggered fears of ballooning Medicare and Medicaid spending into the billions on a single drug.

Centers for Medicare & Medicaid Services Administrator Mehmet Oz encouraged states to free up Medicaid money through the adoption of biosimilars.