FDA chief talks about the need for speed in drug approvals

Getting prescription drugs to market faster is a major priority for the Food and Drug Administration, its commissioner said during the AHIP Medicare, Medicaid, Duals and Commercial Markets Forum in Washington.

Martin Makary discussed his agency’s progress in getting more drugs approved and approving them more quickly.

“We are challenging the assumptions that it takes 10-12 years for a drug to come to market and that better health care means more health care, more drugs or more hospitalization,” he said.

Makary said the FDA is redoing its entire drug approval process, giving priority to medications that reduce downstream health care, medications meeting an unmet public health need and medications that make health care more affordable. In addition, the FDA is prioritizing approval for companies that are onshoring their drug manufacturing as a security issue.

As an example of accelerated drug approvals, Makary noted that the FDA approved Zongertinib in only 44 days, a drug that treats HER2-mutant small-cell lung cancer.

But the FDA has another goal in addition to getting drugs approved, he said. “Affordability is a massive problem in health care,” he said. “And we don’t want more drugs; we want more healthy food.”

Makary said the FDA wants to see more cures and more meaningful treatments in addition to lower drug prices.

The agency is cutting what he called unnecessary steps toward drug approval. For example, the FDA has made progress in reducing unnecessary animal testing.

Using AI for speed

Using artificial intelligence can also speed up a drug’s approval process by about two months, Makary said.

Makary also called for reducing the research and development cost for biosimilars so they are more affordable.

“If half of the American public can’t afford their medications, it now becomes an access issue,” he said. “If the medication has an 80% cure rate and half the population can’t afford it, then the cure rate is now 40%.”

The FDA chief also aimed at direct-to-consumer marketing of drugs, criticizing companies for the volume of consumer advertising – usually on TV.

“It’s not right when 90% of doctors tell us they are on board with companies playing by the rules, but some haven’t been playing by the rules,” he said. “They are selling products that are not even FDA approved, or selling drugs as an online pharmacy without any mention of possible side effects.

“It’s not right when someone goes to the doctor begging them for a specific medication when the doctor knows it's not right for them.”

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Susan Rupe is editor in chief, magazine, for InsuranceNewsNet. She formerly served as communications director for an insurance agents' association and was an award-winning newspaper reporter and editor. Contact her at [email protected].