Tuesday, January 28, 2020

Tuesday, January 28, 2020

Congress must consider legislation to allow fast track approval of drugs available in other developed countries: researcher

Congress should work on legislation allowing the FDA to fast-track the approval of some drugs already on the market in other developed countries, according to one researcher attached to a west coast free market think tank.

As the Trump Administration continues to make statements on how it might control the price of drugs, Henry Miller, a senior fellow with the Pacific Research Institute argues that competition is the key to keep down prices and make sure the right medicines are delivered to patients as quickly as possible.

“[A] solution would be congressional authorization of drug-approval reciprocity among select foreign counterparts, giving patients rapid access to drugs that have been already proven to work in countries whose testing and review regimens are similar to our own,” Miller said.

MIller said reciprocal approval would “benefit patients directly,” countering what he describes as the “negative effects of FDA delays in approving certain new drugs.”

He cited as an example the delay in approving the MenB vaccine to treat meningitis B, sold under the brand name Bexero. It was approved in the European Union, Canada, and Australia a full two years before the FDA gave the green light. In the interim, people died or lost limbs, MIller said, adding that the Centers for Disease Control had to make an emergency application to the FDA to acquire the European version of the treatment.

“The essence of it is getting more drugs on the market,” Miller told FDA Reporter. “I don't have data to support the notion, but I assume that reciprocity would spur FDA to speed up its reviews.”

More generally, Miller said the FDA “needs more responsive, aggressive, enlightened management.”

He criticized former FDA commissioner Scott Gottlieb, who delivered what the researcher described as an “inadvisable parting salvo,” particularly relating to the requirements for approval of some drugs, notably opioids.

The commissioner testified before the Senate Appropriations Committee that Congress should add a new requirement for opioid approvals, that is they must demonstrate superiority rather than being showing to be safe and effective.

“It would be a bad idea. It shows how out of step Dr. Gottlieb was with the intention of Congress and the Trump administration to increase competition in the marketplace and put downward pressure on drug prices,” Miller said.

He referred to an MIT study that stated secondary approvals of drugs account for “a substantial share of drug utilization and associated economic and medical benefits.”

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US Food and Drug Administration

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