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The FDA seeks a new way to review old drugs without causing prices to soar

Harris Meyer, Kaiser Health News on

Published in News & Features

Chuck Peterson of Omaha, Nebraska, recently experienced a swollen, painful knuckle caused by arthritis. He got a prescription for colchicine.

Doctors have used the drug for treating gout and other rheumatic conditions for well over two centuries.

When Peterson went to the pharmacy, he was shocked to discover that a two-month supply of 120 pills, distributed by Par Pharmaceutical, would cost him $225 out-of-pocket on his Medicare Part D drug plan. Taking it for an additional three months, as his rheumatologist wanted him to do, would cost him nearly $600 under his drug plan.

A dozen years ago, the drug cost about a dime per pill.

“My reaction was ‘goodness gracious,’ or maybe something I couldn’t say in polite company,” he said.

The startling price hike was precipitated by a well-intentioned federal government program, called the Unapproved Drugs Initiative, that created unforeseen consequences. It was supposed to protect the public by ensuring that older drugs went through a Food and Drug Administration approval process to determine their safety and efficacy and that older versions were taken off the market.

 

In November, the departing Trump administration unexpectedly ended the FDA program that led to a price spike for colchicine and other older drugs, saying it drove up drug costs and in some cases caused shortages. Now the FDA is considering whether and how to replace it, while advancing the Biden administration’s goal of reducing prescription drug prices overall. An announcement is expected soon.

But health care policy analysts and executives fear drugmakers still will find ways to maintain high prices for drugs already approved through the program, and to jack up prices for remaining unapproved drugs on the market, estimated to number at least 1,500. They note that the manufacturers of drugs that were granted FDA approval and market exclusivity through the UDI program, including colchicine, have aggressively used the courts to block other drug companies from marketing cheaper generic alternatives, often for many years.

Colchicine was one of many drugs that were sold before the FDA was created in 1938. No manufacturer ever took it through the agency’s approval process for determining safety and efficacy, but its approval for wide use was effectively grandfathered in.

Then the FDA, under the UDI program it launched in 2006, approved a branded version of colchicine in 2009, gave the manufacturer seven years of exclusivity and ordered previous versions off the market. With no competition, the price soared to about $4.50 a pill. That has since dipped to less than $2 a pill since generic competitors were approved by the FDA and entered the market in the past few years. However, the price is still much higher than before.

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