December 19, 2018

The U.S. Food and Drug Administration (“FDA”) holds the incredible power of approving new prescription drugs before doctors can use them to treat patients. Though the government approval process was intended to protect patients, it has morphed into a broken bureaucratic nightmare that is costing lives, as Goldwater Institute national investigative journalist Mark Flatten explained in a radio interview this week:

“It takes about 12 to 15 years to get a novel new drug approved,” Flatten said on the Ross Kaminsky Show. “It costs about a billion and a half dollars, and the result of that is people who could be saved by this medication do not have access to it because it’s stuck in testing — unneeded testing — testing that doesn’t make us any safer.”

Flatten exposed the FDA’s drug approval process and its consequences in a recent report for the Goldwater Institute in which he showed how complex government rules are preventing new and beneficial treatments from getting to patients suffering from diseases like heart disease, cancer, Alzheimer’s, and diabetes. What’s more, the FDA’s overcaution has little benefit.

“If you look at the percentage of drugs that are approved by the FDA and later have some kind of safety issue, the percentage that are actually withdrawn largely for safety issues has really held remarkably steady since the 60s — what’s considered the modern era of drug regulation,” Flatten noted.

“Pretty much about a third of all new products that are approved by the FDA later have some kind of safety issue, and it’s not necessarily that they get withdrawn, but they might have to change the label or change the dosage. So all of this extra regulation and extra testing isn’t making us any safer. All it’s doing is sort of fulfilling this bureaucratic statistical requirement, because the FDA is afraid to make a decision.”

The FDA isn’t the only guilty party, Flatten explained. Congress, too, shares the blame for the flawed system.

“Congress has created the negative incentive. If a drug is approved, if you save 95 out of 100 terminal patients, nobody is going to care about the 95 you saved. The way the incentive is set up, you’re going to get hauled in front of Congress and be forced to explain the five who didn’t survive. It’s a perverse system that has created its own dynamic,” Flatten said.

That dynamic has resulted in a reactionary, politically-driven patchwork of reforms to try to bring drugs to market faster. Broader reform, though, has largely been out of reach. Fortunately, the tide might be turning. The recently enacted federal Right to Try law championed by the Goldwater Institute allows patients with life-threatening conditions to access medications that could save their lives but have not received final approval from the FDA. The law sailed through the U.S. Senate without opposition and won broad support in the U.S. House. Similar measures were passed on a bipartisan basis in 41 states.

More, though, needs to be done to create an approval system that rewards innovation and allows patients and their doctors to take greater control over medical decisions.

Read more in Flatten’s report, Studied to Death: FDA Overcaution Brings Deadly Consequences.

For more information about the Goldwater Institute’s work to make the FDA more patient-centric, read about Free Speech in Medicine and Right to Try

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