Faster Drug Approval: Winners and Losers

By Kristen Fischer, HealthZette

July 1, 2016

[…] Recently, due to calls for novel treatments that move faster from the (lab) bench to the bedside, a legislative effort is attempting to speed up that process. The 21st Century Cures Act would allow companies to submit evidence of safety based on patient stories instead of actual clinical trials.

The House already passed its own version; the Senate is expected to review it in the coming weeks, STAT reported.

While the measure could speed up the process, some people fear it would also remove a lot of quality control. And when it comes to health, it’s good to know that the medications you take have been tested extensively and are backed by reliable data.

Another concern is any new fast-track process would enable pharmaceutical companies, for the most part, to dictate the efficacy of a drug instead of the FDA as a third party.

Patience for Patients

[…] Dr. David Gortler, a former FDA senior medical officer and current drug safety and FDA policy expert at FormerFDA.com, told LifeZette he doesn’t agree with speeding up the process because lawmakers typically don’t have an extensive pharmacology background. Circumventing the time-tested FDA process will not help Americans.

“They [lawmakers trying to speed up the process] don’t trust these people who have dedicated their lives to pharmacology and medicine,” Gortler said.

People think they know better, but they are really just putting their lives at risk, he added. “They don’t trust doctors or pharmacists. They trust GNC.”

In a Washington Post editorial, Susan F. Wood, an associate professor at George Washington University’s Milken Institute School of Public Health and a former FDA assistant commissioner, explained that the 21st Century Cures Act is based on an assumption that there will be more cures if drugs and devices are studied more quickly on fewer patients.

She, along with Diana Zuckerman, president of the National Center for Health Research, believes the studies would be too small to allow safety and effectiveness findings to be broken down into subgroups such as male and female.

“This embrace of smaller, more preliminary studies could drastically lower scientific standards. When fewer people are studied, it is more likely that a drug will seem safe and effective even if it has dangerous side effects for many patients — who may not have been included in those small studies,” they wrote.

[…]

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