Will Gottlieb’s Faster Drug Approvals at FDA Help or Harm?


Gottlieb and Trump want faster drug approvals to help more patients, but studies show faster approvals might cause harm.

The Senate voted 57 to 42 this week to confirm Dr. Scott Gottlieb as commissioner of the FDA, but Gottlieb’s policies could have both positive and negative impacts on pharmacy and the health-care industry as a whole.

Gottlieb, a former acting FDA deputy commissioner, has said he-following President Donald Trump’s directive-would speed up the drug approval process. This would get much-needed medications to patients quicker. However, cutting corners on the FDA’s drug approval process could cause problems down the road.

A new Yale School of Medicine study found that around a third of drugs approved by the FDA from 2001 through 2010 had major safety issues years after they became widely available to patients.

Related article: 10 More Newly Approved Drugs

It took a median of 4.2 years after a drug was approved for the safety concerns to be revealed, according to the study, published in the May 9 issue of JAMA. The safety concerns were more common among medications the FDA approved as regulatory deadlines were nearing, and for biologic and psychiatric drugs.

In addition, about a third of the drugs with safety concerns required a “black box” warning about serious side effects or a safety announcement about new risks, or were withdrawn from the market.

 “While the administration pushes for less regulation and faster approvals, those decisions have consequences,” Dr. Joseph Ross, one of the study’s authors and a professor at Yale, told Stat.

Another analysis found that FDA’s decision not to rush approval for Eli Lilly's experimental solanezumab for Alzheimer’s disease, may have saved United States taxpayers as much as $100 billion over the past four years. Final-phase testing of the drug showed it was no better than placebo, researchers reported in a May 4 New England Journal of Medicine study. Eli Lilly abandoned development of the drug.

Related article: Fighting Alzheimer's

However, if solanezumab had been approved in 2012 based on a looser standard that only required a slight indication of effectiveness, billions would have been spent-including by Medicare-before the final phase testing.

"These studies, if they are performed, are often not completed until many years after marketing begins,” the researchers said.

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