Wednesday, February 19, 2020

Wednesday, February 19, 2020

Study says new drug applications are almost always disclosed by drug companies

A new research study in the JAMA Internal Medicine said most new drug applications are acknowledged by drug companies.

The research, based on documents from 2010 to 2016, examined drug applications in the form of press releases filings with the Securities and Exchange commission.

The Food and Drug Administration’s office of public health strategy and Analysis said 89.2 percent of 249 total applications for new drugs and biologics submitted to the FDA were disclosed, mostly in press releases.

Since the FDA keeps their new drug applications a secret, they will not confirm any leak of applications.

“It makes no sense for the FDA to keep the filing of new drug applications secret from the public at the same time the drug companies are putting out press releases about them,” said Peter G Lurie, president of the center for science in public interest and co-author of the JAMA internal medicine paper.

Lurie also wants the FDA to make rejection letters public. Currently they only make public drug which are permitted to be marketed.

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US Food and Drug Administration

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