FDA fails to collect over one billion dollars in fines from law-breaking pharma companies and universities | transparimed

peter.suber's bookmarks 2018-11-16

Summary:

"The FDA Amendments Act was originally introduced to prevent companies from burying research results that show their drugs to be harmful or ineffective. Negative publicity around past disasters linked to hidden clinical trials seems to have pushed pharma companies into compliance. Today, the leading drug companies publish their trial results as required by law nearly all of the time, though some of the less prominent commercial trial sponsors continue to do badly.

In contrast, even some of the major universities and nonprofits perform dismally....

If the FDA was enforcing the law, New York University School of Medicine alone would be facing a $7,647,109 fine for its illegal and unethical behaviour. However, to date, the FDA has not collected a single cent in fines....

The FDA has recently signalled that it may in future start selectively imposing fines on some occasions. Transparency advocates have sharply criticized the FDA's plan for lacking teeth. ..."

Link:

https://www.transparimed.org/single-post/2018/11/09/FDA-fails-to-collect-over-one-billion-dollars-in-fines-from-law-breaking-pharma-companies-and-universities

From feeds:

Open Access Tracking Project (OATP) » peter.suber's bookmarks

Tags:

oa.new oa.pharma oa.data oa.compliance oa.unfamiliarity oa.industry oa.universities oa.usa oa.usa.fda oa.hei

Date tagged:

11/16/2018, 12:10

Date published:

11/16/2018, 07:10