[te...] Posted April 8, 2019 Share Posted April 8, 2019 According to this article, the division of the FDA that approves opioids is 75% funded by the drug companies themselves... no wonder the FDA stood by and did nothing to avert the crisis... https://www.newsday.com/opinion/editorial/opioids-1.29433231 Link to comment Share on other sites More sharing options...
[Ho...] Posted April 11, 2019 Share Posted April 11, 2019 I work in the pharma industry. And yes, much of the FDA is funded through "user fees" supplied by the industry. Every application to market a new drug requires a fee. Every manufacturing site a company has pays a yearly fee for every drug that site manufactures to register the site. It's also how the FDA polices the industry. It used to be, when a company submitted an application for a new drug, it took years for the FDA to act on the application. The industry complained bitterly. So a compromise was struck: in return for paying fees, the FDA would use those fees to hire more people to review the industries filings. This was the Prescription Drug and User Fee Act (PDUFA), passed in the mid-90s I think, if I remember correctly. The FDA is really there to advance the interests of the industry. Protecting the consumer is kind of secondary. But still, if a company wants to market a drug in Europe - and Europe is a huge market - then companies also have to comply with European laws on drugs. And Europe is much stricter about these things. Just my 2 cents. Link to comment Share on other sites More sharing options...
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