USFDA Acts to Encourage Generic Competition for Complex Drug
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In order to reduce these high drug prices, the U.S. Food and Drug Administration is encouraging the development of generic versions of hard-to-make medicines by giving companies guidance on how to win approvals, including offering meetings with agency staff early on, to shorten the time for development and approval. Certain complex drugs and drug-device combinations don't get generic competition as they are difficult to create and get approval. As a result, the patients don't get cheaper drugs and the brand makers continue to make a hefty sum of money. For this purpose, the FDA has made changes to increase competition including reducing a backlog of generic pills that were awaiting approval and addressing some loopholes brand-name makers use to delay competition.

The FDA Commissioner Dr. Scott Gottlieb has asked brand-name drugmakers to focus on developing new drugs, not wringing extra money out of blockbusters long on the market while encouraging generic makers. Longer-term plans include coming up with new, better tools to determine if a proposed copycat of a complex injected drug really will affect patients the same way...

https://www.nytimes.com/aponline/2017/10/02/health/ap-us-med-fda-generic-medicines.html
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