FDA Votes to Broaden User Fee System

Yesterday, the Senate voted to support a new bill  that increases the fees Pharma pays to see their products through the review process.  Over the next four years, they are expected to pay $4 billion, which is an increase of 6%.  Biosimilars have a rate of $128 million locked in through 2017 and generic drug companies will pay $1.5 billion.  Also included in the legislation is a requirement for drug companies to share problems in the drug supply, as this helps the overall rate of drug shortages drop.  The FDA will also increase it's inspections in international drug manufacturing sites and drop investigations of US manufactures to inspections once every two years.  For more on this story, visit First World Pharma.

This September at the Business of Biosimilars and Generic Drugs Summit in Boston, we'll have the latest updates of the FDA's biosimilars guidelines.  For more information on the event, download the brochure.  As a reader of this blog, if you'd like to join us, register today and mention code XP1786BLOG and save 25% off the standard rate!

How do you think this new bill will help the generics industry?

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