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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FDA realigns to support possible biosimilars change

Image Source: FDA

On August 15, the generics industry stuck a deal with the FDA that could expedite the approval process of generic drugs after fees are paid.  It is believed that first year fees could reach up to $299 million to speed up the review process which typically takes 2 1/2 years currently for approval.

The FDA Office of Generic Drugs has reported they are adding a second Division of Bioequivilance and a fourth Division of Chemistry.  Director Helen Winkle released the plans in a memo from the Office of Pharmaceutical Science.  According to Cutting Edge Information, they believe that the addition of a second Division of Bioequivilence could indicate that there has been an agreement reached after the initial Biologics Price Competition and Innovation Act passed Congress in 2009.

The Business of Biosimilars and Biobetters Conference will be addressing the abbreviated pathway  head on, with a panel of experts examining the pros and cons of paying for expediting the process of the approval of generics.

How do you feel about paying to expedite the review process?

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