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GDUFA Fees Announced for FY 2016 – Surprise, Surprise!

The new GDUFA fees for 2016 were published today in the Federal Register (here) and there were some real surprises.  For instance, the ANDA fee (that we thought was going to decrease given the fact that 2014 saw a record 1465 ANDAs submitted) soared and apparently FDA is justifying that the fee increase is due to the lower number of ANDAs that have been submitted so far in 2015 (377 through June 2015 with a straight line projection at that rate of 502 to be submitted in FY 2015).

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Just When You Thought All the Questions on 180-Day Exclusivity Were Answered!

Late Tuesday evening, the FDA placed a “Dear Applicant Letter” on Regulations.gov relative to a request for comments from interested and affected parties on two very interesting issues relative to 180-day exclusivity. The drug product in question is Cyclosporine Ophthalmic Emulsion. As part of its consideration, FDA is considering whether the fact that FDA did not issue an Acknowledgement Letter for this drug product until after the patent expired impacts this analysis. FDA also seeks comment on whether there are any other factors that are material to this question.

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Quality Metrics Draft Guidance Issues

Today, the FDA released its draft Guidance entitled, “Request for Quality Metrics.” The document outlines the FDA’s thinking on the use of quality metrics data “to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.”

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FDA Denies Petition and Revises Bioequivalence Guidance for Lubiprostone

The innovator for Lubiprostone (trade name Amitza) petitioned the FDA to change the requirements for demonstrating bioequivalence of the product to require additional BE studies with clinical endpoints for various other approved indications. The FDA explained in its denial letter that it has been reviewing the approval requirements for all locally acting drug products in the gastrointestinal (GI) tract and had decided to revise its BE recommendations for all. However, its revised recommendations actually made the path to approval for a duplicate version of the drug potentially easier for generic entrants.

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Special Termination of Debarment for One FDA Reviewer is Granted

In a Federal Register Notice today, the FDA announced the termination of permanent debarment of David Brancato.  David was one of the original FDA staff members implicated in the Generic Drug scandal.  He was originally debarred on January 6, 1994.

Special termination of debarment can occur when there is a determination that an individual substantially assisted in and cooperated with authorities in the investigation. 

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The Backlog at OGD – a Historical Look

Yesterday, a reporter asked me how long has there been a backlog at the Office of Generic Drugs (OGD).  I told the reporter that the nature of the ANDA review and approval process will guarantee that there is always a backlog.  That is because firms submit applications on an ongoing basis, and it takes the OGD time to review and assess each application. 

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Generics Statistical Report Partially Updated

Today, the Activities Report of the Generic Drug Program 2015 received its first update since March 2015. However, it was only a partial update, as no information relative to amendments received for original or supplemental applications were posted.