Regulatory Affairs Updates: Latest on ANDA User Fees (GDUFA)

FDA and industry leaders have agreed on legislation that, if passed by Congress, will usher in user fees for ANDA sponsors.  As currently drafted, a one-time backlog fee is anticipated for “Each person that owns an abbreviated new drug application that is pending on October 1, 2012, and that has not received a tentative approval prior to that date”.  The draft legislation notes that the backlog fee will be computed by dividing the total number of applicable ANDAs into $50 million.  As of December 2011 the backlog consisted of approximately 2,500 applications, though not all could be considered “applicable”.  Once the backlog fee is calculated, the amount will be announced in the Federal Register.  Click here for help with your ANDA, 505(b)(2) or NDA submission and other FDA consulting needs.   Click on the following links to learn more about GDUFA:

• September 9, 2011 Letter from GPhA Board of Directors Chairman, Paul Bisaro
• http://www.fdanews.com/newsletter/article?articleId=143219&issueId=15420
• http://gphaonline.org/media/press-releases/2012/gpha-applauds-fda-completing-generic-drug-user-fee-act-recommendations
• http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM287735.pdf
• http://www.fda.gov/downloads/Drugs/NewsEvents/UCM284150.pdf
• http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm256662.htm
• http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm256661.htm

Time and Extent Applications for Nonprescription Drug Products (OTC) Guidance Introduced

According to FDA, "This guidance is intended to explain what information an applicant should submit to the Food and Drug Administration (FDA) to request that a drug product be included in the over-thecounter (OTC) drug monograph system and to describe the process for submitting that  information.  FDA regulations set forth criteria and procedures by which OTC drugs that initially were marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any U.S. marketing experience can be considered for inclusion in the OTC drug monograph system (21 CFR 330.14)."  Contact PDG to learn more about how this may affect your introduction of OTCs into the market given the latest Guidance on unapproved drugs.

Unapproved Drug Enforcement Policy Revised by FDA

On September 19, 2011, FDA published a Notice to Industry announcing its revised Guidance for Marketed Unapproved Drugs – Compliance Policy Guide, replacing the version previously released in June 2006.  This guidance represents a shift in FDA's approach to enforcement actions related to marketed drugs without approved NDAs, ANDAs or OTC monograph compliance.  To learn how PDG can help you ensure compliance with this, or other FDA mandates, contact us now.