The Generic Drug User Fee Amendments (GDUFA) of 2012 grant the U.S. Food and Drug Administration (FDA) the authority to collect user fees from the generic drug industry to assist with the cost of regulation, from reviewing drug applications to inspecting facilities. FDA uses a portion of the collected fees to fund the regulatory science program, a generic drug research program aimed at advancing public health by providing access to safe and effective generic drugs. Each year, FDA gathers input from the generic drug industry and the public in order to select research topics for the year.
On October 3, FDA announced the regulatory science research priorities for fiscal year 2015:
1. Post-market evaluation of generic drugs
FDA will research monitoring methods and will work to better understand patient perceptions of generic drug quality and effectiveness. The agency will work to ensure generic drugs are fully interchangeable, safe, and effective in comparison to their reference listed drug. FDA will also evaluate extended release formulations.
2. Equivalence of complex drug products
FDA will look into making generic versions of drugs available for all product categories, including complex drugs with unique characteristics. The agency will work to develop guidance and policies that clarify the Abbreviated New Drug Application (ANDA) pathway for complex products. In “Regulatory Science and Generic Prescription Drugs”, FDA Deputy Director for Science Robert Lionberger listed a variety of things that could make a drug complex, such as a larger-than-normal molecule size, structural complexity, or the drug delivery mechanism.
3. Equivalence of locally-acting products
FDA will research into new bioequivalence methods and pathways for locally-acting drugs, re-evaluate statistical methodologies for topical and transdermal product irritation, and investigate in vitro alternatives to clinical endpoint bioequivalence studies. Lionberger described locally acting products as those that “are applied directly to the skin or mucous membranes.”
4. Therapeutic equivalence evaluation and standards
FDA will work to ensure therapeutic equivalence across all dosage forms and routes of delivery of generic drugs. According to Lionberger, “therapeutic equivalence means that generic products can be freely substituted for the brand-name product and for each other — thus giving the patient the assurance of safety and effectiveness.”
5. Computational and analytical tools
FDA will investigate modeling and simulation tools, as well as research priorities for advanced analytical methods.
Registrar Corp is an FDA compliance firm that helps generic drug establishments comply with FDA regulations. We can properly register a drug establishment with FDA and list its products, review and modify drug labels for FDA compliance, and more. If you have any questions about FDA drug regulations or would like more information about Registrar Corp’s services for drug establishments, contact us at +1-757-224-0177 or receive Live Help from our Regulatory Specialists 24/7 at https://www.registrarcorp.com/livehelp.