FDA Outlines Critical Path Opportunities for Generic Drugs

Rockville, MD (May 1)-The US Food and Drug Administration (www.fda.gov) issued a report, “Critical Path Opportunities for Generic Drugs,” to identify the scientific challenges, including those in manufacturing science, in developing generic drugs and the opportunities for collaborative solutions in resolving those challenges.

To receive approval, generic drug applicants must demonstrate that their products are pharmaceutically equivalent and bioequivalent to the reference product. Pharmaceutically equivalent products have the same active ingredient in the same strength in the same dosage form. For many drug products, demonstrating pharmaceutical equivalence and bioequivalence is relatively straightforward, but the FDA report points out that for certain products, such as topical and inhaled products, there are scientific challenges in developing equivalent products.

FDA identifies four areas where collaborative activities could advance developing generic drugs:

• Improve the science underlying quality by design for developing and manufacturing generic drug products;

• Improve the efficiency of current methods for assessing bioequivalence of systemically acting drugs, including products that use complex and novel drug-delivery technologies;

• Develop methods for assessing bioequivalence of locally acting drugs such as topical and inhalation products;

• Develop methods for characterizing complex drug substances and products.

The full report may be found at www.fda.gov/oc/initiatives/criticalpath/reports/generic.html.