Drugs

2 Bills Introduced to Speed Generic Drugs

Two bipartisan U.S. Senate bills have been introduced with the stated purpose of speeding the development of and improving access to lower-cost generic drugs. The bills, which were introduced by senators Bill Cassidy (R-LA) and Tina Smith (D-MN), are intended to make changes to the Food Drug and Cosmetic Act (FDCA) and 505(b)(2) approval pathway.

The Simplifying the Generic Drug Application Process Act would repeal section 505(j)(2)(C) of the Food Drug and Cosmetic Act (FDCA) so that sponsors can submit certain ANDAs without the need for FDA to first grant a suitability petition, which is required for any proposed generic drug that differs from the brand in terms of its route of administration, dosage form, or strength. The FDCA requires the agency to respond to such petitions within 90 days, but if FDA does not respond, the generic sponsor cannot file the ANDA. “Unfortunately, FDA has not responded to many suitability petitions filed over the last seven years — preventing submission of ANDAs for drugs in shortage and drugs without generic competition,” the senators said in a release.

The Modernizing Therapeutic Equivalence Rating Determination Act would require FDA to assign therapeutic equivalence ratings for 505(b)(2) applications at an applicant’s request, as it does for ANDAs. The 505(b)(2) approval pathway allows certain safety and efficacy information on the active ingredient to come from studies about an already approved drug that were not conducted by or for the applicant. A therapeutic equivalence rating is necessary to trigger automatic pharmacy substitutions. Currently, ANDA sponsors have to request a rating via the citizen petition process, but this process is time consuming. “Requiring FDA to assign a therapeutic equivalence rating for 505(b)(2) applications will level the playing field for 505(b)(2) products to compete with name brand drugs,” the senators said.

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FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome