US FDA to institute effort for "widespread" testing of generic drugs
A prominent US news source reported Saturday that FDA is instituting a new program of widespread testing for US generic drugs. This effort is to be funded with $20 million from GDUFA funds. The testing is to be undertaken by academic centers under a grant program. Academic centers named in the article included Duke University, Johns Hopkins University, Brigham & Women's Hospital, and the Universities of Florida, Michigan, and Maryland. The first drugs to be tested are cardiovasculars, ADHD treatments, immunosuppressants, anti-seizure medications, and antidepressants. The program is scheduled to continue through 2017.
FDA maintains a small market surveillance program that includes testing of samples of marketed products but the number of drugs tested each year has been small and the testing is largely confined to testing against specification. This new program is said to include studies on absorption, inactive ingredients, and packaging and how these factors affect generic efficacy.
The last publically acknowledged widespread testing of generic drugs occurred in the wake of the Generic Drug Scandal from 1989 to 1991. This effect tested samples of every generic drug in the top 200 generic products by volume. This effort was testing to specification and only a very few problems were found, none deemed harmful to patients. This new program sounds more wide reaching in testing and it will be interesting to hear more from FDA about the goals of this new effort.
