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Is the FDA’s Competent Generics Program Successful?
(Thursday, August 22, 2024) In 2017, the FDA created its Competent Generic Drugs (CGD) program to encourage the development of generic versions for off-patent drugs with no competition. This was in response to a widespread practice in the industry where a monopoly for a product allowed the manufacturer of such drugs to gouge the prices of their product with impunity. Seven years since the program was launched, its success is mixed. The FDA has approved more than 300 generic drugs under the CGD program. These represent about 100 off-patent drugs. Most of the generic versions are unique, meaning that there is one generic version of the off-patent drug. About 26 drugs have more than one generic version of which 14 have more than 3 generic versions. It can be argued that only drugs that have more than 3-5 competing products could effectively counter the monopoly of the original drug. There are many reasons why the CGD program has limited success so far. The market demand governs the main reason for the lack of generic versions of drugs. The events of 2017 that led to the hoopla were due to an outlier exploited by an obnoxious developer. It was not an isolated case and had it not been for the egregious actions of Martin Shkreli, we would not have known about it. The CGD program still provides a lot of opportunities for generic developers. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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