FDA Confirms Widespread Generic-Drug Equivalency Testing Program

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FDA has now confirmed that the first widespread generic-drug equivalency testing program was initiated last September (without public notice).
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The $20 million testing program was initiated in response to growing concerns from the medical community regarding poor generic drug equivalence. Previously in 2012, FDA found that the generic Wellbutrin XL® was not as effective as the originator product. In addition, a study conducted at Brigham and Women’s Hospital found evidence indicating that some generic forms of Lipitor® were ineffective due to manufacturing-associated impurities.

Despite a small-scale generic-drug equivalency testing program already in place, Kathleen Uhl, Acting Director of FDA’s Office of Generic Drugs, stated that the Agency wanted to initiate a widespread generic-drug equivalency testing program for a long time but was unable to do so due to a lack of funding. However, the recent addition of user fees from the generic drug industry to fund FDA reviews provided funding for the widespread generic-drug equivalency testing program.

Dozens of academic centers across the U.S. have received grant funding, and generic-drug equivalency testing will take place until 2017. Grant recipients will conduct research to determine how absorption, inactive ingredients and packaging affect generics’ efficacy. FDA is currently targeting specific therapeutic areas for evaluation this fiscal year, including cardiovascular drugs, antidepressants, immunosuppressants, anti-seizure medicines and ADHD drugs.

Depending on the results of this program, generic drug manufacturers in the targeted therapeutic areas could face increased regulatory scrutiny. Specifically, if the results of FDA’s testing reveal that generic drugs are not equivalent to their brand counterparts, the Agency must decide whether further action is required. In the case of generic Wellbutrin XL®, further action included requests for additional studies or requests that generic manufacturers withdraw their products from the market.

FDA will utilize the results of its equivalency testing program to inform regulatory decisions regarding generic drugs moving forward. According to Acting Director Uhl, FDA will take a wait-and-see approach that would be contingent on the results of generic-drug equivalency testing. In the interim, FDA will establish a new Office of Pharmaceutical Quality to improve the Agency’s scrutiny of brand name, generic and over-the-counter drugs, and FDA will also work with industry to develop data that may signal when manufacturing sites are deviating from quality standards and require FDA inspection.

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