The US Food and Drug Administration (FDA) announced its $20 million research on the first extensive safety and quality evaluation of generic drugs.
Composing of at least 12 academic centers involved in the testing programs, the evaluation started September and will end in 2017 focusing on heart drugs, ADHD treatments, immunosuppressants, anti-seizure medication, and antidepressants, agency officials said in Bloomberg Businessweek. Results are not yet available.
Kathleen Uhl, acting director of the FDA Office of Generic Drugs, mentioned in an interview at the Generic Pharmaceutical Association annual meeting the lack of funds for testing generics. The federal agency used to have only about $2 or $3 million budget for research program each year until the Congress approved an increase on their funds in 2012 so that they can do more-broad-based testing.
The program puts premium on the FDA standards on quality of copycat drugs - both domestically and overseas made drugs undergo rigorous testing. Over the last nine months, treatments from four at four-India based plants were banned from importing. Dialogue among the government officials, companies and the FDA chief took place since then.
One of the studies included is a research on widespread impurities in copies of Pfizer Inc. (PFE)'s Lipitor cholesterol pill made outside US by a Boston-based researcher. According to Bloomberg's report, FDA Spokesman Christopher Kelly stated that this research is being reviewed by the agency. The study is being evaluated at the Preston Mason at Brigham & Women's Hospital - however, there is no mention of the review completion on the Lipitor study.
This study uncovered the overseas-made copies of this cholesterol medication are not effective at all due to the manufacturing impurities in it.
Another study in 2012 revealed that copies of an anti-depressant medication Wellbutrin XL did not work as well as the original. This led to the recall this particular version from the market by Teva Pharmaceutical Industries (TEVA) Ltd.
