FDA given $20 million for generic testing
pharmafile | February 24, 2014 | News story | Manufacturing and Production, Sales and Marketing | ADHD, FDA, generics, hamburg
The FDA has been given $20 million to help it assess generic treatments, a group of drugs that makes up around 80% of all medicines in the US.
Funded by the government and pharma the research money will run until 2017 and is a substantial sum for the body. For this year its focus will be on heart drugs, ADHD treatments, immunosuppressants, anti-seizure medicines, and antidepressants the regulator said.
Kathleen Uhl, acting director of the FDA’s Office of Generic Drugs told Bloomberg that while the agency has wanted to test generics for a long time, “we didn’t have money for that.” Before this year she said, “there was a very small research programme […] $2 or $3 million each year.”
The new cash advance will help increase generic drug assessment, the testing of which currently has only been done on an occasional basis in the US.
This all comes as the FDA’s commissioner, Dr Margaret Hamburg, travelled to India this month to oversee quality issues as concerns grow over just how well made – and safely exported – medicines are.
It is a pressing issue for the regulator as India’s pharma industry supplies 40% of over-the-counter and generic prescription drugs consumed in the US, and now FDA investigators are directly targeting Indian drug plants such as Ranbaxy under new quality control measures.
Speaking at a recent conference about generic medicines in the US, Tony Mauro, the North American president of Mylan – the largest U.S. generic-drug manufacturer – said problems with quality have a negative effect on all generic drugmakers, no matter where they’re located.
“The industry as a whole always suffers when there are challenges from a quality perspective because this whole industry’s foundation is about sameness of the brand,” Mauro said.
The FDA is also creating a new Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand name, generic and over-the-counter drugs.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said the agency is “talking with the industry to develop data that may signal which manufacturing plants are straying from standards and need inspection”.
Ben Adams
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