FDA Commissioner Margaret Hamburg is in India this week trying to build rapport with regulators and drugmakers in her ongoing quest to stress quality manufacturing in a country that produces a huge amount of the generic drugs used by U.S. consumers. But back home, questions of quality are brewing as Congress prepares to look deeper into whether generic drugs manufactured outside the U.S. are making the grade.FDA Commissioner Margaret Hamburg
Hamburg struck a deal with Indian officials this week to have their inspectors "shadow" FDA inspectors during visits to Indian production plants, Bloomberg reports. The U.S. has been expanding its inspections in the country, and in the last year has banned two plants owned by Ranbaxy Laboratories and two owned by Wockhardt from exporting to the U.S. because they failed quality standards. Those actions have created some tensions with officials and drugmakers in India.
U.S. lawmakers want to know more about the quality of the drugs coming out of India and other countries and a February 26 Congressional hearing is set to find out more. One of the people slated to testify is Cleveland Clinic cardiologist Harry Lever, who tells Bloomberg his experience is that drugs manufactured by Indian companies don't work like they should. He said he switched one heart patient from a diuretic made in India to one made by another company and the patient lost 15 pounds of fluids in a week. "All we have to do is switch them and the patients are better," Lever claimed.
Lever is having some drugs tested by Preston Mason, a researcher at Brigham & Women's Hospital in Boston, whose study of 15 generics of Pfizer's ($PFE) Lipitor found that some of the drugs were ineffective because of the manufacturing impurities. He published his results last year in the Journal of Clinical Lipidology. "There's very little room for error in the manufacturing of these agents," Mason told Bloomberg.
Hamburg has been careful during her trip this week to emphasize the agency believes many Indian drugmakers produce top-quality products that are safe and effective. "Unfortunately the many Indian companies that understand good manufacturing and quality processes have been overshadowed by recent lapses in quality at a handful of pharmaceutical firms," Hamburg said in a blog post about the agreement struck with India's Ministry of Health and Family Welfare.
- read the Bloomberg story