US Congress awaiting face-to-face with FDA commissioner before deciding on Indian generic market

Margaret Hamburg, commissioner of the U.S. Food and Drug Administration (FDA), is presently in India for building a concord with Indian regulators and drugmakers, after seeing the satisfactory results from her ongoing investigation on India's generic drug production.

However, U.S. Congressmen have plans of grilling her over the matter once her trip comes to an end and she's headed home. They are fully prepared to assess every aspect before deciding on a green signal for generic drugs being manufactured outside the United States, particularly in India and whether they are up to the mark.

Hamburg struck a deal with Indian officials to have their inspectors "shadow" FDA inspectors during visits to Indian production plants, Bloomberg reports. The United States has been expanding its inspections in the country, and banned two plants owned by Ranbaxy Laboratories and two owned by Wockhardt from exporting to the United States because they failed quality standards.

Those actions 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 Feb. 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 said.

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 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 said.

Hamburg has been careful during her trip 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 of the agreement struck with India's Ministry of Health and Family Welfare.

By Ruchi Singh

Park Sae-jin swatchsjp@ajunews.com