In an effort to get itself into a place where it can again ship from its FDA-approved plants in India, Ranbaxy Laboratories says it is taking a hard look at how it runs its API operations.
One of the issues that the FDA has uncovered at several Indian drug manufacturing plants it has inspected is a penchant for messing with drug analytics to get the data companies need for drugs to be approved. Now the FDA has sent a warning letter to yet another Indian drugmaker accusing its analytics lab of making up sample weights used to test drugs, then using the results in FDA drug applications.
The FDA approved AstraZeneca's drug for a diabetes-related rare disease, but, following a vote from a panel of advisers, only for a portion of a tiny patient population, putting a clamp on already staid sales estimates.
India moved one step closer to approving critical changes to laws governing its medical devices. In a regulatory push, the country's health ministry agreed to examine recommendations of the standing committee on a new amendments bill, the Indo Asian News Service reported.
The cost-effectiveness agency recommended that Bristol-Myers Squibb's widely embraced Yervoy (ipilimumab) should not be used as a first-line treatment for melanoma. The agency does recommend the drug for second-line treatment, but says BMS needs to do more clinical trials to prove its "clinical effectiveness" for earlier use.
In the last 6 months the FDA has banned two more Ranbaxy plants, leaving it with just one of 5 FDA-approved facilities able to serve the U.S. So the maker of generics will try yet again to put things right so that it can sell more products in its largest market.
Studies are popping up that highlight safety risks associated with testosterone drug use, and the FDA said last month it would reassess the issue after two years of monitoring. But so far, the agency hasn't drawn any conclusions on whether testosterone treatments increase the risk of stroke, heart attack or death--and so a public advocacy group is taking matters into its own hands.
A congressional hearing Wednesday will hear from researchers who contend that because of quality and manufacturing shortcomings, at least some generic drugs made outside the U.S. don't work as well as the branded drugs they copy. And the FDA is already looking deeper into the equivalency issue.
The FDA has taken some tough action against Indian drugmakers like Ranbaxy Laboratories. It has a dozen inspectors stationed in India and will beef that up to 19. But the agency doesn't have it out for Indian drugmakers, FDA Commissioner Margaret Hamburg insists. Its actions there just reflects that India has become one of the biggest links in the global supply chain.
Sales whistleblowers have struck again, this time landing Endo Health Solutions in a $193 million hole.