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US FDA’s Hamburg offers few details on trip to India

By Zachary Brennan , 25-Feb-2014

In a conference call Friday, FDA Commissioner Margaret Hamburg explained the importance of her recent trip to India, calling for more harmonization between the regulators.

The importance of the trip rests with the fact that India provides about 80% of the world’s APIs, she said, noting that she met with top Ministry of Health and Family Welfare employees, as well as the DCGI (Drugs Controller General of India) in New Delhi.

India stands out as particularly important, especially since it’s the 3rd largest trade partner for the US,” Hamburg said.

The US and India signed the first ever statement of intent to work collaboratively to ensure products are safe and of high quality. Hamburg noted that the statement of intent is a commitment over the next 5 years but it’s “not a work contract per se,” as it’s “a broad framework.”

Commissioner Hamburg “did not visit drug manufacturing plants, but did meet with industry representatives at a special roundtable event,” FDA spokesman Stephen King told In-Pharmatechnologist.com.

What we want to do is work with India to ensure the quality and availability of the product,” she said. “We do think that the work in India is critically important because they’re such a significant supplier of drugs to this country. Quality issues are often amongst the reasons why we have shortages.”

As far as her meeting with the DCGI, she said the agency is crafting a “framework for our action together, and we discussed their eagerness in participating, receiving technical assistance, creating opportunities …every authority must work within their own laws, but when used by Americans, those products have to meet our standards.”

No specifics

Hamburg refused to discuss any “on going investigations” when one reporter asked a specific question about Ranbaxy, which has been hit with at least three recent warning letters.

Other reporters asked if the FDA was cracking down on specific companies and Hamburg said the agency is not targeting specific companies.

We discussed more opportunities to press on counterfeit drugs and capacity building,” she said, noting that the last leg of her trip ended in Mumbai with a roundtable discussion by leading women on research and pharma issues, as well as data standards, and the challenges female leaders face.

The FDA will expand its presence in the subcontinent from 12 to 19.

One of the great things about having an office in India is that it enables great communication, especially with companies, so they can understand why. There are companies that are inspected that weren’t inspected before and they are expressing concerns or asking questions, but by a process of enhanced communication, some of those concerns will be addressed,” she said.

Generic Quality Push

The commissioner’s trip also coincides with a new push by the agency to ensure the quality of its generic drug supply.

The agency has awarded 19 research grants so far this year as part of the GDUFA (Generic Drug User Fee Act) and are funded through GDUFA user fee money. The grants include ones for the development of in vivo predictive dissolution method for orally inhaled drugs; one to Cirrus Pharmaceuticals for the evaluation of excipient effects on the efficacy of metered dose inhaler products; two the University of Michigan and others to various universities.

As far as others, King said that with atorvastatin, “we’re aware of an external study on the quality of generic statins and reviewing that study.”

A public meeting was held in June 2013 and research priorities were publicly posted .   

 Over the past year, the FDA also “has been working on the Generic Drug User Fee regulatory science research program. The research studies conducted under these initiatives will advance the public health by providing access to safe and effective generic drugs. The regulatory science results will provide new tools for FDA to evaluate generic drug equivalence and for industry to efficiently develop new generic products in all product categories,” King said.

Over the past few months, grants have been awarded and research is beginning, King added. 

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