FDA Commissioner's India visit coincides with trade actions

Late last year, FDA Commissioner Margaret Hamburg's first official trip to India was postponed for undisclosed reasons. It was rescheduled and now happens to coincide with actions designed to put ultimate pressure on India over its low regard for patents on drugs that it thinks are too expensive.

FDA Commissioner Margaret Hamburg--FiercePharma file photo
FDA Commissioner Margaret Hamburg

Hamburg's weeklong meetings started today amid tension between the countries over the FDA's treatment of Indian manufacturers and India's stance on intellectual property. In a move that is certain to add to that tension, U.S. Trade Representative Michael Froman was set to announce an enforcement action against India later today, Reuters reports.

Froman's office didn't let on what the action would be, but on Friday the U.S. Chamber of Commerce again called on the U.S. to act on the intellectual property rights issue, a stance that the industry's trade group PhRMA has been lobbying for as well. The Chamber is even calling for India to be tattooed as a Priority Foreign Country, a designation given to the most egregious violators of intellectual property rights, and one that could lead to U.S. trade sanctions. If that doesn't get the country's attention, on Wednesday and Thursday, the U.S. International Trade Commission will hold a hearing on India's trade and investment practices, Reuters said.

India has continued to pull already-granted patents, even as foreign drugmakers have raised a chorus of protests. India has pulled the patents for Allergan's ($AGN) eye drug Restasis as well as Roche's ($RHHBY) hepatitis C drug Pegasys and others. Last year a patent office refused Roche protection on its breast cancer drug Herceptin, saying it had not filed its application properly. But in the last week, foreign drugmakers have won some rulings to thwart Indian officials intent on tossing aside drug patents. On Friday, Delhi's high court interrupted the launch of a biosimilar of Roche's Herceptin by U.S. drugmaker Mylan ($MYL) and its Indian partner, Biocon. The action came after the Swiss drugmaker argued there was no way the two could have met all of the steps in India's biosimilar guidelines set out in 2012. On the same day, an Indian appeals board said that Bayer could appeal a 2010 decision by the patent board denying it protection for its birth control pills Yasmin and Yaz, the Business Standard reported.

All of the back-and-forth is sure to escalate tensions. Already in a meeting Monday, India's Commerce and Industry Minister Anand Sharma told Hamburg that his office believes the FDA has taken harsh steps against Indian drugmakers before they have been given a fair hearing about FDA concerns, the Hindu Business Line reports. The agency in the last year has banned two Ranbaxy Laboratories plants and two Wockhardt plants from shipping to the U.S. Those actions came after the agency added inspectors in the country. It also enlisted the help of Indian-born Altaf Ahmed Lal, Ph.D., who has worked in health policy for years in the U.S. One of his charges is to work with manufacturers in India on quality issues.

Underlying all of this is outrage in India after U.S authorities arrested and strip-searched India diplomat Devyani Khobragade for alleged visa fraud and underpaying her maid. The deputy consul general left the U.S. in January, but the charges remain in place.

- read the Reuters story
- more from the Business Standard
- here's the Hindu Business Line story

Related Articles:
Pharma giants arm-twist U.S. government for IP action in India
Roche legal action messes with Mylan's India launch of its Herceptin biosimilar
FDA Commissioner Hamburg heads for India to talk about quality manufacturing
U.S. access group aims to block Indian patent for Gilead's hot hep C drug
Allergan takes latest IP hit as India revokes 2 patents

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