Will Tamiflu Shortage Drive U.S. To India's Version?
With demand for the swine flu vaccine outpacing supply, the Centers for Disease Control and Prevention says it is open to considering importing a generic flu drug from India. There's just one problem: Tamiflu, the brand-name drug, is still under U.S. patent.
Flu-related hospitalizations and deaths are still on the rise in the United States. But in some areas of the country, there's a shortage of Tamiflu, the anti-viral medication that can protect against complications caused by the illness.
To deal with the shortage, the CDC has ordered more Tamiflu from Roche, its Swiss manufacturer — but it is not expected to arrive until January.
Antiflu, a generic version of Tamiflu, is made by the Indian company Cipla — despite the fact that Tamiflu's patent is protected under U.S. law until 2016. The Cipla version costs 20 to 30 percent less than the brand-name drug.
Dr. Yusuf Hamied, chairman of Cipla, says he is eager to provide the U.S. market with his generic version of the drug.
"We would keep our factories open night and day, because this is an emergency," he told NPR's Steve Inskeep.
"We would certainly cooperate in whatever way possible."
The U.S. government has already released its last 200,000-some doses of the oral liquid version of Tamiflu for children. The highest hospitalization rate for swine flu is in children age 4 and under.
A recent poll from the Harvard School of Public Health found that only about a third of adults who have tried to get a swine flu vaccine have been able to get it.
Hamied says Antiflu is an exact clone of Tamiflu. It has been approved by the World Health Organization and is already for sale in India.
In 2001, Cipla tried to import its generic version of the antibiotic Cipro — which was stockpiled after the anthrax attacks in 2001.
"The drug was covered under patent," Hamied said.
"And I think what happened — the American government stockpiled Ciprofloxacin and probably made a deal with Bayer [the manufacturer] at a much lower price than what was the prevailing market price at the time."
Hamied said his new plan to export Cipla's version of Tamiflu to the United States faces similar problems.
To import Antiflu before 2016, the U.S. government would have to override patent law, which it would likely only do in a real emergency. And Cipla's drug does not yet have Food and Drug Administration approval.
India is the largest and fastest-growing producer of generic medicines; Hamied's company has a long history of producing generic drugs to sell at cheap prices in the developing world.
The most famous of these is Cipla's generic anti-retroviral drug. It is considered to be lifesaving for HIV-positive people in Africa, because it is available for a fraction of the cost of brand-name anti-retrovirals.
In developed countries, anti-retrovirals cost around $6,000 per patient per year; the Indian generic version is available in the developing world for $800.
All of this has not made Cipla — or Hamied — popular among pharmaceutical companies.
In the interview, Inskeep mentioned that the head of the pharmaceutical giant GlaxoSmithKline has called Hamied a "pirate" and described the quality of Indian generic drugs as "iffy".
"You know what I replied to that, Steven?" Hamied said. "I said, 'We do not break any laws. We live by the laws of the land.' And then I sometimes add that even Robin Hood was regarded as a pirate."
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