Monday, January 14, 2008

FDA nod for generic cancer drug


FDA nod for generic cancer drug


In a move to increase public access to affordable cancer drugs, the Food and Drug Administration (FDA) has registered one of three generic versions of a cancer drug that is likely to be listed for a compulsory license. Public Health Minister Mongkol Na Songkhla yesterday said Indian-made cancer drug docetaxel had passed the registration process with the FDA. He did not disclose the generic maker, but said the process would help fast-track the import of the drug for use if the policy to bypass the patent of the drug is needed for the original version.

Sanofi-Aventis owns the patent of this medicine commonly used to treat breast cancer.

Speaking after visiting cancer drug manufacturers in India, Dr Mongkol said the ministry would import the cancer drug and use it for treating patients under the universal healthcare scheme only.

He conceded that it may be impossible to derive the knowledge of how to make the cancer drug for use in the country because the research and development needed was too complicated for local industry.

The National Health Security Office, which oversees the universal healthcare scheme for 48 million people, last September asked the Public Health Ministry to consider overriding the patents of four cancer drugs _ imatinib, letrozole, docetaxel, and erlotinibas _ because they are too expensive for local people.

However, the government revoked a decision to bypass the patent on imatinib after both the state and patent owner Novartis agreed to provide free medication for 900 patients under the universal healthcare scheme.

FDA secretary-general Siriwat Tiptaradol said he would have to negotiate the price of the cancer medicine with the Indian drug maker before importing the drug for local use.

The cost of the generic version of docetaxel is 4,000 baht per 80mg dose.

The retail price of erlotinibas is 2,800-3,000 baht per tablet compared with the generic version, which costs between 275-735 per tablet.

Letrozole, meanwhile, costs about 230 baht per tablet, but its generic version is priced at only 7-10 baht.

The Thai government angered some of the world's biggest pharmaceutical firms by announcing compulsory licensing for the Aids drugs Efavirenz and Kaletra along with the heart drug Plavix last year.

Compulsory licensing is allowed by the World Trade Organisation in the case of a national emergency. This lets the government bypass drug patents and import or produce generic versions of patented drugs for non-commercial purposes.

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