Drug :: Pharma jockeys language against compulsory licensing into FDA re-authorization – AHF

AIDS Healthcare Foundation (AHF), the US? largest provider of HIV/AIDS healthcare, education and prevention and operator of free AIDS treatment clinics in the US, Africa, Latin America/Caribbean and Asia, today blasted the Pharmaceutical Research and Manufacturers of America (PhRMA), the industry?s powerful and deep-pocketed lobbying group, for successfully jockeying language opposing the issuance of compulsory licenses for the manufacturing or importation of generic drugs?including lifesaving AIDS drugs?by certain countries into the Food and Drug Administration Revitalization Act under the ?Prescription Drug User Fee Amendments of 2007? clause.

The drug industry-backed language, which serves more as an admonishment of other countries? behavior?something for which the FDA has little or no control or jurisdiction over?came in response to the Government of Thailand?s recent issuance of compulsory licenses for certain AIDS and cardiac medicines after price reduction negotiations between that country and the drug manufacturers broke down.

?It appears that some legislators in Congress have fallen prey to the drug industry?s lobbying group and inserted incorrect and vindictive language in the FDA Reauthorization Act to oppose other countries? issuance of compulsory licenses to improve access to potentially life-saving AIDS and other drugs,? said Michael Weinstein, AIDS Healthcare Foundation President. ?First, we have long opposed the FDA policy of charging drug companies users? fees to approve and review drugs. There is simply too much potential for conflict of interest: a classic case of the fox watching the henhouse. However, to also now include language railing against compulsory licensing?a World Trade Organization-granted right and one which has absolutely nothing to do with the FDA?into the law re-authorizing the Food and Drug Administration and its mission smacks of the worst sort of cronyism. We strongly urge the House Energy and Commerce Committee to quickly pull this potentially harmful language from the bill.?

The questionable language was inserted into a version of the bill that cleared the Health Education Labor and Pensions (HELP) Committee, and later, the full Senate in late May. It is believed that many legislators who voted in favor of the bill had no knowledge that the language, , had been added to the legislation.

PhRMA?s swift jockeying to get the reprimand into the bill followed Thailand, Brazil and other countries’ recent successful efforts to improve access to lifesaving medicines, by issuing, or stating their country?s intentions to issue compulsory licenses for the manufacturing or importation of generic drugs?including lifesaving AIDS drugs. The issue of compulsory licenses is not directly related to the substance of the FDA reauthorization bill; however, PhRMA evidently was able to get language inserted on this topic. Following is a portion of the language that was slipped into the bill:

?There are concerns that certain countries have engaged in unfair price manipulation and abuse of compulsory licensing. Americans bear the majority of research and development costs for the world, which could undermine the value of existing United States pharmaceutical patents and could impede access to important therapies.?

AIDS Healthcare Foundation has contacted legislators in Washington to urge them to remove the language from the bill.

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