triplecocktail - P a ge |1 POLS 341 Memo To: From: Date:...

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P a g e | 1 POLS 341 Memo To: From:: Date: 5/8/2009 Re: FDA Approval of Generic Foreign AIDS drug Combination and PEPFAR Dilemma The world is currently facing an AIDS epidemic and the cost of the treatment is expensive (appendix). According to a CBS News Report, the cost of prescription drugs is about $14,000 annually. Reasons for High Drug Costs Patent Laws o Hatch Waxman Act of 1984 Supposed to encourage generic drug companies to enter the marketplace while keeping financial incentives for drug companies Loopholes allow drug companies to extend patents o Prescription drug patents last 20 years o Small changes can be patented 2/3 of all new patents are for modification not new drugs 1
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o 30 month stays A pharmaceutical company can delay a generic drug for 30 months multiple times by filing patent infringement suits Removing this process would be able to save consumers an estimated 2.04 billion dollars a year New drugs cost an estimated $800 million to bring to market Each country has different patent laws which affect the global market o Beginning in January of 2008, African countries will no longer be able to import generic antiretrovirals from India due to a change in India’s patents laws. History AIDS was started to become a public issue 1980s; however it wasn’t until the early 1990’s that governments started to recognize the problem as an epidemic. Famous people such as Magic Johnson (NBA basketball player who went public with his HIV diagnosis in 1991) helped bring the issue to the forefront. It is also during the 1990’s that AIDS is recognized as an epidemic worldwide that governments not just individuals have to deal with(San Francisco 2007). Currently AIDS is no longer looked at as a personal problem affecting only individuals; instead it is looked at as a global problem affecting everyone. The most recent and one of the largest AIDS funding campaigns began in 2003 when President Bush announced his PEPFAR plan which will be discussed in this memo. Page 2
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Solution to expensive treatment The Food and Drug Administration (FDA) granted tentative approval to a generic AIDS drug regimen in January of 2005. This was the first time that the FDA had approved a drug that was not made and patented in the United States. This was expected to expand the treatment of AIDS(Klein 2007). As the AIDS epidemic spreads, there is a greater need for cheaper medication, and a higher availability of that medication. The FDA approval allows for the PEPFAR plan to purchase these generic drugs and provide them to people that are covered under the plan. What is PEPFAR? President George W. Bush announced and put into policy his Presidential Emergency Plan For AIDS Relief (PEPFAR) in 2003. The plan called for 15 billion dollars over a 5 year span in government spending to
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This note was uploaded on 04/26/2008 for the course POLITICAL 350 taught by Professor Lindamen during the Spring '08 term at Winona.

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triplecocktail - P a ge |1 POLS 341 Memo To: From: Date:...

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