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McClellan cites 'crisis' in affordable medicines. (US Food and Drug Administration Commissioner Mark McClellan).

CANCUN, Mexico -- Food and Drug Administration commissioner Mark McClellan is urging countries lacking well-regulated, high-quality generic drug industries to take the steps needed to do so or to work to import drugs from other nations that have established such a system.

He made his remarks last month at an international colloquium on generic medicine.

"It is no accident that my first international speech concerns the topic of improving the development and availability of affordable and safe medicines," he told representatives of the international generic drug community attending the meeting here.

"When it comes to affordable, safe and innovative medicines, we are facing a global crisis; this crisis will get worse if we do not take more steps now to start working together to address it," he said.

McClellan complimented Mexican efforts to set standards for interchangeable generics.

"We intend to share and exchange our expertise and collaborate with Mexico as you continue the promising work you have started," he vowed. "We are willing to provide similar assistance to other countries that follow Mexico's example.

"We are willing to do this not only out of concern for international health, we are doing it to help prevent unsafe medications from entering our drug supply as well."

McClellan told the gathering that improving the generic drug industry in the United States has been one of his priorities since becoming FDA commissioner.

"As soon as legitimate drug patents expire we should all work to make safe and effective generic drugs available," he said.

"Within the past year the FDA has implemented new regulations to prevent legal challenges that inappropriately delay generics competition, we have conducted a bilingual education campaign in collaboration with many outside groups on the benefits of generic drugs, and we have announced fundamental reforms and the largest expansion ever of our generic drug program, which we expect to reduce the time for generic drugs to be approved in the U.S. by months."

McClellan pointed out that generic drugs now account for a majority of prescriptions in the U.S. and that the country has some of the lowest-price generic drugs available in the world.

"Mexico is taking similar steps," he pointed out. "And other countries should as well so that their generic prices will fall and their generic use will increase as it has done in the U.S."

For example, Canada is under pressure to quickly allow generic pharmaceutical makers to supply products to poor countries.

The United Nations special envoy on HIV/AIDS in Africa has called on Canadian officials to amend that country's patent law so generic drug makers can participate in a recent World Trade Organization agreement that allows some countries to override patents and order copies from generics manufacturers.

Canada's patent laws ban drug producers from copying patented medicines for 20 years, except in national emergencies.

McClellan noted that although slightly over half of all prescriptions in the U.S. are for generic drugs, the share in Canada is 40% or less and in France it is under 10%.

"I am also pleased that the interchangeable generics industry in Mexico intends to respect patent rights so that legitimate brand-name drugs that are still on patent will not be improperly copied," McClellan said. "This is very important, because with a far greater number of new drugs and biologics in development than ever before it is essential for the long-term health of the world's generic drug industries.

"Without more new drugs being developed and subsequently coming off patent the generics industry has no future."

McClellan noted that the FDA is taking other steps to reduce the cost of developing drugs--both new medications and generics.

"We want to partner with all of your countries in this effort," the commissioner emphasized.

"A key element of our new planning is what we call efficient risk management," he said. "In all of our policies and regulations we're seeking to use the best biomedical science, the best risk management science and the best economic science to achieve our health policy goals as efficiently as possible."
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Title Annotation:Focus
Comment:McClellan cites 'crisis' in affordable medicines. (US Food and Drug Administration Commissioner Mark McClellan).(Focus)
Publication:Chain Drug Review
Geographic Code:00WOR
Date:Oct 27, 2003
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