FDA Proposes Guidelines for Genetically Engineered Animals
(BioWorld Today Via Acquire Media NewsEdge) Washington Roundup
WASHINGTON - The FDA last week proposed new guidelines intended to clarify the agency's regulatory authority over genetically engineered animals and its requirements and recommendations for drugs, devices and food derived from such animals.
Genetic engineering — the process in which recombinant DNA technology is used to introduce new characteristics or traits into organisms - has been widely used in agriculture to make crops resistant to certain pests or herbicides or with improved nutritional qualities, regulators noted.
In medicine, genetic engineering is used to develop microbes that produce drugs and other therapeutic products for use in humans, and in food, the process is used to produce microorganisms that aid in baking, brewing and cheese-making, the FDA said.
Regulators stressed that genetically engineered animals are not clones — genetic copies of the animals from which they are produced.
Many kinds of genetically engineered animals are in development but none have been approved by the FDA for marketing in the U.S.
Such animals can be classified in groups based on their intended use, regulators explained. For example, biopharm animals are those that have undergone genetic engineering to produce particular substances, such as human insulin, for pharmaceutical use. Research animals may be engineered to make them more susceptible to particular diseases, such as cancer.
Food use animals are engineered to provide healthier meat, such as pigs that contain healthy omega-3 fatty acids at levels comparable to those in fish, regulators explained.
The draft guidelines, which are open for public comment until Nov. 18, are not legally binding or enforceable as with regulations, the FDA noted.
Rather, the guidelines provide advice to industry about how best to comply with statutory or regulatory requirements.
The FDA said its existing statutory authorities under the new animal drug provisions of the Food, Drug and Cosmetic Act and current rules are sufficient to regulate genetically engineered animals.
While the FDA's Center for Veterinary Medicine will be responsible for overseeing biopharm animals, the final pharmaceutical will be reviewed by either the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research, the agency said.
Genetically engineered mice in research laboratories are not covered by the FDA's guidance, but instead remain under the National Institutes of Health's guidelines for recombinant DNA research, regulators said.
"Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment and the production of new materials," said Randall Lutter, deputy commissioner for policy at the FDA. The agency, he said, has "long been involved" in the scientific evaluation of such animals.
"Through genetic engineering animals can produce pharmaceutical proteins and replacement tissues in their milk, eggs, and blood, which can be used in the treatment of human diseases such as cancer, heart attacks, hemophilia, rheumatoid arthritis, pandemic flu, malaria and small pox," said Barbara Glenn, the Biotechnology Industry Organization's managing director of animal biotechnology.
In addition, she noted, research also is being conducted to produce transplant organs in pigs that may be a source of organs for humans.
Giuliani to Fight Ranbaxy's Import Ban
After the FDA last week said it was banning imports of drugs made at two plants owned by Indian drugmaker Ranbaxy Laboratories Ltd, the firm hired former New York Mayor Rudolf Giuliani to help fight its case.
The FDA said Ranbaxy had repeatedly failed to fix problems at two plants in Dewas and Paonta Sahib, India. Therefore, regulators said they issued an alert to U.S. Customs officials to detain 30 generic drugs made at the plants, which include gabapentin, cephalexin and zidovudine, a drug designated under the President's Emergency Program for AIDS Relief (PEPFAR) program.
Because Ranbaxy is the sole supplier of the antiviral drug ganciclovir, the FDA said it would not "generally" detain shipments into the U.S. of that drug.
Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research, stressed that the agency had no concerns so far about any drugs from the plants that currently are on U.S. pharmacy shelves and had no evidence that Ranbaxy has shipped defective products.
"This is a preventive action taken to protect the quality of the drugs used each day by millions of Americans by ensuring that the process used to make the drugs adheres to the FDA standards for quality manufacturing," Throckmorton told reporters during a media briefing.
A spokeswoman for the agency told BioWorld Today that U.S. regulators had analyzed about 80 samples of finished drugs from the two Ranbaxy plants and found that "all samples met their applicable specifications."
Regulators said until the firm addresses its manufacturing plant deficiencies, the drugs from the two plants would remain on the import alert and the agency would not approve any of Ranbaxy's other drug applications.
Ranbaxy, meanwhile, has hired New York-based Giuliani Partners LLC at an undisclosed fee. "Ranbaxy is committed to a swift resolution to address these issues and to continuing to supply the global marketplace with safe and effective pharmaceuticals," the firm said in a statement.
The India-based company also is the subject of an investigation by the Justice Department for possible fraud and other improprieties in the firm's applications to sell drugs in the U.S.
Rep. John Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, Thursday said he was expanding an ongoing investigation into whether the FDA knowingly allowed drugs suspected of being fraudulently approved and manufactured in violation of good manufacturing practices to be sold in the U.S. to include Ranbaxy's PEPFAR drugs. "It is important that the recipients of PEPFAR drugs know the FDA has done everything it should be doing to ensure the safety and effectiveness of these life-saving medications," Dingell said.
PEPFAR drugs are supplied to developing nations to treat HIV/AIDS and are granted expedited reviews by the FDA. However, the drugs cannot be granted approval for marketing in the U.S.
Copyright—2008 Thomson BioWorld, All Rights Reserved.
Sunday, September 21, 2008
Wednesday, September 3, 2008
pending further research, this is interesting
Mills: The Dangerous Myth of Energy Independence
Originally posted By Juan Cole to Informed Comment at 2/9/2008 12:16:00 AM.
Robin M. Mills writes in an op-ed for IC
A pernicious myth has recently re-emerged: that oil is ‘running out’, that global production will soon peak and enter inexorable decline. What is the proper response to ‘peak oil’ – to attempt energy self-sufficiency, or to take military control of oil producing regions before the Chinese or Russians get there?
The current high energy prices emerge from a long period of low prices and under-investment, itself the fruit of the breakdown of international energy relationships in the oil crises of 1973-4 and 1978-80. Contrary to vocal ‘peak oil’ claims, high prices are not due to a lack of resources in the ground. There remains vast potential around the world for increasing recovery from existing fields, discovering new oil, as recently in deepwater Brazil, or in the largely untouched US offshore, and for ‘unconventional’ sources such as Canada’s famous ‘oil sands’, biofuels, synthetic fuels from natural gas and coal, and others.
Ideas about forestalling an oil crisis by ‘energy independence’, or by military action, are therefore mistaken. Indeed, such ‘solutions’ are likely to create the crisis they seek to mitigate. ‘Energy independence’ for the United States was touted by Nixon in 1974, by Ford in 1975, by Carter in 1977, by Reagan in 1981, by Bush Senior in 1991, by Clinton in 1992 and by Bush Junior in 2003, during which time American oil imports doubled. ‘Peak oil’ ideas, recent high oil prices and fears of Middle East hostilities seem to have made the quest more urgent. Campaigns encourage American consumers to boycott Middle Eastern ‘terrorist oil’, and laws are proposed to sue OPEC. When Arab countries, even staunch US allies, attempt to recycle their oil earnings into the faltering American economy, politicians whip up media storms to keep them out.
Such a climate, with elements of paranoia, racism and Islamophobia, is profoundly harmful to the proper objective of energy policy: not independence, but security. Energy security is achieved when suppliers find markets, and markets find supply, at prices permitting both of them economic stability and growth. This requires a complex web of inter-relationships between producers and consumers. As the oil company Chevron observes in its advertising, ‘There are 193 countries in the world. None of them are energy independent’, a fact well illustrated by the USA’s recent deal to supply nuclear power technology to the oil-rich United Arab Emirates. In a global market, like that for oil, no country can wall itself off - compare the flourishing state of energy-poor Japan or Singapore with the poverty of isolated Burma or North Korea. Attempts by a major nation to achieve energy self-sufficiency are very distorting to economic competitiveness, as is clear from the contradictory blunders of 1970s US energy policy.
It is even worse when bad relations with major energy suppliers, and conflicting messages about future energy policy, discourage much-needed investment. If one side believes they are buying oil from terrorists, and the other thinks they are selling to neo-imperialists, it is not surprising that oil prices are high, investment is lacking and most of world oil reserves are monopolised by state companies. In fact, the Middle Eastern nations have generally been very reliable suppliers, and use of a mythical ‘oil weapon’ is very unlikely – any régime would be reliant on its oil earnings to sustain the economy, while strategic reserves in the industrialised countries give some ‘staying power’ to outlast an embargo. Moreover, while terrorists might manage to penetrate the strong defences of an oil facility and mount a spectacular attack, it is unlikely that they could achieve major, long-running disruptions in global energy supplies.
Policies to encourage US domestic production, increase efficiency and introduce alternative energy sources are desirable, often for environmental rather than energy security reasons, but they have to be pursued with vigour and resolution. With its ‘pork barrel’ subsidies and the interminable, inconclusive debates over whether to open new exploration areas, build new pipelines and terminals for clean natural gas, extend support for renewable energy and increase mileage standards, United States energy policy has been more erratic and hostile to increasing output than most of the Middle Eastern countries. Promises to ‘jawbone’ OPEC into supplying more oil sit very oddly with the US’s uniquely comprehensive moratoria on offshore oil and gas production.
Because of the abundance of oil and other energy sources, an era of ‘resource wars’, predicted by some, is far from inevitable, and certainly not a desirable policy outcome even for the likely ‘winners’ of such wars. We should certainly not fall into the monomaniac trap of seeing every geopolitical conflict as rooted in oil policy. Military ‘control’ of oil is not achievable or cost-effective, as the Iraq war shows, and as we know already from the Japanese experience in World War II, and Saddam Hussein’s attack on Iran. The expenditure on such wars vastly exceeds the value of any oil ‘secured’, and while production can struggle along in war-torn areas, it is impossible to develop major new fields. ‘Police actions’ to deal with specific threats are entirely reasonable, as long as they are multi-lateral and proportional to the danger posed. It would be nice, although possibly a lot to ask, for them to be carried out competently.
Thus grandiose military adventures destroy the co-operation which is essential for global energy trade. ‘Energy independence’ is a chimera, expensive, unachievable, and swimming against the tide of greater global economic integration. The world is not running out of oil, but we need a rational and balanced dialogue about how to co-operate on bringing that abundant energy to consumers. If the profound misunderstanding of, and hostility towards, the Middle East, continues, the house of energy security is being built on sand.
Robin M. Mills, author of ‘The Myth of the Oil Crisis’ (Praeger, 2008)
ROBIN M. MILLS is an oil industry professional with a background in both geology and economics. Currently, he is Senior Evaluation Manager for Dubai Energy. Previously, he worked for Shell. Mills is a member of the International Association for Energy Economics and Association of International Petroleum Negotiators. He holds a Master's Degree in Geological Sciences from Cambridge University
A pernicious myth has recently re-emerged: that oil is ‘running out’, that global production will soon peak and enter inexorable decline. What is the proper response to ‘peak oil’ – to attempt energy self-sufficiency, or to take military control of oil producing regions before the Chinese or Russians get there?
The current high energy prices emerge from a long period of low prices and under-investment, itself the fruit of the breakdown of international energy relationships in the oil crises of 1973-4 and 1978-80. Contrary to vocal ‘peak oil’ claims, high prices are not due to a lack of resources in the ground. There remains vast potential around the world for increasing recovery from existing fields, discovering new oil, as recently in deepwater Brazil, or in the largely untouched US offshore, and for ‘unconventional’ sources such as Canada’s famous ‘oil sands’, biofuels, synthetic fuels from natural gas and coal, and others.
Ideas about forestalling an oil crisis by ‘energy independence’, or by military action, are therefore mistaken. Indeed, such ‘solutions’ are likely to create the crisis they seek to mitigate. ‘Energy independence’ for the United States was touted by Nixon in 1974, by Ford in 1975, by Carter in 1977, by Reagan in 1981, by Bush Senior in 1991, by Clinton in 1992 and by Bush Junior in 2003, during which time American oil imports doubled. ‘Peak oil’ ideas, recent high oil prices and fears of Middle East hostilities seem to have made the quest more urgent. Campaigns encourage American consumers to boycott Middle Eastern ‘terrorist oil’, and laws are proposed to sue OPEC. When Arab countries, even staunch US allies, attempt to recycle their oil earnings into the faltering American economy, politicians whip up media storms to keep them out.
Such a climate, with elements of paranoia, racism and Islamophobia, is profoundly harmful to the proper objective of energy policy: not independence, but security. Energy security is achieved when suppliers find markets, and markets find supply, at prices permitting both of them economic stability and growth. This requires a complex web of inter-relationships between producers and consumers. As the oil company Chevron observes in its advertising, ‘There are 193 countries in the world. None of them are energy independent’, a fact well illustrated by the USA’s recent deal to supply nuclear power technology to the oil-rich United Arab Emirates. In a global market, like that for oil, no country can wall itself off - compare the flourishing state of energy-poor Japan or Singapore with the poverty of isolated Burma or North Korea. Attempts by a major nation to achieve energy self-sufficiency are very distorting to economic competitiveness, as is clear from the contradictory blunders of 1970s US energy policy.
It is even worse when bad relations with major energy suppliers, and conflicting messages about future energy policy, discourage much-needed investment. If one side believes they are buying oil from terrorists, and the other thinks they are selling to neo-imperialists, it is not surprising that oil prices are high, investment is lacking and most of world oil reserves are monopolised by state companies. In fact, the Middle Eastern nations have generally been very reliable suppliers, and use of a mythical ‘oil weapon’ is very unlikely – any régime would be reliant on its oil earnings to sustain the economy, while strategic reserves in the industrialised countries give some ‘staying power’ to outlast an embargo. Moreover, while terrorists might manage to penetrate the strong defences of an oil facility and mount a spectacular attack, it is unlikely that they could achieve major, long-running disruptions in global energy supplies.
Policies to encourage US domestic production, increase efficiency and introduce alternative energy sources are desirable, often for environmental rather than energy security reasons, but they have to be pursued with vigour and resolution. With its ‘pork barrel’ subsidies and the interminable, inconclusive debates over whether to open new exploration areas, build new pipelines and terminals for clean natural gas, extend support for renewable energy and increase mileage standards, United States energy policy has been more erratic and hostile to increasing output than most of the Middle Eastern countries. Promises to ‘jawbone’ OPEC into supplying more oil sit very oddly with the US’s uniquely comprehensive moratoria on offshore oil and gas production.
Because of the abundance of oil and other energy sources, an era of ‘resource wars’, predicted by some, is far from inevitable, and certainly not a desirable policy outcome even for the likely ‘winners’ of such wars. We should certainly not fall into the monomaniac trap of seeing every geopolitical conflict as rooted in oil policy. Military ‘control’ of oil is not achievable or cost-effective, as the Iraq war shows, and as we know already from the Japanese experience in World War II, and Saddam Hussein’s attack on Iran. The expenditure on such wars vastly exceeds the value of any oil ‘secured’, and while production can struggle along in war-torn areas, it is impossible to develop major new fields. ‘Police actions’ to deal with specific threats are entirely reasonable, as long as they are multi-lateral and proportional to the danger posed. It would be nice, although possibly a lot to ask, for them to be carried out competently.
Thus grandiose military adventures destroy the co-operation which is essential for global energy trade. ‘Energy independence’ is a chimera, expensive, unachievable, and swimming against the tide of greater global economic integration. The world is not running out of oil, but we need a rational and balanced dialogue about how to co-operate on bringing that abundant energy to consumers. If the profound misunderstanding of, and hostility towards, the Middle East, continues, the house of energy security is being built on sand.
Robin M. Mills, author of ‘The Myth of the Oil Crisis’ (Praeger, 2008)
ROBIN M. MILLS is an oil industry professional with a background in both geology and economics. Currently, he is Senior Evaluation Manager for Dubai Energy. Previously, he worked for Shell. Mills is a member of the International Association for Energy Economics and Association of International Petroleum Negotiators. He holds a Master's Degree in Geological Sciences from Cambridge University
Originally posted By Juan Cole to Informed Comment at 2/9/2008 12:16:00 AM.
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