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No agreement reached in talks on access to cheap drugs
POLICY AND PEOPLE
US government report released on deceptive drug advertisements US government report released on Dec 4 found that drug companies promote misleading advertisements for their products, even after the Food and Drug Administration (FDA) has tried to halt them. Further, the report notes that drug companies have continued to make misleading claims even after being cited, in some cases repeatedly, for violations. Owing to a recent change instituted by the Bush administration, there is a long delay between the FDA’s finding of deception and notice to the manufacturer of such a finding. The administration, under the auspices of the US Department of Health and Human Services (HHS), now requires a lengthy review process, during which time the notices are reviewed by government attorneys for “legal sufficiency and consistency with agency policy”. The result is that enforcement is being delayed by 2 to 11 weeks. With the life of many advertisement campaigns less than 2 months, the misleading information may have been completely disseminated before the manufacturer receives the FDA letter. Thus, consumers are exposed to inaccurate or incomplete information because the cycle of advertising has
A
usually run its course before the FDA directive arrives. The FDA says that drug companies have, in every case, stopped misleading advertisements when they have received enforcement letters.
Rights were not granted to include this image in electronic media. Please refer to the printed journal. Misleading claims made about drugs
However, companies continue to make false claims in subsequent, new advertisements for the same drugs. According to the report, entitled FDA Oversight of Direct-to-Consumer [DTC] Advertising Has Limitations, (available at http://www.gao.gov), spending for drug research and development (US$30·3 billion) still exceeds that for advertising ($19·1 billion). However, spending on promotional activities, including DTC advertising, rose at a much greater rate than did
research spending (in the years 1997–2001, spending for DTC advertising increased by 145%, whereas spending on research and development rose by only 59%). In 2001, 55% of drug companies’ expenditures on promotional activities went toward providing samples to doctors, 29% was for sending drug company representatives to meet with doctors, 14% was for DTC advertising, and 2% went for advertising in medical journals. Guidelines for DTC advertising were relaxed in 1997. Since then, DTC advertising, much of it on television, has risen by nearly 150%. The result may be increased prescription drug use and increased sales of DTC-advertised drugs. In addition, each year some 8·5 million consumers ask their doctors for and receive a prescription for a drug they have seen as part of a DTC advertising campaign. The report notes that the new review policy has impeded the FDA’s ability to effectively oversee drug advertisements, and recommends that HHS speed up the process so that misleading advertisements can be withdrawn or revised in a timely manner. Faith McLellan
No agreement reached in talks on access to cheap drugs t a meeting on Nov 25–27 in Geneva, Switzerland, the Council for the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) was expected to finalise a plan that would enable generic drug manufacturers in countries such as Brazil, India, and China to export drugs still under patent, under certain circumstances, to countries with little or no manufacturing industry. Instead the TRIPs Council meeting, which followed a “miniministerial” meeting held earlier in November (see Lancet 2002; 360: 1670), ended without any prospect of reaching agreement. During the meeting the USA, Japan, and Canada argued in favour of the introduction of a temporary waiver against bringing disputes to the WTO if the case concerns generics that are to be imported to the least developed countries. Other countries, particularly developing countries, supported by groups such as Oxfam and Médecins Sans Frontières, preferred a permanent amendment of TRIPs. This, they suggested, would offer certainty to all parties and an encouragement to
A
manufacturers of generics to gear up for larger-scale production. At present, a WTO agreement interpreting TRIPs, known as the “Doha Declaration”, allows countries to issue compulsory licences during national emergencies such as HIV/AIDS, malaria, tuberculosis, and other epidemics. In these circumstances, a local third-party manufacturer may produce the necessary drugs for domestic use and reasonable compensation must be paid to the patent holder. At the meeting, the USA attempted to limit the diseases that might be covered by the new agreement to HIV/AIDS, tuberculosis, and malaria, and “other infectious epidemics of comparable gravity and scale that may arise in the future”. This restrictive language was not acceptable to other members, however. Disagreement also arose at the meeting as to what might constitute reasonable compensation and who might be liable to pay it. The USA further endeavoured to limit the number of countries that might benefit from the importation of
THE LANCET • Vol 360 • December 14, 2002 • www.thelancet.com
cheaper generic versions of patented drugs. The Council agreed that the 49 least developed countries should be automatically entitled to benefit, but no agreement was reached on the extension of this to other developing countries. Developing countries rejected this division. The US position is undoubtedly in line with the desires of industry. A letter dated 25 Nov, 2002, from 20 pharmaceutical companies to the US Trade Representative, Robert Zoellick, states: “An open-ended or unclear exception to the standards for patent protection would seriously undermine our interest and set back the long-term public health objectives Doha was designed to achieve. We urge you to negotiate a solution that is specifically limited to the diseases that were the focus of the Doha Declaration, namely HIV/AIDS, TB and malaria and other epidemics of similar scale. In addition, it should be clear that only truly disadvantaged countries in sub-Saharan Africa, be the recipient of the changed rules.” Bebe Loff
1951
For personal use. Only reproduce with permission from The Lancet Publishing Group.
US government report released on deceptive drug advertisements US government report released on Dec 4 found that drug companies promote misleading advertisements for their products, even after the Food and Drug Administration (FDA) has tried to halt them. Further, the report notes that drug companies have continued to make misleading claims even after being cited, in some cases repeatedly, for violations. Owing to a recent change instituted by the Bush administration, there is a long delay between the FDA’s finding of deception and notice to the manufacturer of such a finding. The administration, under the auspices of the US Department of Health and Human Services (HHS), now requires a lengthy review process, during which time the notices are reviewed by government attorneys for “legal sufficiency and consistency with agency policy”. The result is that enforcement is being delayed by 2 to 11 weeks. With the life of many advertisement campaigns less than 2 months, the misleading information may have been completely disseminated before the manufacturer receives the FDA letter. Thus, consumers are exposed to inaccurate or incomplete information because the cycle of advertising has
A
usually run its course before the FDA directive arrives. The FDA says that drug companies have, in every case, stopped misleading advertisements when they have received enforcement letters.
Rights were not granted to include this image in electronic media. Please refer to the printed journal. Misleading claims made about drugs
However, companies continue to make false claims in subsequent, new advertisements for the same drugs. According to the report, entitled FDA Oversight of Direct-to-Consumer [DTC] Advertising Has Limitations, (available at http://www.gao.gov), spending for drug research and development (US$30·3 billion) still exceeds that for advertising ($19·1 billion). However, spending on promotional activities, including DTC advertising, rose at a much greater rate than did
research spending (in the years 1997–2001, spending for DTC advertising increased by 145%, whereas spending on research and development rose by only 59%). In 2001, 55% of drug companies’ expenditures on promotional activities went toward providing samples to doctors, 29% was for sending drug company representatives to meet with doctors, 14% was for DTC advertising, and 2% went for advertising in medical journals. Guidelines for DTC advertising were relaxed in 1997. Since then, DTC advertising, much of it on television, has risen by nearly 150%. The result may be increased prescription drug use and increased sales of DTC-advertised drugs. In addition, each year some 8·5 million consumers ask their doctors for and receive a prescription for a drug they have seen as part of a DTC advertising campaign. The report notes that the new review policy has impeded the FDA’s ability to effectively oversee drug advertisements, and recommends that HHS speed up the process so that misleading advertisements can be withdrawn or revised in a timely manner. Faith McLellan
No agreement reached in talks on access to cheap drugs t a meeting on Nov 25–27 in Geneva, Switzerland, the Council for the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPs) was expected to finalise a plan that would enable generic drug manufacturers in countries such as Brazil, India, and China to export drugs still under patent, under certain circumstances, to countries with little or no manufacturing industry. Instead the TRIPs Council meeting, which followed a “miniministerial” meeting held earlier in November (see Lancet 2002; 360: 1670), ended without any prospect of reaching agreement. During the meeting the USA, Japan, and Canada argued in favour of the introduction of a temporary waiver against bringing disputes to the WTO if the case concerns generics that are to be imported to the least developed countries. Other countries, particularly developing countries, supported by groups such as Oxfam and Médecins Sans Frontières, preferred a permanent amendment of TRIPs. This, they suggested, would offer certainty to all parties and an encouragement to
A
manufacturers of generics to gear up for larger-scale production. At present, a WTO agreement interpreting TRIPs, known as the “Doha Declaration”, allows countries to issue compulsory licences during national emergencies such as HIV/AIDS, malaria, tuberculosis, and other epidemics. In these circumstances, a local third-party manufacturer may produce the necessary drugs for domestic use and reasonable compensation must be paid to the patent holder. At the meeting, the USA attempted to limit the diseases that might be covered by the new agreement to HIV/AIDS, tuberculosis, and malaria, and “other infectious epidemics of comparable gravity and scale that may arise in the future”. This restrictive language was not acceptable to other members, however. Disagreement also arose at the meeting as to what might constitute reasonable compensation and who might be liable to pay it. The USA further endeavoured to limit the number of countries that might benefit from the importation of
THE LANCET • Vol 360 • December 14, 2002 • www.thelancet.com
cheaper generic versions of patented drugs. The Council agreed that the 49 least developed countries should be automatically entitled to benefit, but no agreement was reached on the extension of this to other developing countries. Developing countries rejected this division. The US position is undoubtedly in line with the desires of industry. A letter dated 25 Nov, 2002, from 20 pharmaceutical companies to the US Trade Representative, Robert Zoellick, states: “An open-ended or unclear exception to the standards for patent protection would seriously undermine our interest and set back the long-term public health objectives Doha was designed to achieve. We urge you to negotiate a solution that is specifically limited to the diseases that were the focus of the Doha Declaration, namely HIV/AIDS, TB and malaria and other epidemics of similar scale. In addition, it should be clear that only truly disadvantaged countries in sub-Saharan Africa, be the recipient of the changed rules.” Bebe Loff
1951
For personal use. Only reproduce with permission from The Lancet Publishing Group.