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USA: "User fees" to speed drug approvals
718
had been misunderstood. Regardless of what lies ahead, Dr Sullivan soon after was on the political ramparts, staging a press conference on Congressional turf to denounce Democratic machinations in the health arena. It appears that, by some means, Republicans obtained a transcript of a Democratic Congressional meeting held in July to discuss various issues, including health care. In the course of the discussion, the earthy legislator, John Dingell, of Michigan, expressed the opinion that, whatever he and his colleagues do, they should strive to "screw the Republicans". Dr Sullivan, maestro of marathon studies but little else in the health-care field, said of the Democrats, "They want to put political partisanship as a first priority, rather than the health needs of the American people". House Speaker Thomas Foley, apparently pained by this accusation, admonished Dr Sullivan, declaring that "It doesn’t advance the debate on alternatives for health care for the Secretary of Health and Human Services to play a partisan, political role and make partisan, political charges of that kind". Despair over the quality of the dialogue is surely warranted. But it should be noted, too, that the repeated skirmishing on health care in this presidential campaign is unprecedented. Whether that foretells change is another matter.
Daniel S.
Greenberg
Round the World USA: "User fees" to speed
drug approvals
The US Food and Drug Administration is supporting another initiative to improve the drug review process and speed up drug approval. Earlier initiatives included an accelerated approval policy (Lancet, April 18, p 982), a number of management reforms, and a pilot programme to conduct 6 to 12 external reviews that will be evaluated in 18 months. At a recent hearing, Dr David A. Kessler, Commissioner of the FDA, testified before the House Health and Environment Subcommittee that his agency backs the draft proposal to establish a system of user fees to speed up drug approval. The plan requires that pharmaceutical companies pay fees to the FDA that will allow the agency to hire several hundred reviewers to expedite drug approval. The fees being considered include $150 000 for each new drug application,$50 000 annually for each manufacturing site as establishment registration; and$5000 for each product on the market. There is no fee for small companies or those with no product. It is anticipated that the FDA will collect$200 million through the fees. Such fees are a minimal burden on the companies, said Dr Kessler. A drug product that achieves$200 million in annual sales with an 80% gross margin loses more than $10 million each month that marketing is postponed due to delay in FDA review. Therefore he said, "We are talking about fees that pale in comparison to what everyone could benefit from". The fee will be used to fund all activities attached to the approval process. The FDA will be able to review and act on all priority drug applications within 6 months, and within 12 months on all standard drug applications. It is hoped that by virtue of this plan all backlogs that now exist in the drug review process will be eliminated and reviews of new drug applications will start immediately. "It’s absolutely clear
that the FDA cannot do the job with the current resources I am very concerned about what’s going to happen. Review time is going to double if we don’t do something, and do something soon", said Dr Kessler. Drug companies had opposed the concept of user fees in the past because they feared that the fees may not be used specifically to speed drug approval. However, the industry supports the idea now. "The implementation of such a system will help assure a steady steam of revenue to the agency to allow it to focus on its critical task-the review and approval of new medications", said Irwin Lerner, who chairs the US Pharmaceutical Manufacturers’ Association’s FDA panel. The legislative proposal drafted by Representatives John Dingell and Henry Waxman is likely to be introduced and enacted in a law in the current session of Congress, which adjourns in October. ....
Syed Rizwanuddin Ahmad USA: Radical restructure of health
care
proposed A proposal to restructure the nation’s health-care system, by setting an annual health budget, limiting doctor and hospital fees, and providing uniform comprehensive benefits for all public and private patients was proposed on Sept 14 by the nation’s largest medical specialty society. The plan, offered by the American College of Physicians, a 77 000-member group, would retain the public-private sponsorship of insurance but overhaul each with the goals of cost
cutting and achieving universal access and quality for
everyone. A national commission
representing all sectors of society and approved by Congress would be charged with setting an annual budget. This spending cap would cover public and private spending and take account of changing health needs, new technology, and general inflation. The planners assume that the elimination of duplicative efforts of insurance companies in marketing and billing, over-use of technology and expensive procedures, and overpriced care would allow coverage for everyone without increasing costs beyond the 1992 spending level of$809 billion. Employers could choose to offer employees their own health coverage or pay a tax to enrol their workers in publicly sponsored insurance. If private insurance is provided, employees would pay a share of the premium. Insurers would have to accept all applicants regardless of pre-existing conditions and calculate premiums based on the health status of the entire community, rather than on an individual employer. Benefits for the private and public system would be determined by the national health-care commission. Coverage would consist of all medically effective and necessary services. The public system would consolidate all current public programmes, including Medicare, the current programme for persons over 65 years old, and Medicaid, the programme for the poor. It would cover workers aged over 60 and people of any age needing high-cost care, plus the unemployed and retirees. Besides the tax received from employers who do not offer private insurance, funding would come from Medicare and Medicaid, other government health programmes, premiums from retirees, and other tax revenue. Physicians and hospitals and other health providers would negotiate fees with states, and all insurance plans would pay providers the same fees. Managed care would be
had been misunderstood. Regardless of what lies ahead, Dr Sullivan soon after was on the political ramparts, staging a press conference on Congressional turf to denounce Democratic machinations in the health arena. It appears that, by some means, Republicans obtained a transcript of a Democratic Congressional meeting held in July to discuss various issues, including health care. In the course of the discussion, the earthy legislator, John Dingell, of Michigan, expressed the opinion that, whatever he and his colleagues do, they should strive to "screw the Republicans". Dr Sullivan, maestro of marathon studies but little else in the health-care field, said of the Democrats, "They want to put political partisanship as a first priority, rather than the health needs of the American people". House Speaker Thomas Foley, apparently pained by this accusation, admonished Dr Sullivan, declaring that "It doesn’t advance the debate on alternatives for health care for the Secretary of Health and Human Services to play a partisan, political role and make partisan, political charges of that kind". Despair over the quality of the dialogue is surely warranted. But it should be noted, too, that the repeated skirmishing on health care in this presidential campaign is unprecedented. Whether that foretells change is another matter.
Daniel S.
Greenberg
Round the World USA: "User fees" to speed
drug approvals
The US Food and Drug Administration is supporting another initiative to improve the drug review process and speed up drug approval. Earlier initiatives included an accelerated approval policy (Lancet, April 18, p 982), a number of management reforms, and a pilot programme to conduct 6 to 12 external reviews that will be evaluated in 18 months. At a recent hearing, Dr David A. Kessler, Commissioner of the FDA, testified before the House Health and Environment Subcommittee that his agency backs the draft proposal to establish a system of user fees to speed up drug approval. The plan requires that pharmaceutical companies pay fees to the FDA that will allow the agency to hire several hundred reviewers to expedite drug approval. The fees being considered include $150 000 for each new drug application,$50 000 annually for each manufacturing site as establishment registration; and$5000 for each product on the market. There is no fee for small companies or those with no product. It is anticipated that the FDA will collect$200 million through the fees. Such fees are a minimal burden on the companies, said Dr Kessler. A drug product that achieves$200 million in annual sales with an 80% gross margin loses more than $10 million each month that marketing is postponed due to delay in FDA review. Therefore he said, "We are talking about fees that pale in comparison to what everyone could benefit from". The fee will be used to fund all activities attached to the approval process. The FDA will be able to review and act on all priority drug applications within 6 months, and within 12 months on all standard drug applications. It is hoped that by virtue of this plan all backlogs that now exist in the drug review process will be eliminated and reviews of new drug applications will start immediately. "It’s absolutely clear
that the FDA cannot do the job with the current resources I am very concerned about what’s going to happen. Review time is going to double if we don’t do something, and do something soon", said Dr Kessler. Drug companies had opposed the concept of user fees in the past because they feared that the fees may not be used specifically to speed drug approval. However, the industry supports the idea now. "The implementation of such a system will help assure a steady steam of revenue to the agency to allow it to focus on its critical task-the review and approval of new medications", said Irwin Lerner, who chairs the US Pharmaceutical Manufacturers’ Association’s FDA panel. The legislative proposal drafted by Representatives John Dingell and Henry Waxman is likely to be introduced and enacted in a law in the current session of Congress, which adjourns in October. ....
Syed Rizwanuddin Ahmad USA: Radical restructure of health
care
proposed A proposal to restructure the nation’s health-care system, by setting an annual health budget, limiting doctor and hospital fees, and providing uniform comprehensive benefits for all public and private patients was proposed on Sept 14 by the nation’s largest medical specialty society. The plan, offered by the American College of Physicians, a 77 000-member group, would retain the public-private sponsorship of insurance but overhaul each with the goals of cost
cutting and achieving universal access and quality for
everyone. A national commission
representing all sectors of society and approved by Congress would be charged with setting an annual budget. This spending cap would cover public and private spending and take account of changing health needs, new technology, and general inflation. The planners assume that the elimination of duplicative efforts of insurance companies in marketing and billing, over-use of technology and expensive procedures, and overpriced care would allow coverage for everyone without increasing costs beyond the 1992 spending level of$809 billion. Employers could choose to offer employees their own health coverage or pay a tax to enrol their workers in publicly sponsored insurance. If private insurance is provided, employees would pay a share of the premium. Insurers would have to accept all applicants regardless of pre-existing conditions and calculate premiums based on the health status of the entire community, rather than on an individual employer. Benefits for the private and public system would be determined by the national health-care commission. Coverage would consist of all medically effective and necessary services. The public system would consolidate all current public programmes, including Medicare, the current programme for persons over 65 years old, and Medicaid, the programme for the poor. It would cover workers aged over 60 and people of any age needing high-cost care, plus the unemployed and retirees. Besides the tax received from employers who do not offer private insurance, funding would come from Medicare and Medicaid, other government health programmes, premiums from retirees, and other tax revenue. Physicians and hospitals and other health providers would negotiate fees with states, and all insurance plans would pay providers the same fees. Managed care would be