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FDAMA's written request list: medicines for children
CORRESPONDENCE
spirit of openness, your readers can find out more for themselves on our dedicated BSE website at www.bsereview.org.uk (accessed Dec 6, 2000). Geoffrey Podger Food Standards Agency, PO Box 30080, 5th Floor, Hannibal House, London SE1 6YA, UK 1
Anon. The Phillips report on BSE and vCJD. Lancet 2000; 356: 1535.
A challenge for reform in South Korea Sir—The Korean Medical Association (KMA), mentioned in your Nov 4 news item1 is right in its concern over pharmacists prescribing medications without proper medical training. Taking away the doctors’ right to sell drugs may trim medical costs, but the Korean government can hardly call this reform when it ignores or encourages the practice of medicine by pharmacists. As you pointed out, Korean pharmacies are selling a far wider range of drugs without a doctor’s prescription than would be permitted in other countries. It is unfortunate that the KMA chose to strike in response to the government’s move. In doing so it brought about a serious health crisis of its own making. It is not surprising that the public would view the KMA’s motives with great suspicion. Shouldn’t they have anticipated the reaction? Wouldn’t it have been better to achieve its goals through lobbying or raising public awareness? Surely, but perhaps the decision to strike reflected the limited options created by barriers to participation, the lack of transparency in the country’s legislative process, or both. It is also fair to question the extent to which the government has used its influence to portay a negative image of doctors in the media. Does sufficient access to the media exist to allow a fair exchange of views? Genuine reform of Korea’s national health-insurance system would separate the prescribing and dispensing roles of physicians and pharmacists. If a separation of roles were to be enforced along with reasonable restrictions in sales of over-the-counter drugs, real cost savings might be realised while protecting the public’s health. Physicians and pharmacists would compete within their respective domains instead of with each other. Korean physicians would not need to dispense medications to supplement their incomes. Over time, the Korean government might even allow its health
THE LANCET • Vol 357 • February 3, 2001
system to evolve to the point where, dare we say, the free market might determine the cost of physician consultation and treatment. We hope that all the parties in this dispute will rise above their perceived self-interests and take the next step in advancing the nation’s health care system for the sake of its own people. The Korean government must act as an honest broker to make this happen. It is not enough for the prime minister to declare that everyone must be prepared to tolerate some inconveniences. As a newly emerged democracy, the rest of the world will be paying close attention.
We suggest that the distribution of drug classes is not in proportion to the need for these drugs in paediatric care. Under the FDAMA, a manufacturer who submits the paediatric studies required can receive a 6-month extension of patent exclusivity for that drug. The extension of exclusivity was intended as an extra financial incentive to study drugs in children that are really needed. Financial benefits are, however, likely to be high for some drugs, since the 6 months extension of exclusivity or patent protection applies to all formulations of the drug type, whether appropriate for paediatric use or not. We welcome the developments that have resulted in more clinical trials of medicines in children. However we also need to recognise the limitations of the FDAMA, under which 22 antihypertensive drugs can be studied, when it is clear that so many antihypertensives are not required in paediatric patients. The Food and Drug Administration needs to be more proactive in ensuring that medicines of clinical value to paediatric patients are studied, as specified in the ICH guidance on clinical investigation of medicinal products in children. We need to ensure that any financial incentives introduced in Europe are targeted at those medicines of greatest need.
*Christopher C Lee, Robert S Crupi Department of Emergency Medicine, Flushing Hospital Medical Center, Flushing, NY 11355, USA 1
Watts J. Strikes in South Korea as doctors fight drug reform. Lancet 2000; 356: 1583.
FDAMA’s written request list: medicines for children Sir—We support all initiatives that will increase the limited evidence base for the treatment of neonates, infants, and children with medicines such as those mentioned in your Nov 11 editorial.1 In response to the 1997 Food and Drug Administration’s modernisation act (FDAMA), a written requests list is issued for the products they think are most useful and necessary in paediatric pharmacotherapy (www.fda. gov/cder/pediatric). We assessed which drugs written requests have been issued for by drug class, category, and main indications,2 and data are shown in the table. The largest drug category was cardiovascular drugs (n=36). Although heart disease, hypertension, and hyperlipidaemia are experienced by children, they are not major causes of morbidity in the paediatric population.
Geert W’t Jong, John N van den Anker, *Imti Choonara Pharmacoepidemiology Unit, Departments of Internal Medicine and Epidemiology and Biostatistics, Erasmus Medical Centre Rotterdam, Netherlands; Division of Neonatology, Department of Paediatrics, Sophia Children’s Hospital, Rotterdam, Netherlands; and *Academic Division of Child Health, University of Nottingham, Derbyshire Children’s Hospital, Derby DE22 3NE, UK 1 2
Anon. How best to serve children. Lancet 2000; 356: 1619. Martindale, the complete drug reference, 32nd edn. London: Pharmaceutical Press, 1999.
Drug category
Number of Examples drug class drugs
Number of drugs
Cardiovascular drugs
36 (26%)
Non-cardioselective -blocker 12 (9%) Angiotensin-converting-enzyme inhibitor 6 (4%) Carbonic anhydrase inhibitor 5 (4%) Cardioselective -blocker 4 (3%)
Antiviral drugs
12 (9%)
Protease inhibitor Nuclease reverse transcriptase inhibitor
5 (4%) 4 (3%)
Analgesics, anti-inflammatory drugs, and antipyretics 12 (9%)
NSAID Opioid agonist
7 (5%) 4 (3%)
Antidepressants
8 (6%)
SSRI
6 (4%)
Bronchodilators and anti-asthmatic drugs
7 (5%)
Leukotriene antagonist or inhibitor
4 (3%)
Lipid regulation drugs
5 (4%)
HMG-CoA inhibitor
5 (4%)
Gastrointestinal drugs
5 (4%)
Proton-pump inhibitor
2 (1%)
NSAID=non-steroidal anti-inflammatory drugs; SSRI=serotonin-selective reuptake inhibitor.
Drug classes in Food and Drug Administration’s written request list
398
For personal use only. Reproduce with permission from The Lancet Publishing Group.
spirit of openness, your readers can find out more for themselves on our dedicated BSE website at www.bsereview.org.uk (accessed Dec 6, 2000). Geoffrey Podger Food Standards Agency, PO Box 30080, 5th Floor, Hannibal House, London SE1 6YA, UK 1
Anon. The Phillips report on BSE and vCJD. Lancet 2000; 356: 1535.
A challenge for reform in South Korea Sir—The Korean Medical Association (KMA), mentioned in your Nov 4 news item1 is right in its concern over pharmacists prescribing medications without proper medical training. Taking away the doctors’ right to sell drugs may trim medical costs, but the Korean government can hardly call this reform when it ignores or encourages the practice of medicine by pharmacists. As you pointed out, Korean pharmacies are selling a far wider range of drugs without a doctor’s prescription than would be permitted in other countries. It is unfortunate that the KMA chose to strike in response to the government’s move. In doing so it brought about a serious health crisis of its own making. It is not surprising that the public would view the KMA’s motives with great suspicion. Shouldn’t they have anticipated the reaction? Wouldn’t it have been better to achieve its goals through lobbying or raising public awareness? Surely, but perhaps the decision to strike reflected the limited options created by barriers to participation, the lack of transparency in the country’s legislative process, or both. It is also fair to question the extent to which the government has used its influence to portay a negative image of doctors in the media. Does sufficient access to the media exist to allow a fair exchange of views? Genuine reform of Korea’s national health-insurance system would separate the prescribing and dispensing roles of physicians and pharmacists. If a separation of roles were to be enforced along with reasonable restrictions in sales of over-the-counter drugs, real cost savings might be realised while protecting the public’s health. Physicians and pharmacists would compete within their respective domains instead of with each other. Korean physicians would not need to dispense medications to supplement their incomes. Over time, the Korean government might even allow its health
THE LANCET • Vol 357 • February 3, 2001
system to evolve to the point where, dare we say, the free market might determine the cost of physician consultation and treatment. We hope that all the parties in this dispute will rise above their perceived self-interests and take the next step in advancing the nation’s health care system for the sake of its own people. The Korean government must act as an honest broker to make this happen. It is not enough for the prime minister to declare that everyone must be prepared to tolerate some inconveniences. As a newly emerged democracy, the rest of the world will be paying close attention.
We suggest that the distribution of drug classes is not in proportion to the need for these drugs in paediatric care. Under the FDAMA, a manufacturer who submits the paediatric studies required can receive a 6-month extension of patent exclusivity for that drug. The extension of exclusivity was intended as an extra financial incentive to study drugs in children that are really needed. Financial benefits are, however, likely to be high for some drugs, since the 6 months extension of exclusivity or patent protection applies to all formulations of the drug type, whether appropriate for paediatric use or not. We welcome the developments that have resulted in more clinical trials of medicines in children. However we also need to recognise the limitations of the FDAMA, under which 22 antihypertensive drugs can be studied, when it is clear that so many antihypertensives are not required in paediatric patients. The Food and Drug Administration needs to be more proactive in ensuring that medicines of clinical value to paediatric patients are studied, as specified in the ICH guidance on clinical investigation of medicinal products in children. We need to ensure that any financial incentives introduced in Europe are targeted at those medicines of greatest need.
*Christopher C Lee, Robert S Crupi Department of Emergency Medicine, Flushing Hospital Medical Center, Flushing, NY 11355, USA 1
Watts J. Strikes in South Korea as doctors fight drug reform. Lancet 2000; 356: 1583.
FDAMA’s written request list: medicines for children Sir—We support all initiatives that will increase the limited evidence base for the treatment of neonates, infants, and children with medicines such as those mentioned in your Nov 11 editorial.1 In response to the 1997 Food and Drug Administration’s modernisation act (FDAMA), a written requests list is issued for the products they think are most useful and necessary in paediatric pharmacotherapy (www.fda. gov/cder/pediatric). We assessed which drugs written requests have been issued for by drug class, category, and main indications,2 and data are shown in the table. The largest drug category was cardiovascular drugs (n=36). Although heart disease, hypertension, and hyperlipidaemia are experienced by children, they are not major causes of morbidity in the paediatric population.
Geert W’t Jong, John N van den Anker, *Imti Choonara Pharmacoepidemiology Unit, Departments of Internal Medicine and Epidemiology and Biostatistics, Erasmus Medical Centre Rotterdam, Netherlands; Division of Neonatology, Department of Paediatrics, Sophia Children’s Hospital, Rotterdam, Netherlands; and *Academic Division of Child Health, University of Nottingham, Derbyshire Children’s Hospital, Derby DE22 3NE, UK 1 2
Anon. How best to serve children. Lancet 2000; 356: 1619. Martindale, the complete drug reference, 32nd edn. London: Pharmaceutical Press, 1999.
Drug category
Number of Examples drug class drugs
Number of drugs
Cardiovascular drugs
36 (26%)
Non-cardioselective -blocker 12 (9%) Angiotensin-converting-enzyme inhibitor 6 (4%) Carbonic anhydrase inhibitor 5 (4%) Cardioselective -blocker 4 (3%)
Antiviral drugs
12 (9%)
Protease inhibitor Nuclease reverse transcriptase inhibitor
5 (4%) 4 (3%)
Analgesics, anti-inflammatory drugs, and antipyretics 12 (9%)
NSAID Opioid agonist
7 (5%) 4 (3%)
Antidepressants
8 (6%)
SSRI
6 (4%)
Bronchodilators and anti-asthmatic drugs
7 (5%)
Leukotriene antagonist or inhibitor
4 (3%)
Lipid regulation drugs
5 (4%)
HMG-CoA inhibitor
5 (4%)
Gastrointestinal drugs
5 (4%)
Proton-pump inhibitor
2 (1%)
NSAID=non-steroidal anti-inflammatory drugs; SSRI=serotonin-selective reuptake inhibitor.
Drug classes in Food and Drug Administration’s written request list
398
For personal use only. Reproduce with permission from The Lancet Publishing Group.