I received many kind responses on my request for information on
`Pharmaceutical regulation/registration', posted a few months ago.
All respondents agreed that the questions raised are very interesting
and important. Many thanks. I feel that it is worth sharing the
information with all of you:
1. F.M.Haaijer-Ruskamp recommended two books
1.1 The Future of Medicines in Health Care, Scenario Report
commissioned by the Steering Committee on Future Health
1.2 Contested Ground by Peter Davis, 1995
2. Leo Offerhaus offered the title `The Effects of International Drug
Regulation' written by Prof GMN Dukes.
3. Joel Lexchin gave a list of many relevant papers:
3.1 Rosier J, Demoen P. Requirements for chemical and
pharmaceutical data in support of clinical trial applications in
the United Kingdom, Canada, the USA, the Nordic countries,
and Australia. Drug Information Journal 1990;24:427-447.
3.2 Sidney Wolfe, Public Citizen's Health Research Group.
Differences in the number of drug safety withdrawals: United
States, United Kingdom, Germany, France 1970-1992. (Available
from Health Research Group)
3.3 General Accounting Office. FDA Drug Review: Postapproval
risks 1976-85. Document Number GAO/PEMD-90-15. (Available
for free. Write: U.S. General Accounting Office, Post Office Box
6015, Gaithersburg, Maryland 20877, USA)
3.4 Pieterson EA. A comparison of regulatory approval times for
new chemical entities in Australia, Canada, Sweden, the United
Kingdom, and the United States. J Clin Pharmacol
3.5 Parker J. Who has a drug lag? J Social and Administrative
Pharmacy 1989; 6:138-152.
3.6 Griffin JP, Diggle GE. A survey of product licensed in the
United Kingdom from 1971-1981. Brit J Clin Pharm 1981;
3.7 Speirs CJ, Griffin JP. A survey of the first year of operation
of the new procedure affecting the conduct of clinical trials
in the United Kingdom. Brit J Clin Pharm 1983;15:649-655.
3.8 Bakke OM, Wardell WM, Lasagna L. Drug discontinuations in
the United Kingdom and the United States, 1964 to 1983:
issues of safety. Clin Pharm and Ther 1984;35:559-567.
3.9 Rawlins MD, Jefferys DB. Study of United Kingdom product
license applications containing new active substances, 1987-9.
B M J 1991;302:223-5.
3.10 Hass AE, Portale DB, Grossman RE. New drugs: their market
life and safety. The Pharm J 1985;234(No.6317):235-8.
3.11 Dukes MNG. The importance of adverse reactions in drug
regulation. Drug Safety 1990;5:3-6.
3.12 Bakke OM, Manocchia M, de Abajo F, Kaitin KI, Lasagna L.
Drug safety discontinuations in the United Kingdom, the
United States, and Spain from 1974 through 1993: a
regulatory perspective. Clin Pharm & Ther 1995;58:108-17.
3.13 Dukes MNG, Lunde I. Review of restrictive actions under the
Australian drug regulatory system. Med J Australia
3. Barbara Mintzes showed interest in the outcomes, since they could
help to shape strategies to most effectively influence regulatory
4. Dennis Ross-Degnan pointed out the complexity of the US system
and listed some papers dealing with it:
4.1 Soumerai SB, Avorn J, Ross-Degnan D, and Gortmaker S.
Payment restrictions for prescription drugs in Medicaid:
Effects on therapy, cost, and equity. N Engl J Med 1987;
4.2 Ross-Degnan D, Gortmaker S, Avorn J. Withdrawing payment
for non-scientific drug therapy: Intended and unexpected
effects of a large-scale natural experiment. J Am Med Assoc
1990; 263(6): 831-839.
4.3 Soumerai SB, Ross-Degnan D, Avorn J, McLaughlin TJ,
Choodnovskiy I. Effects of Medicaid payment limits on
admissions to hospitals and nursing homes. N Engl J Med
1991; 325: 1072-1077.
4.4 Soumerai SB, Ross-Degnan D, Fortess EE, Abelson J. A critical
analysis of studies of state drug reimbursement policies:
Research in need of discipline. Milbank Quarterly 1993; 71(2):
4.5 Ross-Degnan D, Soumerai SB, Fortess EE, Gurwitz J. Examining
product risk in context: Market withdrawal of zomepirac as a
case study. J Amer Med Assoc 1993; 270(16): 1937-42.
4.6 Soumerai SB, McLaughlin TJ, Ross-Degnan D, Casteris CS,
Bollini P. Impact of a Medicaid drug benefits limit on use of
psychotropics and acute mental health care among
schizophrenic patients. N Engl J Med 1994; 331 (10): 650-655.
5. Vithaya Kulsomboon shared his idea that this topic is important
but is quite broad and needs specific objectives to research it.
The terms regulatory system, regulatory change have to be clearly
6. Hari-Sven Krishnan suggested three journals - Regulatory Affair
Journal, Soc Sci Med, and Scrip.
I agree that the term `pharmaceutical regulation' is big and broad,
covering many areas of the drug system, from registration through
procurement and production, distribution, and use. Each step needs a
different regulation. To do research in this area should be very
Health Policy Unit,
London School of Hygiene & Tropical Medicine
London, WC1E 7HT, UK