E-drug: Generic quality (cont)
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Mohga,
Joel is right, you have to distinguish between developed and developing
countries.
If a generic is registered in a country, quality will have been checked and
found in order. There are regulatory requirements for generic drugs which
are less stringent than for originator's brand, i.e. generics are only to
show bioequivalence, clinical trials are rarely needed. See e.g.
WHO/DMP/PRGS/98.5: Marketing authorisation of pharmaceutical products
with special reference to multisource (generic) products; a manual
for a drug regulatory authority. There are studies in the US showing
that quality is no problem - one study was even held back from
publication for five years by the originator because the generic
showed at least as good result! As you might know, some
multinationals such as Merck even have generic
subsidiaries. So this is not so easy.
Drug and Therapeutics Bulletin has addressed the issue a few times e.g. in
February 1997: Generic medicines - can quality be assured? (vol 35 no 2).
There was an E-drug message 5 February 1998 quoting a FDA letter saying
generic drugs is as good as brand names. Check our archives. See also
www.fda.gov/cder/news/nightgenlett.htm and
www.fda.gov/cder/news/ntiletter.htm and
http/jama.ama-assn.org/issues/v282n21/full/jfd90010-2.html (Henney J.
Review of generic bioequivalence studies JAMA 1 December 1999).
I have a study of clarithromycin products from South America and Asia
(incl. Turkey) which I am going to comment on soon. Some generics failed
some of the tests.
I would also recommend you to search the E-drug archives because we have
discussed this before, search also for bioequivalence and essential
similarity as search strings.
It might also be worth while to contact the generic manufacturers'
associations:
To get a list of generic manufacturers in Canada contact the Canadian Drug
Manufacturers Association:
4120 Yonge St., Suite 409
Toronto, Ontario
Canada M2P 2B8
T: +416-223-2333
F: +416-223-2425
e mail: info@cdma-acfpp.org
Website: www.cdma-acfpp.org
There are three major generic manufacturers association in the U.S. namely:
Generic Pharmaceutical Industry Association
1620 I(Eye) Street, NW, Suite 800
Washington, DC 20006, USA
Phone: 1-202-833-9070, Fax: 1-202-933-9612, Email: diane@gpia.org
www.gpia.org
National Association of Pharmaceutical Manufacturers
320 Old Country Road
Garden City, NY 11530, USA
Phone: 1-516-741-3699, Fax: 1-516-741-3696
National Pharmaceutical Alliance
421 King Street, Suite 222
Alexandria, VA 22314, USA
Phone: 1-703-549-4749, Fax: 1-703-836-8816, Email: npa@erols.com
URL/Website: http://www.n-p-a.org (with membership directory)
NPA and GPIA will merge early 2001
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In Europe, Greg Perry (gperry@egagenerics.com) is the Director of the
European Generic Medicines Association. The web site is at
http://egagenerics.com and contains a lot of interesting information.
Kirsten
Kirsten Myhr, MScPharm, MPH
Bygdoy alle 58B
0265 Oslo, Norway
Tel.: +47 22 56 05 85
myhr@online.no
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