[Ip-health] Re: NY Times: Pfizer Pays $2.3 Billion to Settle Marketing Case

[Ken Harvey]

On Wed, 2009-09-02 at 08:47 -0700, Ethan Guillen [Ip-health] wrote:

> Prosecutors said that they have become so alarmed by the growing criminal=
ity
> in the industry that they have begun increasing fines into the billions o=
f
> dollars and will soon start charging doctors individually as well.

Not in Australia unfortunately!

This topic was aired on ABC Radio "World Today" program today:

http://www.abc.net.au/worldtoday/content/2009/s2675412.htm

The transcript hasn't added my interview but I made the point that
Pfizer Australia has had 17 complaints against Medicines Australia
self-regulatory Code of Conduct upheld during 2005-09. Although one of
these complaints received the maximum fine of $200,000, over this time
the fines only averaged $50,000. There is no evidence that such fines
have reduced Code violations by Pfizer or other member companies.

Somewhat different to the $2.8 billion fine imposed on Pfizer by U.S.
regulators!

Which is why Choice (Australian Consumers Association) and others wanted
Medicines Australia to increase the maximum fine for Code transgressions
to $1 million in submissions to the recent Code review. Not
surprisingly, this was rejected by MA who then went on to make a token
increase in fines of $50,000 only taking the maximum fine to $250,000.

See: http://www.medicinesaustralia.com.au/pages/page223.asp

Currently, Australia has a variety of complex and convoluted
co-regulatory systems to control unethical therapeutic claims and
promotional practices depending upon the type of product (innovator and
generic prescription, over-the-counter and complementary medicines,
therapeutic devices, food and cosmetics) and the media in which claims
are made. There are different standards and gross inconsistencies
between various Codes of Conduct, their complaint processes, timeliness,
transparency, sanctions, monitoring and effectiveness.

I have suggested to the Australian Competition and Consumers Commission
(ACCC) that it is time this craziness was simplified and unified by
creating one Code applicable to all therapeutic claims and promotional
practice; one complaint (and appeal) process, one monitoring process and
one set of effective sanctions, including corrective advertising orders
and fines related to the sales income of the product and company
involved. The process should be overseen by government, funded by
industry (using a moiety of product registration fees), and administered
by an independent committee representative of all stakeholders. The
system should have a legislative base in the Therapeutic Goods Act
and/or regulations and be capable of being enforced. South African
legislation provides a model of such a broader system (involving all
types of medicines), see:

http://www.piasa.co.za/assets/attachments/SACode_for_Marketing_Medicines_08=
0129.pdf

This would be in line with the 2007 World Health Assembly Resolution WHA
60.16.5 on Rational Use of Medicines which urged member states to,

        =E2=80=9CEnact new, or enforce existing, legislation to ban inaccur=
ate,
        misleading or unethical promotion of medicines, to monitor
        promotion of medicines, and to develop and implement programmes
        that will provide independent, non-promotional information about
        medicines=E2=80=9D.

Cheers
Ken
--
Dr. Ken Harvey
Adjunct Senior Research Fellow
School of Public Health | La Trobe University
M: 0419 181 910 | F: 03 9818 1875|
E: ken.harvey@latrobe.edu.au | W: www.medreach.com.au