Dr Martin Goldman
Senior Medical Advisor
Forest Laboratories UK Ltd
tel +44 (0)1322 550550
direct line +44 (0)1322 429355
fax +44 (0)1322 555469
www.forestlabs.com
-----Original Message-----
From: Mary Hawking [mailto:[log in to unmask]]
Sent: 01 October 2004 06:54
To: [log in to unmask]
Subject: Re: Vioxx medico-legal question
Interesting question.
How is the problem of stock handled when a drug is suddenly withdrawn?
Logistically?
[Martin Goldman]
We would usually advise local destruction, and wholesalers would return
to industry source, usually UK marketing authorization holder
Presumably the wholesalers and pharmacists holding stock
have to destroy it or return it to the manufacturers.
[Martin Goldman] Correct
. At whose expense?
[Martin Goldman] usually company will set a plan for withdrawal in place
Accountancy - who takes the financial loss?
[Martin Goldman] Mostly the company, but there will be others who make a
collateral loss, hopefully the internet pharmacies
Communications? Who is responsible for informing patients?
[Martin Goldman] The prescriber
Legally. Does world-wide withdrawal by the manufacturers *automatically*
stop it being a "medicine" under national legislation - here or
elsewhere? And is any such legislation EU, UK, or devolved?
[Martin Goldman] Once a license is surrendered, it ceases to be a
legally approved and licensed medicine, but doctors are entititled to
prescribe whatever they feel is best for their patients within the
limits of criminal law (e.g. not creosote).
Depends on exact legal status, but withdrawals usually handled at a
national level, because of the interrelationship with the prescribers.
EU body does not seem to have much a role in this.
At the end of the day, this is a reaction to ensure the safety of
patients, and protect the company from liability in the context of
evidence of safety, but the only winners will be the lawyers.
MaryH
In message <002e01c4a73a$5fa9c5c0$0d00000a@dylan>, Jeff Green
<[log in to unmask]> writes
>A hypothetical question ;-)
>
>With the worldwide withdrawal of Vioxx presumably it's license is now
>revoked. At this point is it no longer a medicine? (as
>defined in law as opposed to reality)
>
>Or to put it another way - would it be illegal (as opposed to
>unethical) to sell my existing stocks on e-bay as "collectors
>items"
>
>
>Regards
>
>Jeff
>
--
Mary Hawking
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