FDA threatens Kiwi chemists

New Zealand pharmacies are feeling the heavy hand of the US Food and Drug Administration, which is unhappy about the selling online of drugs not approved in the US market.

New Zealand pharmacies are feeling the heavy hand of the US Food and Drug Administration (FDA). The FDA is unhappy about the selling of drugs it hasn't approved in the US market and the selling of prescription drugs without a US prescription.

"The sale and distribution of this product on your Internet Web site may be illegal in this country," says an FDA letter to Albany Street Pharmacy, which trades through http://www.onlinepharmacy.co.nz . The drug in question is Codcomol - a pain killer.

"All shipments offered for importation into the US as a result of your activities may be detained and subject to refusal of entry."

Debbie Young, who runs the Albany Street Pharmacy in Dunedin, finds the letter "arrogant in the extreme".

"Who do they think they are? They think everything is about America and it's not. Our site sells to anywhere in the world."

Young says the whole issue is more about protecting the US market where drugs typically cost up to 10 times their New Zealand equivalent. "It's extortion what they charge over there."

Pharmaceutical Society of New Zealand's Ewan Galloway says the main problem lies in the differences between New Zealand and US drug practices.

Young's site doesn't sell the big three drugs of the online world, Viagra, Xenical and hair restorative Propecia. Most of the letters on the FDA's web site refer to the illegal sale of these drugs. "That sort of thing does have to stop - that's quite dangerous," says Young.

Galloway says in the US drugs are either prescription or freely for sale. However, in New Zealand there is an additional tier, pharmacy only sales, and it is the drugs in this category which are the issue.

The FDA demands that any company selling drugs into the US market meet all the requirements of each and every state before offering them for sale - something Galloway says is all but impossible.

Health minister Annette King says it is up to the Pharmaceutical Society to inform and monitor its members. "It would be very bad for New Zealand pharmacists to be seen as willing to flout other countries' laws in pursuit of a dollar."

She urges the Society to take control of its members and address the issue firmly.

"They have an occupation regulation statute of their own and have the ability to censure their membership and they ought to use it."

The Ministry of Health has proposed amending the Medicine Regulations Act of 1984 to disallow "the export of prescription medicines for retail sale without a prescription" and submissions on the matter officially closed on April 7, although they are still being received.

The Pharmaceutical Society of New Zealand is supporting the government's proposed changes to legislation. "We've made submissions and wholeheartedly support the move to plug this loophole," says Galloway.

Research company Boston Consulting Group's figures on retail e-commerce in New Zealand puts health firmly in first place, with one third of all online sales being of a pharmaceutical or health and beauty nature. Health doesn't rate in any other Asia-Pacific country measured in the survey.

The Ministry of Health's discussion document can be found at: . The F detailing the problem can be found at: .

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