9 June, 2016
The Deputy Secretary General of the Food and Drug Administration ( “FDA” ) recently announced that the FDA had received complaints from consumers, asking it to inspect the sale and advertising of drugs on an online shopping website.
Subsequent inspections revealed that eight drug products were being advertised for sale on the website and sold online. Most alarming was the fact that this website was also advertising drugs which are considered as “specially controlled drugs” and even offered them as complimentary gifts.
The selling of drugs and the advertisement for sale of such drugs are strictly regulated under the Drug Act, B.E. 2510 (A.D. 1967) (” Drug Act “).
Under the Drug Act, drugs must only be sold and handed over to patients under the supervision of a pharmacist and at a licensed location, e.g. a location which has been registered with the FDA and where a pharmacist is present to hand over the product to the patient (such as a licensed pharmacy.) In practice, this means that drug products cannot be sold online.
Moreover, the Drug Act stipulates that persons wishing to advertise drug products for sale must first obtain the FDA’s approval before they can use the said advertisement.
The FDA’s announcement signifies its intentions to clamp down on the online sale and advertising of drugs, including sales and advertising through social media platforms. This may be especially true in the case of specially controlled drugs where the uncontrolled use of such drug products, without proper supervision from medical professionals, may lead to adverse health risks for consumers.
What is also interesting about this announcement is that the FDA claimed that it not only fined the operator of the website, but also fined the license holders who own the products.
If the above is true, this development may indicate a worrying trend for license holders who own drug products. In reality, such license holders may not be involved in, and more likely are not aware of, illegal acts carried out by the website operators. It is also entirely possible that the website operators are located in countries outside Thailand and will therefore fall outside the reach of both the license holder and the FDA.
It, may, therefore be debatable as to whether the license holders should carry the burden of monitoring external sites to ensure that there are no illegal sales and advertising of their drug products online, especially if they do not have any control over such website operators.
However, the actions taken by the FDA in this case may relate to the FDA’s internal guidelines and policies, which may seek to hold the license holders jointly liable with the website operators and so pass on the monitoring role to the license holders. Such license holders should therefore remain vigilant and make sure that any possible illegal online sale and advertising of their drug products are disclosed to the FDA as soon as they become aware of it.
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