FDA’s Warns Online Pharmacies Selling Drugs Illegally Highlighting Challenges to Enforcement
[Posted on: Thursday, August 30, 2018] Yesterday FDA announced that earlier this month it issued Warning Letters to four networks selling opioid drugs illegally online via 21 websites. Earlier this summer FDA had issued similar Warning letters to a total of 13 companies marketing opioid drugs illegally on about 70 websites. It is questionable if these measures are an effective deterrence to the nefarious operators of these businesses. A review of these Warning Letters shows that most of these letters are not issued to individual owners of these companies but to corporate names indicating that FDA could not determine who owned these websites. There are no physical addresses on the letters or any names of individuals. At the bottom of these letters, the internet hosting services are listed which are all based outside the US. There Warning Letters were announced publicly about 2 weeks after they were issued, hinting that FDA wanted to wait till the statutory the 10 days it gave each operator to take down their sites so that when FDA announces these actions the websites are either altered or removed. FDA is taking other actions to regulate these websites as well but all these demonstrate the almost impossible task of enforcing laws on online pharmacies. Online pharmacies account for about $30 billion in sales in the US alone. Many online pharmacies hide behind layers of secrecy and are physically based outside the US, outside FDA’s jurisdiction. There have been very rare cases of perpetrators being identified and legal action taken against them. FDA plays a constant game of Whack-A-Mole with these websites. The number of sites and companies warned by FDA are a very small fraction of the total number of such operations. Add to that, seemingly the only penalty of operating such sites is having to shut them down upon receiving FDA’s letter. The operators almost always end-up reopening their online shops in new names and new appearance literally the same day they close the websites objected to by FDA. And most operators anyway run 10 to hundreds of sites many of which can continue business despite Warning Letters to close a few. Data shows that patients and consumers continue to purchase drugs online despite these cases. Online purchase offers convenience and lower cost. It also allows anonymity if one wants to buy drugs that would be hard to get prescription for, such as opioid drugs. Investigations have found that consumers many a times buy illegal prescription drugs online using anonymizing internet protocols such as the Tor browser and dark web. It is hard to believe that the patient purchasing drugs online from suspicious vendors are unaware of the risk of doing so. It is also impossible that the sellers of such drugs not know that these are illegal actions. So, where does that leave FDA. Obviously, the Agency must do something, which it does with these cosmetic actions and announcements. The final barrier to these websites is the consumer. Till people are willing to risk buying drugs from online pharmacies that allow risky practices, there is little FDA can do to protect these same consumers. The responsibility lies on the consumer not the FDA.
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