FDA Cracks Down on Internet Pharmacies

The FDA’s enforcement action against online pharmacies led to the shutdown of more than 18,000 illegal pharmacy websites and the seizure of $10.5 million worth of pharmaceuticals around the world.

The FDA has cracked down on more than 4000 Internet pharmacies that were selling unapproved, potentially dangerous drugs to consumers. The agency announced the crackdown, which was carried out in cooperation with regulatory and law enforcement agencies from 100 countries, on October 4, 2012.

The enforcement action, which took place between September 25 and October 2, led to the shutdown of more than 18,000 illegal pharmacy websites and the seizure of $10.5 million worth of pharmaceuticals around the world, according to the agency.

“Consumers in the United States and around the world face a real threat from Internet pharmacies that illegally sell potentially substandard, counterfeit, adulterated, or otherwise unsafe medicines,” said FDA Commissioner Margaret A. Hamburg, MD, in a press release. “This week’s efforts show that strong international enforcement efforts are required to combat this global public health problem. The FDA is committed to joining forces to protect consumers from the risks these websites present.”

Among the illegal medicines indentified by the operation were:

• Domperidone, which was withdrawn from the United States market in 1998 due to the risk of serious adverse effects, including irregular heartbeat, heart stoppage, and sudden death. These risks can be passed on to a baby via breast milk, a particular risk among women who take the medication to increase milk production.
• Isotretinoin, which was marketed in the United States as Accutane to treat severe acne, has significant potential risks, including severe birth defects if one becomes pregnant while using it. Its distribution is restricted in the United States.
• Tamiflu (oseltamivir), an antiviral medication used to treat influenza, is often marketed online as “generic Tamiflu,” although there is no FDA-approved generic version of the drug. Tests of “generic Tamiflu” have found active ingredients that would be ineffective in fighting the flu and that could cause severe allergic reactions in some users.
• Viagra (sildenafil), used to treat erectile dysfunction, should not be used by patients with certain health conditions and should be taken under the supervision of a health care professional to ensure avoidance of potential drug interactions.

In conjunction with the crackdown, the FDA has launched “BeSafeRx,” a campaign to educate Americans about the risks of buying prescription medications over the Internet. A section of the campaign geared toward health care professionals includes tips on how to determine whether a patient may be likely to buy drugs from an online pharmacy and how to protect patients from doing so.

Previous Pharmacy Times coverage of Internet pharmacies:

• Exposing the Dangers of Illegal Online Pharmacies
• Pfizer Warns of Fake Drugs Sold Online
• NABP Stresses Need for International Collaboration to Combat Online Counterfeit Drug Distribution