Illegal online drug sellers: How to stop them?

ASOP supports pending legislation

 

Safe online pharmacy websites do exist. But the vast majority of Internet destinations that look like pharmacies are fraudulent or fake. Sometimes called rogue online pharmacies, these websites often sell counterfeit, substandard, adulterated, or misbranded prescription medications—usually without a prescription.

“Thousands of so-called ‘pharmacy’ sites operate in violation of state and federal laws put in place to protect patients,” said Libby Baney, JD, Vice President, B&D Consulting, and advisor to the Alliance for Safe Online Pharmacies (ASOP). “They are purporting to be pharmacies but have no actual pharmacy license or a practicing pharmacist behind the scenes of the website.”

In the eyes of ASOP, “illegal online drug sellers” is the preferred term for the proliferating problem. “We don’t want to confuse patients or the public about the difference between a legitimate, licensed pharmacy and a rogue website,” Baney told Pharmacy Today.

Identifying illegal online drug sellers as a danger to patients in a complicated context, Members of Congress have introduced three pieces of legislation: two very broad and controversial companion bills—the Preventing Real Online Threats to Economic Creativity and Theft of Intellectual Property Act (PROTECT-IP) (S. 968) and the Stop Online Piracy Act (SOPA) (H.R. 3261)—and the newer, more narrowly targeted Online Pharmacy Safety Act (S. 2002).

ASOP supports these initiatives. While the issue cuts across many stakeholder groups and can be viewed from different angles, ASOP’s perspective is patient safety, complementing the work of other stakeholders on the international crime or intellectual property aspects. Formed in September 2009 to address patient safety on the Internet in a cross-sector way, ASOP comprises nine members, including APhA, and four observers; additional members are welcome.

Widespread problem

One in six Americans—an estimated 36 million people—have purchased prescription medication on the Internet without a prescription, according to a survey of 1,015 adults released by the Partnership at Drugfree.org at a White House forum hosted by the Office of the U.S. Intellectual Property Enforcement Coordinator (IPEC) on December 14, 2010; the research was funded by ASOP, of which the Partnership is a member.

Where is this sizable slice of the population clicking, and what are they getting? More than 96% of 8,445 reviewed websites selling prescription medications were found to be “out of compliance with pharmacy laws and practice standards” established in the United States, according to the October 2011 quarterly progress report from the National Association of Boards of Pharmacy (NABP) Internet Drug Outlet Identification Program; NABP is an observer of ASOP. While it’s difficult to quantify the amount of counterfeit drugs sold, given the nature of criminal activity, “medicines purchased over the Internet from illegal [websites] that conceal their physical address have been found to be counterfeit” in more than 50% of cases, according to the World Health Organization website.

Congressional activity

PROTECT-IP, introduced in the U.S. Senate on May 12, and SOPA, introduced in the U.S. House of Representatives on October 26, both would remove liability for stopping the facilitation of illegal online drug sellers to encourage the Internet ecosystem of credit card companies, search engines, and other Internet intermediaries to do the right thing voluntarily. The House Judiciary Committee held a hearing on SOPA on November 16 that lined up five pro-SOPA witnesses, including Pfizer and the Motion Picture Association of America, against one anti-SOPA witness (Google’s testimony reflected the Internet industry uproar), and marked up the bill on December 15 and 16 in what the Washington Post labeled a circus atmosphere.

“There are active discussions about how to address some of those [Internet industry] concerns and yet still move the legislation forward in a meaningful way,” Baney said. Alternative pieces of legislation are being worked on, she added.

The Online Pharmacy Safety Act, introduced in the Senate by Sen. Dianne Feinstein (D-CA) and Sen. Jeff Sessions (R-AL) on December 15, would empower FDA to create a list of all safe online pharmacy websites and also define a “valid prescription” for the purposes of the Federal Food, Drug, and Cosmetic Act. This latest bill follows up on 2008’s Ryan Haight Online Pharmacy Consumer Protection Act, which focuses on controlled substances available online, by addressing the full world of prescription medications sold over the Internet.

Referring to the Feinstein–Sessions legislation, Baney said, “It’s targeted, it’s reasonable, and it provides essential tools” to consumers and health professionals to confirm that a website is safe, to Internet intermediaries to check that they’re doing business with safe online pharmacies, and to law enforcement to dig a little deeper into websites not on the list.

Multiple fronts

In the war on illegal online drug sellers, the issue is being addressed on multiple fronts in Congress; by federal agencies such as FDA, IPEC, and U.S. Customs and Border Protection; and by other stakeholders too numerous to name here. These activities, Baney told Today, are strong statements of support for increased consumer protection and patient safety on the Internet. Asked to peer into a congressional crystal ball, she said, “My prediction would be that all of these conversations will come back together in 2012 and will need to be reconciled in order to move any of these pieces of legislation forward.”

For more information, visit ASOP at www.safeonlinerx.com. “We’d love to have others join the cause,” Baney said.