As pharmacy and other health care stakeholders convened last week to discuss myriad issues surrounding illegal online sales of prescription drugs, one FDA official called for companies that manage and sell internet domain names to ramp up enforcement of their terms of use agreements and stop allowing violative website operators to continue leasing domains under different website names. This, the official said, would help fix the whack-a-mole issue on FDA’s side of enforcement.
Additionally, an official with the U.S. Pharmacopeia (USP) said that FDA and USP should work together to figure out how to leverage certain quality performance standards to make them more practical and able to better identify and address drug safety issues.
The discussion, held Nov. 14 during the Alliance for Safe Online Pharmacies (ASOP) Global Foundation’s 2018 Research Symposium, “Spotlight on Illegal Online Sales of Medicine,” comes amid FDA’s efforts to crack down on internet firms that illegally market opioids and other unapproved drugs.
In June, FDA convened a summit with other federal agencies and more than 15 internet companies, patient advocacy organizations and universities to talk about how to stem the online sale and purchase of illicit opioids. And on two separate occasions in June and August, the agency sent a surge of warning letters to multiple online networks for marketing misbranded opioids, including tramadol.
During the ASOP event, FDA’s Donald Ashley, director of the drug center’s office of compliance, said the agency, in its efforts to curb illegal online sales of medications, has hit some significant challenges dealing with registries and registrars -- companies that manage and sell domain names to individuals or businesses who operate websites.
When FDA sends a warning letter to a website operator that is illegally selling opioids or other drugs, it also notifies the registry or registrar from which the website operator is leasing the domain name.
According to Ashley, FDA would like to see registries and registrars take more action in response to those notifications.
For one, the agency would like to see the registries and registrars enforce the terms of use agreements they impose upon website operators, as many of those terms of use agreements feature a clause allowing for a contract to be terminated if the website operator conducts illegal activity.
Additionally, the agency would like to see the registrars decline to sell another domain name once the first domain name has been identified in a warning letter. If that were to happen, Ashley said, it could help with the “whack-a-mole” situation FDA finds itself in when one website is taken down but then the website operator is able to buy another domain name to replace the defunct website.
Despite FDA making it a regular practice to notify registries and registrars when one of their customers is caught illegally selling medications online, many of the companies have been unresponsive to the agency.
“Unfortunately, the level of cooperation we’re receiving from a large number of these companies is less than satisfactory. We’ll receive a response back like: ‘We don’t have any control over the content,’ ‘We don’t have any idea whether this conduct is illegal’ and ‘We won’t take action without a court order,’” Ashley said.
He continued: “The problem is that these companies are just turning a blind eye to the conduct that’s being facilitated through the sale of these domain names, and they’re refusing to take any responsibility for it.
Ashley did acknowledge that the agency and stakeholders have made quite a lot of progress in the agency’s voluntary compliance campaign, but, he said, it’s an evolving discussion and more work needs to be done. FDA, he added, has urged internet stakeholders to address illegal sales of opioids online “with the same level of creativity and effort” they have had in addressing child pornography, terrorism and bullying.
In a separate panel discussion, Elizabeth Miller, vice president of regulatory affairs for USP, said that the online pharmacy distribution model is not going away -- in fact, it will continue to grow. And drug quality is one of the biggest issues that will need to be dealt with as that happens.
“There are quality issues in the lifecycle of medications at every step through the pharmacy and the medication lifecycle from how a product is manufactured all the way through to its distribution, how it gets to the patients, how it’s sorted, how it’s shipped,” Miller said. “And all of these things are really critical to ensuring that what the patient holds in their hands at the end of the day is safe, effective and of quality.”
FDA and USP may be able to better identify when there’s a quality issue with medications by leveraging practical quality and performance standards, Miller said. The two agencies already work closely on safety of prescription and over-the-counter medicines, and according to Miller, pharmacists understand USP quality standards.
Specifically, she said the pharmacopeia and others could work together to leverage quality standards and make them practical and usable to address some of the problems with drug safety.
Miller pointed to FDA’s chemistry, manufacturing and controls regulations -- which focus on identity, strength, quality, purity and potency of drug products -- as one area the pharmacopeia could have an effect. Additionally, experts and regulators should look at practices and guidelines that address various aspects of the drug supply chain, including how the active pharmaceutical ingredients are sourced, manufactured and synthesized, all the way through the drug distribution system and how medications get into hospitals and pharmacies.
“Some of those things, as we move from the traditional distribution system have to be thought about, and we need more people at that table to think about this kind of new world we’re living in with online distribution,” Miller said. “Standards would have to be practical -- they have to be usable so they can be implementable and adoptable. And then they have to keep up with the times. As these actors are evolving, we have to think about how those countermeasures that we put in place need to evolve to keep up with those things.”
USP’s Quality Institute, launched in 2017, is already looking at problems that intersect health economics with product quality and medicines quality issues, Miller said, adding that USP wants to start to convene conversations around those issues.
“We really want to be here at the table thinking about how can we work together to develop solutions that are actually practical, implementable and adoptable to help address these problems,” Miller said. -- Beth Wang (bwang@iwpnews.com)
