UPDATE: Senator Amy Klobuchar (D-MN) has withdrawn her sponsorship and support for this bill.
A new bill introduced by Sens. Mark Rubio (R-FL) and Amy Klobuchar (D-MN), called the “Domain Reform for Unlawful Drug Sellers Act’’ or, for short, the ‘‘DRUGS Act,’’ could effectively end online access to safe and affordable imported medicines for Americans. The bill is promoted as a way to stop opioid abuse, in particular, fentanyl. But the FDA already has a program for tackling online opioid drug dealers. The DRUGS Act has other targets. The true aim of the bill’s backers may be to stop personal importation of non-addictive, non-opioid, more affordable medicines that help patients get the treatments they need.
First, a primer of the issue at large.
Prescription drug prices are much lower in most other countries than in the United States. Tens of millions of Americans cannot afford prescribed medicines domestically. While imports of prescription medicines for personal use are under most circumstances prohibited, individual patients are not charged or prosecuted for such imports, and the law says that that the FDA should allow them. About 2.3 million people with a prescription obtain medicines this way each year, and many more could benefit from it.
Drug companies and big chain pharmacies don’t want the competition of lower drug prices offered by international online pharmacies because it means lower profits. They want the FDA to shut down those sites, but, it seems, under current law, the international online pharmacies used to facilitate importation are not illegal. To shut them down, they need a new law such as the DRUGS Act. The bill would empower the FDA and other federal agencies, and organizations or private companies they deputize, to effectively shut down an online pharmacy in another country that sells lawful medicines and requires valid prescriptions if they sell to patients in the United States.
Those deputized organizations or companies will probably be ones financially supported by or associated with the pharmaceutical industry, such as the National Association of Boards of Pharmacy (NABP) and LegitScript. Listed as endorsers and supporters of the bill are the NABP, and pharma-funded groups, such as the Alliance for Safe Online Pharmacies and Partnership for Safe Medicines. [FULL DISCLOSURE: my company, PharmacyChecker, has sued all of the above in an antitrust action alleging that they conspired against PharmacyChecker to censor its online pharmacy verification and drug price information.]
Here’s how the law would play out.
Online pharmacies, like any website, such as this one, are registered with a domain name seller, a registrar, such as Go Daddy, Domain.com, or Enom, Easy DNS, etc. Those domain companies are retailers for registries. Registries are the companies that operate “.com” (Verisign), “.org” (The Internet Society), “.biz” (Afilias), etc. If the bill becomes law, an entity like the NABP, as a “Trusted Notifier,” could notify a registrar or registry that a certain website is used by Americans to buy prescription medicines that are then imported for personal use. The bill’s provisions define such a website as one that “is used to facilitate the online sale of drugs illegally.” The bill’s provisions provide no distinction between safe online pharmacies and dangerous opioid-selling rogue websites. This bill’s provisions would equally apply to a Canadian pharmacy website that does NOT sell opioids or other addictive drugs and requires a valid prescription, and a website that offers fentanyl or other opioids to whoever wants them. Upon that notification, the registrar or registry would have to lock that website within 24 hours and then, within seven days, suspend it. Registrars and registries that did not lock and suspend domain names per the notification of the trusted notifier would be in violation of federal law.
The playbook of the pharmaceutical industry in opposing importation once focused mostly on the dangers of counterfeit drugs, conflating them with safe medicine imports from licensed pharmacies. Their current public relations tactics are more focused on the opioid epidemic, hoping that legislators and the media will endorse or give favorable coverage to public policies that seem to take a hardline with opioid drugs, but surreptitiously want to end access to affordable prescription drugs through personal importation.
Sadly, the issue of opioids and counterfeit drugs have converged because drug dealers (and I’m not referring to Purdue Pharma) use fentanyl ingredients to create counterfeit versions of prescription opioid drugs. The crisis, as I wrote in The Hill a few months ago, however, should not be used to stop safe personal medicine importation. In that article, I talked about how, under the banner of stopping opioids, the FDA has received increased funding for enforcement efforts at international mail facilities that is used to prevent patients from getting non-opioid, regular prescription medicines from international online pharmacies. Many of those patients rely on safe international online pharmacies and the DRUGS Act would serve to get rid of them.
Senator Mark Rubio’s press release identifies the organizations that endorse the bill. Without exception, they are all tied to the pharmaceutical industry through funding and/or memberships. “The DRUGS Act has been endorsed by the Alliance for Safe Online Pharmacies, the National Association of Boards of Pharmacy, the National Consumers League, RESOLVE: The National Infertility Association, the International Federation of Pharmaceutical Wholesalers, the Coalition for Online Accountability, the Partnership for Safe Medicines, and the Pharmaceutical Security Institute.” Some of these groups were founded by and almost, if not completely, funded by drug companies.
National Association of Boards of Pharmacy (NABP)
As an association of boards of pharmacy, the NABP’s members are not drug companies. However, NABP’s initiatives regarding online pharmacies have been funded by, among others, Pfizer, Merck, Eli Lilly, Gilead, Janssen: https://web.archive.org/web/20160308062428/https://www.nabp.net/programs/pharmacy/pharmacy-and-nabp/coalition-support.
Alliance for Safe Online Pharmacies (ASOP)
ASOP was launched with money from Eli Lilly, the National Association of Chain Drug Stores (think Walgreens and CVS), and LegitScript. Its membership includes drug companies Amgen, Eli Lilly, Gilead, Merck & Co., Takada Pharmaceuticals, and lots of other entities that are funded by drug companies or have commercial interests in U.S. pharmacy sales. NABP Solutions, LLC, is also a member. Here’s a link to ASOP’s membership: https://buysaferx.pharmacy/about-asop-global/members-and-observers-2/.
Partnership for Safe Medicines (PSM)
PSM is conspicuously tied to the pharmaceutical industry and loudly outed as such by Patients for Affordable Drugs, Kaiser Health News, and Bloomberg News, and specifically criticized for its deception about drug importation by PolitiFact.
National Consumers League (NCL)
NCL’s Health Advisory Council for 2020 is a list of multinational drug corporations: https://web.archive.org/web/20210121213022/https:/nclnet.org/health-advisory-council/hac_members/.
Pharmaceutical Security Institute (PSI)
From PSI’s website: “Today, PSI membership includes thirty-seven pharmaceutical manufacturers from many nations.” Also, “PSI shares information with the public through its collaboration with the Partnership for Safe Medicines (PSM).”
The Coalition for Online Accountability (COA).
COA is not a pharma-front group. It is a coalition of the largest copyright holder industries that want to protect their intellectual property rights on the Internet. In this policy goal, COA and the pharmaceutical industry are allied. This alliance was behind the infamous online censorship bill, the Stop Online Piracy Act (SOPA). SOPA initially had congressional support, only to dramatically lose it once members of Congress came to understand its antidemocratic nature: https://www.eff.org/issues/coica-internet-censorship-and-copyright-bill.
The International Federation of Pharmaceutical Wholesalers (IFPW)
IFPW is a federation of wholesale pharmacy businesses that includes drug companies as members: https://www.ifpw.com/manufacturers.htm.
RESOLVE: The National Infertility Association.
This organization appears to have limited membership or affiliation with drug companies: https://resolve.org/about-us/corporate-council/.
This bill’s sponsors appear to focus on fentanyl sales that happen over the Internet. The FDA already has a program to stop online drug dealers. Invoking the cruel toll of opioid abuse, addiction, and death to move this legislation forward that will end online access to safe and affordable medicine is wrong on so many levels that I doubt even Big Pharma can pull this off.
I wish that Sens. Mark Rubio (R-FL) and Amy Klobuchar (D-MN and others in Congress could suffer the consequences of their legislation to see how it effects real Americans living on limited resources and having to make decisions between necessary medication and groceries and rent on a month to month basis. I am firmly against illicit drug use and doctors who prescribe RX meds without need such as opioids like Fentanyl. At the same time I believe that it is impossible to legislate against stupidity and those who would abuse such drugs. Pushers and dealers, along with doctors who pen prescriptions without need, need to be dealt with harshly. For drugs to be a problem, there must be a wanton demand and those who would break the law to fulfill it. Write the law succinctly and in this case singularly to deal with opioids…create additional hurdles to jump through to get the problem drugs. Those who really need them would be able to get their meds and others without justification could not legally procure such dangerous drugs.
I can only see such a broadly reaching bill to be in support of big Pharma and their programs of constantly increasing drug prices here in the United States. They tout research and development as the reason for insane prices for RX meds in the U.S. but the facts are clear that well in excess of 50% of the prices are tied up in lobbying legislators, doctors, hospitals and advertising. Let’s get our legislators off the the black back door payroll by making the “perks” illegal for those who write our laws. It’s a form of legalized bribery and payola.
In closing, don’t hurt Americans by writing laws which place additional burdens of cost on life saving medications. Close up the loopholes of questionable availability, activity and procurement of the very specific drugs which need additional control. Continue to allow Americans to source their meds through legitimate pharmacies outside the U.S. such as Canada, when using U.S. doctor written prescriptions. (Note: Canadian pharmacies will not fill requests for drugs such as Fentanyl and other narcotics even with a legitimate U.S. doctor’s prescription)
This was an amazing comment. Thank you for weighing in.
I feel this was paid for by big pharma to stop affordable life-saving drugs such as insulin from coming in from Canada rather than opioids or fentanyl. This bill could easily be modified to allow Americans, who otherwise couldn’t afford their meds and would probably die without them, from getting it through a legitimate Canadian pharmacy with a prescription from their doctor. It really exposes how corrupt politicians can be.