On February 12th of this year, we sent a comprehensive report about buying medication online to the Senate Committee on Health, Education, Labor and Pensions and House Committee on Energy and Commerce. Our purpose was to correct the public record by challenging a flawed report about Internet pharmacies written by the Government Accountability Office (GAO) back in 2013. The GAO’s report essentially parroted the narrative that the pharmaceutical companies, U.S. pharmacies, and FDA want you to hear, which ignores the existence of safe international online pharmacies that help Americans afford safe medication. Due to the incredible importance of this issue, we are publishing a section of our report each week. For the full report, click Online Pharmacies, Personal Drug Importation and the Public Health.
This week you can read a “History of Online Pharmacies.” It’s not a comprehensive history but gives the reader enough background to digest the larger issues contained in the report. When you think about, online pharmacies are really “mail order pharmacies” with websites. Did you know that mail order pharmacy has been around for well over a hundred years?
Tagged with: GAO, Kathleen Sebelius, Maine
The Internet has facilitated a major proliferation of mail-order pharmacy operations. Mail-order pharmacies are not new; they have served Americans since the late 1800s. Internet pharmacies, often referred to as “online pharmacies,” can be defined as websites that market and sell prescription medication over the Internet that is dispensed by mail-order. When they began operating in the mid to late 1990s, online pharmacies quickly became a subject of concern for federal regulators and Congress due to dangerous and illicit practices. The NABP created the Verified Internet Pharmacy Practice Sites (VIPPS) in 1999, a voluntary program open to domestic pharmacies to help consumers identify safe online pharmacies.
Drugstore.com, which launched its website in 1999, was considered a first-mover in the industry and an example of a safe online pharmacy without a bricks-and-mortar presence. It required a valid prescription and dispensed medication from a licensed pharmacy. By the beginning of the last decade, most major chain pharmacies were doing business online by taking new and refill prescription orders, and mailing them across the country. Drugstore.com and most but not all online pharmacies associated with major chain pharmacies and Pharmacy Benefit Management (PBM) companies became VIPPS-approved by 2003.
Around 2000, Canadian pharmacies began online marketing to reach American consumers, which provided Americans with access to low-priced drugs. Previously, personal drug importation from Canada was relegated to those living on border-states. This issue also gained public attention through media coverage of bus trips, which brought seniors up to Canada to buy medication and were sometimes sponsored by U.S. politicians supportive of reforming drug importation laws. Canadian pharmacies later began partnering with licensed pharmacies in other countries, such as Australia, New Zealand, and the UK, and later India and Turkey, as well as those in free trade zones. They did so in part to evade supply restrictions imposed by pharmaceutical companies against Canadian pharmacies, but also to take advantage of even lower drug prices found elsewhere and to increase profits.
In 2002, PharmacyChecker.com began operations to verify both U.S. and foreign online pharmacies – as well as to compare drug prices for consumers seeking the lowest prices for their medications. CIPA was founded that same year. CIPA’s vice president testified at a congressional hearing in 2003 entitled: “International Prescription Drug Parity: Are Americans Being Protected or Gouged?” In 2004, the FDA recognized PharmacyChecker.com’s efforts to help consumers find the lowest prices and directed people to www.pharmacychecker.com as part of media relations efforts to show that U.S. generic drug prices are lower in the U.S. than in Canada.
While the Internet has enabled millions of Americans to find safe and lower cost medication from outside the U.S., it has also created a public health minefield where dangerous websites posing as safe pharmacies, U.S. and foreign, are accessed every day. Such websites sell fake, adulterated and/or low quality medication, or genuine and safe prescription drugs but without requiring a prescription. These rogue online pharmacies are a serious threat to patient safety and have caused sickness and death.
While too many Americans today have online access to and buy from rogue foreign pharmacies, many are benefiting from safe foreign pharmacies. Americans, including elected officials and public health regulators, know that low-priced and safe prescription medication can be found online internationally. For instance, former Health and Human Services Secretary Kathleen Sebelius adopted a personal drug importation program when she was Governor of Kansas that allowed consumers to find international pharmacies over the Internet. The State of Maine recently updated its pharmacy licensure requirements to permit sales from pharmacies that are licensed in Australia, Canada, New Zealand and the United Kingdom, in effect abolishing state restrictions on personal drug imports from those countries.
Unfortunately, a Maine state law that was created to help people access lower cost medication from licensed pharmacies in Australia, Canada, New Zealand and the United Kingdom, was invalidated yesterday in a decision by federal court Judge Nancy Torresen. Basically the judge, invoking a legal doctrine called “preemption,” concluded that federal law beats state law when it comes to foreign commerce, and since federal law technically bans personal drug importation under most circumstances, Maine’s law is trumped. I’ll return at the end to deal with a little legalese fun (but not too much!).
Taking a walk down memory lane here: personal drug importation programs in Maine, such as one operated for the City of Portland, Portland Meds since 2004, which has helped Americans save many millions of dollars, were shut down in 2012 by former State Attorney General William Schneider. The programs were shut down because Maine’s pharmacy groups persuaded AG Schneider that Canadian and all foreign pharmacies should be stopped from mail order pharmacy sales into Maine because they are not licensed in Maine. Most U.S. states require pharmacies based elsewhere to obtain an out-of-state pharmacy license if they want to sell medication by mail to their residents. While there are exceptions, most states do not allow pharmacies in other countries to obtain an out-of-state license.
Maine legislators were angered by this action and passed a law, LD 171 “An Act To Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies,” that exempted licensed pharmacies in Australia, Canada, New Zealand, and the UK from having to obtain an out-of-state Maine pharmacy license. Not only was this law passed on a bi-partisan basis but the vote was overwhelming: Maine’s House voted 107-37: the Senate voted 30-4. And with that the personal drug importation programs resumed.
The law was invalidated, now what?
Programs like Portland Meds will not necessarily shutdown. We’ll have to wait and see what happens. But if they do shutdown then thousands of Mainers will be paying more for their medications. More seriously, some Mainers will likely end up skipping their medications because the prices at their local pharmacies are too high for them. Back in 2012, an owner of one company that worked with CanaRx, a Canadian pharmacy benefit company, admitted that by working with licensed foreign pharmacies his company saved money: but there was more to the story than simply a company saving money. Quoting a journalist from the Bangor Daily News:
While acknowledging that Hardwood Products “as a company is trying to save money,” Young said his greatest fear is that a spike in costs will spur his employees to stop taking medications for conditions such as diabetes and asthma.
“We have many people here who are hourly employees,” he said. “We pay a fair wage, but the impact out of the family net income will be significant. More important than the money is the health and well being of the employees and their families. What dollar figure do you put on that?”
…but all hope is not even close to lost! Americans still have access to safe and more affordable medication available online, and, again, Maine’s programs have not yet shut down. Equally as important to the longer term cause of prescription justice, the ruling leaves the door open for the State of Maine to appeal the decision up the legal food chain to the 1st Circuit Court of Appeals in Boston. If Maine wins then other states may follow its lead by passing similar legislation to promote access to lower costs medications from other countries.
I’m pretty certain that, with the requisite political will from Maine’s legislators, citizen rabblerousing, and some good legal marksmanship, there are ways to overcome and defeat Judge Torresen’s ruling.
To conclude, I’d like to challenge something Judge Torresen opined in her ruling to nullify Maine’s foreign pharmacy law:
“Congress enacted the FDCA [Food, Drug and Cosmetics Act] to bolster consumer protection against harmful products.”…In furtherance of this purpose, Congress has created a complex regulatory scheme covering the importation of pharmaceuticals into the United States…
Is that so? Maybe…in part. However, I believe that banning Americans from importing lower cost and safe prescription medication from licensed pharmacies for their own use does nothing to bolster consumer protection against harmful products but quite a lot to bolster protection of big drug company and U.S. chain pharmacy profits. I know that the ban impedes Americans from taking medications they need and forces more financial hardship. Are these facts that could hold up in court? I think so.
Tagged with: CanaRx, legal, Maine, Torresen
In George Orwell’s famous novel 1984, published in 1949, we find a future in which totalitarian, one-party rule has run amuck on a global scale. It is a world in which whatever “The Party” (think Communist or Nazis) states is a fact must be believed, regardless of the obtuse logic and propagandistic origins of that so called “fact.” The quintessential and frightening example provided by Orwell is the notion that 2+2=5 if The Party Say’s so. When I attended the Partnership for Safe Medicines (PSM) conference last week, it felt as if many people were willing to believe absurd notions about online pharmacies. Most positions espoused at PSM’s conference support the following fallacious statement: IF an online pharmacy is not based in the U.S. and sells prescription drugs to the U.S. THEN it is dangerous. They essentially put on a show in which different people in a myriad of ways communicate that 2+2=5.
The event, called the PSM Interchange, is a Lion’s Den with many people who are directly paid by drug companies, indirectly paid by drug companies, U.S. pharmacies or their trade groups, or those who would like to be paid by the aforementioned entities someday, either directly or indirectly. PSM’s stated mission, “working together to protect the safety of your prescription drugs,” is, it seems, a smoke screen for big drug companies working together to keep drug prices as high as possible in their most cherished market – America. (more…)
Tagged with: CanaRx, Kenneth "mac" McCall, Libby Baney, Maine, Partnership for Safe Medicine, Peter Pitts, phrma, PSM, Todd Brown