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: Canadian pharmacies, CIPA, GAO, Kathleen Sebelius, mail-order pharmacies, Maine, NABP, PBM, pharmacychecker, VIPPS
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.
Continuing our quest to get the truth out and for our elected leaders in Congress to take bold action to protect online access to safe and affordable medication, we’re publishing a section a week of our report called Online Pharmacies, Personal Drug Importation, and Public Health. The Government Accountability Office Report on Internet pharmacies, which we’ve attested contains inaccuracies and is misleading about buying medication online, clearly relied heavily on pharmaceutical industry sources. Here’s how:
Tagged with: Alliance for Safe Online Pharmacies, Eli Lilly, GAO, NABP, national association of chain drugstores, National Associations of Boards of Pharmacy, phrma
Some pharmaceutical companies, including many members of the PhRMA, view foreign online pharmacies as a commercial threat because Americans are able to obtain medications at lower prices leading to lower profits. The U.S. pharmacy industry views non-U.S. online pharmacies as unfair competition because the latter can charge lower prices. Many of the groups identified by GAO as stakeholders are drug companies and U.S. pharmacies or groups that they fund, including the following groups:
- Alliance for Safe Online Pharmacies
- International AntiCounterfeiting Coalition
- National Association of Boards of Pharmacy Pharmacies
- National Association of Chain Drug Stores
- National Community Pharmacists Association
- Partnership for Safe Medicines
- Pharmaceutical Security Institute
Of the 35 stakeholder groups identified by GAO, at least 33% (13) are pharmaceutical companies or groups that receive funding by pharmaceutical companies or U.S. pharmacies. Another stakeholder is the Center for Safe Internet Pharmacies (CSIP), as are eight of its member companies. CSIP is a private consortium of businesses formed in response to pressure by the White House Office of the Intellectual Property Enforcement Coordinator, which mostly operates as another voice and information clearinghouse for the other stakeholders listed. Three associations representing U.S. pharmacy boards and pharmacies are listed above.
To see just how drug company lobbyists snake their way into the legislative process please read this next section, which follows the executive summary.
You can view the whole report here.
The GAO inquiry into online pharmacies mandated by FDASIA in its Section 1127 was drafted by a lobbyist in the employ of a government relations firm (FaegreBD Consulting) hired by the Alliance for Safe Online Pharmacies (ASOP), a group that is led by Eli Lilly, the National Association of Chain Drugstores and LegitScript.The executive director of ASOP is Libby Baney, who now runs a consulting firm called FWD Strategies International.1 According to its website, FWD Strategies International “is not just a name; it is what we do – moving your vision forward.” In marketing her firm, Ms. Baney notes that one of its services is drafting congressional legislation. As an example of draft legislation, she notes Section 1127 of FDASIA among others relating to online pharmacy.
As evidenced above, it’s not surprising that Section 1127 did not encourage the GAO to perform serious research and independent analysis about online pharmacy safety. Instead Section 1127 conspicuously calls for GAO to report on “laws, policies, and activities that would educate consumers about how to distinguish pharmacy Internet web sites that comply with Federal and State laws and established industry standards from those pharmacy Internet websites that do not comply with such laws and standards…” That language represents the “vision” of the founders and funders of ASOP, companies and people with a history of working to curtail access by Americans to lower cost medication from safe international online pharmacies.2
Tagged with: 1127, Alliance for Safe Online Pharmacies, ASOP, Eli Lilly, faegre, FDASIA, FWD Strategies International, GAO, Libby Bainey, lobbyist
1 Libby Baney is identified as a lobbyist for the Alliance for Safe Online Pharmacies in this lobbying disclosure report: http://soprweb.senate.gov/index.cfm?event=getFilingDetails&filingID=6B1B406C-D5C0-48C6-9484-B9FF3B372B1F&filingTypeID=51 [Last accessed 10/21/2014].2 Some of ASOP’s funders seek extreme actions, such as “delisting,” to achieve their goals. Eli Lilly recommends that search engines remove organic results so that Americans can no longer find online pharmacies that are not based in the U.S. See, testimony by Bruce Longbottom, JD, Eli Lilly, Statement to the House Energy and Commerce Committee, Subcommittee on Oversight and Investigations, February 27th, 2014, see http://docs.house.gov/meetings/IF/IF02/20140227/101804/HHRG-113-IF02-Wstate-LongbottomB-20140227.pdf [Last accessed 10/24/2014]. View the actual testimony about delisting here.
Last week we wrote that we would present a new section of Gabe Levitt’s report on online pharmacies. This week, we are going to start off with the Executive Summary of the report. We’ve given a sample below, but you’ll have to visit PharmacyChecker.com to view the whole Executive Summary.
Tagged with: CDC, Commonwealth Fund, drug affordability, FDASIA, GAO, government auditing standards, Medication Adherence, Section 1127
The U.S. government relies on the Government Accountability Office (GAO) for objective and independent research and analysis of government programs and policies that affect public health. GAO’s report entitled Internet Pharmacies: Federal Agencies and States Face Challenges Combatting Rogue Sites, Particularly Those Abroad (the “GAO report”) contains critical inaccuracies and omits important peer-reviewed research to the extent that lawmakers and their staffs will likely draw erroneous conclusions about international online pharmacies that could lead to overreaching and unnecessary enforcement actions that disadvantage consumers and threaten public health. The GAO report was written pursuant to Section 1127 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), a law dedicated to protecting public health.
In contrast to the GAO report, the following holistic, consumer-focused, evidence-based analysis discusses online pharmacies within the important context of a health crisis caused by high drug prices in America, and can more appropriately guide lawmakers on how to protect the public from counterfeit or substandard medication. Legitimate public health concerns about rogue online pharmacies are being used to encourage legislative, regulatory, and private sector actions that curtail online access to safe and affordable medication. The consequence of overreach could be millions more Americans facing economic hardship or having to forgo prescribed medication, which studies show can lead to more sickness and death.
Fifty million Americans did not fill a prescription due to cost in 2012, according to the Commonwealth Fund. According to the Harvard School of Public Health, over half of Americans who do not take prescription medication due to cost report becoming sicker.1 That means potentially 25 million Americans become sicker each year because they can’t afford prescribed medication. According to the U.S. Centers for Disease Control and Prevention (CDC), about five million Americans buy prescription drugs from foreign sources each year for reasons of cost. Additional estimates show that between four and five million Americans get their imported prescription drugs through international online pharmacies due to their lower prices.
Correcting the Public Record about Online Pharmacies and Personal Drug Importation
In July of the 2013, the Government Accountability Office (GAO) published a report about Internet Pharmacies with a focus on foreign websites that I believe strongly distorted the public record about buying medication online through personal drug importation. GAO’s report was submitted to Congress in response to Section 1127 of the Food and Drug Administration Safety and Innovation Act, intended to protect the public health. I wrote a report to refute the GAO’s positions in order to correct the public record regarding the intersection of online pharmacies, personal drug importation, drug affordability and the public health. I believe that my report about online pharmacies proves that the GAO’s efforts fell very short in getting to the truth about buying medication online.
Americans buy lower cost and safe medication internationally, often online, and it benefits their health and financial well-being. If it were not for the option of personally importing lower cost medication, often using the Internet, many Americans would just not be able to get medical treatments they need. People who can’t take needed medication often get sick and may even die. The GAO report did not mention these facts.
The GAO seemed to conflate safe international online pharmacies with rogue online pharmacies in the same manner we’ve come to expect from the pharmaceutical industry, U.S. pharmacy trade associations and the FDA – by calling safe international online pharmacies “rogue.” The problem, for me, is that its lead author is not with the pharmaceutical industry, a U.S. pharmacy trade association, or the FDA. She is someone I’ve come to admire over the years just by following her work with GAO. So I can’t just say “look, it’s big Pharma again!” So for almost a year and a half I’ve written a report to, in part, prove to and remind myself that “we’re right and they’re wrong.” I’ve done that. I look forward to this report becoming a part of the public record.
Rogue online pharmacies, meaning drug-selling websites that are not safe (see my report for details), should be shutdown. Let’s get rid of them! However, if our elected leaders and regulators allow or enact policies to bring about an end to online access by Americans to safe and affordable medication and people get hurt, then they can’t say they didn’t know.
Below, I’ve pasted the cover letter from Tod Cooperman, MD, president of PharmacyChecker.com, and I that accompanied the hardcopy of the report we sent the congressional committees that received the GAO’s report in 2013. Each week we’ll be commenting on and posting the different sections of my report. To read the report now, visit “Online Pharmacies, Personal Drug Importation and Public Health”.
Tagged with: GAO, Internet pharmacies, personal drug importation, public health, rogue online pharmacies