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Online Pharmacies, Personal Drug Importation and Public Health: Illegal Doesn’t Mean Unsafe

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. Our report refutes a flawed GAO report about Internet pharmacies.

This week we look at the evidence that proves that illegal personal drug importation is not inherently unsafe. First of all, when Americans buy medication from a licensed pharmacy in Canada, India, Turkey, or the UK, the pharmacy itself is legal in those countries: after all its licensed. Unfortunately, it’s technically illegal under most circumstances for a consumer to import meds for their own use from those pharmacies. It’s very common for groups funded by big drug companies to confuse consumers and even lawmakers that this illegality means the practice is inherently not safe, but that’s not true…

Illegal Doesn’t Mean Unsafe

 

The GAO report misconstrues safety and legality in its analysis of Internet pharmacies. The report states: “By violating federal and state laws, rogue Internet pharmacies threaten the public health.” For about fifteen years, often in violation of federal and state laws, millions of Americans have safely imported medication ordered online, pursuant to a valid prescription for their own use. As evidenced throughout this report, it’s not the violation of federal or state laws that threaten the public health but the actions of rogue pharmacy operators who sell fake or otherwise dangerous medication, or real medication without requiring a prescription.

The facts about personal drug importation are as follows: 1) Through orders placed online, tens of millions of Americans have imported medication from licensed pharmacies that require a prescription over the past 15 years with no reported deaths or serious adverse effects; 2) the practice is technically illegal under most circumstances; 3) there is no evidence that shows personal drug importation of non-controlled medication where a prescription is required is inherently unsafe; 4) according to the FDA, no one has ever been prosecuted for importing small quantities of prescription drugs for personal use.1

If an American receives a drug ordered online that was dispensed and mailed properly from a licensed pharmacy, it makes no difference from a safety perspective whether the product came from a U.S. or foreign licensed pharmacy, as long as the drug has the right amount of the active ingredient, treats the condition as intended, and is administered in the manner intended by the physician who prescribed the drug. Like those sold in U.S. pharmacies, medications ordered from credentialed international online pharmacies are produced in factories employing Good Manufacturing Practices (GMP) and are distributed, stored, dispensed, and mailed properly. The drugs are the same as or foreign versions of those sold in U.S. pharmacies.


1“Should You Use an Overseas Pharmacy,” MoneyTalksNews.com, 2/1/2013. An email written by Christopher Kelly, Center for Drug Evaluation and Research, FDA, states: “FDA is not aware of any actions taken against an individual resulting from their purchase of small quantities of unapproved drugs for personal use.” http://www.moneytalksnews.com/2013/02/01/is-it-safe-to-use-an-overseas-pharmacy/, [Last accessed 12/17/2013].

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Online Pharmacies, Personal Drug Importation, and the Public Health: History of Online Pharmacies

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?

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.

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Online Pharmacies, Personal Drug Importation, and Public Health: Industry Dominance of “Stakeholders” Consulted by GAO

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:

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:

  1. Alliance for Safe Online Pharmacies
  2. International AntiCounterfeiting Coalition
  3. National Association of Boards of Pharmacy Pharmacies
  4. National Association of Chain Drug Stores
  5. National Community Pharmacists Association
  6. Partnership for Safe Medicines
  7. Pharmaceutical Security Institute
  8. PhRMA

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.

(more…)

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