GAO Report Misleads Congress on Safety of International Online Pharmacies, Says New PharmacyChecker.com Report

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A new report corrects the public record on personal drug importation and online pharmacies by providing data and analysis that refutes the positions of an earlier GAO report about Internet pharmacies. The new report demonstrates how overreaching federal and private sector enforcement actions curtail online access to safe and affordable medication.

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The GAO report wrongly labels safe foreign online pharmacies as rogue online pharmacies. This misrepresentation is leading to misguided policies that hinder online access to safe and affordable medication

The leaders of the House Committee on Energy and Commerce and Senate Committee on Health, Education, Labor and Pensions each received a comprehensive report countering a GAO report[1] on Internet pharmacies. Written by Gabriel Levitt, vice president of PharmacyChecker.com, the report corrects the public record and informs elected officials and the healthcare community about online pharmacy safety and affordability. Mr. Levitt stated:

“The GAO report wrongly labels safe foreign online pharmacies as rogue online pharmacies. This misrepresentation is leading to misguided policies that hinder online access to safe and affordable medication.”

“According to the CDC, about five million Americans personally import prescription drugs from foreign sources each year due to high domestic drug prices. Safe international online pharmacies are a lifeline of affordable medication for Americans. Ill-considered federal enforcement or private actions will lead more Americans to skip needed medication, which leads to more hospitalizations, sickness and death.”

According to the new report, there are critical errors of auditing standards, omission, fact, or analysis, found in the GAO report about Internet pharmacies, such as those identified below:

1.    The GAO report doesn’t meet Generally Accepted Government Auditing Standards (GAGAS) because it relies almost exclusively on sources biased against safe personal drug importation, particularly the U.S. pharmaceutical and pharmacy industries.

The analysis and conclusions found in the GAO report are overly reliant on stakeholders who have significant financial interests in the audit’s outcome, such as pharmaceutical companies and U.S. pharmacies, as well as the associations and groups they fund.

GAGAS standards require that audits exercise “reasonable care and professional skepticism… Professional skepticism is an attitude that includes a questioning mind and a critical assessment of evidence.”[2] Mr. Levitt’s report demonstrates that the GAO s relies on data it was presented by industry sources, and the FDA, without a “questioning mind and a critical assessment of evidence.”

2.    The GAO report omits critical peer-reviewed studies and even its own earlier conclusions about online pharmacies.

Peer-reviewed research clearly demonstrates the authenticity and safety of medications ordered from foreign, credentialed online pharmacies that require valid prescriptions, including hundreds of orders placed with foreign pharmacies verified by PharmacyChecker.com [3]. Furthermore, GAO’s earlier research clearly showed that many Canadian online pharmacies are safe [4].

3.    The GAO report mentions Section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA) only once in a footnote to explain that the law expands federal authority to destroy imported prescription orders, but does not explore the unintended consequences of seizing and destroying medications imported for personal use.

In contrast, Senators Charles Grassley (R-IA), Dean Heller (R-NV), Angus King (I-ME), David Vitter (R-LA) expressed serious concerns about the “potential health threat to hundreds of thousands of Americans” from Section 708 [5]. Congressman Keith Ellison wrote the FDA about many of his constituents, underscoring that Section 708 will impede their access to safe and affordable medication [6].

4.    The GAO report wrongly identifies a safe international online pharmacy – CanadaDrugs.com – as a “rogue.”

CanadaDrugs.com was wrongly labeled a “rogue” pharmacy in the GAO report, despite its record of safety. In fact, due to its verifiable licensure, long history of pharmacy safety, and website transparency, CanadaDrugs.com could be used as a good example of how Americans are benefiting from lower cost medications from other countries.

5.    The GAO report doesn’t fully analyze or explain FDA survey data relating to how many Americans are using online pharmacies, potentially encouraging confusion about the problem’s scope.

GAO writes: “According to a recent survey conducted by the Food and Drug Administration (FDA)… nearly one in four adult U.S. Internet consumers surveyed reported purchasing prescription drugs online. At the same time, nearly 30 percent said that they lacked confidence about how to safely purchase medicine online. This is a matter of grave concern as rogue Internet pharmacies may sell products that, among other things, have expired; been labeled, stored, or shipped improperly; and may even be counterfeits—unauthorized versions—of other drugs.”

The GAO report omits a crucial finding of FDA’s data: while 23% of American adults may have bought medication online, 83% of them buy medication from U.S. online pharmacies “associated with their health insurance” [7]. These figures and further analysis demonstrate that less than 4% (not “one in four”) Americans are purchasing from unsafe or foreign online pharmacies.

6.    The GAO report doesn’t recognize that Americans can and do benefit from Canadian and other foreign pharmacies accessed online, yet its lead author has, elsewhere, noted the benefits of personal drug importation via online pharmacies.

In an interview on GAO Live, the lead author of the GAO report spoke with a consumer who orders from a Canadian online pharmacy and stated that if the patient has “done some kind of verification that it’s a Canadian pharmacy, and she knows that the drug she has been receiving is the drug that has been prescribed, that’s fine”[8]. This position is not included in the GAO report.

To read and download the whole report for free go to http://www.pharmacychecker.com/online-pharmacies-personal-drug-importation-public-health.pdf.

PharmacyChecker.com (http://www.pharmacychecker.com) is the only independent company that verifies U.S. and international online pharmacies and compares prescription drug prices. It was formed in 2002 when its founder, Tod Cooperman, M.D., saw that increasing numbers of Americans were looking on the Internet to save money on medication but did not have adequate information to protect their health. PharmacyChecker.com is a stakeholder in the online consumer-driven healthcare community, seeking an open Internet environment that promotes innovation and new business models, especially those that serve the public interest.

ENDNOTES

[1] Internet Pharmacies: Federal Agencies and States Face Challenges Combatting Rogue Sites, Particularly Abroad, GAO-13-560 (Washington, D.C. July 2013)..
[2] Government Auditing Standards, GAO-12-331G (Washington, D.C., December 2011).
[3] Bate, Roger, Ginger Zhe Jin, and Aparna Mather, “In Whom We Trust: The Role of Certification Agencies in Online Drug Markets,” The B.E. Journal of Economic Analysis & Policy. December 2013, Volume 14, Issue 1, Pages 111–150, ISSN (Online) 1935-1682, ISSN (Print) 2194-6108, DOI.
[4] Internet Pharmacies: Some Pose Safety Risks for Consumers, GAO-04-820 (Washington, D.C.: June 17, 2004).
[5] U.S. Senator David Vitter, “Vitter Fights to Keep Prescription Drug Prices Affordable Through Reimportation,” July 9, 2014 [press release].
[6] Letter to the U.S. Food and Drug Administration by Congressman Keith Ellison dated July 1st, 2014.
[7] FDA Consumer Survey Highlights: “FDA’s Center for Drug Evaluation and Research (CDER) conducted a behavioral assessment survey to understand the knowledge, attitudes and practices associated with purchasing prescription medicine from online pharmacies in May 2012.”
[8] See point no. 6 to link to the relevant clip of an interview with Marcia Crosse, Ask GAO Live: Chat on Internet Pharmacies, August 12th, 2013.

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