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”.
February 12, 2015
The Honorable Lamar Alexander
The Honorable Patty Murray
Committee on Health, Education, Labor and Pensions
United States Senate
The Honorable Fred Upton
The Honorable Frank Palone, Jr.
Committee on Energy and Commerce
U.S. House of Representatives
SUBJECT: The public record on Internet pharmacies, GAO report, drug safety and affordability
In June of 2013, pursuant to Section 1127 of the Food and Drug Administration Safety and Innovation Act, your committee received a report from the GAO about Internet pharmacies – entitled “Internet Pharmacies: Federal Agencies and States Face Challenges Combatting Rogue Sites, Particularly Those Abroad” – that ignored evidence and analysis showing that safe international online pharmacies are a lifeline of affordable medication for millions of Americans. Instead, the GAO wrongly labels safe foreign online pharmacies as rogue online pharmacies. To correct the public record,we have prepared and are providing to your committee the enclosed holistic, consumer-focused, evidence-based analysis about online pharmacies within the important context of a health crisis caused by high drug prices in America. This report, entitled, “Online Pharmacies, Personal Drug Importation and Public Health,” can more appropriately guide lawmakers on how to protect the public from counterfeit or substandard medication from rogue online pharmacies. The report is authored by Gabriel Levitt, Vice President of PharmacyChecker.com, who has been directly involved, on a daily basis, for the past 12 years with the evaluation of online pharmacies and prescription drug costs and has participated in multiple forums and published several articles as an expert on this topic, including providing testimony before the House Judiciary Committee’s Subcommittee on Courts, Intellectual Property and the Internet.
We urge you to read the enclosed report and include it in the public record to help prevent a completely unnecessary travesty in which millions of Americans are cut off from safe and affordable medication due to actions stemming from the flawed research and analysis in the GAO report.
Legitimate public health concerns about rogue online pharmacies are being misused by the pharmaceutical industry to encourage legislative, regulatory, and private sector actions that curtail access to licensed pharmacies providing 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. Already, tens of millions of Americans go without medications due to cost.
Despite federal prohibitions, according to the CDC, about five million Americans buy prescription drugs from foreign sources each year for reasons of cost. Many of these purchases are from safe international online pharmacies that require valid prescriptions. Yet the Obama administration and the FDA have worked in tandem with the pharmaceutical industry to educate consumers not to purchase more affordable, genuine medication from Canadian and other pharmacies that could save their lives. The well-documented facts of our report help provide a road map for action that is beneficial to regulators, lawmakers, private industry and, most importantly, millions of cash-strapped Americans who are struggling to afford life-saving medications.
We are available on short notice to answer your questions in writing or in person.
Tod Cooperman, M.D., President
Gabriel Levitt, Vice President
CC: By Email/PDF:
Reps. Rosa DeLauro, Keith Ellison, Darrell Issa, Nita Lowey, Carolyn Maloney, Nydia Velazquez
Sens. Susan Collins, Kristin Gillibrand, Charles Grassley, Dean Heller, Amy Klobuchar, John McCain, Rand Paul, Bernie Sanders, Charles Schumer, David Vitter
Stephen Barrett, MD, Quackwatch
Roger Bate, Ph.D., American Enterprise Institute
David Belk, MD, The True Cost of Healthcare
Kenneth G. Berge, M.D., Mayo Clinic
Robin A. Cohen, Ph.D.., U.S. Centers for Disease Control and Prevention
Gabrielle Cosel, Manager, Drug Safety, The Pew Charitable Trusts
Sara R. Collins, Ph.D., Commonwealth Fund
Allan Coukell, Senior Director, Health Programs, The Pew Charitable Trusts
Marcia Crosse, GAO
Laurie Garrett, Senior Fellow for Global Health, Council on Foreign Relations
Lee Graczyk, Lead Organizer, RxRights
Joe Graedon, People’s Pharmacy
Peter Maybarduk, JD, Director, Global Access to Medicines, Public Citizen
Dena Mendelsohn, JD, MPH, Consumers Union
Lee Purvis, AARP
Elisabeth Rosenthal, New York Times
Ed Silverman, Wall Street Journal
Sean Vitka, Sunlight Foundation
Maria A. Villarroel, Ph.D., U.S. Centers for Disease Control and Prevention