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Online Pharmacies, Personal Drug Importation and Public Health: Section 1127 of FDASIA Was Drafted By a Lobbyist for a Pharmaceutical Industry Funded Group

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


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.

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Online Pharmacies, Personal Drug Importation and Public Health: Executive Summary

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.

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.
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