by PharmacyChecker.com | Mar 6, 2015 | Pharmacychecker Online Pharmacy Report
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.
Tagged with: 1127, Alliance for Safe Online Pharmacies, ASOP, Eli Lilly, faegre, FDASIA, FWD Strategies International, GAO, Libby Bainey, lobbyist
by PharmacyChecker.com | Feb 27, 2015 | Pharmacychecker Online Pharmacy Report
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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Tagged with: CDC, Commonwealth Fund, drug affordability, FDASIA, GAO, government auditing standards, Medication Adherence, Section 1127
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Feb 19, 2015 | Pharmacychecker Online Pharmacy Report
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”.
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Tagged with: GAO, Internet pharmacies, personal drug importation, public health, rogue online pharmacies
