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.
Tagged with: GAO, personal drug importation, public health
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].
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:
Tagged with: Alliance for Safe Online Pharmacies, Eli Lilly, GAO, NABP, National Associations of Boards of Pharmacy, phrma
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:
- Alliance for Safe Online Pharmacies
- International AntiCounterfeiting Coalition
- National Association of Boards of Pharmacy Pharmacies
- National Association of Chain Drug Stores
- National Community Pharmacists Association
- Partnership for Safe Medicines
- Pharmaceutical Security Institute
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.
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
Tagged with: ASOP, Eli Lilly, GAO, Libby Bainey
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.
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.
Tagged with: drug affordability, FDASIA, GAO, Medication Adherence
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.
This will not be major headline news anytime soon but it’s true. Last week our friends at RxRights blogged about new data from the Commonwealth Fund showing that the number of Americans ages 19-64 who did not fill prescriptions due to cost decreased to a depressing 35 million in 2014 from the even more depressing figure of 50 million in 2012. Obamacare, lower unemployment, and a stronger economy in which people feel more secure paying for even very expensive medications are largely responsible. Minus the very expensive medications – that’s all good stuff.
And how about international online pharmacies and personal drug importation? Well, just yesterday the U.S. Centers for Disease Control and Prevention (CDC) reported that about 2% of Americans are still buying medication from foreign countries. That’s about 5 million Americans who would potentially go without needed medication if it were not for lower cost foreign medication sold by safe international online pharmacies.
I did not use the word “potentially” loosely. Some of those five million are getting nabbed by rogue online pharmacies, resulting in too many Americans taking substandard, adulterated, or counterfeit medications. If those people are informed properly they will not be victims. PharmacyChecker.com is there for you: if you are one of the 35 million Americans wondering whether you can afford that medication prescribed by your doctor, we’re doing better than ever at empowering you with information that helps you get the medications you need at a price you can afford while steering clear of rogue online pharmacies.
It’s important to remember how dangerous it is to not take the medications you need. One expert at CDC stated: “People who do not take their medication as prescribed have more hospitalizations, emergency room visits and an increased burden of their illness.”
It’s important to note that the CDC report provided lower figures on how many Americans are going without prescribed medications due to cost than the Commonwealth Fund reported: about one in 10. We’re going to look at the data in the coming weeks and provide you some guidance on this discrepancy. But clearly the overall numbers have gotten better in the last two years.
We thrive on these better numbers – more consumers accessing the healthcare they need –but with tens of millions of Americans saying they can’t afford their meds there’s so much more work to be done!
Tagged with: CDC, Commonwealth Fund
A Bittersweet Prescription
OPEN enrollment for Medicare Part D drug plans ended this past Sunday, but my thoughts about them linger. Our website www.MedicareDrugpPlans.com received about 150 ratings of part D plans in 2014 – most of them highly critical, and some of them downright scathing! Whether it’s a plan’s horrible customer service, lack of coverage of many brand name drugs, or dropped coverage, we’re hearing from many irate seniors. At the same time, some studies have shown most seniors are happy with their plans. Why all the contradictions about Part D? To understand, please join me on a trip down Part D memory lane.
When PharmacyChecker.com was founded in 2002, American seniors did not have pharmacy benefit plans through Medicare. While most seniors had some drug coverage through private health insurance or Medicaid, 25% were without any drug coverage and, thus, vulnerable to a pharmacy’s highest retail price. Just eight months after our website launched in April 2003, Congress passed and the president signed the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), which created a pharmacy benefit opportunity for all Medicare enrollees known as Part D.
It’s amazing and sad to report that, today, the problem of high drug prices for Americans overall is worse than the problems existing before the MMA was born. In 2001, the Commonwealth Fund reported that 28 million Americans did not fill a prescription due to cost. That number shot up to 50 million Americans in 2012!
Tagged with: MMA, Part D, seniors