As you’ll discover below, the Obama administration’s policies to combat the manufacture and sale of counterfeit medications have a lot to do with furthering the agenda of the pharmaceutical industry in discouraging and curtailing online access by Americans to safe and affordable medication. Remember “The Deal” between the Obama administration and Big Pharma, in the form of the Pharmaceutical Researchers and Manufacturers of America (PhRMA), in which the Obama administration agreed to abandon supporting drug importation legal reform to lower drug prices for Americans if PhRMA would support Obamacare? I’ve always wondered how far that deal went.
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.
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].
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”.