For the past three months or so, we’ve published a section a week of our report called “Online Pharmacies, Personal Drug Importation and Public Health.” The report was written to call attention to a woefully flawed and highly misleading report published by the Government Accountability Office about Internet pharmacies and how best to carry out enforcement actions to protect consumers from rogue online pharmacies. Rogue pharmacy websites that endanger public health require serious efforts by regulators and law enforcement personnel, domestically and globally. However, instead of focusing all efforts on the tens of thousands of rouge pharmacy websites polluting the Internet, the federal government and private industry are also targeting the safest international online pharmacies, ones that Americans rely on to obtain affordable medication. Why?
Through this series on our blog, we’ve tried to draw the attention and understanding of our elected leaders and the public-at-large to the fact that the pharmaceutical industry, along with U.S. chain pharmacies, are clearly the ones driving policy, including enforcement priorities when it comes to the issue of online access to safe and affordable medication. In some cases, drug companies are directly funding law enforcement officials. And those companies don’t want Americans obtaining much more affordable and safe medication from pharmacies outside the U.S. And with that, we publish the conclusion to our report.
chain pharmacies, GAO, Government Accountability Office, pharmaceutical industry, public health, rogue online pharmacies
The GAO report conflates online pharmacies operating internationally that offer Americans a source of safe and affordable medication with dangerous pharmacy websites by referring to them both as “rogue”. It omits empirical data and analyses about matters relating to Americans obtaining prescription drugs online that may lead lawmakers to make or allow the continuation of misguided public policies, or to encourage misguided voluntary actions by companies.
Due to the public health crisis of high drug prices, Americans have come to rely on safe international online pharmacies, such as CanadaDrugs.com, which GAO refers to as “rogue”. Misleading information about online pharmacies encourages overreaching federal enforcement and private sector actions that endanger the public health by curtailing access to lower-cost, safe, prescribed medication.
Lawmakers should oppose legislation that would aggravate the public health crisis by curtailing access to safe international online pharmacies. In contrast, Congress should pass legislation to facilitate actions that shut down dangerous rogue pharmacy websites but explicitly prohibit funding for federal regulators to shut down safe international online pharmacies.
While the FDA has never prosecuted an individual for importing small quantities of prescription drugs for personal use, the law should not subject Americans to even the possibility of criminal or misdemeanor charges simply for buying medication for their own use and health protection. Criminal penalties were created for those who are illegally importing and re-selling prescription drugs, not individuals who are struggling to afford prescription medication. Technically, under current law, an American could be charged, prosecuted and put in jail for buying safe medication internationally for her or his own use. The relevant statutes should be amended to remove criminal penalties for personal drug importation.
Section 708 of FDASIA facilitates the destruction of safe, personally imported drugs. According to the FDA’s proposed regulations, Section 708 is a public benefit to the extent that “illnesses and deaths are avoided because FDA destroyed a drug valued at $2,500 or less…that posed a public health risk.” FDA fails to note the cost to the public health. Clearly, destroying prescription drug orders of safe and effective medication will threaten the public health because people won’t receive the medications they ordered. Congress can pass legislation to clarify under what circumstances FDA and CBP should not refuse admission to personally imported medications.
Coordinated, federal and global efforts that bring together law enforcement and private industry in annual campaigns called Operation Pangea have proven effective in shutting down tens of thousands of rogue online pharmacies. Pangea’s “Activities target the three principal components used by illegal websites to conduct their trade – the Internet Service Provider (ISP), payment systems and the delivery service.” Additionally, counterfeiters and those threatening the public health through online drug sales have been arrested and imprisoned.Continuing such enforcement efforts, without overreaching to engulf safe international online pharmacies; developing public education campaigns that do not scare consumers away from safe international online pharmacies; and using all measures possible to lower drug prices in America will greatly reduce threats to the public health from rogue online pharmacies, while not endangering the public health by curtailing online access to safe and affordable medication.
 For specific suggestions on how to best implement Section 708, see
PharmacyChecker.com Public Comments on FDA’s proposed regulations to implement Section 708 of the Food and Drug Administration Safety and Innovation Act (FDASIA), July 4th, 2014: http://www.pharmacychecker.com/pdf/public-comments-fda-section-708.pdf [Last accessed 11/13/14].
 See Operation Pangea information on Interpol’s website: http://www.interpol.int/Crime-areas/Pharmaceutical-crime/Operations/Operation-Pangea [Last accessed 10/30/2014].