Importation

Critics argue that the importation of medicines would help save consumers money. What proponents of importation often miss is the critical issue of safety and how this would impact access to new, innovative treatments. Under both democratic and republican administrations, the Food and Drug Administration (FDA) has stated it cannot assure the safety of imported medicines from foreign countries. In a recent letteri , four former FDA commissioners wrote, “importation represents a complex and risky approach [...] that is likely to harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation’s medical products.” Below are five key facts regarding the negative implications of importation of unapproved medicines:

  1. Opening our borders to imported drugs could increase the flow of counterfeit drugs into the United States, harming patients.
    The World Health Organization estimates up to 10 percent of medicinesii worldwide – and up to 50 percent of medicines consumed in developing countries – are counterfeit. Without proper FDA oversight and enforcement of laws that protect patient safety, these products could infiltrate the U.S. pharmaceutical supply, with life-threatening consequences. In the European Union (EU), where parallel trade is sanctioned, the European Commission seized 34 million counterfeit pillsiii , including antibiotics, cancer, cholesterol, and anti-malaria medicines across the EU borders over just a two-month period in 2009.
  2. The risk from the counterfeit drug trade is growing.
    It is becoming increasingly easy for counterfeiters to make packages and bottles that look genuine, but often contain laced, adulterated, or fake medicines. Recent threats to the U.S. drug supply from counterfeiters include an alleged conspiracy between Americans and a Canadian online pharmacyiv to smuggle mislabeled and unapproved drugs into the United States. A 2014 survey of online drug sellersv by the National Association of Boards of Pharmacy found that 96 percent were “operating out of compliance with U.S. pharmacy laws and standards. Within that 96 percent, NABP found that 88 percent of drug sellers did not require a valid prescription, 12 percent dispensed controlled substances, and 91 percent appeared to have affiliations with rogue networks of internet drug operators.” Counterfeiting has also been on the rise around the world, with no signs of slowing down. Data from the Pharmaceutical Security Institute showed that drug counterfeiting increased 122 percentvi between 2005 and 2010.
  3. Foreign drugs could enter the U.S. system without any oversight or regulation, posing significant health and safety risks to patients.
    Foreign governments are not in the position to monitor and regulate medicines that are intended for the U.S. market. For example, the Canadian government is on record saying that while it regulates medicines manufactured for its citizens, it cannot be expected to ensure the safety of medicines that are shipped through Canada for export to the United States or other countries. In fact, many drugs that pass through Canada to patients in the United States may not actually originate in Canada, but instead can come from places with lax regulatory systems, like Pakistan. Also, given that drugs imported from abroad will effectively lack oversight by any health authority, there is a high likelihood such drugs are mishandled (e.g., proper temperature control is not maintained, which causes rotting, counterfeit, or display deceptive or incorrect packaging and labeling). In 2015, Interpol’s pharmaceutical investigation, Operation Pangea, seized almost 21 million counterfeit pillsvii , up from 2.4 million fakes in 2011. Interpol officials have said “very few” countries have the infrastructure to effectively combat pharmaceutical counterfeiting.
  4. There is no guarantee that importing medicines will actually save consumers money.
    Both the Department of Health and Human Servicesviii (HHS) and the Congressional Budget Officeix (CBO) have stated that any potential savings generated from the importation of unapproved medicines would not be passed on to the patient. HHS has stated total savings would be 1 to 2 percent of total drug spending, and the CBO determined that importation would reduce drug spending by “roughly 1 percent.” The European experience demonstrates that this practice benefits intermediaries rather than consumers. In a peer-reviewed studyx of previously introduced importation legislation, researchers from the University of Pennsylvania and Arizona State University found that “intermediaries may capture a significant share of any savings that are available” and that consumers are “likely to realize even smaller savings, because they lack the leverage relative to pharmacies, especially if supply of imported drugs is limited or sporadic.”
  5. Safe solutions exist to help patients afford their medicine.
    While importation is often talked about as the only solution for patients who cannot afford their medicines, there are many other, safe alternatives available to patients. For example, the Partnership for Prescription Assistance (PPA) (http://www.pparx.org or 1-888-4PPA-NOW) offers a single point of access to more that 475 public and private patient assistance programs, including more than 200 programs offered by pharmaceutical companies. Since the launch of the program in 2005, PPA has helped nearly 10 million uninsured and underinsured Americans get information about programs that provide prescription medicines for free or nearly free.” Other ways consumers can potentially save include: asking for generic versions of medicines, shopping around to various pharmacies to get the best deal, participating in state prescription assistance programs, and enrolling in the Medicare prescription drug program (Medicare Part D), for those who qualify.

i. Dr. Mark. McClellan and Dr. Robert Califf, “Counterfeit Medicines: an update on estimates 15 November 2006”, Duke Margolis Center for Health Policy. March 17,2017. https://healthpolicy.duke.edu/news/former-fda-commissioners-letter-opposes-re-importation

ii. International Medical Products Anti-Counterfeiting Taskforce, “Counterfeit Medicines: an update on estimate 15 November 2006”, World Health Organization. November 2006. http://www.who.int/medicines/services/counterfeit/impact/TheNewEstimatesCounterfeit.pdf

iii. “Growing threat from counterfeit medicines”. Bulletin of the World Health Organization, Volume 88, Number 4. April 2010 http://who.int/bulletin/volumes/88/4/10-020410/en/

iv. Dan Mangan, “Canada pharmacy charged in $78M drug export scheme.” CNBC. August 19, 2015. http://www.cnbc.com/2015/08/19/canada-pharmacy-charged-in-78m-drug-export-scheme.html

v. “About Online Pharmacies and Canadian Pharmacy Websites.” Alliance for Safe Online Pharmacies. 2017. http://buysaferx.pharmacy/for-the-media/about-online-pharmacies-and-canadian-pharmacy-websites/ - _ftn3

vi. Tim K. Mackey et al. “Counterfeit Drug Penetration into Global Legitimate Medicine Supply Chains: A Global Assessment.” The American Journal of Tropical Medicine and Hygiene 92. June 3, 2015 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4455087/

vii. Alexandra Ossola, “The Fake Drug Industry is Exploding, and We Can’t Do Anything About It.” Newsweek. September 17, 2015 http://www.newsweek.com/2015/09/25/fake-drug-industry-exploding-and-we-cant-do-anything-about-it-373088.html

viii. Dr. Richard H. Carmona, et al. “Report on Prescription Drug Importation.” U.S. Department of Health and Human Services Task Force on Drug Importation. December 2004 https://archive.hhs.gov/importtaskforce/Report1220.pdf

ix. CBO Cost Estimate for FTC Reauthorization Act of 2005 (S. 1392). Congressional Budget Office. September 8, 2015 https://www.cbo.gov/sites/default/files/109th-congress-2005-2006/costestimate/s13920.pdf

x.Patricia M. Danzon et al. “Commercial Importation of Prescription Drugs in the United States: Short-Run Implications.” Journal of Health Politics, Policy and Law, Vol. 36, No. 2. April 2011 https://faculty.wharton.upenn.edu/wp-content/uploads/2012/04/2011_DanzonJohnsonLongFurukawa_2011_CommercialImportationOfPrescriptionDrugsInTheUnitedStates_Short-RunImplications_JOfHealthPoliticsPolicyAndLaw36.2_April2011.pdf

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