The Prescription Justice Board of Directors stands with AARP and Families USA in support of the administration’s Safe Importation Action Plan but strongly urges Congress and the administration to quickly enact more impactful reforms to address the nation’s prescription drug price crisis.
Each year, tens of millions of Americans are forced to forgo filling their prescription because of cost. Forgoing prescribed medication leads to sickness, death, and even larger healthcare costs from hospitalizations when patients stop taking their medications. Every effort to open the door to lower-cost prescription drugs is a step forward to ending this crisis, including safe prescription drug importation.
The administration’s Safe Importation Action Plan relies on the authority granted to the Secretary of the Health and Human Services (HHS) under Section 804 of the Food, Drug and Cosmetics Act. Under the act, the Secretary can authorize individual states, wholesalers or pharmacists to submit demonstration project proposals to HHS which outline a plan to import certain types of drugs from Canada.
The plan would also allow drug manufacturers to import foreign versions of FDA-approved drugs, if the manufacturers can prove the drugs are the same as the FDA- approved versions. An example of such a drug is GlaxoSmithKline’s Daraprim (pyrimethamine). The FDA-approved Daraprim from Vyera Pharmaceuticals is about $750 per pill in the U.S. The version from GlaxoSmithKline, which is not FDA-approved, is about $3 per pill in the UK.
Critics of the administration’s plan argue that the imported drugs may not be safe because they will not meet the same quality control measures required by U.S. law. While there is room for reasonable debate on safety measures, it’s unreasonable to assert that drugs sold in many other countries are less safe. Between 40-70% of brand name drugs sold in the U.S are already made outside the U.S. Many of those exact same drugs are the ones sold in Canada, the UK and countries of the European Union.
The importation envisioned in the administration’s plan does not directly benefit U.S. consumers. The importation envisioned is at the wholesale level so that pharmacies could obtain lower wholesale drug prices. We would like to see the administration use its executive authority to articulate a more helpful policy for Americans to safely import medicine for personal use, which is also provided for under Section 804(j) of the Food, Drug and Cosmetic Act, which states:
“The Secretary should exercise discretion to permit individuals to make such importations in circumstances in which (i) the importation is clearly for personal use; and (ii) the prescription drug or device imported does not appear to present an unreasonable risk to the individual.”
The administration’s plan to open the door on importation is a step in the right direction, but we state emphatically that much more must be done. Policy solutions such as allowing Medicare to exercise its vast purchasing power to negotiate lower drug prices, banning “pay-for-delay” deals that prevent lower-cost generics from entering the marketplace, and ending giveaways to drug companies in trade deals that extend their monopolies on biologic drugs, are vital components to ending the crisis of high drug prices.