States, importation, and drug safety
States, importation, and drug safety
Over the past ten years, a number of states have experimented with the idea of importing non-FDA-approved medication from foreign unlicensed pharmacies in order to save money for American patients. These programs are often based on myths people have about importing drugs from Canada.
These programs endanger patients’ lives, cost more money than they save, and are illegal. Here is a short primer on recent events and counterfeit drug importation.
Talking points on importation program legality:
- Importation programs are not safe, do not save money, and are illegal under the Food and Cosmetics Act. [Many resources below]
- Multiple studies have found that both consumers, health plans, and states can save more money without sacrificing safety by comparison shopping, emphasizing generics, and connecting qualifying patients with discount programs [NeedyMeds, PPARX].
Talking points on patient safety programs that AGs should embrace:
- The number of patient safety incidents within the US is on a sharp rise with both patients themselves and healthcare professionals breaking the secure supply chain.
- Comparison shopping is a powerful tool for saving money and has been proven by both Consumer Reports and PSM for patients and health plans.
- American patients are increasingly being exposed to counterfeit drugs because their healthcare providers are breaking the supply chain. Education is crucial is stemming this problem. [TIPS educational campaign link]
May 2013, Maine: During a debate over importation legislation in the Maine statehouse, Maine AG Janet Mills was asked by the committee of jurisdiction whether or not she could find plans to import non-FDA approved drugs consistent with the relevant law. She declined, and allowed the previous AG’s opinion to stand.
May 2013, Maine: During a debate over a drug importation proposal the Partnership for Safe Medicines obtained a bid submitted by an unlicensed foreign drug broker to a Maine state employee union. PSM studied the bid and discovered that the union could save more money and protect patients by choosing generics bought from licensed pharmacies in the US than if they bought non-FDA-approved medications from unlicensed pharmacies abroad. [Study link]
April 2013, Kentucky: Kentucky Attorney General Jack Conway filed a civil lawsuit against a osteopath for filing false claims with the Kentucky Medicaid program. The osteopath illegally imported non-FDA approved medical devices and then submitted claims to Medicaid for them. [Link]
August 2012, Maine: Maine Attorney General William Schneider ruled that a program in the city of Portland, ME to import non-FDA-approved medication from foreign entities was illegal because the pharmacies involved were not licensed in Maine. [Link]
November, 2010, Texas: Texas Attorney General Greg Abbott charged an orthopedist with providing foreign treatments to patients that were not approved for use in the United States. [Link] The Attorney General “strongly discourages consumers from buying medicines from any online pharmacy that is not based in the United States.” [Link]
September 2006, Illinois: The Illinois Auditor General studied the iSaveRX program, designed to save money by importing non-FDA-approved medication from unlicensed foreign entities. They found safety violations and cost overruns. [Link to Auditor General report]
January 2006, Nevada: Nevada Attorney General George Chanos opined that only FDA approved medications may enter the state legally. [Link]
2005-2003, Tennessee, Kansas, Maryland and Ohio: Attorney Generals from four states rule that legislation intending to allow the importation of medication from foreign sources such as Canada violate the Food, Drug and Cosmetics Act. [TN Link, KS Link, MD Link, OH Link]