drug importation: maine's experience with unreliable foreign 'pharmacies,'...

Drug Importation: Maine's Experience with Unreliable Foreign "Pharmacies"

2013-2014

Jim Dahl Assistant Director

FDA’s Office of Criminal Investigations (FDA-OCI), retired

Board Member, Partnership for Safe Medicines

© 2016 Partnership for Safe Medicines, All Rights Reserved

About Maine LD 171

In 2012 the Maine State Employees Association contracted with CanaRx to import "Canadian" medicines for employees.

The AG shut the program down because allowing pharmacies to distribute medications without a license was illegal.


In 2013, the Maine Legislature responded with LD 171, the "Act to Facilitate Personal Importation of Prescription Medication from International Mail Order Prescription Pharmacies."

The law was constructed to legalize CanaRx's program.

About Maine LD 171


The law legalized the importation of prescription drugs from licensed retail pharmacies in Canada, the United Kingdom, the Commonwealth of Australia and New Zealand.

It also legalized entities (like CanaRx) that would facilitate that importation.

About Maine LD 171


LD171 was struck down in February 2015. Maine’s “singling out of certain countries from which

pharmaceuticals may be imported compromises the tightly regulated structure” set up under federal law and “compromises federal government’s ability to ‘speak with one voice’ when it regulates foreign commerce.”

~ U.S. Chief District Judge Nancy Torresen

About Maine LD 171


LD171's Shortcomings: Lack of oversightForeign pharmacies and "entities that contract to provide or facilitate the exportation of prescription drugs" were "exempt from licensure under this Act." It established:

No governing group in Maine monitoring the quality of foreign pharmacies or the medicines they sell.

No mechanism for legal action against companies exporting medicine.

No recourse for a consumer if the medicine is dangerous or ineffective.


What Happens if Patients Take Substandard Medicine?

Unlicensed distributors often sell medicine that is

● too strong or too weak

● missing key ingredients or made with dangerous ingredients

● made, stored or handled unsafely

● expired


Patients who receive these medicines may suffer overdose, unexplained therapeutic failure, poisoning or death.

Because foreign sellers are outside Maine's jurisdiction, Maine residents harmed by fake drugs have no legal recourse.

What Happens if Patients Take Substandard Medicine?


Example 1: Canada Drug CenterIn 11/2013, Maine Pharmacy Association President Kenneth "Mac" McCall saw an ad from Canada Drug Center in the newspaper.

The pharmacy's website bore "certifications" from Pharmacy Checker, CIPA, and IPABC that make it look legitimate to consumers.


“A Deal too good to be true.”

McCall wanted to know what Canada Drug Center was selling. He ordered three widely used generic maintenance medications for heart disease, inflammation and acid reflux.

The pharmacy assigned him a Canadian MD, asked him to waive any liability for bad outcomes, and mailed him the drugs.


“A deal too good to be true.”What he got was not what the patient needed.

Esomeprazole (the generic of Nexium, which treats acid reflux disease)

INSUFFICIENT ACTIVE INGREDIENT. ONLY 58% OF THE PRESCRIPTION DOSAGE.



Celecoxib (the generic of Celebrex, an anti-inflammatory)

INSUFFICIENT ACTIVE INGREDIENT. 23% LESS THAN PRESCRIPTION DOSAGE



Clopidogrel (the generic of Plavix, a blood thinner)

CONTAMINATED!

The Clopivas product contained an unknown contaminant. (Possibly methyl chloride, known to exhibit genotoxic properties.)


"This is not what the doctor ordered."

● Medicines manufactured in India and filled by pharmacies in India, Mauritius and Turkey.

● None of the prescriptions complied with LD171, which specified Canada, the UK, Australia or New Zealand as approved sources.

● None of the medicines were approved in the US or Canada.

PRODUCT MANUFACTURER FILL CENTER MAILING ADDRESSClopivas-75

(clopidogrel)Cipla LTD

Malpur, IndiaMer Rouge, Mauritius Zurich, Switzerland

Izra-20(esomeprazole)

Unichem Labs LTDBhatauli Kalan, India

Delhi, India Delhi, India

Cobix-200(celecoxib)

Cipla LTDTanda Mallu, India

Istanbul, Turkey Woking, England

Not from countries approved by the legislation


“A deal too good to be true.”Additionally in November 2013, Portland's WGME News ordered Viagra from another online seller. They received "Fildena," instead, manufactured in India. McCall’s testing found:

INSUFFICIENT ACTIVE INGREDIENT. ONLY 13% OF THE PRESCRIPTION DOSAGE.


The Bait and SwitchCanada Drug Center, like CanaRx, does NOT dispense prescriptions to Canadians.The National Association of Boards of Pharmacy lists CanadaDrugCenter.com on their "Not Recommended Sites.”None of the 3 prescriptions from Canada Drug Center were manufactured or filled in Canada.


The Bait and SwitchAll 3 prescriptions from Canada Drug Center were unapproved FDA products and violated Maine’s Public Law 2013, Chapter 373 because they were filled in India, Turkey and Mauritius. They were also not medicines approved for Canadians by Health Canada.


We've tried this before: ISaveRx Illinois' “Canadian” prescription program (2004-2009)

● Working with CanaRx, Illinois and 4 other states set up a government-sponsored Canadian importation program.

● Illinois even sent employees to inspect overseas pharmacies (though they had no legal authority to license pharmacies and no powers of enforcement).


In a 2006 report, the Illinois AG found:

● Poor oversight: None of the entities were licensed in Illinois, or by any other governing body.

● Poor inspections: 40% the inspections were never completed; many forms were unreadable.

● Entities that had not been approved were filling prescriptions for residents.

We've tried this before: ISaveRx


Regulating Foreign Pharmacies is Beyond U.S. JurisdictionWe cannot ensure:

● That patients are buying from sellers that meet state safety requirements

● That sellers—approved or not—are providing legitimate medicine made in "approved" countries

● That the U.S. can prosecute safety violators who are working beyond U.S. borders


What's The Worst That Can Happen?YOU CAN DIE. Ordering from unlicensed pharmacy websites can exchange your medication for a deadly one.

In late 2015, at least 2 Northern California residents died (and many more overdosed) after buying "Xanax" that had been acquired online. The drug contained deadly quantities of fentanyl, a dangerous opiate that is usually prescribed in tiny doses.


How to Purchase Safely from Online Pharmacies● Buy online from VIPPS-certified pharmacies

(safedr.ug/vipps-rx)

● Compare prices at different VIPPS-certified pharmacies. Prices can vary be as much as 50%.

● Consider generic alternatives: American generics offer considerable savings, and are less expensive than Canadian generics.

● Check with www.NeedyMeds.org and www.Pparx.org to see if you qualify for patient assistance.


drug importation: maine's experience with unreliable foreign 'pharmacies,'...

Health & Medicine