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PSM applauds the members of the House of Representatives for passing HR 1919, “Safeguarding America’s Pharmaceuticals Act of 2013.”
Today, our system of prescription drug distribution heavily relies on trusting the entity you’re dealing with and their judgment. If a mistake is made, or anyone farther back in the supply chain makes a mistake in purchasing a substandard drug product, there is no ability for a good actor down the line to know this. Criminals have taken advantage of this fact, and such incidents are growing in number every year. Life-saving medications that treat osteoporosis, cancer, heart disease, and many other serious medical conditions have been faked just in the last few years, as the rules of the road have failed to keep up with the innovative nature of the criminals that prey on American patients.
Robert Harshbarger
Jr. of Kingsport, TN pleaded guilty to charges he replaced FDA-approved iron
sucrose for use in kidney dialysis with
cheap foreign versions of the drug. Patients
in Kansas were unwittingly exposed to the misbranded drugs.
Harshbarger was originally charged by the FDA in March
2012. In the indictment, he was charged
with one count of selling misbranded drugs, one count of mail fraud and five
counts of health care fraud, for substituting cheap Chinese-made iron sucrose
for the FDA approved Venofer he claimed to be filling prescriptions with,
reported the Department of Justice at the time of Harshbarger’s indictment.
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…
Read MorePartnership for Safe Medicines Field Resources Page A short issue brief (with powerful images) on the danger of counterfeit drugs in the US [PDF] State Focused Handouts Mississippi Counterfeit Drug Incidents.pdf (120.5K) Tennessee Counterfeit Drug Incidents.pdf (124.0K) Virginia Counterfeit Drug Incidents.pdf (123.6K) Therapeutic Category Handouts Counterfeit Drug Incidents and Kids.pdf (115.9K) Counterfeit Drug Incidents with Pain Meds.pdf (119.0K) Counterfeit Drug…
Read MoreThe Partnership for Safe Medicines recently gained access to a RFP submission from a foreign drug broker, purporting to save money for a Maine employee union. We studied the top 30 medications purchased by this union and price-compared black market foreign pharmacies to pharmacies who possessed a pharmacy license in Maine.
Using legitimate, FDA approved generic saves more than 80% of the cost of the name-brand medication, while purchasing from the black market foreign pharmacy saves less than 50%, while exposing patients to the dangers of substandard, misbranded and counterfeit drugs.
Read MoreView larger map On May 25, 2013, France’s Ministry of Economy announced the largest seizure of counterfeit medication ever made by France and the European Union. French customs agents in Le Havre discovered 1.2 million doses of counterfeit aspirin hidden in a shipment of tea originating from China. The goods in the shipment were destined for a Spanish company located…
Read MoreTrack and Trace Legislation Resource Page Learn more about H.R. 3024: RXTrace on the DQSA Securing Industry on pharmaceuticals FDA on the Drug Supply Chain Security Act and Standards Development for Prescription Drug Supply Chain Security FiercePharma Manufacturing on track and trace H.R. 3204, The Drug Quality and Security Act (DQSA) was signed by President Obama on November 27, 2013.…
Read MoreThe US Department of Justice reports that a plea agreement by the US branch of Indian generic drug giant Ranbaxy is the largest ever against a generic drug manufacture. Ranbaxy admitted to selling unapproved and adulterated prescription drugs in the United States.
According to the Department of Justice statement on this case, the drugs manufactured at two different plants in India, one in Dewas, and another in Paonta Sahib. The manufacturers failed to follow Current Good Manufacturing Practices (cGMPs) as mandated by the FDA. In many cases the drugs were not up to FDA standards and degraded much faster than their authentic counterparts. The Department of Justice also reports that Ranbaxy knowingly made false statements to the FDA as to the testing, content and quality of the drugs it sold in the United States.
Read MoreMay 28 2013 is World Anti-Counterfeiting
Day. The
Global Anti Counterfeiting Network has announced Interpol and the Malaysia Health Service as the winners of their 15th
Annual Global Anti Counterfeiting Awards. While
not an event traditionally widely observed, this day gives us a chance to try and highlight our work to protect
patients from counterfeit drugs. If
you’re reading this, you probably care about protecting patients, but you
haven’t done anything to prepare for the event. The Partnership for Safe Medicines has made
it easy for you to highlight patient safety on this day, by giving you easy
resources for writing tweets, posting to Facebook, sending email, or writing a
letter to the editor on this day.
If you’re planning to help, please send us a note and we’ll keep an eye out for your messages!
Quick links:
- Campaign homepage: http://www.safemedicines.org/patient-and-doctor-tips-shareable-content.html
- TIPS for American patients: http://www.safemedicines.org/drug-safety-tips-for-patients.html
- TIPS for American physicians: http://www.safemedicines.org/drug-safety-tips-for-doctors.html
What we have planned
We are launching our patient and physician TIPS campaign on
World Anti-Counterfeiting Day. The
campaign includes 25+ tips on how patients can avoid counterfeit drugs, and
physicians can avoid unauthorized distributors selling counterfeit drugs. The tips have short versions that can fit in
a tweet or Facebook message, or longer versions that can fit in an email or
print newsletter. Each one contains an
original illustration like this one: