Navigation Links
FDA Participates in Global Efforts to Protect Consumers and Patients from Unsafe Drugs on the Internet
Date:9/29/2011

SILVER SPRING, Md., Sept. 29, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration and other regulatory and international partners have completed the International Internet Week of Action (IIWA), a cooperative effort to curb online sales and distribution of counterfeit and illegal medical products.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

This year's IIWA, which ran between Sept. 20 and Sept. 27 is called OPERATION PANGEA IV, focused on websites supplying illegal and dangerous medicines. The operation is the largest Internet-based action of its kind in support of the International Medical Products Anti-Counterfeiting Taskforce.

The goal of the IIWA is to protect the public health by increasing the public's awareness about the dangers and risks associated with purchasing medicines and medical devices from websites, to identify the producers and distributors of counterfeit or otherwise illegal pharmaceutical products or medical devices, to target these individuals or businesses with civil or criminal action, and to seize counterfeit and illegal products and remove them from the supply chain.

"The FDA will continue to work closely with our domestic and international law enforcement and regulatory partners to protect consumers from unapproved and potentially harmful products sold over the Internet," said Dara Corrigan, associate commissioner for regulatory affairs.  "We will continue to aggressively pursue those who sell products which may pose a significant risk to consumer health."

The IIWA also provided an excellent opportunity for the FDA to enhance cooperation with international and domestic regulatory and law enforcement partners to effectively target those involved in the manufacture and distribution of illegal medicines.

FDA's Office of Criminal Investigations, in conjunction with the Center for Drug Evaluation and Research, and the Office of Enforcement targeted 997 websites that are engaged in the illegal sale of unapproved and/or misbranded medicines to U.S. consumers.

During OPERATION PANGEA IV, FDA focused its efforts on websites selling unapproved drugs, such as drugs containing human growth hormone (HGH), sildenafil citrate, or isotretinoin. These unapproved drugs can be detrimental to public health.  Although some drugs containing these active ingredients are approved by FDA for use under the supervision of a licensed medical practitioner, the drugs offered for sale on these websites were not FDA approved, and were offered for sale without requiring a valid prescription.

Improper use of HGH can lead to side effects, including an increased risk of cancer, nerve pain, and elevated cholesterol or glucose levels. Sildenafil citrate tablets are used to treat erectile dysfunction and should not be used in some consumers with heart problems.  Isotretinoin capsules, previously marketed as Accutane in the United States, are used to treat severe nodular acne. The drug carries significant potential risks, including severe birth defects if pregnancy occurs while using this medicine.

To minimize potential risks, FDA approved isotretinoin capsules are only available through restricted distribution in the United States, and patients purchasing unapproved products containing this active ingredient are placed at a higher risk because, among other issues, they bypass existing safety controls.

The FDA sent Warning Letters to the operators of the identified websites, all of which appear to be associated with the same individuals and corporate entities located outside of the United States.

As a follow up, the agency sent notices to the Internet Corporation for Assigned Names and Numbers, Registries, Internet Service Providers (ISPs), and Domain Name Registrars (DNRs) informing them that these websites were selling products in violation of U.S. law.

In many cases, conducting illegal activities also violates ISP and DNR policies and agreements, giving the hosting companies the opportunity to terminate the websites and suspend the use of the domain names. Of the 717 websites addressed in the Warning Letters, a total of 578 have been suspended or no longer offer pharmaceuticals for sale.  The FDA is working with its foreign counterparts to address the remaining websites, which continue to offer unapproved or misbranded prescription medicines to U.S. consumers.

The FDA encourages consumers to report suspected criminal activity at www.fda.gov/oci.

The IIWA is a coordinated effort by INTERPOL, the World Customs Organization, the Permanent Forum of International Pharmaceutical crime , the Heads of Medicines Agencies Working Group of Enforcement Officers, as well as national health and law enforcement agencies from 81 participating countries.  

For more information:

  • Buying Medicines over the Internet

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/BuyingMedicinesOvertheInternet/default.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. MobileMD Participates in NJ-DV HIMSS Conference, Interoperability Demo
2. Sinovac Participates in UBS Greater China Healthcare Corporate Day
3. Ironman Competitor with Diabetes Encourages Others to Live Without Limits; Inspiring Triathlete Participates in Health Fair at The Medicine Stop 5525 South Pulaski Road, Chicago Thursday, August 26, 2010, 1:00 pm - 4:00 pm
4. Winner Medical Participates in CMEF 2010, China International Medical Equipment Fair, in Shenzhen
5. US Oncology Research Network Participates in Seven Oral Clinical Studies Presentations and 15 Posters at 2009 San Antonio Breast Cancer Symposium
6. PharmaNet Development Group Management Participates in the 8th Annual Partnerships in Clinical Trials Conference in Rotterdam
7. UPDATE: US Oncology Research Network Participates in Phase III Follow-up Study to BiPars Investigational Cancer Drug BSI-201
8. Reproductive Partners Participates in New IVF Progesterone Delivery System Study
9. Inverness Medical Innovations Participates in Meeting on HIV/AIDS with UN Secretary-General
10. Georgia Reproductive Specialists Participates in Largest-Ever In Vitro Fertilization Clinical Trial in the World
11. Global Radiation Therapy Equipment Industry
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016  Collagen Matrix, ... design, development and manufacturing of collagen and mineral ... announced today that Bill Messer has ... Marketing to further leverage the growing portfolio of ... devices. Bill joins the Collagen Matrix ...
(Date:6/24/2016)... -- The Academy of Managed Care Pharmacy (AMCP) today ... allow biopharmaceutical companies to more easily share health care ... coverage decisions, a move that addresses the growing need ... The recommendations address restrictions in the sharing of product ... a prohibition that hinders decision makers from accessing HCEI ...
(Date:6/24/2016)... 2016   Pulmatrix, Inc ., (NASDAQ: ... drugs, announced today that it was added to the ... its comprehensive set of U.S. and global equity indexes ... important milestone for Pulmatrix," said Chief Executive Officer ... our progress in developing drugs for crucial unmet medical ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements ... that was developed to enhance the health of felines. The formula is all-natural and ... main herbs in the PawPaws Cat Kidney Support Supplement Soft Chews are ...
(Date:6/25/2016)... ... , ... Austin residents seeking Mohs surgery services, can now turn to Dr. ... Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to include ... in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of Glenn ...
(Date:6/25/2016)... CA (PRWEB) , ... June 25, 2016 , ... As ... with Magna Cum Laude and his M.D from the David Geffen School of Medicine ... and returned to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article published June 14 ... The article goes on to state that individuals are now more comfortable seeking to ... operations such as calf and cheek reduction. The Los Angeles area medical group, Beverly ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association (PHA) ... will receive two significant new grants to support its work to advance research ... anniversary by recognizing patients, medical professionals and scientists for their work in fighting ...
Breaking Medicine News(10 mins):