News
FDA participates in global efforts to
protect consumers and patients from unsafe drugs on the
internet
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.
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
href="http://www.fda.gov/oci">www.fda.gov/oci.
The IIWA is 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:
href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=42#8">
Buying Medicines over the Internet
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.
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