FDA Sends Stern Warning About Internet Pharmacies:
Only 3% Meet U.S. Standards
BeSafeRx is national campaign to better educate
Americans on drug purchasing, fake pharmacies; seniors not the prime
targets they were before Medicare drug program
Oct. 1, 2012 – The Food and Drug Administration has
launched a new campaign warning Americans about the prevalence of
fraudulent Internet pharmacies and their danger to patient health. The
public awareness campaign says only 3 percent of these drug dealers meet
U.S. standards. It also aims to help consumers make safe online
purchases. Senior citizens, major shoppers for lower priced drugs before
the Medicare drug program was launched, still may seek low-cost options
if they fall into the Plan D donut hole.
BeSafeRx – Know Your Online Pharmacy provides resources for patients
and caregivers who might purchase medication online to better understand
who they are buying from, and that the medication they buy matches what
their doctor prescribed. (See FDA Q&A below story for more details.)
Nearly 1 in 4 Internet consumers has purchased
prescription medicine online, according to a new FDA survey. At the same
time, nearly 30 percent said they lacked confidence about how to make
safe online purchases. The risk of purchasing from a rogue seller is
high, with the National Association of Boards of Pharmacy reporting that
less than 3 percent of online pharmacies meet state and federal laws.
“Buying medicines from rogue online pharmacies can
be risky because they may sell fake, expired, contaminated, not approved
by FDA, or otherwise unsafe products that are dangerous to patients,”
said FDA Commissioner Margaret Hamburg, M.D.
Citizens No Longer the Prime Target of Foreign Pharmacies
Medicare 2013 Open Enrollment
Oct. 15 – Dec. 7,
There was a time when senior
citizens – often with very limited assets and often surviving on
prescription drugs – were very tempted by the lower prices on
prescription drugs offered by online pharmacies. There were even
groups of seniors organizing bus shopping trips to Canada, where
many drugs are cheaper.
The addition of the Medicare drug
program made all this much less attractive to seniors, except
for those falling into the donut hole. This happens when a
patient and their Medicare drug plan have spent $2,840 for
covered drugs. The Medicare senior was then responsible for
paying the next $3,700 in drug costs, which put them at the
“catastrophic limit,” when coverage started again.
The 2010 Affordable Care Act
(Obamacare) began shrinking the donut hole in 2011. This year,
instead of paying for the entire cost of drugs while in the
donut hole, people with Part D drug coverage are getting a 50
percent discount on name-brand drugs and a 14 percent discount
These discounts will continue to increase over the
next few years, until 2020, when it disappears.
Numerous studies have shown
senior citizens are prone to skipping their prescribed drugs due
to the high price.
Medicare says Obamacare has
already saved millions of seniors who fell into the donut hole
millions of dollars.
“Fraudulent and illegal online pharmacies often
offer deeply discounted products. If the low prices seem too good to be
true, they probably are. FDA’s BeSafeRx campaign is designed to help
patients learn how to avoid these risks.”
Fraudulent online pharmacies use sophisticated
marketing efforts or phony web storefronts to appear legitimate.
Patients who buy medicines from these websites may be putting their
health at risk because the products may contain the wrong ingredients,
contain too little, too much, or no active ingredient at all, or be made
with other harmful ingredients.
Patients should only buy prescription medicine through online pharmacies
● require a valid prescription from a doctor or other health care
● are located in the United States;
● have a licensed pharmacist available for consultation; and
● are licensed by the
patient’s state board of pharmacy.
In addition to tips and for patients and
caregivers, the FDA has also developed BeSafeRx campaign materials for
other federal agencies, nonprofit and private organizations to use for
their own educational efforts. These resources can be found at
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
the nation’s food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco products.
Buying prescription medicine from fraudulent online
pharmacies can be dangerous, or even deadly. At best, counterfeit
medicines are fakes of approved drugs and should be considered unsafe
and ineffective. These medicines may be less effective or have
unexpected side effects.
In addition to health risks, most fraudulent online
pharmacies may put your personal and financial information at risk. Some
intentionally misuse the information you provide. These sites may infect
your computer with viruses, and they may sell your information to other
illegal websites and Internet scams.
FDA does not have jurisdiction of prescription
medication from other countries; therefore, FDA cannot guarantee the
safety or effectiveness of those medication. Medicines approved in other
countries may have slight variations, or different ingredients, that
could cause you to develop a resistance to your medicine or result in a
misdiagnosis by your doctor. If you take more than one medicine, these
differences could also cancel out the effects of your medicines or cause
harmful interactions. Additionally, many of these illegal pharmacies use
fake “storefronts” to make consumers think they come from countries with
high safety standards, but the medicines could have been made anywhere.
No, it may not be obvious that an online pharmacy
is fake. Many illegal online pharmacies use fake “storefronts” to make
you think they are real pharmacies. Fraudulent sellers run fake online
pharmacy scams to exploit American consumers by pretending to be
legitimate pharmacies offering prescription medicines for sale. However,
the products they provide may be fake, expired and otherwise unsafe. In
fact, many online pharmacy scams are so sophisticated that even health
care professionals can have a hard time detecting illegal sites at first
The Internet provides consumers with instant access
to information and services, including online pharmacies for
prescription medicines. Health insurance plans are encouraging home
delivery of maintenance medications and use of pharmacy services online.
As the cost of prescription medicine continues to increase, consumers
may look for cost savings from online pharmacies to afford their
medicines. In addition, many consumers value the convenience and privacy
of purchasing their medicines online. For those consumers that may be
considering purchasing from online sources that are not associated with
health insurance plans or local pharmacy, these consumers need to know
the risks of buying from fraudulent online pharmacies.
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