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Medicare News

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.

Senior Citizens No Longer the Prime Target of Foreign Pharmacies

Medicare 2013 Open Enrollment

Oct. 15 – Dec. 7, 2012

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 on generics.

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 that:

   ● require a valid prescription from a doctor or other health care professional;

   ● 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.

FDA’s Frequently Asked Questions


Related Archive Stories


Seniors Must Shop to Avoid Big Hikes in Top Medicare Drug Plans: Avalere

Average increase may be moderate in 2013, but varies widely; 7 of top 10 plans have double digit premium jumps - Sept. 26, 2012

Medicare Enrollment to Open with Premiums Flat for Drug, Advantage Plans in 2013

Medicare Advantage Plans expected to continue growth – up 28% since Obamacare, cost down 10%; Enrollment opens Oct. 15 for 2013 plans - Sept. 20, 2012

Obamacare Saves Seniors, Disabled $3.9 Billion on Prescription Drugs

First half of 2012 a million Medicare beneficiaries have saved average of $629 under Affordable Care Act - July 30, 2012

More Evidence Senior Citizens in Donut Hole Cut Back on Prescribed Drugs

Medicare depression patients take considerable risk in skipping drugs; many cut back on other critical medicine, too; Obamacare could help - July 2, 2012


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1. What are the risks of purchasing from a fake online pharmacy?

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.

2. What are some of the warning signs of a fake online pharmacy?

   Avoid online pharmacies that:

   ● Allow you to buy drugs without a prescription or by completing an online questionnaire

   ● Offer discounts or cheap prices that seem too good to be true

   ● Send unsolicited email or other spam offering cheap medicine

   ● Ship prescription drugs worldwide

   ● State that the drugs will be shipped from a foreign country

   ● Are located outside of the United States

   ● Are not licensed by a state board of pharmacy in the United States (or equivalent state health authority)

3. What are some tips to identify safe online pharmacies?

   To identify a safe online pharmacy, make sure that the online pharmacy:

   ● Requires a valid prescription

   ● Provides a physical address in the United States

   ● Is licensed by the state board of pharmacy in your state and the state where the pharmacy is operating

   ● Has a state-licensed pharmacist to answer your question

4. Is it okay to buy prescription medicine online from other countries?

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.

5. Aren’t most online pharmacies safe and legal?

No. Only 3 percent of online pharmacies reviewed by the National Association of Boards of Pharmacy are in compliance with U.S. pharmacy laws and practice standards.

6. Isn’t it obvious which online pharmacies are fake and which are legitimate?

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 glance

7. Why are consumers increasingly turning to online pharmacies for their medicines?

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.

FDA Blog: FDA Voice and visit the FDA on Facebook, Flickr, YouTube and Twitter

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