Scam Alert: Beware of Bogus FDA Agents

Scam Alert: Beware of Bogus FDA Agents

FDA Scammers

FDA Scammers Beware

On this page:

  • Hang Up the Phone
  • Trustworthy Websites

No doubt about it, purchasing your medications online is quick and convenient. But it could also place your personal information in the hands of criminals.

Since 2008, hundreds of people who have purchased drugs over the Internet or via telephone have unwittingly exposed themselves to extortion by individuals posing as Food and Drug Administration (FDA) agents.

Despite ongoing investigations and arrests by FDA, the Drug Enforcement Administration and the Immigrations and Customs Enforcement’s, Homeland Security Investigations, such scams are hard to trace and eliminate. And according to Philip Walsky, special agent in charge at FDA’s Office of Criminal Investigations (OCI), they are likely to continue.

FDA has warned in the past that consumers face an increased risk of purchasing unsafe and ineffective drugs from websites operating outside the law, and about the danger that personal data can be compromised.

These criminals are getting personal information from transactions with individuals buying drugs online or by telephone, or from medical questionnaires frequently sought by illegal online websites. Personal information can also turn up on customer lists obtained by criminals. These lists can contain tens of thousands of names and a great deal of self-reported information, including names, addresses, telephone numbers, Social Security numbers, dates of birth, purchase histories and credit card account numbers.

Here’s how the scam works: Someone will call you and identify him or herself as an FDA special agent or another kind of law enforcement official. You’ll be told that purchasing drugs over the Internet or telephone is illegal and be threatened with prosecution unless a fine or fee—ranging from $100 to $250,000—is paid. If you refuse to pay up, the caller threatens to search your properties, arrest or deport you, put you in jail, and even physically harm you.

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Hang Up the Phone

Since the scams first came to FDA’s attention, Walsky and other OCI staff have handled dozens of calls from alarmed consumers. “I tell them it’s a scam,” Walsky says, “and that the best thing they can do is ignore the caller and hang up.”

Walsky and others who have spoken to concerned consumers also assure that no federal official would ever contact a consumer by phone and demand money or any other form of payment. As for actual physical danger, no known victim has ever been approached in person. Most of the fraudulent callers are actually based overseas, Walsky says.

The call is likely a scam if the so-called agent directs you to send the money by wire transfer to a designated location, usually overseas, and if you are warned not to call an attorney or the police. In fact, FDA special agents and other law enforcement officials are not authorized to impose or collect fines imposed for criminal acts. Only a court can take such action, with fines payable to the U.S. Treasury.

According to Walsky, some fraudulent callers have a “veneer of legitimacy” about them.

Like many telephone solicitors for illegal prescription medications, he says, they’re based overseas and use voice over internet protocol (VOIP) telephone numbers, which enable extorters to select phone numbers with specific area codes, and change numbers frequently.

Some even go to the trouble of using the Internet to find names of actual FDA law enforcement personnel, Walsky says. And they are adept at exploiting people’s fears.

What is the best way to make the calls stop?

Walsky advises victims of these scams to change whatever phone number(s) the caller used to contact them in the first place, and to stop buying drugs online unless they know the website is trustworthy. If you have purchased medication online or via telephone, you may also want to alert your credit card company and make sure that your account is up to date, and that no suspicious charges have been made against your credit card.

Victims can report their experience to FDA via OCI’s website. Click on “Report Suspected Criminal Activity.”

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Trustworthy Websites

Some online websites sell prescription and over-the-counter (OTC) medications that may not be safe and can put your health at risk, including counterfeit versions of FDA-approved medications. When buying medications online, it helps to know the following signs of a trustworthy website:

  • It’s located in the United States and provides a physical street address.
  • It’s licensed by the state board of pharmacies where the website is operating. A list of these boards is available at the website of the National Association of Boards of Pharmacy (NABP).
  • It has a licensed pharmacist available to answer your questions.
  • It requires a prescription from your licensed health care professional for prescription medicines.
  • It provides contact information and allows you to talk to a person if you have problems or questions.

In addition, many websites display the Verified Internet Pharmacy Practice Site (VIPPS) seal. The VIPPS seal verifies that an Internet pharmacy is safe and meets state licensure requirements and other NABP requirements.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

September 25, 2012

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Vaccines, Blood & Biologics – 2012 Biologics Recalls

FDA 2012 Biologics Recalls

Date  Notification Brand Name Product Description Reason/Problem Company
8/2/2012 Recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25mg/vial Lot # C0072 Genzyme is initiating a voluntary recall of Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] 25mg/vial. This recall was initiated when one Thymoglobulin lot (C0072) failed a periodic stability test for the molecular size distribution test. Genzyme Corporation
6/21/2012 M-M-R® II (Measles, Mumps, and Rubella Virus Vaccine Live) Lot # 0851AA Merck is voluntarily recalling M-M-R® II due to the inadvertent shipment of doses from the lot to US customers. These doses were distributed between May 17, 2012 and May 25, 2012. Merck & Co., Inc.
Immune Globulin Intravenous (Human), 10% Solution
Product Code 1502797 This recall is being conducted as a precautionary measure due to a labeling error noted on the product vial label and unit carton. The labels on the unit carton and product vials indicate an incorrect manufacturing date and expiry date. Baxter Healthcare Corporatioin, Westlake Village, CA
3/2/2012 Plasma Bottle with Saline Adapter Lot 1201553B Haemonetics recently discovered a label discrepancy on the outer carton of Haemonetics’ Plasma Bottles with Saline Adapter lot 1201553B. An undetermined quantity of product from lot number 1201553B contains an incorrect expiration date on the outer carton label only.
Haemonetics Corporation
Braintree, MA
2/29/2012 Blood-Pack Unit with Flex-Excel Red Cell Filter
Product Code 4R1583
Lot Number FM10J08050
Fenwal identified a labeling  issue with one batch of Product code 4R1583 in which the label for the whole blood collection container incorrectly identifies the contents as leukoreduced red cells.
Fenwal, Inc.
Lake Zurich, IL
2/29/2012 Blood-Pack Unit with Flex-Excel Red Cell Filter
Product Code 4R1582
Lot Numbers:
Fenwal identified a labeling  issues with three batches of Product code 4R1582 in which the label for the leukoreduced red cell storage container incorrectly identified the contents as non-leukoreduced red cells.
Fenwal, Inc.
Lake Zurich, IL
2/29/2012 Blood-Pack Unit Whole Blood Filter, Fenwal Express System, Product Code 4R3307E

Lot Number: FM10F02019
Fenwal identified a labeling issue with the 4R3307E Blood-Pack unit in which the label for the satellite bag incorrectly identifies the product as Whole Blood.
Fenwal, Inc.
Lake Zurich, IL
2/29/2012 Blood-Pack Unit
Product Code 4R3459
Lot Number FM11J03027
Fenwal identified an assembly issue with the 4R3459 Blood-Pack Unit in which the satellite bag used for the storage of platelets was PL146 instead of the expected PL2209 plastic bag.
Fenwal, Inc.
Lake Zurich, IL
2/10/2012 Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine 0.5mL pre-filled syringes Pfizer Inc voluntarily initiated this recall when it was determined the lot was formulated and filled with expired serotype 3 conjugate material.

New York, New York

1/25/2012 CaridianBCT Trima Accel System Disposable Tubing Sets CaridianBCT has become aware of a defect that occurred during the manufacturing of Trima Accel tubing sets
CaridianBCT, Inc.
Lakewood, CO
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