FDA Send Warning Letter to NorthwestPharmacy.com

Northwest Pharmacy 5/24/12

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Silver Spring, MD  20993-0002

TO:          CustomerService@NorthWestPharmacy.com
FROM:     United States Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance
Office of Drug Security, Integrity and Recalls
Division of Supply Chain Integrity
RE:         Internet Marketing of an Unapproved and Misbranded Drug
DATE:     May 24, 2012

WARNING LETTER

The United States Food and Drug Administration (FDA) reviewed your website, http://www.NorthWestPharmacy.com, on January 4, 2012 and has determined that your website offers products for sale in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). More specifically, the website offers an unapproved and misbranded new drug for sale in violation of sections 502(f) and 505(a) of the FD&C Act [21 U.S.C. §§ 352(f) and 355(a)], which are prohibited acts under sections 301(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 331(a) and 331(d)], respectively. We request that you immediately cease marketing violative drug products to United States consumers.

Unapproved New Drug

Alitretinoin, trade name, Toctino, is offered for sale on your website “to treat severe long-term eczema that affects the hands … for patients who have not found success using other corticosteroid treatments.” Based on this claim, Toctino appears to be a drug within the meaning of section 201(g) of the FD&C Act [21 U.S.C. §321(g)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or it is intended to affect the structure or function of the body. Moreover, Toctino appears to be a new drug within the meaning of section 201 (p) of the FD&C Act [21 U.S.C. §321(p)] because it is not generally recognized as safe and effective for its labeled use. Although Toctino is approved in Canada, no approved application pursuant to section 505 of the FD&C Act [21 U.S.C. §355] is in effect for this product. Accordingly, its introduction or delivery for introduction into interstate commerce violates section 505(a) of the FD&C Act [21 U.S.C. §355(a)] and is prohibited under section 301(d) of the FD&C Act [21 U.S.C. §331(d)].

Misbranded Drug

Alitretinoin is a retinoid that is potentially dangerous when orally administered due to its teratogenicity. Because of this potential toxicity, its Canadian labeling states that it should be prescribed only by physicians knowledgeable in the use of systemic retinoids and who understand the risks of teratogenicity in females of childbearing potential. In addition, these females are required to have pregnancy tests before, at regular intervals during, and after discontinuation of alitretinoin therapy to exclude pregnancy. Because Toctino is unapproved in the United States, these safety controls are bypassed when alitretinoin is purchased over the Internet by customers in the United States without consultation with and a valid prescription from a physician. This places American patients who use the drug at risk for adverse effects. Thus, Toctino offered for sale on your website is misbranded within the meaning of section 502(f)(1) of the FD&C Act [21 U.S.C. §321(f)(1)] in that the labeling for Toctino fails to bear adequate directions for use. The introduction or delivery for introduction into interstate commerce of a misbranded drug product is a prohibited act under section 301(a) of the FD&C Act [21 U.S.C. §331(a)].

FDA is taking action against your firm because of the inherent risk in buying unapproved and misbranded new drugs. Unapproved new drugs may not have the same assurance of safety, efficacy, and quality as drugs subject to FDA oversight, and such drugs have been found to be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. FDA- regulated drugs offer protections that include rigorous scientific standards for new drug approval, labeling review for accuracy and completeness, and manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities. In addition, pharmacies and wholesalers who sell or distribute prescription drugs in the U.S. are licensed by the states. Unapproved new drugs delivered to the American public may not be safe and effective.

This letter is not intended to identify all of the ways in which your activities might be in violation of law. It is your responsibility to ensure that all products marketed by your firm are in compliance with FD&C Act and its implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in FDA regulatory action, including but not limited to, seizure or injunction, without further notice.

Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the correction(s) will be completed. Your response should be sent to DrugSupplyChainintegrity@fda.hhs.gov. Please direct any inquiries concerning this letter to Leigh Verbois, Acting Deputy Director for the Division of Supply Chain Integrity at the above address.

Sincerely,

/s/

Thomas Christl, Office Director (Acting)
Office of Drug Security, Integrity and Recalls
Office of Compliance

New Variation on Telephone Collection Scam Related to Delinquent Payday Loans

02/21/12—

The Internet Crime Complaint Center (IC3) continues to receive complaints scamalertfrom victims of payday loan telephone collection scams. As previously reported in December 2010, the typical payday loan scam involves a caller who claims the victim is delinquent on a payday loan and must make payment to avoid legal consequences.

Callers pose as representatives of the FBI, “Federal Legislative Department,” various law firms, or other legitimate-sounding agencies and claim to be collecting debts for companies such as United Cash Advance, U.S. Cash Advance, U.S. Cash Net, or other Internet check-cashing services. The fraudsters relentlessly call the victim’s home, cell phone, and place of employment in attempts to obtain payment. The callers refuse to provide information regarding the alleged payday loan or any documentation and become verbally abusive when questioned.

The IC3 has observed variations of this scam in which the caller tells the victim that there are outstanding warrants for the victim’s arrest. The caller claims that the basis of the warrants is non-payment of the underlying loan and/or hacking. If it’s the latter, the caller tells the victim that he or she is wanted for hacking into a business’ computer system to steal customer information. The caller will then demand payment via debit/credit card; in other cases, the caller further instructs victims to obtain a prepaid card to cover the payment.

The high-pressure collection tactics used by the fraudsters have also evolved. In one recent complaint, a person posed as a process server and appeared at the victim’s job. In another instance, a phony process server came to a victim’s home. In both cases, after claiming to be serving a court summons, the alleged process server said the victim could avoid going to court if he or she provided a debit card number for repayment of the loan.

If you are contacted by someone who is trying to collect a debt that you do not owe, you should:

  • Contact your local law enforcement agencies if you feel you are in immediate danger;
  • Contact your bank(s) and credit card companies;
  • Contact the three major credit bureaus and request an alert be put on your file;
  • If you have received a legitimate loan and want to verify that you do not have any outstanding obligation, contact the loan company directly;
  • File a complaint at www.IC3.gov.

Lawyers’ Identities Being Used for Fake Websites and Solicitations

09/14/12

A recent scam has surfaced in which the identify of a Texas attorney, who had scamalertnot practiced in years, was used to set up a fake law firm website using the attorney’s maiden name, former office address, and portions of her professional biography. Other attorneys have complained about the use of their names and professional information to solicit legal work.

All attorneys should be on the alert to this scam. If you become aware of the same or a similar situation involving your name and/or law firm, you should immediately report the incident to local authorities, your state Bar, and the FBI at the Internet Crime Complaint Center.

Additionally, be sure to closely monitor your credit report or bank accounts to ensure that your identity is not the only thing being stolen.

If you have been a victim of an Internet scam or have received an e-mail that you believe was an attempted scam, please file a complaint at http://www.IC3.gov.

Extortion Scam Related to Delinquent Payday Loans

Extortion Scam Related to Delinquent Payday Loans

Washington, D.C. December 07, 2010
  • FBI National Press Office (202) 324-3691

The Internet Crime Complaint Center has received many complaints from victims of payday loan telephone collection scams. Callers claim the victim is delinquent in a payday loan and must repay the loan to avoid legal consequences.

The callers purport to be representatives of the FBI, Federal Legislative Department, various law firms, or other legitimate-sounding agencies. They claim to be collecting debts for companies such as United Cash Advance, U.S. Cash Advance, U.S. Cash Net, and other Internet check-cashing services.

According to complaints received from the public, the callers have accurate data about victims, including Social Security numbers, dates of birth, addresses, employer information, bank account numbers, and the names and telephone numbers of relatives and friends. How the fraudsters obtained the personal information varies, but in some cases victims have reported they completed online applications for other loans or credit cards before the calls started.

The fraudsters relentlessly call the victim’s home, cell phone, and place of employment. They refuse to provide any details about the alleged payday loans and become abusive when questioned. The callers have threatened victims with legal actions, arrests, and, in some cases, physical violence if they do not pay. In many cases, the callers harass victims’ relatives, friends, and employers.

Some fraudsters have instructed victims to fax a statement agreeing to pay a certain amount, on a specific date, via a pre-paid Visa card. The statement further declares the victim will never dispute the debt.

If you receive these calls, do not follow the caller’s instructions. Rather, you should:

  • Notify your banking institutions.
  • Contact the three major credit bureaus and request an alert be put on your file.
  • Contact your local law enforcement agencies if you feel you are in immediate danger.
  • File a complaint at www.IC3.gov.

Tips to avoid becoming a victim of this scam:

  • Never give your Social Security number—or personal information of any kind—over the telephone or online unless you initiate the contact.
  • Be suspicious of any e-mail with urgent requests for personal financial information. The e-mail may include upsetting or exciting but false statements to get you to react immediately.
  • Avoid filling out forms in e-mail messages that request personal information.
  • Ensure that your browser is up-to-date and security patches have been applied.
  • Check your bank, credit, and debit card statements regularly to make sure that there are no unauthorized transactions. If anything looks suspicious, contact your bank and all card issuers.
  • When you contact companies, use numbers provided on the back of cards or statements

Federal Bureau of Investigation [FBI] – Payday Loans Warning