Monday, March 2, 2009

Sale Of Non-FDA Approved Items: Recent Case Shows Why Providers Should Be Careful

There is a recent internet pharmacy case from San Diego which shows the government’s commitment to prosecuting the sale of illegally imported non-FDA approved medicines (and other items) from abroad. See United States v. Kirtar Munshi, Criminal Case No. 08cr2105-LAB (facts are set forth below). Although this case has some extreme facts, this case is a reminder for health care providers to not sell, distribute or bill for any item that is non-FDA approved and that the penalties for doing so can be great.

Commentary: Health care providers need to be careful about whether they provide non-FDA approved devices and medications to patients. The market is full of them and some sales representatives are not disclosing the appropriate FDA status of the item. We have represented several providers who provided non-FDA approved IUDs to patients . Some of them were charged criminally since they had billed Medi-Cal for these devices and falsely represented they were an FDA-approved device.

What should you watch for?

1. If the price is low, it is a signal that this could be non-FDA approved. Remember that even if it is the same product manufactured in another county -- it still may be non-FDA approved. Let our office staff know that they will not be saving you money in the long run if the buy non-FDA approved items and expose you to charges or sanctions.

2. Deal only with approved and well-known suppliers who are not buying from abroad. Obtain written warranties that the items are FDA approved. Door-to-door salespeople offering close-outs and specials may be selling non-FDA items that they bought in other countries or other places. In one of our cases, the non-FDA item that was sold to our doctor client had been bought at a local swap meet and then resold to him.

3. Look to see where the product is made and whether the product information is in another language. This is a red flag.

4. If you suspect it could be counterfeit, contact the U.S. supplier to see if you can determine that it is authentic. Document your efforts and communications.

5. If you have unwittingly sold or used non-FDA approved items and are audited, do not meet with government representatives without an attorney or before meeting with experienced legal counsel. The cases that we have seen result in criminal charges were brought, in large part, because the individuals confessed to buying and selling non-FDA approved items and did not have legal counsel.
6. If as part of your practice you are selling or using FDA approvided devices, create a compliance plan to ensure that the items are FDA approved.

Case Information:

On February 10, 2009, in the United States District Court for the Southern District of California, Judge Larry Alan Burns sentenced Kirtar Munshi to serve twelve months in custody, pay a $6,000 fine and to forfeit profits of $219,000 as a result of his role in selling non-FDA approved medications from India via an internet pharmacy.

Munshi pled guilty in July 2008, to conspiracy to import merchandise contrary to law, commit mail fraud, and introduce into interstate commerce an unapproved drug, during the period from January 2006 to April 2008. Munshi further admitted that he agreed to supply tablets and capsules containing the active ingredients found in prescription pharmaceuticals such as Viagra, Cialis and Levitra, manufactured in India, to the operator of an internet pharmacy for shipment to over 250 individuals throughout the United States.

At the time of his plea, Munshi admitted that he knew that these “generic” copies of the prescription pharmaceuticals manufactured in India were not approved for sale in the United States by the Food and Drug Administration. Munshi acknowledged that the pharmaceuticals were sold via telephone solicitation, mail order and via the internet to customers who did not possess a lawfully issued prescription for the drugs, and customers were falsely assured they could lawfully purchase these pharmaceuticals.

A number of agencies were involved in this case: FBI, IRS Criminal Division, FDA Office of Criminal Investigations, Department of Homeland Security, Immigration and Customs Enforcement.

Related court documents and information for Criminal Case No. 08cr2105-LAB may be found on the website of the District Court for the Southern District of California at or on

Any questions or comments should be directed to:  Tracy Green is a principal at Green and Associates. The firm focuses its practice on the representation of professionals, particularly health care professionals including individual physicians, corporate providers and group practices.


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