from Elite Med to relieve joint pain in patients.
“Unknown to the physician, the dis- tributor was unlicensed. Upon learning this, the physician immediately quit buying from Elite Med,” Mr. McClendon said. “At all times, the patients received original product from the original manu- facturer. There has never been a patient complaint, and these injections greatly benefited the patients.”
The state, he said, had his physician client “on a technicality.”
“It never dawned on the physician or
the staff to check if Elite was licensed. I spoke to other doctors around the state, and they too were unaware distributors had to be licensed. And there is no law requiring a doctor to make sure the dis- tributor is licensed,” he said. According to a press release from the attorney general’s office, other physi- cians and clinics improperly acquired ar- thritis injections from Elite Med, which distributed arthritis injections Orthovisc, Synvisc, Hyalgan, and Eufflexa. Elite Med purchased the drugs in bulk from MTE Diagnostics, a Canadian company. The state contends Elite Med violated state law when it failed to seek a license from DSHS.
After inspecting Mr. Bailey’s records, DSHS officers used lot numbers on in- voices and conversations with the manu- facturer to determine the devices were intended for shipment to Turkey and other countries. MTE Diagnostics, how- ever, shipped the unapproved devices back to the United States. DSHS also found labels on the de- vices in languages other than English, another violation of state law. DSHS determined that because the products’ original export destination was outside the United States, they were misbranded devices and not legally authorized for use in this country. According to the attorney general’s office, Mr. Bailey could not provide documentation to DSHS verifying FDA approval of Elite Med’s products or clearance for entry by the U.S. Customs Service.
The attorney general’s office wouldn’t comment on how many physicians have been investigated for buying and using
Verify souces of drugs and medical devices
Physicians can verify all drug distributor and in-state medical de- vice distributor licenses online through the Public License Search feature provided by the Texas Department of State Health Services (DSHS) Division of Regulatory Services at
https://vo.dshs.state
.tx.us/datamart/txrasMainMenu.do. Physicians may ask the distribu- tor to provide a copy of the license. For distributors of medical devices located outside Texas, DSHS
recommends physicians verify that the supplier is lawfully engaged in the wholesale or retail distribution of such devices in their resi- dent state. For additional assistance, contact the DSHS Drugs and Medical
Devices Group at (512) 834-6755. To check a product’s authenticity, visit Drugs@FDA,
www.ac
cessdata.fda.gov/scripts/cder/drugsatfda/index.cfm, or www.fda .gov/AboutFDA/Transparency/Basics/
ucm194882.htm, or Daily Med,
http://dailymed.nlm.nih.gov/dailymed/about.cfm. In addition, the websites of products or manufacturers typically
provide links to all marketed products and their labels. The Food and Drug Administration (FDA) advises physicians
to make medical product Internet purchases from state-licensed distributors or pharmacies in the United States to avoid breaking federal law and to reduce their risk of receiving unapproved or adul- terated devices. Licensed Internet pharmacies display a Verified Internet Pharma-
cy Practice Sites (VIPPS) seal. To access a list of VIPPS pharmacies, visit
http://vipps.nabp.net/verify.asp. Under the Texas Food, Drug, and Cosmetic Act, DSHS warns phy- sicians against:
• Purchasing or administering drugs or devices that are not ap- proved by the FDA and that do not have labeling in English. These products are considered misbranded.
• Purchasing or administering drugs from manufacturers or dis- tributors located either in Texas or outside Texas who are not licensed with DSHS.
• Purchasing or administering devices from manufacturers or distributors located in Texas who are not licensed with DSHS or located outside of Texas without verifying that the supplier is lawfully engaged in the manufacture or distribution of such de- vices in the United States.
August 2011 TEXAS MEDICINE 51
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