LAW
Free advice AG offers guidance on buying drugs, devices BY CRYSTAL CONDE After months of negotiating, the Texas
Medical Association persuaded the Texas Attorney General’s Office to give physicians some guidance on how to avoid legal problems when purchasing drugs and medical devices. That advice, however, may be hard to follow. TMA asked for the guidance because Attorney General Greg Abbott has been cracking down on physicians who purchase medical products and drugs deemed illegal to use in the Unit- ed States. In some instances, the physicians purchased mis- branded products or medical devices that the U.S. Food and Drug Administration (FDA) had not approved from companies outside the United States. And some physicians unknowingly bought products from a distribu- tor not licensed or authorized to do business in Texas or in the United States.
When physicians find them- selves in these situations, they must either settle with the attor- ney general or endure the costly and time-consuming process of defending themselves at trial. The attorney general’s office gen- erally alleges receiving and us- ing unapproved drugs or devices violate the Texas Deceptive Trade Practices Act (DTPA). The penal- ties are severe. The attorney gen- eral may seek up to $20,000 per violation, plus an added penalty
and Cosmetic Act. The civil penalty may not exceed $25,000 a day for each violation under the act. In determining the pen- alty, the court considers:
• Any previous violations, • The seriousness of the violation, • Any hazard posed to the public’s health and safety, and • Demonstrations of good faith by the person charged.
TMA protested the attorney general’s hardline position and
sought clear guidance for physicians on the legal requirements for drug and device purchases. Tom Kelley, spokesperson for
“No doctor’s office has the time to spend hours trying to find out
who is licensed.”
of up to $250,000 if the affected consumer is older than 65. Six Grapevine physicians were embroiled in a lawsuit with the attorney general in 2010 for selling patients a version of the Mirena intrauterine device the FDA has not approved for distribution in the United States. The physicians last March agreed to pay $271,605 in civil penalties, attorneys’ fees, and Texas Department of State Health Services (DSHS) investiga- tive costs. They agreed not to purchase or sell unapproved or misbranded drugs or devices.
Physicians also can face violations of the Texas Food, Drug,
Attorney General Abbott, says the agency “worked with TMA to in- form doctors about the problem, educate physicians about applica- ble legal requirements, and estab- lish steps doctors and their staff can implement to avoid conduct- ing business with an unlicensed distributor.” Attorneys say portions of the attorney general’s guidance seem simple to follow. For instance, the guidance advises physicians to check with DSHS before buy- ing drugs or medical devices from Texas or out-of-state companies. The DSHS Drug and Medical De- vices Group licenses drugs and
medical device distributors in the state.
But attorneys say it could be difficult for physicians to com- ply with other parts of the guidance. For example, the attorney general says if DSHS doesn’t license an out-of-state medical device distributor, physicians have to contact the appropriate state’s licensing agency. To read the guidance document, visit
www.texmed.org/medicaldevices/. To find out if a drug has FDA approval, email Drugs@FDA .com or call (888) 463-6332. For information about medical device approvals, visit
http://1.usa.gov/rjDrwB.
June 2012 TEXAS MEDICINE 43
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