TEMPLE, Texas — One of the key figures in the debate over importing prescription drugs from Canada is hungry -- and he's got his eyes on a platter of pork ribs.
"Gimme some of that hawg," he drawls to an amused waitress at the County Line, a barbecue joint.
If his twang and blue-jeans business attire aren't enough of a clue, Tom Curb is happy to explain what he's all about.
"I'm country," he said. "My daddy was a cedar cutter. We used a [potato] sack for a front door. I was born on the kitchen table."
Casual though he is, this 63-year-old country boy may find himself in a court battle with the U.S. Food and Drug Administration.
For more than two years, Curb and a partner have operated a business, out of a single-story brick building in this central Texas town, that helps consumers get cheaper brand-name drugs by going outside the country -- which the FDA says defies its regulations.
His two companies, SPC Global Technologies and Expedite-Rx, have processed more than 52,000 prescriptions from foreign pharmacies, primarily in Canada, for U.S. consumers.
The city of Montgomery, Ala., contracts with Curb's businesses to help city employees fill prescriptions from foreign and U.S. pharmacies. Last week, Orange County Supervisor Chuck Smith toured Curb's offices, exploring the idea of using his companies to manage a program that would allow the county's 17,000 employees to fill their prescriptions through foreign pharmacies.
The FDA sent two warning letters to Curb this year, telling him that his businesses were violating federal law by facilitating the importation of prescription medicine. On Friday, a top FDA official reiterated that stance and said the agency may take its case against Curb's companies a step further.
"We've already notified Expedite-Rx that, in our view, they're violating the law," said William Hubbard, associate commissioner of the FDA. "The next step would be to file suit against them."
Curb says he doesn't believe his companies are doing anything wrong. He notes that they don't receive or ship any of the medications. Rather, they process payments to pharmacies and track customers' prescription histories, hoping to flag dangerous combinations of drugs that might go unnoticed by pharmacists working on opposite sides of the U.S. border. Curb charges an administrative fee for each prescription filled.
For several years, U.S. consumers have traveled to Canada or used the Internet to buy brand-name prescription medicine from Canadian pharmacies, taking advantage of federal price controls in that country.
The FDA says it's illegal to import drugs from other countries. So far, the agency has not gone after consumers but focused on storefront operations in the United States that were making a profit brokering Canadian drugs.
Curb says he's willing to risk a showdown with the FDA because he believes he's doing the right thing. People are going to buy brand-name drugs from outside the United States no matter what the FDA does, Curb said, so it's important that businesses like his try to make the process as safe as possible.
Last month, his company expanded beyond Canada to Israel, Chile, England and Australia.
Several times a day, Curb says, his company notifies pharmacists in Canada and other countries that they shouldn't ship prescriptions because they will interact dangerously with other medicines consumers are taking.
"We got into this because we had plans whose members were at risk. We identified a problem.... We felt it was ethical to fix it," he said.
It's that position that helped make Curb an unlikely figure in the national debate about prescription drug imports. Curb, who uses a cane because of childhood polio and wears Levis and cowboy boots to business meetings, has been a licensed pharmacist for 41 years. He's spent most of his career managing prescription benefit programs.
The problem, Hubbard said, is that Curb's companies profit from the illegal importation of drugs. "If you put up signs around town saying, 'I can link you up with a heroin dealer for 10 bucks,' and then you give people a heroin dealer for 10 bucks, then you have a problem," Hubbard said.
Despite the FDA's objections, several states and local government agencies have set up programs to make it easier for employees to fill their prescriptions through Canadian pharmacies. Officials in Springfield, Mass., said the city saved more than $2 million the first year of its program, and other cities have reported considerable savings.
It's also become an issue in California. Gov. Arnold Schwarzenegger vetoed three measures last week that could have increased the flow of drugs from Canadian pharmacies into the state. One bill called for a state-run website with links to Canadian pharmacies; another would have allowed the state to buy Canadian drugs for its prison system; the third would have permitted the state to reimburse Canadian pharmacies for medications issued to Medi-Cal and AIDS patients.
So far, FDA hasn't cracked down on any of the cities doing business with Curb.
Curb traveled to Maryland this year to speak to a commission appointed by the U.S. Department of Health and Human Services to study the importation of prescription medicine. He said most medicines sold in Canada are manufactured by U.S. companies and identical to those available in the United States.
"If we were to just pack it in," Curb said later, "then we've left unprotected all these people we know are going outside the United States to get their drugs. And, in my opinion, we would be violating our ethics as a health care provider."
Taking on the federal government is also entertaining, Curb said. He last heard from the FDA after he mailed a six-page letter detailing his stance that his company is not violating federal law.
"If it weren't so fun rubbing their nose in it, I'd probably get out of it. But, at my age, there's not much you can do that's fun," Curb said.