For the past few years, Peggy Lewis has paid $10 or less for a 90-day supply of her gout drug, colchicine. But Lewis, 71, fears she will soon be forced to pay hundreds of dollars more for that medication.

Lewis, of Fairfield, Ohio, has taken colchicine for about 20 years to prevent attacks of gout, a form of arthritis that causes flares of sudden pain, stiffness and swelling in joints.

But sometime in 2010, Lewis will have to replace her current version with a brand-name colchicine medication, Colcrys, which, she was told, could cost up to $550 for a 3-month supply.

“I think it’s a shame," she says of the price increase. “It would take my whole Social Security check."

The jump in price follows a push by the U.S. Food and Drug Administration (FDA) to stop the sale of hundreds of medications that had been grandfathered onto the drug market because they were dispensed before the agency began reviewing and approving new drugs.

Colchicine, for example, which is made from a flowering plant called the Autumn Crocus, was first used for gout treatment in the 1800s.

It’s estimated that thousands of drugs fall into this “marketed, unapproved” category, and they include many other medical mainstays, including forms of the painkiller morphine and the heart drug nitroglycerine.

The agency says it is concerned that many of these medications could have safety issues that have never been brought to light. In 2008, for example, the FDA banned injected forms of colchicine after 23 deaths were linked to its use.

The FDA has called on drug manufacturers to conduct clinical trials on these unapproved medications. In return, the Agency offers them some patent protections so they can recoup their investments in the drugs.

In 2009, Philadelphia-based company, URL Pharma, which is thus far the only company that has tested colchicine and submitted an application for FDA approval, was granted the exclusive rights, for three years, to market colchicine as a treatment for gout attacks. The company was also granted the right to be the sole supplier of colchicine as a treatment for familial Mediterranean fever, a rare disease, for seven years.

Colchicine currently accounts for about 3.5 million prescriptions in the U.S. annually, according to IMS Health.

Pharmacies still carry the unapproved, generic versions of colchicine, but as these versions are forced off the market, at some point, those supplies will dry up.

When that happens, the price of colchicine is expected to soar from about $.10 to $5 per tablet.

The steep increase of Colcrys has alarmed both patients with these diseases and the rheumatologists who treat them.

“Rheumatologists are incensed – there’s anger out there," says Edward Herzig, MD, an Ohio rheumatologist who treats Lewis.

In response to the price uproar, URL Pharma points out that their testing of colchicine revealed that lower doses were equally effective as the dose commonly prescribed by doctors. The company also points to newly-identified drug interactions between colchicine and some kinds of antibiotics and antifungal drugs, which might not have been identified without its research.

The company also promised to expand its patient assistance and co-pay programs, which, the company says, should make Colcrys affordable to all.

Nevertheless, the American College of Rheumatology in January said it asked the FDA to prolong the typical "grace period" of one year before forcing other colchicine makers to halt production.

“The fact [URL Pharma] did safety studies is to be applauded," says Dr. Herzig, adding that some return on investment is appropriate. But he says that at $5 a pill, "my personal belief is that it’s gouging."

Currently, some patients have been forced to go to several pharmacies to get the cheaper drug, says Chris Morris, MD, a Kingsport, Tenn., rheumatologist.

Stanley Cohen, MD, president of the American College of Rheumatology, says the company appears willing to listen to physician concerns about the cost of Colcrys. Yet Dr. Cohen adds that he believes the FDA “was not prepared for the unintended consequences" of having just one company control the colchicine market.

FDA spokeswoman Karen Riley said the agency does not address pricing issues. “We took action on colchicine to ensure that what was on the market had been reviewed for safety and effectiveness," she said recently. But other experts say the FDA should be concerned about the price impact.

In “The Curious Case of Colchicine,” an editorial published online on April 14, 2010, in the New England Journal of Medicine, Aaron S. Kesselheim, MD, and Daniel Solomon, MD, both of Brigham and Women’s Hospital, in Boston, said that reward to drug companies for testing older drugs appears to be out of proportion to their level of investment with “no evidence of any meaningful improvement to the public health."

“An alternative solution,” they wrote, “probably much less expensive, would be for the FDA or the National Institutes of Health to fund trials that address outstanding questions related to widely available drugs such as colchcine.”.

Meanwhile, Kindle Horton of Jonesborough, Tenn., says the higher price is likely to lessen access to colchicine for many people with familial Mediterranean fever.

Horton, 29, was diagnosed with the disease after years of misdiagnosis and devastating pain and weakness. The disease is a rare, inherited disorder that produces recurrent fevers and painful inflammation of the abdomen, lungs and joints.

“The colchicine gave me my life back,” she says.

Horton is now taking an older version. The eventual switch to Colcrys will increase her health insurance costs, she says. “This is horrible that you take away something that can help people," she says. “This is a huge, huge issue, especially since we are supposed to be reforming health care."

URL Pharma, which as a privately held firm does not publicly disclose its financial information, says that improving its patient assistance program should make Colcrys affordable to everyone without insurance. 

A patient in a family of four making up to $132,000 a year will now qualify to pay, on a sliding scale, from $5 to $25 for a month’s supply of Colcrys, the company said. In addition, people with health insurance can qualify for a $25 co-pay plan.

“We want to make sure people get access to Colcrys,” says Matthew Davis, MD, the chief medical officer for URL Pharma.

Still, Nancy Sparks Morrison, who has familial Mediterranean fever, wants to see how the new pricing plays out with her Medicare Part D plan.

Morrison, 71, of Cross Lanes, W.Va., who blogs on familial Mediterranean fever and monitors a support group on the condition, now orders colchicine from Canada, paying $100 for 200 pills. She says she may run into the Medicare Part D doughnut hole after a few months – and pay a lot more for her drugs – if she starts taking brand-name Colcrys.

Before this year, Morrison says, most patients were paying 10 cents a pill for colchicine. “People are worried," she says. “A lot of folks are ordering it from Canada or Israel."