As fans of My Big Fat Greek Wedding know, virtually anything worthwhile in life is very ancient and very Greek. My dad understood this, and was understandably surprised when he walked into a rheumatology conference several years ago to be confronted by a flashy display featuring “newly approved” (and as he would learn, many times more costly) Colchicine.
“What are you talking about?,” he asked the representative. Colchicine—an ancient and unquestioned Greek remedy for gout—had been cheaply and easily accessible for as long as he had been practicing medicine. It was one of countless drugs already on the market before the FDA began requiring newly developed drugs to pass tests for “safety and effectiveness” in 1962. All medicines already in use were grandfathered in under the 1962 Kefauver-Harris Amendment to the Food, Drug, and Cosmetic Act, assumed to be safe and effective by virtue of being safely used by patients.
That changed in 2006, when the FDA introduced the Unapproved Drugs Initiative, aimed at “[removing] unapproved drugs from the market.” While the FDA asserted that it would “concentrate its resources on those products that pose the highest threat to public health… without imposing undue burdens on consumers,” it also stated that the goal of this initiative would be to “efficiently and rationally [bring] all such drugs into the approval process.”
Of course, this presented a problem for consumers; in the case of Colchicine, patients suffering from swollen wrists or feet began foregoing treatments due to skyrocketing costs. When Colchicine was approved by the FDA in 2011—granting marketing exclusivity to URL Pharma—its price quickly climbed by approximately 2,600 percent. The cost of a monthly prescription rose from an estimated $6.72 to $185.53. Insurance companies stopped covering Colchicine, and doctors were forced to choose among other, riskier drugs to prescribe to suffering patients.
In response to my dad’s stunned question, the Colchicine representative explained (smugly) that while the current stock of unapproved Colchicine could still be sold, once the stock was depleted, only the “new and approved” version would be available, at any price URL Pharma wished to set. There was no substantive difference between the approved and unapproved versions, and no indication that the unapproved versions posed any additional risk.
Several years later at another rheumatology conference, my father shouted from the audience at an FDA presentation, “Please give us back Colchicine!” and the room full of rheumatologists reportedly burst into applause. The FDA presenters echoed the sentiments of the Colchicine representative from years ago, explaining that URL Pharma had “proven” thatColchicine safely and effectively treated gout, and were therefore entitled to exclusivity. As Deborah Autor, a former FDA official who went on to work for Mylan Pharmaceuticals (following the career trajectory of many FDA officials), explained, “One company chose to seek FDA approval and they spent tens of millions of dollars in order to present data necessary for that approval and in the process, there were some important things that came out of the approval process.”
In other words, Colchicine worked for thousands of years and one company spent tens of millions of dollars to prove it—including user fees to the FDA.
Colchicine is just one example of the many drugs whose prices have leaped due to the Unapproved Drugs Initiative. This arrangement offers no benefit to patients, doctors, or medical innovation. It only helps the FDA and the companies who invest in “proving” what everyone knows to be true, at the expense of the patients paying for it.
