Marketing Exclusivity in The United States
As a drug predating the FDA, colchicine was sold in the United States for many years without having been reviewed by the FDA for safety and efficacy. In 2009, the FDA reviewed an NDA submitted by URL Pharma and approved colchicine for gout flares, awarding Colcrys a three-year term of market exclusivity, prohibiting generic sales, and increasing the price of the drug from $0.09 to $4.85 per tablet.
Numerous consensus guidelines, and previous randomized controlled trials, had concluded that colchicine is effective for acute flares of gouty arthritis. However, as of 2006, the drug was not formally approved by the FDA, owing to the lack of a conclusive randomized control trial (RCT). That year, the FDA started an Unapproved Drugs Initiative, through which they sought more rigorous testing of efficacy and safety of colchicine and other unapproved drugs. In exchange for paying for the costly testing, the FDA gave URL Pharma three years of market exclusivity for its Colcrys brand, under the Hatch-Waxman Act, based in part on URL-funded research in 2007, including pharmacokinetic studies and a randomized control trial with 185 patients with acute gout. URL Pharma also received seven years of market exclusivity for Colcrys in treatment of familial Mediterranean fever, under the Orphan Drug Law. URL Pharma then raised the price per tablet from $0.09 to $4.85 and sued to remove other versions from the market, increasing annual costs for the drug to U.S. state Medicaid programs from $1 million to $50 million. Medicare also paid significantly higher costs—making this a direct money-loser for the government. (In a similar case, thalidomide was approved in 1998 as an orphan drug for leprosy and in 2006 for multiple myeloma.)
In April 2010, in an editorial in the New England Journal of Medicine (NEJM), A.S. Kesselheim and D.H. Solomon said that the rewards of this legislation are not calibrated to the quality or value of the information produced, that there is no evidence of meaningful improvement to public health, that it would be much less expensive for the FDA, the National Institutes of Health or large insurers like medicare and medicaid or coalitions of private insurers to pay for trials themselves. Furthermore, the cost burden of this subsidy falls primarily on patients or their insurers. URL Pharma posted a detailed rebuttal of the NEJM editorial.
In September 2010, the FDA ordered a halt to marketing unapproved single-ingredient oral colchicine.
Read more about this topic: Colchicine
Famous quotes containing the words united states, united and/or states:
“Of all the nations in the world, the United States was built in nobody’s image. It was the land of the unexpected, of unbounded hope, of ideals, of quest for an unknown perfection. It is all the more unfitting that we should offer ourselves in images. And all the more fitting that the images which we make wittingly or unwittingly to sell America to the world should come back to haunt and curse us.”
—Daniel J. Boorstin (b. 1914)
“I feel most at home in the United States, not because it is intrinsically a more interesting country, but because no one really belongs there any more than I do. We are all there together in its wholly excellent vacuum.”
—Wyndham Lewis (1882–1957)
“It is impossible for a stranger traveling through the United States to tell from the appearance of the people or the country whether he is in Toledo, Ohio, or Portland, Oregon. Ninety million Americans cut their hair in the same way, eat each morning exactly the same breakfast, tie up the small girls’ curls with precisely the same kind of ribbon fashioned into bows exactly alike; and in every way all try to look and act as much like all the others as they can.”
—Alfred Harmsworth, Lord Northcliffe (1865–1922)