For the past few years, FDA has attempted to re-approve all the old drugs that made it to market before the current regulatory framework was in place. In an effort to catch up, the Wall Street Journal says, the regulatory body has been offering three years of market exclusivity to any company willing to do the clinical work and affirm the older drugs' efficacy. As part of that program, generic manufacturer URL Pharma did the testing for the gout medication colchicine, and got three years of market exclusivity – and then promptly jacked up the price by about 15 times, and filed suit against several small companies that were selling colchicine on the generic market. In the Pipeline's Derek Lowe asks, "Is it an abuse of the system by a company that saw an opportunity to suddenly acquire pricing power?" The problem in cases such as this, he adds, is that while companies need an incentive to go back to older medicines and clinically test them, what's to keep them from ramming that incentive down the throats of other companies? "It's not like URL Pharma discovered colchicine, or had to do any of the risky early-stage work on it. … A generic company that's coming in to dot the Is and cross the Ts on the FDA paperwork is something else again," Lowe says. Instead, he suggests that FDA fund such work itself to avoid such problems.
The Colchicine Conundrum
Apr 16, 2010