For these reasons, the approval was considered questionable and amounted to a gamble. And this week, it would appear the agency lost. Ranbaxy (NSE) has halted production of generic Lipitor after glass particles were found in more than three dozen lots spanning three different doses, although not the highest 80mg dosage (read more here). No safety issues or adverse events have so far been reported, but the move opens the door to a round of second guessing.
This raises prospect, in fact, of a congressional probe, as Michael McCaughan of Prevision Policy points out in The RPM Report. He plays connect-the-dots by noting that the newly named chair of the House Energy & Commerce Oversight Subcommittee is Tim Murphy, a fifth term Republican whose Pittsburgh area district that includes Mylan corporate headquarters (see this).
As we have reported previously, Mylan unsuccessfully filed a lawsuit against the FDA in hopes of forcing the agency to approve its own application to market a generic version of the Lipitor pill. Mylan had argued that the so-called 'first to file' right held by Ranbaxy should have been negated due to the extensive manufacturing problems. However, a federal judge ruled that Mylan did not have standing and bounced the case (see this).
However, McCaughan notes that Murphy was an original sponsor of the Generic Drug User Fee legislation, which was a "compromise forged largely by Mylan and, not surprisingly, he shares Mylan’s view that the new program is as much about assuring a level playing field between US and overseas manufacturers as it is about the speed of generic drug reviews."
So far, the FDA has indicated that a shortage of generic Lipitor is "not anticipated," but the agency is "proactively monitoring the situation for the possibility of a shortage” and working with other manufacturers “to ensure adequate market supply in order to avoid shortages.” This may be an invitation to not only pick up work on legislation on drug shortages, McCaughan adds, but also a chance to probe the FDA.
Of course, there may well have been valid legal considerations that prompted the FDA to allow Ranbaxy to make and market generic Lipitor. The pill is not being made in the facilities that ultimately were cited in the consent decree issued this past January, although Ranbaxy has refused to discuss the source of the troubled product. Nonetheless, this latest episode raises questions about the extent to which the feds bargained hard enough if the integrity of the supply chain and patient safety were paramount goals. What do you think?