FDA Blocks Generic Oxycontin

When a drug’s original patent expires, the FDA usually approves generic versions of the drug.  There are winners and losers when this happens.  Patients win because generics cost less than the patented drug.   Generic drug manufacturers win too.  The only loser is the original patent-holder, whose profits usually fall dramatically when a blockbuster drug’s patent expires.  But don’t feel too bad for them; they’ve made plenty of profit from the drug already.  The high profit they make while the drug is under patent protection (up to 20 years) is supposed to compensate them for the high costs of drug development and testing, which the generic drug companies don’t need to do.

That’s how it usually works.   But this week the Food and Drug Administration (FDA) refused to approve a generic version of the popular pain-killing drug OxyContin, on the very day that the drug’s patent was set to expire.   Why?   OxyContin (a narcotic) has become an abused prescription drug, in part because the pills could be crushed and then injected or snorted, releasing high levels of narcotic all at once.   The FDA feared that widespread availability of generic OxyContin would lead to even more abuse of the drug.  So in an unusual move, the FDA chose instead to approve a newly-patented, reformulated version of OxyContin that is harder to abuse.   When crushed, the new OxyContin becomes a jelly-like mass that can’t be injected or snorted.  The potential safety benefits of the newer version were so compelling that the FDA was willing to phase out the old version.

But don't expect the old version of OxyContin to disappear just yet.  It turns out that generic OxyContin has been approved for sale in Canada.   Canadian pharmacies are likely to have it for sale within a month.