As diversion, lawlessness and drug profiteering overtook southern and eastern Kentucky, I pleaded with the Food and Drug Administration (FDA) to take immediate action and remove Oxycontin off the pharmacy shelves or at least tighten controls on prescription. Nothing was done. The only federal agency specifically charged to "protect the public health by assuring the safety and security of drugs" seemed paralyzed, unwilling or unable to institute commonsense reforms to our country's drug safety program. As a result, we nearly lost an entire generation of Kentuckians to medicine cabinet addiction. And now, for the first time in history, we're losing more Americans to accidental drug overdoses than to car crashes.
It wasn't until 2007 when drug-maker Purdue Pharma was found criminally liable for misleading the public about OxyContin's risk of addiction and fined a record-shattering $635 million, that the company voluntarily removed these pills from the marketplace. Purdue replaced the original, crushable pills with a "tamper-resistant formulation," or TRF, and as a result, OxyContin misuse has declined. Tragically, this was nearly too late.
I am not naïve enough to believe these formulations are a silver bullet. With enough time and effort, they can be broken. However, when 27,000 people are losing their lives annually, we should take seriously every possible solution to end prescription drug abuse that is currently within our reach.
Unfortunately, we are running perilously close to another potential pain pill cliff. In early 2013, generic versions of early OxyContin are slated to come to market in the U.S. in a low-cost, crushable formula. The impacts of these generics would not only be downright disastrous for the law enforcement and health communities, but would also jeopardize the costly, painstaking gains we've already made in our fight against this scourge - shutting down pain clinics, sending rogue doctors to jail, and standing up interoperable state-based Rx monitoring.
Simply put, this cannot happen. FDA must use its power to prevent these crushable generics from turning up in the hands of children. FDA could approve generic formulations of these pain management drugs only if they demonstrate comparable tamper-resistant technologies, as Congress has suggested in the Stop Tampering of Prescription Pills (STOPP) Act, H.R. 6160. However, if the FDA approves these generic drug applications, the marketplace for more expensive TRFs will inevitably shrivel, and we will be right back where we were ten years ago with pharmacy robberies, drive thru pain clinics, orphaned children, and overcrowded emergency rooms.
The clock is ticking and this health crisis has a partial solution, but failure to intervene by FDA will mean it has failed its basic mission. This doesn't take an act of GOD or an act of Congress; it takes an act of courage on the part of FDA.
Rogers is co-chairman of the Congressional Caucus on Prescription Drug Abuse in the U.S. House of Representatives.