Mr. ROGERS of Kentucky. Mr. Speaker, I want to begin by thanking my colleague and friend from across the Big Sandy that divides Kentucky and West Virginia and my good friend across the aisle, Nick Rahall, for organizing these Special Orders by the Congressional Caucus on Prescription Drug Abuse. Congress, the DEA, the medical community, State partners, and particularly the Federal Drug Administration must do more to fight the medicine cabinet epidemic.
The Office of National Drug Control Policy in the White House has identified prescription drugs as our Nation's fastest growing drug problem, easily eclipsing cocaine and heroin abuse. As has been said, the national Centers for Disease Control has said that prescription drug abuse is now a national epidemic.
In 2010, 254 million prescriptions for opioids were filled in this country. That's enough painkillers to medicate every American adult around the clock for a month.
Our military soldiers are coming back from Iraq and Afghanistan hooked on these pain pills. In the last 2 years, over 150 of our soldiers have died from overdoses.
In my home State, Kentucky's losing roughly 82 people a month to prescription drug deaths, more than car crashes. Our medicine cabinets are more dangerous than our cars.
But these statistics, of course, are just numbers. So many Americans, including members of our caucus who've taken to the House floor today, have been touched by this tragedy in some personal way. In some counties in my district, half of the children are living in a home without their parents in large part because of prescription drug abuse.
I've met single moms struggling to get through drug court and employers who can't string together a clean workforce. We've lost mothers. We've lost grandfathers, police officers, children, brothers and sisters, husbands and wives.
This epidemic does not distinguish between socioeconomic lines or gender lines or geographic lines. It's indiscriminate in its path of destruction, and it has to stop.
FDA has to be part of saying ``no'' to the abuse of legal drugs. FDA is the primary entity for regulating prescription drugs with its hands on the spigot. For years, I've pleaded with the FDA to take a harder look at how these painkillers are allowed to be prescribed.
Congressman Frank Wolf of Virginia and I have implored FDA to make these painkillers available only for severe pain. Prescription painkillers such as OxyContin and Opana were originally intended to treat severe pain caused by cancer, but over the years, based in large part on marketing practices, many physicians, dentists, other health care providers began prescribing opioid painkillers for moderate-to-severe pain. A toothache or a stubbed toe has become an excuse for an Oxy prescription.
Now, OxyContin's a wonderful drug, intended for terminally ill cancer patients, people in severe pain that need a time-released capsule over 12 hours. It helped the patient and helped the caregiver. But it's also a very addictive drug and very difficult to kick once addicted. So this is really a dangerous drug when not used in the prescribed way.
This FDA-approved indication for moderate-to-severe pain can create the false assumption that opioids are a safe and effective treatment for chronic, noncancer pain. On the contrary, more than 30 leading clinicians, researchers, and health officials recently petitioned the FDA to strike the term ``moderate'' from the indication for noncancer pain, add a maximum daily dose and a maximum duration of 90 days for continuous daily use.
When we're losing 16,000 people a year to these drugs, the FDA must take this petition seriously.
Second, the FDA shortly will make a vital determination about whether to approve generic versions of the original formulation of the drug OxyContin.
In 2007, the manufacturer of this drug, Purdue Pharma, was found criminally liable for deliberately misbranding their product.
After paying an unprecedented $630 million penalty, Purdue voluntarily removed the original formulation of OxyContin from the market--and reissued the drug with a formulation which is much more difficult to abuse.
Since this new, more ``gummy'' drug has come on the market, abuse of OxyContin has steadily declined--while the abuse of other painkillers, like Opana, is on the rise.
Purdue's patent on the original OxyContin formulation expires in 2013, and at least three companies have filed applications with FDA to produce generic versions.
If approved, this stands to be a disaster:
1. As previously seen, original Oxy was incredibly misused and wrought havoc. We could see a new wave of deaths if this drug is available in a cheaper, generic form.
2. This would also be a tremendous setback to companies developing abuse-resistant pain medications. If generic OxyContin is available on the market for a low price, there is no financial incentive for investment in the development of abuse-resistant drugs.
FDA must realize the wide-reaching implications of this pending decision, and I encourage the Agency and Commissioner Hamburg not to put this potent drug back on the market when there are so many alternatives already available and under development.
Mr. Speaker, this epidemic is touching people in every corner of our great nation--and for that reason, I invite all of my colleagues to join us in the fight by becoming a member of the Congressional Caucus on Prescription Drug Abuse and working with us in pressing FDA to make the right decisions.