Earlier this week, pharmacy interest groups defeated an amendment to the Food and Drug Administration Safety Innovation Act that aimed to change the classification of hydrocodone-containing pain relief products from Schedule III to Schedule II, putting hydrocodone painkillers into the same category as OxyContin and Percocet. Hydrocodone is the most-prescribed prescription drug in the U.S., with 131.2 million prescriptions written in 2010 alone. The provision had been accepted as an amendment to the U.S. Senate’s version of the bill, but it was cut from the final bill that reconciled the Senate and House provisions after the Generic Pharmaceutical Association objected to it, claiming it would restrict access and increase prices to the painkillers.
Today, Oxy Watchdog caught up with the amendment’s author, U.S. Senator Joe Manchin (D-W.Va.), who said the bipartisan measure was defeated due to the efforts of high-powered and well-funded lobbyists representing groups that have a huge financial stake in keeping these pills as accessible as possible. But he vowed to continue the fight against prescription drug abuse, and said he planned to re-introduce the amendment in the future.
Watchdog: Tell us more about the reasons you decided to introduce this measure. What’s the landscape like in West Virginia regarding prescription drug abuse?
Joe Manchin: My reasons are the same as yours; the same as every person who has been affected by the prescription drug abuse epidemic. The thing that pushed me to this level was visiting a small town in West Virginia that has been ravaged by painkiller abuse. Young, 12- and 13-year-old boys and girls came to me and told me their families are being destroyed; their friends are overdosing and dying. They are asking us for help, and we’re not helping them. Shame on all of us.
Prescription drugs are responsible for 90 percent of drug-related deaths in my state, but this is a nationwide epidemic – I don’t know a person I’ve ever talked to who doesn’t know someone who has been affected by these drugs.
W: Law enforcement and addiction advocacy groups supported this measure. Who was behind its defeat?
JM: Those who supported the amendment were the people on the front lines who have been directly affected by this epidemic. The opponents were those who have financial interests.
W: What about the criticism that the amendment didn’t fit into current business models?
JM: I’m a businessman myself, and I know that when you have a business, you have a model for what it will take to succeed. But I know also that you have a backup plan. I would think that when these drugs were manufactured for the purpose of healing people, the plan wasn’t based around the idea that if patients become addicted, the companies would sell more pills. At the same time, if distributors and doctors are putting more of these drugs on the streets, this affects the original business plan. So they need to go to Plan B. They’ll still be able to survive, they’ll just be saving a few more lives.
Taking hydrocodone from Schedule III to Schedule II would keep it out of the hands of traffickers. Critics say this would be keeping products away from people who really need them, but it just means that patients would need an original prescription to get their pills refilled. Since 2007, doctors can provide patients with a 90-day supply of any Schedule II medication by issuing three prescriptions, one for an immediate supply and two additional prescriptions that can’t be filled until a certain date. If they receive a 90-day supply, patients would only need to visit their doctors four times per year, and if they are dealing with that kind of pain, they probably would want to be evaluated anyway.
W: What are the next steps for the reintroduction of the amendment?
JM: We’ll be asking HHS and the DEA to release their studies in order to find out how addictive these drugs really are. If they refuse, our next alternative will be to call for a Congressional hearing. We’re working with the agencies first, and will be sending a letter to them shortly. I’m not going to give up on this.
W: What would be needed from the public in order to get this passed?
JM: People need to share the devastating effects prescription drug abuse is having on their neighborhoods, friends, and families. Everybody’s got a story, and once we know the true extent of the problem, we can try to prevent or slow down this epidemic. The more of these stories we can get, the quicker this will get passed. But I assure you we will pass this sooner or later. The public can’t remain silent anymore.
Contact information for Sen. Manchin can be found here.
Learn more about his efforts to pass the amendment here.
Read a final summary of the bill here.