TIME FOR THE FDA TO STOP STALLING ON PAIN KILLERS
by FROM THE HILL TO THE MOUNTAINS: A WEEKLY COLUMN BY U.S. SENATOR JOE MANCHIN (D-W.Va.)
Fourteen years is a long time to wait for anything. When you need help, 14 years is a really long time to wait. And yet 14 years is how long it’s been since drug experts first asked the Food and Drug Administration (FDA) for help in stopping an epidemic of prescription drug abuse in America.
And still we wait.
Well, I’ve waited long enough. So have other Members of Congress, Democrats and Republicans alike. This week, nine of us sent a letter to the FDA urging immediate action to combat an epidemic that is devastating families and communities all across the country, including West Virginia.
Specifically, we urged the FDA to tighten restrictions on some of the most powerful, addictive narcotics on the market, which have fueled the epidemic we see today – hydrocodone painkillers, such as Vicodin and Lortab.
It’s not like we came up with this idea overnight. And it’s not like we came up with it on our own.
The petition for greater restrictions on hydrocodone was originally filed with the FDA in 1999. The petition suggested that hydrocodone be reclassified from a Schedule III drug, the category for less addictive drugs like barbiturates and amphetamines, to Schedule II, the category for opium and morphine.
For over 14 years, the FDA has refused to make this commonsense change, even as hydrocodone abuse has taken its toll on our country, reaching the point where police officers in our home state speak today of a “lost generation” of Americans – lost to the lure and easy access to these prescription drugs.
But last January, things started changing dramatically.
After listening to days of testimony from witnesses, including mine, and after reviewing all the evidence, the FDA’s own panel of experts recommended – for the first time – that hydrocodone be reclassified a Schedule II drug.
Under federal drug laws, the FDA is granted “a reasonable time” to respond to recommendations from its own advisory panel. But winter has turned to spring and summer is just around the corner. It seems to me, and to the Members of Congress who joined me in writing the FDA this week, that the federal agency charged with the safety of our food and drugs has exceeded the “reasonable time” requirement.
The fact that we’ve already waited 14 years for the FDA to do the right thing makes this latest delay that much more intolerable.
Recent data from the Centers for Disease Control underscores the urgency of action by the FDA. The CDC reports that drug overdose deaths increased for 11 straight years since 1999. Sixty percent of those deaths (22,134) involved pharmaceutical drug products. And prescription drug products containing oxycodone, hydrocodone, methadone and others represented three-quarters of those deaths (16,651).
Our great state is not immune from this epidemic. In 2010 alone, 512 West Virginians died from drug overdose – a 353 percent increase since 2000. And painkillers now result in more deaths than heroin and cocaine combined.
Ignoring this drug abuse epidemic is unacceptable. A lot of families, doctors, law enforcement officers and public officials have been on the front lines battling this crisis for years.
The time has come for the FDA to stop stalling and step up to give us a hand. This is one of those fights that is going to take everybody’s help to win.
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