Says Crime May Be Side Effect Of Sale
Sen. Charles E. Schumer announced that a series of new and highly potent prescription narcotics, which can be 10 times as strong as Vicodin, are seeking approval from the Food and Drug Administration (FDA) for introduction to the marketplace.
In the face of an epidemic of prescription drug abuse and its related crime-and the immediate aftermath of five deaths on Long Island directly related to pharmacy robberies- Schumer called on the FDA to move extremely cautiously in approving these new super-drugs and not allow them on the market until serious questions are answered about the potential impact their introduction could have on the already exploding prescription drug crisis.
“It’s tremendously concerning that at the same time policy makers and law enforcement professionals are waging a war on the growing prescription drug crisis, new and more powerful super-drugs could well be on their way, flooding the market,” said Schumer. “The FDA needs to grab the reins and slow down the stampede to introduce these powerful narcotics. We’re facing a public health crisis and that needs to be the major consideration before any of these powerful drugs hit pharmacies.”
There are at least four drug manufacturers that are currently conducting research on pure-form hydrocodone pain relievers, with at least one that has publicly announced that it will seek FDA approval to begin marketing their drug in 2013.
Pure hydrocodone has never been approved for sale in the United States and if the FDA grants approval for the drug manufacturers to introduce these new narcotics into the market, they will become the most powerful prescription pain relievers available in the country.
Schumer noted that while there are many patients-some with termi-
–SEE DRUG ON PG. 58- nal and painful diseases-that need access to strong prescription pain relievers, it is important to ensure that access to these types of narcotics are closely controlled. He added that while the government shouldn’t interfere with scientific outcomes, the FDA must consider and research all the implications for approval of these drugs, including whether they will further exacerbate the prescription drug crisis.
Hydrocodone, one of the active ingredients in Vicodin, is considered an opioid, because of its chemical similarities to opium-based drugs like heroin. Hydrocodone is the second most abused medicine in the nation, only behind oxycodone, known popularly as Oxycontin. Currently available hydrocodone-based narcotics like Vicodin contain aspirin or acetaminophen.
News reports state the new superdrugs currently in testing remove the aspirin and acetaminophen additives, leaving pure hydrocodone, with a significantly heightened potency that is time-released in the body once ingested. Drug manufacturers reportedly argue that pure hydrocodone is a better option for patients because of the side effects that acetaminophen and aspirin can have on the human liver.
Each of the companies currently testing the new pain killers are at different stages of development. Zogenix, a San Diego based company, announced publicly that it is planning to file an application for approval for its super-drug, Zohydro, in the early part of 2012 and have it on the market by 2013. The company has reportedly been meeting with the FDA to finalize its application.
In a letter to FDA Commissioner Margaret Hamburg, Schumer called on the agency to use its authority to determine whether the potential for abuse and misuse of these new superdrugs should prohibit their introduction to market.
He also urged the agency to use its statutory authority to make any possible approval contingent on manufacturers adopting any and all technological advances to prevent abuse.
Schumer noted that over the past few years, efforts made to make pain relievers “tamper-proof” have largely failed.
He also called for the FDA to consider requiring tracking technology, already used for Oxycontin bottles, to assist law enforcement.
“There are more questions than answers about the introduction of these new super-drugs to the market,” the senator concluded. “Before we go rushing to provide even more potent and addictive pain killers to the market, the FDA needs to make a strong and compelling case as to their necessity and examine the implications on the prescription drug crisis plaguing in this country.”
