Congress Crack Down on Prescription Painkillers

Congress Crack Down on Prescription Painkillers

March 22nd, 2013 // 4:25 pm @

Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission

In the latest move to crack down on abuse of prescription painkillers, a bill has been introduced in Congress that would move medications that contain hydrocodone, such as Vicodin, to to a more restrictive ranking on the national law enforcement schedule. Specificaly, the Safe Prescribing Act would classify these drugs, which are now classified as Schedule III controlled substances, to the Schedule II designation.

At issue is a widening effort to find a midpoint that balances patient needs for pain relief with ongoing concerns over abuse and addiction associated with these medications. A recent FDA advisory committee meeting was held at the request of the US Drug Enforcement Agency, which has argued for nearly a decade that these drugs need to be more tightly controlled, and voted to reclassify the medicines.

As we previously reported, a 2010 report from the US Centers for Disease Control and Prevention noted that the rise in overdose deaths in the US paralleled a 300 percent increase since 1999 in the sale of prescription painkillers. The drugs were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined. The sponsors of the bill noted that emergency room visits linked to hydrocodone abuse rose from 38,000 in 2004 to more than 115,000 in 2010.

Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission

“This legislation will correct an error made over 40 years ago when the Controlled Substances Act (CSA) incorrectly classified hydrocodone combination products,” says Andrew Kolodny, who heads Physicians for Responsible Opioid Prescribing, in a statement issued by the co-sponsors of the bill. “There is clear and convincing medical evidence that hydrocodone has the same abuse liability as the Schedule II opioids.”

The reclassification would place Vicodin and other drugs in the same realm as other painkillers – such as oxycodone, morphine and fentanyl – which require patients to have a prescription in order to obtain the medications, except in cases of emergency. Pharmacists would also require patients to present an original prescription for refills, and traffickers would be subject to harsher fines and penalties, according to the sponsors of the bill. Distributors would also be subject to more restrictive handling, storage and security requirements (here is the bill).

The legislation comes one month after a group of bi-partisan members of Congress wrote the FDA to demand the agency take “swift action” to follow the recommendation and produce a timeline for doing so. In their letter, they noted that 14 years has passed since the FDA was first asked to reclassify prescription painkillers containing hydrocodone. “The American people have waited too long for action from this agency,” they wrote to FDA commish Margaret Hamburg (back story).

In a relative move to crack down on the abuse of prescription painkillers, 48 states attorney general recently wrote the FDA to ask the agency to require generic drugmakers to produce tamper-resistant versions of medicines that contain opioids

H/T: Pharmalot

Upcoming Events!


Subscribe Now

Testimonial

"ExpertBriefings.com always selects excellent speakers – some of the best I have ever heard. Their messages are direct, clear, timely, and relevant."

Anon A. Mouse

Featured Partner