FDA Bill Missing Important Amendment

FDA Bill Missing Important Amendment


U.S. Senator Joe Manchin (D-West Virginia) is trying to combat the rising toll of addiction and death due to prescription drug abuse by putting stricter controls on hydrocodone, an addictive opioid painkiller used to treat moderate and severe pain.

Sen. Manchin’s amendment to reclassify hydrocodone products from Schedule III drugs to Schedule II was unanimously added to the original Senate version of the FDA User Fee bill, but it was not included in the House version or in a compromise bill the Senate passed Wednesday and sent to President Obama for his signature.

“I am determined to see this thing through. I’m not giving up on this. This measure will pass, whether it passes this year or next year,” Sen. Manchin said. “The stakes are just too high to do nothing. We’re talking about an entire generation that is being devastated by the effects of drug abuse in their communities, in their schools, and in their homes. I recognize that this amendment does not fit into the business model of selling as many pills as possible.”

“We don’t want to put anybody out of business,” Sen. Manchin said in an interview with the New York Times. “But perhaps the chain pharmacies and druggists need to change their business model a bit. These are legal drugs needed by some people. But they can also be addictive. They are so readily accessible, so easy to obtain, that they are ravaging society and ending many young lives.”

According to the Drug Enforcement Agency (DEA), hydrocodone is one of the most misused opioids, yet it has remained a Schedule III narcotic for the past 40 years. Overdoses from prescription painkillers like hydrocodone are killing more Americans than heroin and cocaine combined.

Reclassifying hydrocodone and combination painkillers like Vicodin that contain hydrocodone to Schedule II drugs would require patients to get a new prescription to have their pills refilled. Pharmacists would also be required to store hydrocodone in a locked safe and traffickers would face increased fines and penalties.

Amendment Killed by Pharmacy Lobbying

Efforts to add Manchin’s amendment to the House bill, which was supported by law enforcement officials, failed after an aggressive lobbying campaign by pharmacists and drugstores. The new restrictions, they said, would make it more difficult for some people in pain to obtain treatment, and pharmacies would be saddled with costly administrative burdens.

The National Association of Chain Drug Stores and the National Community Pharmacists Association, said the additional requirements would increase overhead costs for pharmacies. Almost every pharmacy, they said in a letter, would have to buy and install larger safes for storage of the drugs.

Larger safes? Give me a break. Unless it is a “pill mill” pharmacy housing excessive quantities of opioids, why would larger safes be needed? I don’t buy it for a minute and hopefully Congress won’t buy it either.

“Totally bogus,” is what Andrew Kolodny, MD, says about the claim that patients would suffer from additional controls on hydrocodone.

A member of Physicians for Responsible Opioid Prescribing and Chair of the Psychiatry Department at Maimonides Medical Center in Brooklyn, Kolodny says he is treating many patients who became addicted to hydrocodone products in their late teens and early 20’s — and were now taking 20 to 30 tablets a day.

Kolodny told the New York Times that patients would actually benefit from closer monitoring, because they would have to visit their doctors every three months to get their prescriptions renewed.

Reclassifying hydrocodone as a Schedule II drug will save lives — so I ask again — why do lobbying groups with financial interests have such power?

Are billions of dollars in profits worth more than the lives of our young people?

Marianne Skolek is an activist and investigative reporter for Salem-News.com who lost a daughter to prescribed OxyContin in 2002. Marianne writes from the perspective of families devastated by the prescription drug epidemic. 

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Jeff- In many states, the requirement to mail in a hard copy prescription to a pharmacy after phoning in an emergency supply of meds applies to schedule IIIs same as it does to schedule IIs.

If a doc refuses to phone in a small emergency supply of opioids for a known patient suffering from an episode of severe acute pain, simply because mailing in the cover is too much trouble… then there’s a problem with the doctor, not with the drug’s schedule.

As you probably know, the abuse liabilty for Vicodin (Schedule III) is equivalent to the abuse liability for Percocet (Schedule II). Vicodin is a III because a mistake was made when the Controlled Substances Act (CSA) was drafted 40 years ago.

If you agree that scheduling controlled substances (lumping them into categories with similar addiction potential) and linking regulations to the schedule makes sense… then I also hope you’ll agree that the only way the system can work properly is if we put drugs in the appropriate category.

This loophole for Vicodin is one of the main reasons the drug is causing so much harm.

Jeff Junig MD PhD

The biggest change for patients would be the requirement for written prescriptions. Small ’emergency amounts’ of schedule IIs can be called in, but the doc must then provide a written order within several days- something many docs will not do. The result? The person who had wisdom teeth removed and develops dry socket won’t be able to have a few more Vicodin called in; someone will need to pick up a written script. Is it is after hours, the on call doc will be loathe to have the patient stop by the house at 2 am- so people with unexpected moderate pain will not have access to called- in hydrocodone. Yes- it is ‘better care’ to go to the ER. But it is also more expensive, and a waste of resources in patients where the source of pain is known. I’m no fan of opioids, but to say that a change in schedules won’t hurt one patients is taking an indefensible position.