Bill Would Force Drug Makers to Make Painkillers Tamper Resistant

Bill Would Force Drug Makers to Make Painkillers Tamper Resistant

A bipartisan effort in Congress to make more opioid painkillers tamper resistant could also make generic forms of the drugs more costly, according to experts.

Rep. Mary Bono Mack (R-California) and Rep. Bill Keating (D-Massachusetts) have introduced legislation called the “Stop the Tampering of Prescription Pills” (STOPP) Act. If passed, it would require the Food and Drug Administration to order generic drug makers to use tamper resistant formulas to make it harder for drug abusers to inhale or inject narcotic painkillers.

“Today, people try to get high by crushing pills into powder, chewing them, dissolving them in water, or by injecting them.  What we hope to do is make opioid painkillers tamper resistant.  Technologies exist today to make it much more difficult to abuse these medicines,” said Rep. Bono Mack during a news conference with Keating.

Under the STOPP Act, if a drug presently on the market has a tamper-resistant feature, then all other drugs with similar chemical properties must have that feature as well.  Companies that refuse to reformulate their generic versions would be told by the FDA to withdraw the drug from the market.

“It becomes a ‘use it or lose it’ proposition,” said Bono Mack.

In 2010, Purdue Pharma changed the formula for its widely prescribed painkiller OxyContin, making the drug harder to crush and dissolve. The reformulation led to a drop in sales of OxyContin, as many drugs abusers switched to other painkillers that were not tamper resistant or started using heroin to get high.

Patents for OxyContin and Opana, another popular painkiller, are due to expire next year. The FDA hasn’t said if it will require generic versions of the drugs to be tamper resistant.

“The STOPP Act will make tamper-resistant painkillers the norm, not the anomaly.  This alone will not solve the problem, but it’s a proactive step in the right direction that might save hundreds of lives across the country,” said Rep. Keating.

Keating and Bono Mack are both members of the Congressional Caucus on Prescription Drug Abuse and the Youth Drug Caucus. Bono Mack became a leading congressional voice on the issue of prescription drug abuse after her son became addicted to OxyContin and went into rehab.

A spokesman for an industry trade group told the Wall Street Journal the STOPP Act could make generic painkillers more expensive or keep them off the market.

“The proposed legislation would be detrimental to patients and could potentially remove FDA-approved safe and effective generic medicines from those who rely on them,” said Ralph G. Neas, president of the Generic Pharmaceutical Association. “Policy makers should let the medical evidence guide actions in addressing this critical issue.”

Authored by: Pat Anson, Editor

There are 4 comments for this article
  1. Casey at 9:57 pm

    You guys are f**king stupid all it will do like it already has is pushed more people to heroin and kill more since the potency ranges so much if you do this it will kill more and not help anything. You would be better off not changing it. Because when people do a factor made narcotic there is a certain amount of drug in each pill and they have a good idea of how much they can Handel but with heroin the potency ranges so much and people mix it with so much stuff it will only kill more but in a way maybe that’s what we need since this world is already way to overpopulated. Think about it u will kill more and not help anyone by passing that bill.

  2. Bob Twillman, Ph.D. at 7:05 am

    This technology is one step in the right direction. Interestingly, Endo manufactures both brand name (Opana) and generic opioid analgesics, and they are planning to extend the crush-resistant features of their new Opana formulation to all their medications, both branded and generic. So, the argument that this will deter generic manufacturers just doesn’t seem to hold water. The generic companies can still make these formulations–they will just have to charge more for them.

    While this is a helpful step because it makes life harder for the people who abuse these medications by altering their form, it does nothing to help the many (on average, I think it’s about 50%) who abuse opioids by swallowing the intact pill. Once again, we’re trying to control this complex problem by addressing only the supply side of the equation, by making the supply of easily-crushed tablets smaller. That will help, but it also will just push many into abusing heroin (note to the epidemiologists out there: don’t say you are surprised when you find this happening 3 years from now!). An effective comprehensive solution that also addresses the demand side through prevention and treatment is the only thing that will work, in the end.

  3. pain advocate,(D.R.) at 8:27 pm

    Many will think what they want. But only addicts and abusers are altering the pain medications that legitimate pain patients need for relief. So.. They shouldn’t have their grungy hands on our medications anyway.. It’s not right to cater our meds and alter them for drug addicts. They also get ruined for pain patients when they get reformulated. They just don’t work worth a crap!! So I feel that the medications should be left alone and do something about the people that are misusing them. I’m sick of my medications being so expensive for us to buy and not effective at all. The pharmacies in Florida ripping everyone off as it is on generics. It’s a waste of money for insurance companies and patients. So I do not accept ruining the medications. No one would know just how bad they screwed them up except people that rely on them for pain relief.
    Anyone that is dying from medications that are NOT prescribed them, those addicts should be in rehab or some where else. They should not be getting their hands on these pain medicines. In fact, that has slowed way down!! because even legit patients can’t get the medicines they need.
    The only way that this does happen is if they are stolen, like abusers always do or a rogue doctor gives it to them which is rare too now days.., or possibly some idiot doesn’t lock them up. That needs to be taught to patients or those patients should be allowed to get the meds. This education will grow and be taught, because I will make sure of it!! Just watch!! It will be taught to every patient or they will lose their medicines.

    So enough of catering to people that shouldn’t have the medicines in the first place, STOP punishing legitimate patients. I get so pissed off everytime I read about this. It’s stupid!! Drug addicts will just go to herion and the patients will be left with garbage and severe PAIN!! When is everyone going to get some damn common sense??

  4. Unhinged at 5:07 pm

    This article states that when Oxycintin’s formula changed (to tamper resistant), there was a decrease in sales because drug abusers switched to other painkillers that were not tamper resistant , or to heroin to get high. This may be true, however, many legitimate pain patients also switched to other medications because the new formula contains material that was NOT tested on humans, and made many people VERY sick. It took me a couple months to figure out that the pills were different, as they were the same color and shape. During those months, I became increasingly sick with terrible GI upset, headaches, anxiety, increased pain, sleeplessness, irritability, vomiting etc… After my doctor called my pharmacist, we figured out that it was the new formula that was making me sick & I was NOT alone. Thousands of patients had terrible stomach pains, headaches, increased pain, and other symptoms. The Internet was flooded with stories of people getting sick, and even going to the ER with stomach problems. Since going off of the “new” formula, my symptoms have improved, but my pain has never been as well controlled as it was on the original Oxycontin formula. What a shame…. All we talk about is the people who abuse opioids, never the people who use them responsibly, and benefit from their use for severe pain. Now, we are even CHANGING these medications for the drug abusers! Lost in all of this, are the patients who require this medication to function and live. I just pray that don’t ruin any other medication by using dangerous plastics and other material that wrecks people’s digestive systems & doesn’t control pain. So….the drug abusers just go abuse another substance, while the legitimate pain sufferers run out of good options for pain control. What’s wrong with this picture?!?!?!