FDA and Generic OxyContin

As recently reported in the Wall Street Journal, the pain killer OxyContin is set to go generic next year, and Purdue Pharma is trying to postpone it.

A funny thing often happens before a drug goes generic. Close to that time the manufacturer comes up with a new indication, formulation or dose. They claim it’s an improvement in the product, but it often has the appearance of coincidentally coming out close to when they would lose exclusive rights to sell the product. And wonder of wonders, they often get the market to themselves for a longer period of time because of it.

As someone who treats a lot of patients with pain, from my perspective OxyContin is a fairly good drug. Because it’s timed release oxycodone, it often gives better pain control, has a lot of dosing flexibility, and probably has less potential of causing addiction than immediate release oxycodone. Less is not none, however, and it’s still a frequently abused drug, whether swallowing the pills, or more illicitly, snorting or injecting it.

OxyContin has a new formulation containing polyethylene oxide that makes it harder to crush or inject. Although it’s not yet clear how effective it will be, the street price has decreased, suggesting it is a less desirable drug for someone wanting to get high. So Purdue Pharma is arguing that no one should be allowed to sell timed release oxycodone that does not have the protection they have, which of course is itself patented until 2025. Purdue Pharma is being sued for allegedly previoulsy making false claims to doctors, minimizing the risk of addiction. That has bearing on their new claim that it’s the new and improved version that has the low risk.

Besides that the improved safety is still not certain, their logic is false. From the perspective of controlling drug abuse, supply will meet demand. People will find better ways to process the new OxyContin pills to make them easier to abuse, or they will use substitutes.

From the perspective of a clinician treating pain patients, the cost of the pills and insurance formularies often dictate what doctors can prescribe. I often don’t prescribe OxyContin now, even when I want to, because of this, and have to prescribe controlled release morphine (which used to be sold as the brand MS Contin), methadone, which is a tricky drug to prescribe with a higher risk of accidental overdose, or use other alternatives.

I hope the FDA does not accept Purdue Pharma’s argument. They should either allow generic OxyContin, with or without the polyethylene oxide contained in the new pills, or allow generic manufacturers to use other similar methods of deterrence.

Author: Daniel Ginsberg, MD, FACP

I'm an internal medicine physician and have avidly applied computers to medicine since 1986, when I wrote my first medically oriented computer programs. So yes, that means I'm at least 35-years-old!

7 thoughts on “FDA and Generic OxyContin”

  1. What about the relevancy of rx patent protection to support the budget (in pricing along with a profit/return to shareholders) for research and development costs that are substantial but necessary to hopefully allow private industry to find new improved drugs, or even cures, along with the costs of product liability premiums when not enough research (cost) and testing can be budgeted for safety even with FDA approval? Historic legislative intent for patent protection was a well thought out concept for the legislation of patents and the requirements, as well as infringement litigation costs that test and validate patents. And, oh yeah, there is a profit motive too, but somewhere the concept of private improvement to medicine and society, with that incentive, does not fit with a socialist regime. Addiction is a social problem, that can be addressed best by drug enforcement officers and improving family mores; ie. parenting skills and improved social services Maybe drug enforcement and social services should be privatized and the results would be improved. It comes down to a profit incentive to get the best people to do the best job or service, competing for that hire. Because government does not pay that well at the top regulatory positions, the FDA. DSHS, and DEA, do not have the best people in charge; then again, we are not to look to be paid top dollar to serve government and public service; who thought that one up?

  2. The oxy neo makes people sick i get heartburn i throw up and it does not work the same like the old oxy.. The doctors should perscribe it too cancer patient like it made for not for people with mild pain and plus the new oxy neo does not work the same thanks

  3. The American people need to exercise their right to take medication without it being tainted with Polyethylene oxide. We need a control pain released Medication and the old oxycontin is and (works the best for us.)

  4. I am sure there are folks out there that need this. But it ruined my sons life. It is highly addictive and completely changes thought processes. The FDA needs to change the make up of all the opiat based drugs to eliminate addiction. It is terrible out there for our youth. The dealers can get them hooked quick and control them completely. It is a shame.

    1. I’m sorry to hear about your son. Opiates are great if you’re in severe pain, but unfortunately they can be addicting and fatal. I don’t think the FDA can do anything to prevent the medications from being addictive, but I hope and expect that eventually biochemists and pharmaceutical companies will develop medications that effectively treat pain, but are not addicting.

  5. when i went to the pain management doctor about 7 years ago for my neuropathy he put me on methadone
    I thought my life was over all I wanted to do was lay around on my couch and take my pill every 4 hours
    is this why people take heroin how sad not even a life
    I talked to my family doctor and he suggested the oxycontine it was great I was taking 30 milligrams twice a day when I met doctor Ginsberg he thought that a bit much so went down to 20 mg twice a day I am just a the bare minimum but think his decision was right I have run out before and did not go thru withdrawals that they talk about just had the horrible pain
    I think people that take it for fun would go thru the withdrawals us in pain just feel the pain
    wish they would make it generic to bring down my costs but the drug companies only see dollar signs how sad is that
    anyway after seeing these 2 sites he has I see doc Ginsberg truly cares about us his patients and the medical profession keep up the good work doc

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