PAINKILLER LAW BLOG: The FDA’s Original Blessing Isn’t a Pain Doc’s Original Sin

Doctors who prescribe opioid painkillers to chronic pain patients are, as we know, the subject of intense regulatory and law enforcement scrutiny today. Many of my doctor-clients are under investigation or being charged for supposed crimes arising out of their prescription writing. While every case is different, to me there is a universally applicable defense that should be raised on doctors’ behalf in court against a criminal charge.

That defense relates to lack of criminal intent, since opioids’ addictive power was not known or acknowledged until years after the drugs’ approval for mass use. Today, a criminal charge is at its essence a misguided and ill-considered way of blaming doctors for not having seen the future, for not having foreseen what would happen, even though government regulators and even the drug manufacturing companies didn’t see the abuse crisis coming, either.

The FDA originally blessed the prescribing of powerful and potentially addictive medication for chronic pain. We now know that the scientific evidence offered by Big Pharma about the safety of the medications for chronic pain was incomplete at best, wrong at worst. There are attempts being made today by counsel in various parts of the country to uncover any possible funny business or overly cozy relationships which may have existed between government regulators and private business (Pharma advocates) during the drugs’ approval process years ago. Is this the Erin Brockovich-like scandal waiting to break? Could be.

Whether or not a scandal exists or will be revealed, though, it still must be noted that doctors were the ones who were told by the FDA and the pharmaceutical companies that drugs like Oxycontin and other opioid-based painkillers were safe and effective for chronic pain. The addiction risk was significantly downplayed or underestimated by regulators and manufacturers. The drug companies unleashed a marketing and advertising juggernaut to persuade patients that the miracle pain drugs had at last arrived. That was then; this is now. And now that we know the drugs so frequently lead to addiction, we can change the advice and practice guidelines given to doctors, but we cannot hold them legally accountable for not knowing what the rest of us didn’t know, either – or what some people in the game may not have revealed – years ago.

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PAINKILLER LAW: New Drug Control Policy; Caution Urged for Prescription Painkiller Providers

Prevention and treatment of drug abuse are the new watchwords of today’s newly released National Drug Control Strategy, published by the White House’s Office of National Drug Control Policy (ONDCP).  While the government wants to find a workable balance between what it calls the “enforcement-centric war on drugs and the extreme position of legalization,” the MD’s, DO’s and PA’s who write prescriptions for painkillers should only expect continued and increasing government scrutiny.

I say this because the ONDCP’s emphasis on prevention and treatment is directed at the user, not the person who provides the drug to the user.  And while the ONDCP discussion largely focuses on the market for illicit drugs such as cocaine and methamphetamine, the government continually talks of the perceived epidemic of prescription painkiller abuse.  The focus of government agencies like the FDA, DEA, state Medical Boards and local law enforcement is on doctors and physician’s assistants who write prescriptions for controlled substances.  Just today, in fact, the DEA raided (for the second time in several months) a Jupiter, FL Walgreens distribution center, on the theory that Walgreens may be diverting or at least failing to keep track of mass quantities of oxydocone and other opioid derivatives.  Walgreens maintains it is cooperating with federal authorities in the matter.

The lesson from these two stories is that while the end-user, in your case the patient, may benefit from the White House’s new policy imperatives, the healthcare provider writing the Schedule II painkiller prescription will continue to be under the government’s watchful eye.  Now more than at any time in memory, provider compliance with federal and state criminal laws governing the prescription and dispensing of prescription painkillers is critical to the survival of any medical practice.  The range and depth of laws to comply with is formidable, and obtaining competent and thorough legal advice on the matter is highly advisable.

Contact PAINKILLER LAW – the Meister Law Offices – at 213.293.3737 for a free consultation about Criminal Law Compliance for Healthcare Providers.  Or, email us at info@painkillerlaw.com

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