FDA’s Proposed Reclassification of Hydrocodone a Dangerous Precedent for Patient Care

In an effort to apparently combat “misuse and abuse” of pain-killing drugs, the Food and Drug Administration has proposed new restrictions that would change regulations for some of the most commonly prescribed narcotic painkillers on the market, specifically, hydrocodone combination pills also known as opioids, which combine hydrocodone with less potent painkillers such as acetaminophen. One widely-used drug is Vicodin, or hydrocodone APAP with Tylenol.

Currently labeled as Schedule III drugs, hydrocodone combination drugs would, if the reclassification proposal is accepted, be labeled as Schedule II. This means patients would have to have a written prescription from a doctor, instead of a prescription submitted over the phone, to obtain the drugs. And refills would be prohibited. Instead, patients would have to check in with the doctor to get a new prescription for each refill. A Schedule II classification would also put manufacturing quotas in place for these hydrocodone products. Pure hydrocodone is already a Schedule II substance.

These new restrictions would no doubt make it much more difficult for sick patients with legitimate medical concerns to obtain access to these medications that they’ve used safely for years. These new restrictions, if passed, would no doubt put patients under unnecessary risks and stresses, delaying treatment and posing considerable additional costs to patients in time and more costly alternatives. Some patients may also turn to “street” forms of Vicoden, as well as those available over the internet, which can often not be the same drug. The federal government’s DEA agency also led a campaign on these proposed changes, as was the original bill drafted by Sen. Joe Manchin (D-WV).

However, as a patient advocate, neuroscientist, and long-time hydrocodone user for complications relating to hydrocephalus, I view this proposal as a dangerous new precedent and example of government, as an outside 3rd party, over-extending its authority in interfering in patient care in a matter where there is no clear product safety issue. The same could be said for guns or gasoline, where a consenting adult lawfully chooses to shoot him or herself, or drink gasoline. Do you ban the guns and gasoline? They will merely find another alternative, and very likely one that is more problematic.

And it gets even worse. Dr. Sidney Wolfe, long time medical director of the group, Public Citizen, spoke out in favor of the proposed changes saying he thinks it will curtail drug overdoses and mis-use. But, we know that such reasoning has not worked in the past where there is a rational need, no clear risk, and the alternatives, street and internet drugs, then become the new problem. Dr. Wolf’s comments can be found via this link:


The reality is that there is a true medical need in a vast number of the prescriptions amid an aging population, with arguably limited care & alternative options available to the millions of users, and with a pretty widespread lack of understanding of pain management practices by prescribing physicians. Plus, in countries with fewer pain medication problems, they have far more alternative & Eastern medicine modalities at their disposal. In the U.S., such “alternative” therapies like acupressure, massage, energy healing are not covered by insurance. So in these regards, it would appear the U.S. has created many of its own problems.

Most recently, Janet Woodcock, M.D., Director, Drug Evaluation and Research at the Food & Drug Administration, authored a “statement” in support of this hydrocodone reclassification. She takes more the position of the DEA than that of a treating physician on safety and efficacy, and she offers no alternate solution. Her views are unprecedented in patient safety and access to care, where government can see a problem and take action without there being an issue of product safety. Here statement can be found via this link:


As you can see, I do not support the government’s position in restricting access to a medical drug or device where there is no safety issue in the drug or device or medical treatment when used according to the labeling. In my view, the problems are more a misunderstanding of pain management practices, poor & failed care, and a lack of available funded alternatives. Pain management is in fact a medical specialty, where there are specific courses to follow, too few physicians follow these, and where patient and physician widely use drugs like hydrocodone because of economic reasons….. which may amount to one more reason for ObamaCare.

There are many medical products that are safe when used as directed. But, casting a restrictive blanket policy over a class of safe products because of physician expertise or available care dollars, or because “the nation” is suffering a health & mental health crisis, is ludicrous!

Further, these new restrictions will compromise the care of user patients. Some will seek illegal street and cross border drugs, and drugs thru the internet, which pose much higher risks & costs, while others such as myself, will face compromises and a deterioration of their care, and for no other reason than the DEA wants to curtail illegal drug use. This is a failed policy used in the 1930s!

As for the group, Public Citizen, I earlier worked on a shunt device safety issue with them in 1996, and upon their urging, I petitioned FDA on widespread safety issues with CNS anti-siphon shunts. The petition was considerable and took me 9 months to complete. FDA sided with me, and then held the 1999 STAMP Conference on High Risk CNS Shunt Devices in Washington, D.C. But as I had criticized a medical device company (Medtronic Inc.), someone saw to it that I was never placed on the STAMP advisory panel. And in the years since, CNS shunt safety issues have been atrocious, and despite my repeated inquiries to FDA on these safety problems, including, a request in 2003 for new Postmarket Surveillance of CNS shunt technology used in the treatment of hydrocephalus, no new safety initiatives were ever undertaken, and there were clear device safety issues. I find it odd that FDA could not act on CNS shunt safety where there were clear product safety issues, yet, was happy to over-step its authority in this hydrocodone matter where there is no product safety issue. In the latter, the issue is more one of physician oversight and a lack of health care dollars. I do not see how restricting the product solves this!

My latest CNS shunt which was implanted last November 2012 has already been recalled. Oddly, my earlier model like this in 2007 that kept loosing its setting and had to be surgically replaced, never faced any recall, and that issue was much more substantial that the most current model. I cannot wrap my head around the safety views adopted by FDA today. It really is shocking!

As for Public Citizen, I no longer have any relationship with them, in part because they never took any interest in my revelations of widespread failures of CNS shunt devices in the field, some of them involving criminal misconduct. And I felt they’d become too political. Their misguided activism in this recent hydrocodone bill only solidifies my concerns.

But I think my bigger concern now is WHAT’S NEXT? I mean, we already have massive authorization and reimbursement problems with drugs, devices, and many medical tests. And hydrocodone is very cheap in price compared to the alternatives. So how will this new government philosophy concerning medical care more forward, where a 3rd party group with no connection or standing in the care of a patient, is allowed to champion restrictions in patient care merely because they fear the a particular product poses a secondary social issue?

The reality is that this new bill is much bigger than hydrocodone use or misuse. It’s about the government’s prerogative to interfere in one’s access to medical care and treatment, not to mention one’s civil rights pertaining to health & happiness as protected under the Constitution! No doubt this proposed new legislation is a shocking invasion by government into one’s private life and medical matters, and represents a dangerous precedent over matters of patient care.

Stephen Dolle
Dolle Neurosciences
Newport Beach, CA


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