International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Gamma-hydroxybutyric acid (GHB); Ketamine; Dextromethorphan; N-benzylpiperazine (BZP); 1-(3-trifluoromethylphenyl)piperazine (TFMPP); 1-(3-chlorophenyl)piperazine (mCPP); 1-(4-Methoxyphenyl)piperazine (MeOPP); 1-(3,4-methylenedioxybenzyl)piperazine (MDBP); Gamma-butyrolactone; 1,4-Butanediol
cder James R Hunter
2013-02-28 2008-10-07 2008-10-07 2008-10-03
FDA-2008-N-0448-0028 FDA-2008-N-0448-0008 FDA-2008-N-0448-0005 FDA-2008-N-0448-0003
05:00:00 04:00:00 04:00:00 04:00:00
https://api.regulations.gov/v4/comments/FDA-2008-N-0448-0028 https://api.regulations.gov/v4/comments/FDA-2008-N-0448-0008 https://api.regulations.gov/v4/comments/FDA-2008-N-0448-0005 https://api.regulations.gov/v4/comments/FDA-2008-N-0448-0003
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Comment submitted by Hyman, Phelps  McNamara on belhalf of Jazz Pharmaceuticals Inc. Jazz Pharmaceuticals believes that the current scheduling is appropriate and further revision to Schedule 2 or 3 would not serve the public health interests.  Please see attachment. To whom it may concern,We represent the Narcolepsy Network, a patient support organization for people with narcolepsy, their families, friends and treating professionals.We are just completing a very succesful conference for our members.Many of our members use Xyrem (sodium oxybate) and feel that they have been able to lead a normal life since they started using this medication.Two of us work in the office at the Narcolepsy Network and we are only able to do this work, because we use Xyrem. Before Xyrem, the quality of life of two of our staff members was negligible and their sense of self value was one of unimportance. One has narcolepsy with cataplexy. Eveline Honig, Executive Director of the Network does not have narcolepsy, but has seen many people function so much better in their work and personal lives after they started using Xyrem. The people we know have been very responsible with their Xyrem regimen.Sincerely,Eveline Honig, MD, Executive Director, NNJoyce Scannell, Office Manager, NNKathleen Randell, Accounting Manager, NN October 3, 2008Division of Dockets Management(HFA-305)Food and Drug Administration5630 Fishers Lane, rm. 1061Rockville, MD 20852Re: International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs;  Dextromethorphan , 73 Fed. Reg. 51823 (September 5, 2008) [Docket No. FDA-2008-N-0448]Dear Sir or Madam:We are pleased to provide comments to the Food and Drug Administration on our perspectives related to the impact of potential international restrictions being placed on dextromethorphan.  The National Association of Chain Drug Stores (NACDS) represents traditional drug stores, supermarkets, and mass merchants with pharmacies. Its more than 170 chain member companies include regional chains with a minimum of four stores to national companies. NACDS members also include more than 1,000 suppliers of pharmacy and front-end products, and nearly 90 international members representing 29 countries. Chains operate more than 39,000 pharmacies, and employ a total of more than 2.5 million employees, including 118,000 pharmacists. They fill more than 2.5 billion prescriptions yearly, and have annual sales of over $750 billion. For more information about NACDS, visit www.NACDS.org.Dextromethorphan is a safe and highly-effective antitussive.  It is non-addictive.   It is the most common ingredient in over-the-counter cough medicines in the United States.  Dextromethorphan has no practical alternative.  It was approved by the FDA in 1950s to replace codeine in cough syrups to prevent codeine abuse. When used in therapeutic doses, dextromethorphan produces very few side effects and has a decades-long history of safety and efficacy.  We ask FDA to recommend to WHO that dextromethorphan not be subject to additional action by WHOs Expert Committee on Drug Dependence after the April 2009 pre-review.   Additional action is not warranted, and could lead to substantial negative impacts upon U.S. citizens.1.Legitimate use of DextromethorphanDextromethorphan is the most commonly used antitussive in the United States.  It is available without a prescription, but is also included in some combination prescription products.  It has been commercially available as an antitussive since the 1950s, and has a long and well-established history of safety.  It is very well tolerated and is highly efficacious in the treatment of acute coughing, especially related to respiratory infections.  It is available in both solid and liquid dosage forms.  It is used for both adult and pediatric patients.  2.Abuse of DextromethorphanAlthough dextromethorphan is an inherently safe substance, we are aware of reports of individuals taking massive doses, such as 25 times or more of the recommended dose, to achieve a hallucinogenic effect.   Most of this abuse is of the finished, commercially-available products, which are swallowed whole.  To our knowledge, chemical extraction is extremely rare.  We are not aware of any routes of administration for abuse besides oral.  This inappropriate use is among teenagers; in fact, the abuse of prescription and non-prescription medications commonly found in home medicine cabinets is a problem somewhat unique to the current generation of teenagers.  This abuse, and how to address it, are common topics of debate and concern among policymakers.  We expect the abuse of these products by teenagers to wane over time both as a result of successes from educational and similar efforts to reduce abuse, and as the novelty of abusing these products diminishes.3.Control of DextromethorphanSince dextromethorphan in not an addictive substance, it is not subject to the controlled substance laws of the United States federal or state governments. It is commonly available in nonprescription preparations, and can be purchased at most retail outlets in the country.  While the ingredient is not subject to controls and while we are unaware of any reports of unfinished dextromethorphan being illegally diverted from the supply chain, it is important to note that we recognize there are reports of isolated incidences of teens purchasing the unfinished, bulk ingredient as a drug for abuse.  Because unfinished dextromethorphan can pose a greater risk given unknown doses and an ability to take extremely excessive amounts, the National Association of Chain Drug Stores supports bills before the U.S. Congress to make the illicit distribution of unfinished dextromethorphan illegal.  Neither the House nor the Senate bill would schedule dextromethorphan in a finished product form, and the Senate bill would prohibit possession or distribution of unfinished dextromethorphan by anyone who does not have a legitimate need for it.4.Impact of SchedulingIf dextromethorphan were to be placed under international control, we fear that it would lead to unnecessary and burdensome restrictions on American consumers ability to access highly safe and effective antitussive preparations.  International controls would likely lead to increased controls in the United States, such as requirements for a practitioners prescription, or even scheduling under the Controlled Substances Act.  This may lead to unnecessary increases in health care costs due to consumers having to seek office visits with practitioners in order to obtain prescriptions to treat common colds and coughs.  Moreover, this would likely lead to greater abuse of codeine, a substance that is well-known as being potentially addictive and for which abuse does occur.  Many states in the United States do allow for the purchase of codeine-based antitussives without a prescription.There is no practical alternative to dextromethorphan available.  The only other FDA-approved over-the-counter cough suppressant available in the United States is diphenhydramine, which causes drowsiness.  Diphenhydramine is commonly used as an over-the-counter sleeping pill.  This somnolescent effect renders diphenhydramine an unsuitable alternative.5.ConclusionWe believe that it would not be appropriate to subject dextromethorphan to international controls.  It is not an addictive substance, its abuse is limited to a teenage sub-culture, and such abuse is dissimilar from the types of abuse we find related to Schedule I-V controlled substances.  Its abuse appears to be related to peer pressure and novelty, as opposed to physical addiction.  There is insufficient evidence that the abuse or potential abuse of dextromethorphan constitutes a public health and social problem warranting international control.  To the extent that there is local abuse of dextromethorphan, there are no indicators that international controls would address the situation.  Instead, in the isolated countries where abuse has been reported, the course taken in the U.S. provides a far better solution:  raising parental awareness and limiting access of the active pharmaceutical ingredient in its unfinished form to only those with a legitimate need.  If dextromethorphan were to be subject to international scheduling, it could have significant negative impacts on U.S. citizens, who may have no reasonable alternative to treat their coughs.  We urge the U.S. government to recommend to the World Health Organization and its Expert Committee on Drug Dependence that dextromethorphan not be considered for further action.We thank you for the opportunity to share our views with FDA on the legitimate uses of dextromethorphan, the impacts of potential scheduling changes on dextromethorphan, and related issues.   If we can provide further information or assistance, please do not hesitate to contact me at knicholson@nacds.org or 703-837-4183.Sincerely,Kevin N. Nicholson, R.Ph., J.D.Vice PresidentPharmacy Regulatory Affairs