Dextromethorphan likely will escape scheduling as a controlled substance in the near term, but manufacturers and lawmakers should push efforts to curb abuse to keep the cough suppressant available OTC in the long run.

If pending legislation and industry efforts fail to control DXM abuse within two years, FDA and the Drug Enforcement Administration should reconsider scheduling the cough suppressant as a controlled substance, an expert panel recommended Sept. 14.

FDA's Drug Safety and Risk Management Advisory Committee voted 15-9 against scheduling dextromethorphan as a controlled narcotic, which would have severely limited - or in some states eliminated - OTC access to the more than 100 nonprescription products containing the ingredient.

DEA requested a scientific and medical evaluation of the drug and scheduling recommendation in response to teenagers' abuse of the drug for its hallucinogenic effects. Approximately 5 percent of U.S. teenagers in 2009 admitted to "robo-tripping" - a nickname inspired by abusing Pfizer's Robitussin , which contains DXM. Reckitt Benckiser's Delsym and Procter & Gamble's Vicks NyQuil products also include the active ingredient and are abused by some adolescents (¹ 'The Tan Sheet' Jan. 4, 2010, In Brief and ² Also see "FDA Risk Panel DXM Meeting Raises Stakes on Age Restriction Movement" - Pink Sheet, 10 May, 2010.).

Several members of the committee argued the relatively limited extent of abuse did not validate scheduling DXM at this time, but suggested FDA and DEA re-evaluate in two years if Congress does not pass legislation to restrict bulk sales of DXM and prohibit sales of the drug to consumers younger than 18 years.

"If bulk sales don't change, if access to young age groups doesn't change, I would have viewed this vote as a mistake," said Richard Denisco, a medical officer with the National Institute on Drug Abuse, who voted against the change.

Elaine Morrato, assistant director of the Children's Outcomes Research Program at the University of Colorado Denver, who also voted against scheduling the ingredient, added education outreach conducted by the Consumer Healthcare Products Association and "limiting access to teens is my preferred route" to reduce DXM abuse.

But Morrato agreed with Denisco that "we should proceed to scheduling" if legislation restricting sales and limiting adolescent access to DXM does not pass in two years.

Despite competing legislative priorities and partisan bickering, Consumer Healthcare Products Association President Linda Suydam predicted passage by 2012 of S. 1383, which would prohibit the sale of products containing DXM to consumers younger than 18 years, and H.R. 1259, which would restrict the sale of bulk unfinished DXM.

Bills to restrict bulk DXM sales passed the House in 2006, 2007 and 2009 before stalling in the Senate each year (³ Also see "DXM Distribution Legislation Clears House And Moves To Senate Again" - Pink Sheet, 6 April, 2009.). A bill to restrict sales to minors also stalled in the House Judiciary Committee after passing the Senate in June 2009 (⁴ 'The Tan Sheet' June 29, 2009, In Brief).

"I think this can pass," Suydam said, despite a "somewhat paralyzed" Congress and a distracted Senate that has "obviously been engaged with a lot of other activities in the last year, like health care reform, finance reform and Supreme Court nominations."

"All our companies are using their people to go and speak to their congressmen and senators about it, and if we get support from FDA and DEA I think we will have a better chance of getting the bills passed in this Congress. I think that it is key to get it passed this year."

Some Members Doubt Congress Will Act

Not all committee members shared Suydam's optimism and they voted to schedule DXM partly because they said it appears to be the only way to restrict access given Congress' inaction.

"I am not confident Congress will act in a timely manner or at all, and I think it is completely unrealistic that an age restriction would even be enforced for a cough syrup," said committee chairwoman Judith Kramer, associate professor of medicine at Duke University Medical Center.

Indeed, time is running out for the 111 Congress. If legislators fail to pass the bills before the 112 Congress starts in January, they will need to start the process over.

Suydam also discussed the industry's efforts with retailers to establish age restrictions voluntarily (see ⁵ Also see "DXM Panel Proposes Augmenting, Improving Education To Curb Abuse" - Pink Sheet, 20 September, 2010.).

Some View Scheduling As Way To Control Bulk

Considering that "most bills don't make it," Richard Honsinger, a physician at Los Alamos Medical Center Clinic in New Mexico, voted to schedule DXM because, he said, it "is the only way to restrict access to this drug."

Kramer agreed, noting scheduling DXM would be a "roundabout way" to restrict bulk sales and bypass congressional efforts.

She qualified her vote by pointing to a provision in the Controlled Substance Act that would allow manufacturers to apply for an exemption from scheduling for OTC products. Whether DEA would approve such exemptions and how long the process would take was unclear to other panelists.

The exemption would not apply to sales of unfinished bulk DXM, Rx products or illegal products, FDA said.

Scheduling Seen As Too Extreme For Abuse Rate

Given the less restrictive options for potentially controlling abuse, several panelists rejected scheduling as too extreme for the scope of abuse.

"I believe we should try to find the appropriate-sized patch to fix the hole we are trying to patch. I think scheduling is a relatively drastic move to fix a problem that is far from epidemic," said Lawrence Carter, an assistant professor at the University of Arkansas for Medical Sciences Psychiatric Research Institute, who voted no.

The 5 percent abuse rate by teens has held steady since researchers began monitoring cough product abuse. Partnership for a Drug-Free America reveals half of the teens who try DXM do so only a "few times and stop because of negative side effects such as vomiting and dysphoria," CHPA notes in a Sept. 14 statement.

In part for these reasons, Warren Bickel, director of the Arkansas Center for Addiction Research at the University of Arkansas for Medical Sciences, agreed scheduling is too severe.

He noted, "I think we need to have a scalpel to address the problem, not a big hammer."

Other panelists were deterred from scheduling to preserve OTC access.

"Most pharmacies do not carry Schedule V drugs," even though they technically can be OTC in many states, so "if you schedule dextromethorphan it doesn't mean it will be available," said committee member Janet Engle, executive associate dean and head of the department of pharmacy practice at the University of Illinois at Chicago College of Pharmacy (⁶ Also see "NDAC Veterans Join DSaRM Advisory Panel For DXM Safety Meeting" - Pink Sheet, 13 September, 2010.).

Even if a pharmacy carries a Schedule V drug, it would be behind the counter, where there is limited space, Engle said. She explained "there is no way" that all 100-plus DXM products would fit BTC and that most pharmacies "will carry one, if they are lucky," which eliminates consumer choice.

Engle's argument helped sway Morrato to vote no because she said she "was interested in ensuring that OTC access to the drugs is protected." Allen Vaida, executive VP at the Institute for Safe Medication Practices, also voted no partly because he said he "was afraid of the limited access."

Engle added she voted against scheduling DXM because "I don't think there is any data to show that scheduling this drug necessarily decreases abuse."

Indeed, FDA did not present any data showing scheduling limits abuse. On the other hand, Stephen Pasierb, president and CEO of Partnership for a Drug-Free America, presented on behalf of CHPA that scheduling likely would not decrease abuse because so many teenagers easily obtain and abuse scheduled and prescription drugs, such as codeine (⁷ Also see "Extent Of DXM Abuse May Not Support Scheduling" - Pink Sheet, 6 September, 2010.).

"From my standpoint and the child's standpoint the scheduling doesn't have a deterrent impact. Whether or not it has an availability impact is out of my area of expertise. But, clearly we are dealing with prescription opioids, prescription sedatives, prescription tranquilizers and prescription other things that kids are abusing as part of this overall medicine abuse behavior and all of them have the scheduling as a common quality," Pasierb noted.

The Next Step

An FDA official said it will take at least a couple of months before the agency makes a recommendation to DEA on scheduling DXM. The official noted the committee gave the agency multiple options beyond scheduling to consider.

CHPA encourages FDA in its statement to "follow the advisory committee's guidance and weigh the important public benefit of over-the-counter access to these medicines in making its final recommendation."

- Elizabeth Crawford ( ⁸ e.crawford@elsevier.com )

FDA Panel Says Leave DXM Unscheduled For Now, Urges Congressional Action

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