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FDA: Don't Tighten Vicodin Regulation
By David Pittman, Washington Correspondent; Kristina Fiore, Staff Writer, MedPage Today
Published: October 25, 2012
WASHINGTON -- Hydrocodone-containing combination products, such as hydrocodone/acetaminophen (Vicodin), should be kept as Schedule III controlled substances and not be subject to tighter regulations to prevent abuse, the FDA recommended Thursday.
There's insufficient evidence to support the Drug Enforcement Administration's (DEA) finding that hydrocodone-containing products have a similar abuse potential as Schedule II drugs and should be regulated as such, the FDA said in briefing documents released ahead of a public meeting next week on the issue.
"It is clear, however, from [FDA] analyses that combination hydrocodone-containing analgesics are widely abused, but no objective threshold exists to correlate levels of abuse with the level of scheduling," Silvia Calderon, PhD, team leader for pharmacology on the FDA's controlled substance staff, wrote in the documents.
Hydrocodone alone is already a Schedule II drug.
There have been a number of efforts to move hydrocodone combination products to Schedule II, which would put more stringent requirements on storage and prescribing, including limits on oral prescriptions and refills.
The most recent effort on the federal level came as an amendment to the Senate's FDA user fee reauthorization bill. However, that provision was stripped before the final bill was passed, and the two-day meeting being held in Silver Spring, Md., was the compromise for its deletion, according to Sen. Joe Manchin (D.-W.Va.).
And last June, New York state passed a law that will make hydrocodone combination products schedule II drugs.
But the charge to up-schedule these drugs has spanned more than a decade, with the DEA receiving a Citizen's Petition in 1999 to investigate the issue.
In 2004, the DEA asked the Department of Health and Human Services (HHS) to look into a schedule change, and HHS concluded in 2008 that hydrocodone combo products could remain Schedule III drugs.
The following year, DEA asked the FDA's Center for Drug Evaluation and Research to re-evaluate drug abuse-related data for hydrocodone combination products, and the center's final analysis will be presented at a meeting of the agency's Drug Safety and Risk Management Advisory Committee on Monday and Tuesday.
The panel is comprised of the committee's regular members as well as a handful of temporary members who will have the opportunity to vote on whether to up-schedule or not.
Those temporary panelists include Perry Fine, MD, of the University of Utah, a former board member of the American Pain Foundation (APF), which shuttered last spring after reports of its financial ties to the pharmaceutical industry. A Senate Finance Committee investigation into the ties between opioid drugmakers and various physician and advocacy groups is ongoing.
Other temporary panel members also include Angie Gravois, a pain patient who formerly spoke on behalf of the APF, Michael Fry, the pharmacy manager for Rite Aid Corp., and a handful of other pain specialists and chronic pain advocacy groups.
Those panelists are balanced by representatives from the CDC and other clinicians, including Lewis Nelson, MD, of New York University, who have been pushing for increased awareness of the prescription painkiller abuse epidemic.
An FDA spokesperson said it's not unusual to include temporary voting members, though it's not routine for every drug safety advisory committee.
In its own risk analysis study, which it released online ahead of the meeting, the FDA found more emergency department visits and more toxic exposures with oxycodone combination products -- such as oxycodone/acetaminophen (Percocet) -- than hydrocodone combos.
It also highlighted similar initiation rates for both products, and concluded that it "could not find data to support DEA's assertion that the addition of acetaminophen to hydrocodone tablets does not deter abuse."
The FDA and DEA noted that it's difficult to ascertain the abuse of specific hydrocodone combination products, since there is no single national system for collecting data on both events representing abuse and a measurable population exposed to risk.
The FDA outlined a number of other reasons against up-scheduling hydrocodone.
There could be an increase in the use of nonsteroidal anti-inflammatory drugs (NSAIDs) if these other drugs are up-scheduled and therefore become harder to prescribe.
Also, with their usual Schedule III drugs now on Schedule II, providers may be more likely to prescribe Schedule II opioids more frequently, the agency charged.
In addition, codeine-containing cough suppressants would be the sole option among antitussive opioid combination Schedule III products with the up-schedule.
Should the schedule change occur, clinicians will face greater barriers to prescribing the drug. Schedule II drugs must be handwritten and pharmacies must have the original prescription in hand before dispensing. Also in many states, mid-level practitioners are not authorized to prescribe Schedule II drugs.
But critics are still concerned that hydrocodone combination products are just as addictive as oxycodone combination products, which already fall under Schedule II.
"FDA doesn't need to go much further than [a handful of published journal] articles to conclude that Vicodin belongs in the same schedule as Percocet," Andrew Kolodny, MD, chair of psychiatry at Maimonides Medical Center in New York, told MedPage Today.
Still, FDA concluded that "alternatives to up-scheduling may also decrease the levels of abuse and misuse of these products." And an analysis from the Generic Pharmaceutical Association, included in the meeting preview documents, similarly concluded that "drug abuse is a complex problem that is not likely to be addressed by rescheduling of drugs or other regulations."
Several groups, including Advocates for the Reform of Prescription Opioids and Save the Michaels of the World, plan to protest against FDA's stance during the meeting.