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F.D.A. Panel Votes to Restrict Drugs Like Vicodin F.D.A. Likely to Add Reins on Painkillers
(about 3 hours later)
Trying to stem the scourge of prescription drug abuse in the United States, an advisory panel of experts to the Food and Drug Administration voted on Friday to toughen restrictions on Vicodin and other hydrocodone products, the most widely used narcotic painkillers in the country. Trying to stem the scourge of prescription drug abuse, an advisory panel of experts to the Food and Drug Administration voted on Friday to toughen the restrictions on painkillers like Vicodin that contain hydrocodone, the most widely prescribed drugs in the country. 
The panel voted 19 to 10 in favor of the recommendation, which the F.D.A. will likely follow, which would limit access to the drugs by making them harder to prescribe, a major policy change that advocates said could help ease the growing problem of addiction to painkillers. The recommendation, which the drug agency is likely to follow, would limit access to the drugs by making them harder to prescribe, a major policy change that advocates said could help ease the growing problem of addiction to painkillers, which exploded in the late 1990s and continues to strike hard in communities from Appalachia and the Midwest to New England. 
The change would have sweeping consequences for doctors, pharmacists and patients. Under the new rules, refills without a new prescription would be forbidden, as would faxed prescriptions and those called in by phone. Only written prescriptions from a doctor would be allowed, and pharmacists and distributors would be required to store the drugs in special vaults. The vote comes after similar legislation in Congress failed last year, after intense lobbying by pharmacists and drugstores. But at 19 to 10, the vote was far from unanimous, with some opponents expressing skepticism that the change would do much to combat abuse. Oxycodone, another highly abused painkiller and the main ingredient in OxyContin, has been in the more restrictive category since it first came on the market, they pointed out in testimony at a public hearing. They also said the change could create unfair obstacles for patients in chronic pain. 
Prescription drugs account for about three-quarters of all drug overdoses in the United States, with the number of deaths more than tripling since 1999, according to federal data. Since 2008, deaths from overdoses have outpaced deaths from car accidents.  Painkillers now take the lives of more Americans than heroin and cocaine combined, and since 2008, drug-induced deaths have outstripped those from traffic accidents. Prescription drugs account for about three-quarters of all drug overdose deaths in the United States, with the number of deaths from painkillers quadrupling since 1999, according to federal data.
The F.D.A. convened the panel, made up of scientists and other experts, after a request by the Drug Enforcement Administration, which contends that the drugs are among the most frequently abused painkillers in the country. The change would have sweeping consequences for doctors, pharmacists and patients. Refills without a new prescription would be forbidden, as would faxed prescriptions and those called in by phone. Only written prescriptions from a doctor would be allowed. Distributors would be required to store the drugs in special vaults.
“This is the federal government saying, ‘we need to tighten the reins on this drug,'” said Scott R. Drab, associate professor of pharmacy and therapeutics at the University of Pittsburgh’s School of Pharmacy. “Pulling in the rope is a way to rein in abuse, and consequently, addiction.” The vote comes after similar legislation in Congress failed last year, after aggressive lobbying by pharmacists and drug stores.
At a two-day hearing at F.D.A. headquarters in Silver Spring, Md., many speakers opposed the change, including advocates for nursing home patients, who said older, frail residents needing pain medication would now be required to make the arduous trip to a doctor’s office to continue using hydrocodone products. Other experts questioned how effective the change would be. Oxycodone, another highly abused painkiller and the active ingredient in OxyContin, has been in the more restrictive category since it came on the market, but the limited access does not seem to have stemmed abuse, they said. “This is the federal government saying, ‘we need to tighten the reins on this drug,’ ” said Scott R. Drab, associate professor of pharmacy and therapeutics at the University of Pittsburgh’s School of Pharmacy. “Pulling in the rope is a way to rein in abuse, and, consequently, addiction.”
But others, including parents who had lost their children to prescription drug abuse, as well as doctors and pharmacists, testified in favor of the proposed restrictions, sometimes emotionally. Senator Joe Manchin III, a Democrat from West Virginia, where the scourge has been particularly deadly, made an impassioned plea. But at the panel’s two-day hearing at F.D.A. headquarters in Silver Spring, Md., many spoke against the change, including advocates for nursing home patients, who said frail residents with chronic pain would have to make the trip to a doctor’s office. The change would also ban nurse practitioners and physician assistants from prescribing the drugs, making it harder for people in underserved rural areas.
“When I go back to West Virginia, I hear how easy it is for anybody to get their hands on hydrocodone drugs,” Mr. Manchin said on Friday. “For underage children, these drugs are easier to get than beer or cigarettes.” Panelists also cautioned that the change would produce a whack-a-mole effect, pushing up abuse of other drugs, like heroin, which has declined in recent years.
He added that the less restrictive status was “fueling the prescription drug epidemic today.” “Many of us are concerned that the more stringent controls will eventually lead to different problems, which may be worse,” said Dr. John Mendelson, a senior scientist at the Addiction and Pharmacology Research Laboratory at the California Pacific Medical Center Research Institute in San Francisco.
Dr. James P. Rathmell, chief of the division of pain medicine at Massachusetts General Hospital, said hydrocodone products had similar biological effects as oxycodone products and should unquestionably be in the same category of restrictiveness. The F.D.A. convened the panel, made up of scientists, pain doctors and other experts, after a request by the Drug Enforcement Administration, which contends that the drugs are among the most frequently abused painkillers and should be more tightly controlled.
“Knowing what we know today, it was a mistake,” Dr. Rathmell said, referring to hydrocodone products being placed in the looser category when they came on the market. “It should be corrected.” If the F.D.A. accepts the panel’s recommendation, it will be sent to officials at the Department of Health and Human Services, who will make the final determination. The F.D.A. denied a similar request by the D.E.A. in 2008, but the law enforcement agency requested that the F.D.A. reconsider its position in light of new research and data.
Dr. Timothy R. Deer, a pain management specialist at the Center for Pain Relief in Charleston, W.Va., said that he feared for older patients, particularly in rural areas, who would now have farther to drive to get their prescriptions renewed. But since hydrocodone products have been by far the most widely prescribed painkiller, toughening the restrictions on them is a worthy trade-off, he said, particularly in a hard-hit state like West Virginia. While Hydrocodone products are the most widely prescribed painkillers, they make up a minority of deaths, because there is less medication in each tablet than some of the other more restricted drugs, like extended-release oxycodone products, said Dr. Nathaniel Katz, assistant professor of anesthesia at Tufts University School of Medicine in Boston. Oxycodone and methadone products account for about two-thirds of drug overdose deaths, he said, despite accounting for only a fraction of hydrocodone prescriptions.
“At the end of the day, the benefits of reducing abuse will outweigh the harm to legitimate pain patients,” Dr. Deer said. “This will likely reduce the amount of drug falling into the wrong hands.” The importance of Friday’s vote was more symbolic, he said, a message to doctors that they will need to think twice before prescribing hydrocodone, and to patients that the days of “unbridled access” are coming to an end. The tide has been turning against easy opioid prescriptions, as the medical system and federal regulators slowly make adjustments to reduce the potential for abuse.
“It will help shape thinking,” said Dr. Katz, whose clinical research company, Analgesic Solutions, is trying to develop other treatments for pain. “It’s an important marker in the progressively more conservative swing of the pendulum in opioid prescribing.”
He cautioned that patients who need the medications for pain should not suffer inappropriate barriers to access because of the change, a concern that the dissenters shared.  Medical professionals battling the prescription drug abuse epidemic applauded the change.
"This may be the single most important intervention undertaken at the federal level to bring the epidemic under control,” said Dr. Andrew Kolodny, chairman of psychiatry at Maimonides Medical Center in New York and president of Physicians for Responsible Opioid Prescribing, a New York-based advocacy group. "This is about correcting a mistake made 40 years ago that’s had disastrous consequences.”
Testimony at the hearing included emotional appeals from parents who had lost their children to painkiller addiction. Senator Joe Manchin III, a Democrat from West Virginia, a state that has been hit hard by the prescription drug epidemic, pleaded for tougher restrictions.
“When I go back to West Virginia, I hear how easy it is for anybody to get their hands on hydrocodone drugs,” Mr. Manchin said. “For underage children, these drugs are easier to get than beer or cigarettes.”