January 25, 2013

F.D.A. Likely to Add Limits on Painkillers | New York Times

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 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. 

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. 

 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 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.

The vote comes after similar legislation in Congress failed last year, after aggressive lobbying by pharmacists and drugstores.

“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 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.

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.

“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.

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.

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.

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.

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 under-age children, these drugs are easier to get than beer or cigarettes.”

By:  Sabrina Tavernise