PAIN DRUGS TO GET NEW RESTRICTIONS

The Food and Drug Administration said Monday it will subject the
makers of certain extended-release pain drugs to a new risk-management
program designed to cut down on misuse and abuse of the products.

New government figures show a rise in nonmedical use of prescription
pain drugs among adults. Opioid drugs formulated in extended-release
versions of OxyContin, morphine and fentanyl patches are meant for
round-the-clock pain management for patients with cancer and other
chronic conditions.

Misuse and Abuse FDA officials have said they've seen reports of
inappropriate prescribing by doctors amid the increase in misuse and
abuse, both intentional and unintentional, of the products since the
drugs were first approved in the mid-1990s. Active ingredients in the
drugs are designed to treat pain for an extended time, such as 12 hours.

Drug abusers can tamper with such products and get all the effects of
a drug at once, creating a heroinlike high. "We continue to see
reports of an ankle sprain and [patients] are given a fentanyl patch,"
said John Jenkins, the director of the FDA's office of new drugs. He
said a major part of the new program will be efforts to educate
doctors about appropriate prescribing of the products. "This obviously
is going to be the largest risk-management program we've undertaken,"
he said. Although Mr. Jenkins and other agency officials wouldn't
speculate about what the final risk-mitigation program would look
like, it could have elements of a program designed to limit the use of
the acne drug isotretinion (commonly known by the brand name Accutane)
by women of child-bearing age because the product causes birth defects.

That program requires doctors, pharmacists and patients to register
and meet certain requirements in order to get a new prescription each
month. The agency sent letters to 16 manufacturers of 24 products
including Purdue Pharma LP, the maker of OxyContin, which is available
in an extended-release form; a unit of Johnson & Johnson that makes a
fentanyl patch; and King Pharmaceuticals Inc., the maker of an
extended-release form of morphine.

The letters told the drug makers of agency plans to require a
risk-evaluation and -mitigation strategy, or REMS, "to ensure that the
benefits of the drugs continue to outweigh the risks."

Getting Input The FDA said it would meet with the drug manufacturers
next month to talk about developing a REMS and would then meet with
other federal agencies, patient and consumer-advocacy groups and
health-care professionals to get additional input in the coming months.

There will be no immediate changes for prescribers or users of
extended-release pain pills.

An estimated 21 million prescriptions for extended-release opioids
were prescribed for 3.7 million patients in 2007, Mr. Jenkins said.
Other pain pills that are immediate-release and more commonly
prescribed for pain won't be affected.

The agency noted that previous efforts to cut down on abuse and misuse
of extended-release products, such as putting additional warnings on
products labels, haven't really worked.

"Despite these efforts, the rates of misuse and abuse, and of
accidental overdose of opioids, have risen over the past decade," the
agency said in a statement posted on its Web site. "The FDA believes
that establishing a REMS for opioids will reduce these risks, while
still ensuring that patients with legitimate need for these drugs will
continue to have appropriate access." The FDA can mandate the elements
of a risk-management plan as part of legislation that took effect last
year. Mr. Jenkins said that authority should make the new effort to
cut down on abuse and misuse more effective than previous plans.