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One of the FDA's biggest concerns is that doctors dole out these painkillers like candy. For example, fentanyl should be used only in patients with severe or chronic pain - such as cancer pain. But doctors have been known to prescribe fentanyl for ailments as minor as sprained ankles and headaches. As a result, people are dying and manufacturers are being sued.
 
Additionally, "non-medical" use (meaning recreational use) of these opioid meds for 18 to 25-year-old Americans rose from 4.1% in 2002 to 4.6% in 2007. This means that opioid painkillers are so readily available, they're now considered street drugs.
 
And what is the FDA doing about this problem? They're considering an REMS (Risk Evaluation and Mitgation Strategy). They're not establishing one...they're considering one. The FDA defines its REMS as follows:  "A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS. Some drug and biological products that previously were approved/licensed with risk minimization action plans (RiskMAPs) will now be deemed to have REMS ."
 
To sum it all up, the FDA is possibly planning to make a plan. What else is new? Read the Wall Street Journal article below:

Pain Drugs to Get New Restrictions
FEBRUARY 9, 2009, 10:34 P.M. ET
By JENNIFER CORBETT DOOREN

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 non-medical 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 heroin-like 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.

Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com

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