Monday, October 28, 2013

FDA - Regulations to Curb Prescription Drug Abuse

"F.D.A. Shift on Painkillers Was Years in the Making" by BARRY MEIER and ERIC LIPTON, New York Times 10/27/2013


When Heather Dougherty heard the news last week that the Food and Drug Administration had recommended tightening how doctors prescribed the most commonly used narcotic painkillers, she was overjoyed.  Fourteen years earlier, her father, Dr. Ronald J. Dougherty, had filed a formal petition urging federal officials to crack down on the drugs.

Dr. Dougherty told officials in 1999 that more of the patients turning up at his clinic near Syracuse were addicted to legal narcotics like Vicodin and Lortab that contain the drug hydrocodone than to illegal narcotics like heroin.

Since then, narcotic painkillers, or opioids, have become the most frequently prescribed drugs in the United States and have set off a wave of misuse, abuse and addiction.  Experts estimate that more than 100,000 people have died in the last decade from overdoses involving the drugs.  For his part, Dr. Dougherty, who foresaw the problem, retired in 2007 and is now 81 and living in a nursing home.

“Too many lives have been ruined,” his daughter said.

The story behind the F.D.A.’s turnaround on the pain pills, last Thursday, involved a rare victory by lawmakers from states hard hit by prescription drug abuse over well-financed lobbyists for business and patient groups, one that came during a continuing public health crisis.

Just last year, Representative Fred Upton, Republican of Michigan — the House’s biggest recipient during the last election cycle of drug industry campaign contributions, with nearly $300,000 — blocked a measure that would have imposed the restrictions the F.D.A. backed last week.

Among the provisions in the bill, pushed by Senator Joe Manchin III, Democrat of West Virginia, was one that is central to the new F.D.A. recommendations: reducing to 90 days the length of time in which a patient could obtain refills for painkillers containing hydrocodone without a doctor visit.  The drugs are now widely sold by generic producers.

Mr. Upton, who is the chairman of the House Energy and Commerce Committee, argued that imposing new limits would harm patients who needed the drugs, which are used to treat pain from injuries, arthritis, dental extractions and other problems.  That stance was echoed by patient groups, lobbyists representing drug makers, pharmacy chains like Walgreens and CVS, local drugstores and physicians groups like the American Medical Association.

The F.D.A.’s long resistance to added restrictions on the drugs underscores what critics say is its continuing struggle to address the complexities of the painkiller problem in its often conflicting roles — one as a regulator that approves drugs and the other as a drug safety watchdog.

On Friday, public health advocates who had cheered the agency’s decision the day before were dismayed when the F.D.A. approved a new, high-potency painkiller despite an 11-2 vote by an expert panel of its own advisers not to do so.  The panel concluded in December that the long-acting opioid, called Zohydro, could lead to the same type of abuse and addiction as OxyContin.

"FDA plan to limit painkiller abuse may have impact for patients who need them" PBS Newshour 10/25/2013


SUMMARY:  While millions of people use prescription painkillers for relief, their abuse has reached epidemic levels in some places.  To combat rising addiction rates, the FDA has a new plan to limit the distribution of pain meds, specifically containing hydrocodone.  Hari Sreenivasan gets more from Barry Meier of The New York Times.

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