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 Dougherty, had filed a formal petition urging federal officials to crack down on the drugs.
Ronald Dougherty told officials in 1999 that more patients were turning up at his clinic near Syracuse, N.Y., 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. Over 100,000 people are estimated by experts to have died in the last decade from overdoses involving the drugs. "Too many lives have been ruined," Heather Dougherty said.
The story behind the FDA's turnaround Thursday on the pain pills involved a rare victory by lawmakers from states hard hit by prescription drug abuse over well-financed lobbyists for business and patient groups.
Just last year, Rep. Fred Upton, R-Mich., the biggest recipient in the House during the last election cycle of drug industry campaign contributions, with nearly $300,000, blocked a measure that would have imposed the restrictions the FDA backed last week.
Among the provisions in the bill was one that is central to the new proposed FDA regulations: reducing to 90 days the length of time in which a patient could get refills for painkillers containing hydrocodone before going back to see the doctor.
Upton 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.
The FDA's long resistance to added restrictions on the drugs underscores what critics say is its struggle to address the complexities of the painkiller problem in the agency's often conflicting roles — one as a regulator that approves drugs and the other as a drug safety watchdog.