Republicans push FDA to consider tougher curbs on painkillers

A pair of Republican lawmakers is taking the Obama administration to task for not considering tougher restrictions on painkillers in its new strategy to combat prescription drug abuse.

The plan unveiled Tuesday requires drugmakers and prescribers to better inform patients about the risks of painkillers, which are fueling what some have called a national epidemic. The strategy doesn’t make it more difficult for physicians to prescribe painkillers in the first place, however, a move several lawmakers have been advocating.

{mosads}Rep. Mary Bono Mack (R-Calif.) has gone the farthest so far, with legislation that would require the Food and Drug Administration (FDA) to reclassify oxycodone so it can be used only to treat severe pain.

In a Wednesday letter to FDA Commissioner Margaret Hamburg obtained by The Hill, Bono Mack said the administration’s proposal is “underwhelming and a day late” and would “punt to the drug companies when it comes to prescriber education.”

“Tens of thousands of people die each year from prescription drug abuse,” the letter says. “Families are asking why their children are readily able to obtain these powerful painkillers, in all too many cases, without a prescription. They don’t have cancer. They don’t have chronic, debilitating pain. Simply put, these drugs should not be available for everyday aches and pains.

“Instead of merely educating people about dangerous drugs, the FDA should do more to limit access to these potent, addictive drugs so they can only be used when absolutely necessary.”

The FDA says it wants to better educate providers and patients about the risks of painkillers rather than putting in place restrictions that could prevent some people who need them from obtaining them.

“The new [strategy] is a step-wise approach to ensuring that physicians are trained in appropriate pain management, while ensuring that patients continue to have access to needed medications and information on safe use, risks and proper storage and disposal,” spokeswoman Shelly Burgess said in a statement.

Other lawmakers are also advocating for changes in drug classifications.

Reps. Vern Buchanan (R-Fla.) and Edward Markey (D-Mass.), for example, have put forward a bill that would, among other things, reclassify hydrocodone combination drugs to “make them more difficult to prescribe and obtain.”

Buchanan on Tuesday said he “commend[s] the Administration for focusing on such a critical issue.” But in a follow-up conversation with The Hill on Wednesday, Buchanan spokesman Max Goodman said the Florida congressman would like to see more attention paid to restricting painkiller prescriptions.

“We support Ms. Bono Mack’s efforts and believe the reclassification of hydrocodone combination drugs is an important issue,” Goodman said. “We would have liked to see it included in the administration’s framework but it is something we’ll continue to pursue through congressional action.”

Bono Mack, the chairwoman of the Energy and Commerce Committee’s commerce panel, held a hearing on prescription drug abuse last week during which she questioned why the Drug Enforcement Administration was able to collect 121 tons of unused medicines in a four-hour drug take-back event last year.

“It’s a very basic situation for me — the FDA approves and regulates and the DEA is supposed to control,” she said. “And with statistics like that, it shows that we’re failing.”

Among the witnesses at the hearing was the governor of Florida, the epicenter of the painkiller abuse problem. Pressed by Bono Mack to take a stance on her proposal to limit oxycodone, Gov. Rick Scott (R) said he supported the principle.

“We ought to really restrict what it’s prescribed for,” he said.

This story was last updated at 4:04 p.m.