FDA undermines painkillers fight

The most-prescribed drugs in America — painkillers containing addictive opioids — are also driving the deadliest drug problem in America. On average, 46 people a day die from painkiller overdoses, and 1,150 more land in emergency rooms. Deaths from illegal drugs don’t even come close.

Last year alone, doctors wrote about 180 million prescriptions for hydrocodone and oxycodone, nearly one for every adult in the United States.

With millions of Americans suffering chronic pain, drug companies profiting and too many doctors blithely churning out painkiller prescriptions, federal regulators are the last hope to slow the rising epidemic.

But the Food and Drug Administration has come to bat and whiffed. Last year, no sooner had it taken one belated step forward, than it turned around and took one step back.

After underplaying the problem for years, the FDA recommended in October stronger restrictions on access to drugs containing hydrocodone, which is highly addictive. The changes, which limit refills and mandate more frequent visits to doctors to obtain prescriptions, are set to go into effect next month.

But just one day later, the FDA approved Zohydro, a new drug that is pure hydrocodone. Its touted benefit? Unlike other hydrocodone drugs, it contains no acetaminophen, which in high doses can cause liver damage.

The downside? It comes without the abuse-resistant measures now common in most narcotic painkillers, such as hardened shells that make them difficult to crush. In capsule form, Zohydro can be easily crushed to be snorted or injected.

The FDA’s mission is determining whether drugs are effective and safe before approval. In Zohydro’s case, the FDA flouted the recommendation of its own expert panel, which voted 11-2 against approval.

Overriding a panel is not unheard of, but this time the panel was right. The FDA’s safety mission ought to be broad enough to preclude placing an easily abused painkiller on the market amid an abuse epidemic.

Attorneys general in 28 states, members of Congress and at least two governors have criticized the FDA’s decision. Massachusetts tried to ban sales, but a court rejected the move.

The FDA should reconsider Zohydro, and it should encourage other approaches to curbing painkiller abuse, as well.

One of the best is state monitoring systems that can prevent doctor-shopping by patients seeking multiple prescriptions. Practically every state has such databases, but many doctors don’t check them — a failure as mystifying as it is appalling.

Managers of prescription benefits can spot similar trends that suggest abuse, such as patients visiting multiple emergency rooms or doctors for prescriptions.

As pills get harder to come by, robust treatment programs are needed to deter people addicted to painkillers from turning to heroin.

Solving a deadly public health crisis is not a job for the FDA alone. It takes teamwork. But the nation’s drug-safety regulator should be leading the team, not undermining it with bad calls.
— LIVINGSTON DAILY PRESS & ARGUS