States` Pill Bans Get Cheers, Criticisms

April 06--Gov. Deval Patrick's ban of the controversial painkiller Zohydro ER has had a ripple effect in other states, but was met with a strong rebuke from the U.S. Food and Drug Administration.

The FDA, which approved the drug in October, issued a statement calling Patrick's recent action "extremely troubling."

The FDA is trying to balance two different priorities -- preventing prescription drug addiction while still treating those suffering from pain.

"Actions to advance one should not impede the other; we must balance our efforts and apply sound science as we move forward," the FDA wrote. "Efforts by Congress and at the state level to legislate the approval or marketing withdrawal of medications are extremely troubling."

On March 27, Patrick declared a public health emergency of opiate addiction caused by prescription drug and heroin use.

Along with a number of other measures to boost treatment, prevention and use of lifesaving overdose medicines, Patrick advised the state Department of Public Health to ban Zohydro, a pure form of hydrocodone, the opioid ingredient in Vicodin. The ban stays in effect until there is an abuse deterrent form of the medicine, according to the state DPH.

This would make it difficult to crush, snort or inject.

Zogenix Inc. of San Diego, Calif., makers of Zohydro, issued a blistering statement in reaction to the state ban.

Along with saying patients living with pain will suffer, Zogenix argued there already are many opioid drugs on the market with extended-release formulas, and most don't have abuse deterrents.

In 2010, the FDA approved a reformulated version of OxyContin designed to break into a gel or chunks, which made the drug more difficult to snort or inject.

In the last 12 months, more than 360,000 prescriptions for extended-release opioids were dispensed in Massachusetts, according to Zogenix's statement.

"We fail to see how banning the sale of a single new product will achieve the governor's policy objectives when all of the products that are currently part of the epidemic remain available for sale in the state," the company stated.

Zohydro received FDA approval in October against the recommendation of the FDA's own advisory committee, which ruled 11-2 that the potential for abuse of this drug was too great.

Patrick's ban was an end run around the FDA's regulatory process. His announcement has been met with cheers, but also criticism that politicians shouldn't go against the nation's drug regulatory agency.

"It's scary when legislators are usurping the role of the FDA, but (Deval Patrick) had no choice," said Dr. Andrew Kolodny, a founder of the national nonprofit Physicians for Responsible Opioid Prescribing.

"As the governor, he has a responsibility to protect the people in Massachusetts."

Patrick's move is a "massive walk-around of an agency that is not doing its job," Kolodny added.

A RARE MOVE

Patrick used the power that every state has to regulate the prescribing of drugs.

"It is unusual," said Dr. Kenneth Kaitin, a professor at the Tufts University School of Medicine and director of the Tufts Center for the Study of Drug Development.

"A state doesn't often overrule the FDA. But the states are well within their rights to block or approve drugs," he said.

Back in the 1990s when AIDS patients were clamoring for drugs that were slowly moving through the FDA's regulatory process, the state of California approved AIDS medications, he said.

As long as the ingredients and even the bottles were made in California, and didn't trigger interstate commerce laws, it was perfectly legal, he said.

"States can approve or reject a drug, but it's rare," Kaitin said. "States are not set up for that."

But these are not ordinary times. A health crisis started in 1995 when the FDA approved the painkiller OxyContin. Between 1999 and 2010, national opioid sales have increased fourfold, and overdose death rates parallel that, Kathleen Sebelius, secretary of the U.S. Department of Health and Human Services, said in a conference call Thursday.

Prescription drug overdose deaths now exceed all illicit drug overdose deaths in the country, she added.

Heather Gray, the legislative attorney for the National Alliance for Model State Drug Laws, said states vary in their procedures for banning a substance.

"Most states do not allow the governor to unilaterally schedule or ban a drug, as it violates the separation of powers doctrine," she said. "A lot of states do allow the state board of pharmacy, board of health, or similar agency to schedule/ban substances on a temporary, emergency basis, and that appears to be the case here."

RECREATING HISTORY?

The approval of Zohydro -- which like the original OxyContin, is long-acting and can be crushed, snorted and injected to bypass the time-release properties -- caused national outrage. There are two bills pending in Congress to force the FDA to withdraw approval for Zohydro until it's available in an abuse-resistant form.

And other states besides Massachusetts are taking action.

Last week, Vermont placed strict prescribing requirements on Zohydro.

The move requires doctors to document that all other pain medications have been tried first before prescribing Zohydro, said Dr. Harry Chen, Vermont's commissioner of health.

Doctors will need to do pill counts and urine screenings (to be sure the patient is not selling his medications); and doctors must frequently consult with the state's drug monitoring program to see that the patient isn't getting these and other opiate medicines from multiple doctors.

"Many people wanted us to do what your governor did," Chen said.

But an outright ban could possibly lead to a legal challenge, Chen said, so Vermont officials went with strict limits on prescribing.

"This is what we should have done with OxyContin," Chen said.

To that end, Vermont plans to apply these strict prescribing limits to other addictive drugs in the future, Chen said.

In Ohio -- which has the 12th highest fatal drug overdose rate in the nation, according to a national study by the Trust for America's Health -- two state representatives are sponsoring a bill to change Zohydro from a Schedule II to a Schedule I drug. Changing drug scheduling is also within state authority.

The Schedule I designation means a drug has no medical use, and is illegal. One of the sponsors, Ohio state Rep. Ryan Smith, R-Gallipolis, said the scheduling change bill probably won't pass. But he hopes debate about the bill will lead to prescription restrictions like the ones that Vermont has imposed.

"OxyContin was very powerful, extended-release, and long-acting," Smith said.

"It was crushable and snortable. Here we are recreating history. I don't like to be in a position to question the FDA, but we need to keep people safe."

For Janis McGrory, a Harwich High School teacher whose daughter Liz died of a heroin overdose in 2011, the governor's move gives her hope that other states will stand up "to what is killing our children."

Copyright 2014 - Cape Cod Times, Hyannis, Mass.