Fed Judges Rule On Rx Painkillers, Tobacco Warnings

Two decisions by judges in U.S. District Court in Washington, D.C., yesterday –- one finding that companies that distribute prescription painkiller are responsible for making sure they are not diverted to “street sales” and the other batting down the requirement that cigarette packs carry graphic anti-smoking images -- may have major implications for marketers although the judges’ rulings are not likely to be the last word in either case.

The Drug Enforcement Administration accused Cardinal Health, a Fortune 500 drug distribution company, of selling excessive amounts of prescription painkillers to Florida pharmacies, Donna Leinwand Leger reports in USA Today. Judge Reggie Walton ruled that the company must stop shipping drugs from its Lakeland, Fla., distribution center.

Walton says that the government “produced enough evidence to show that the distribution facility posed a public safety threat by shipping heavy volumes of the prescription painkiller oxycodone to pharmacies, including two owned by a unit of CVS Caremark,” reportsBloomberg News’ Tom Schoenberg.



“The government has a particular interest in ensuring that the public is not harmed by these types of dangerous substances,” Walton said. What’s more, as the Wall Street Journal’s Devlin Barrett and Timothy W. Martin write, Walton rules that “drug-distribution companies must police themselves to help the government keep addictive prescription painkillers from finding their way to street dealers and addicts.”

They "have an obligation in the first instance to self-police" in order to track unusually large drug shipments that may signal diversion beyond their proper use, according to Walton.

“The ruling lifts a temporary restraining order that prevented the DEA from enforcing its Feb. 2 suspension of Cardinal's license to distribute controlled substances from the Florida facility,” USA Today’s Leinwand Leger reports.

In an in-depth piece published earlier this week -- “DEA Aims Big in Cardinal Health Painkiller Case" -- Leinwand Leger takes a look at the “aggressive display of the DEA's strategy to attack the prescription drug abuse problem at the highest levels,” pointing out that more than five million people in the U.S. abuse narcotic painkillers.

Cardinal Health says that it disagrees with the Walton’s decision and will fight it in the U.S. Court of Appeals for the D.C. Circuit.

“Effectively addressing prescription drug abuse requires a very different approach than does the war on illicit drugs,” it says in a statement. “We want to work collaboratively with all participants in the drug supply chain -- including regulators, pharmaceutical manufacturers, distributors, pharmacists, doctors and boards of pharmacy -- to combat this serious nationwide issue.”

Meanwhile, U.S. District Court judge Richard Leon issued a 19-page ruling that finds that a federal mandate requiring tobacco companies to graphically warn consumers about the dangers of smoking on cigarette packages is a violation of free speech.

“His ruling largely echoed arguments he made in a preliminary injunction he issued in November,” writes CNN producer Bill Mears, who adds that the Obama administration has appealed the injunction.

"The graphic images here were neither designed to protect the consumer from confusion or deception, nor to increase consumer awareness of smoking risks," Leon writes in his decision. "Rather they were crafted to evoke a strong emotional response calculated to provoke the viewer to quit or never start smoking."

The warning label proposed by the Food and Drug Administration last June can be viewed here.

"The opinion is a straightforward and clear affirmation that compelled speech by the government is not only rarely constitutional but plainly unconstitutional in this case," says attorney Floyd Abrams, representing Lorillard Tobacco, reportsBloomberg News’ Sara Forden.

On the other side, Christopher Hansen, president of the American Cancer Society Cancer Action Network, says the ruling "is bad for public health" and a “victory for big tobacco.” It is asking the Department of Justice to appeal this ruling, as it did with Leon’s previous injunction.”

NPR’s Scott Hensley points out that in a footnote to the ruling, the judge scoffs at the notion that they labels are mere “warnings.”

“‘They are more about shocking and repelling than warning,’ he writes, adding later that the images serve as a deterrent to people buying cigarettes,” reports Hensley, who recalls an interview with FDA commissioner Margaret Hamburg when the labels were proposed. She said last June they are “stark on purpose” and that “various studies showed that existing warnings, such as ‘Cigarette Smoke Contains Carbon Monoxide,’ had lost their power and effectiveness.”

“Leon offered alternative ways to convey the health risks of smoking without violating the First Amendment, such as reducing the amount of space taken up by its warning labels and changing the images to convey ‘only purely factual and uncontroversial information rather than gruesome images designed to disgust the consumer,’” the Times’ Strom reports.

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