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The Providence (R.I.) Journal, April 11, 2014
When Amazon founder Jeff Bezos dazzled "60 Minutes" interviewer Charlie Rose a while back with his supposed plan to deliver products with drone aircraft, he glossed over the obstacles that stand in his way.
"There's no reason they can't be used as delivery vehicles," he said at the time. Then he acknowledged that it won't happen before 2015 because that's the earliest the Federal Aviation Administration will set the rules. And that, he added, may be a little optimistic.
Amazon isn't the only commercial company that's eager to put drone aircraft to work. So would other cargo carriers such as UPS and FedEx, but so also would any business that currently sends people to check on pipelines, cell towers and other infrastructure.
The fact is, the United States lags the rest of the world when it comes to letting unmanned aircraft deploy in the service of commercial business. Only now is the FAA setting up test ranges where operators can fly drones in commercial airspace. At this pace, it will be years before business owners can add them to their management toolkits.
It doesn't have to be this way. The government can accelerate the pace of commercial deployments, while continuing to protect public safety, as it does with commercial aviation.
A group of pilotless aircraft companies and advocates called for expedited rulemaking on commercial drone flights by the FAA. "The current regulatory void has left American entrepreneurs and others either sitting on the sidelines or operating in the absence of appropriate safety guidelines," they said in a letter to the agency.
The FAA moves slowly because, like other federal agencies from the Patent Office to the Food and Drug Administration, it isn't built to keep up with the pace of innovation. Its plan to roll out test ranges had to be imposed upon it by Congress, which ordered the agency to produce a set of rules governing the use of drones by September 2015.
Another wrinkle: A National Transportation Safety Board arbitrator has called into question whether the FAA even has the authority to regulate commercial drones. The FAA has appealed his ruling, which threatens to throw open the doors to unfettered commercial use. That would probably be too much, too soon.
To be sure, there are a multitude of issues that must be resolved or at least framed before drones fly freely in urban areas. When drones are deployed by law enforcement agencies, for example, the public should be informed of where they are and how they are used. It would be entirely appropriate to set rules limiting their ability to observe and collect data on law-abiding citizens.
But this is a time when the technology is available and the customers are ready to use it. There's more to be gained than lost by moving more quickly to let it happen. The FAA should drive the regulatory process, rather than be driven by it.
The Portland (Maine) Press Herald, April 9, 2014
The Food and Drug Administration has certainly heard the criticism of Zohydro, a powerful new painkiller approved last October.
Regulators heard it first from the FDA's own advisory board, which recommended against approval of the drug being compared to OxyContin in its strength and potential for abuse.
They then heard it from the attorneys general of 28 states, including Maine, who last December asked that Zohydro at least be made tamper-proof, so that it can't be crushed, then snorted or injected for a better high.
And they heard it from governors in Vermont and Massachusetts, who both have taken steps to keep Zohydro from being prescribed, and from at least three New England hospitals that will not stock the drug.
Yet still the FDA has done nothing.
Maine should make its voice heard in this latest chorus, and help push the federal agency into action. It is just a small front in the fight against opiate abuse, but without the proper safeguards, Zohydro will end up exacerbating an already dire problem.
There are a few paths Maine could take.
In Massachusetts, Gov. Deval Patrick issued an executive order prohibiting the sale of Zohydro, as part of his declaration of a public health emergency surrounding the growing abuse of opiates.
The maker of Zohydro, Zogenix, however, filed suit, asking the U.S. District Court in Massachusetts to set aside Patrick's order. Zogenix argued that it "impedes the FDA's congressional mandate" to set drug policy.
Vermont Gov. Peter Shumlin, fearing litigation, did not go quite as far.
Shumlin, who used his state of the state speech earlier this year to argue for a strong, treatment-based response to the opiate addiction epidemic there, has issued an emergency order making it more difficult to prescribe Zohydro.
The order, announced April 3, requires prescribers to conduct a thorough medical evaluation and risk assessment, and to show that no other type of painkiller would work for the patient.
Shumlin also has some major health care providers on his side.
Fletcher Allen Health Care, Vermont's largest provider, will not stock Zohydro, nor will Rutland Regional Medical Center in Rutland, Vt., and Dartmouth-Hitchcock Medical Center in Lebanon, N.H.
Gov. Paul LePage should follow Shumlin's lead and put restrictions on Zohydro here in Maine. At the same time, hospitals and physicians should not prescribe the medication.
That will push the FDA to act, and Zogenix to incorporate into Zohydro some abuse deterrents, such as a gel that makes it difficult to crush.
Lessening the prescription drug problem will take a strong drug-monitoring system, which Maine has, and treatment, which has lagged in the past few years because of cuts in funding.
Blocking Zohydro, however, also will help, by keeping it from reaching the streets, and by forcing manufacturers to make better drugs, and better ways to curb abuse.
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