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Federal Government
FDA Commissioner Margaret Hamburg Issues Statement On Prescription Opioid Abuse PDF Print E-mail
Federal Government
By Administrator   
Thursday, 03 April 2014 15:08

RALEIGH, (SGRToday.com) - The Food and Drug Administration's (FDA) approval of an autoinjector to combat the effects of opiate overdoses has prompted FDA Commissioner Margaret Hamburg to issue the following statement about the abuse of opiates. Evzio rapidly reduces the effect of an overdose.  

 
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For more than a decade, the U.S. Food and Drug Administration has been working to address the important public health problems associated with the misuse, abuse, addiction and overdose of opioid analgesics, while at the same time working to ensure continued access to effective and appropriate medications for millions of Americans currently suffering from pain. I firmly believe that these goals are compatible, and that actions to address one should not be at the expense of the other.
Tragically, the most recent data shows that more than 16,000 lives are lost each year due to opioid-related overdoses. In fact, drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. We know that the illegal diversion, misuse, and abuse of prescription opioids are often fueled by inappropriate prescribing, improper disposal of unused medications, and the illegal activity of a small number of health care providers. This highlights the important role that education of prescribers and patients can play in addressing this epidemic. The FDA has taken steps to address this but more work remains to be done.
 
Combatting the serious public health problem of misuse, abuse, addiction and overdose from opioid analgesics is a high priority. Since 2001 the FDA has taken a number of actions designed to help address prescription opioid abuse and to encourage the development of new drug treatments for pain. These actions include:
 
• Revising the labeling for opioid medications to foster their safe and appropriate use, including recent changes to the indications and safety warnings of extended-release and long-acting opioids. 
• Requiring that manufacturers conduct studies of the safety of long-term use of prescription opioids. 
• Improving appropriate prescribing by physicians and use by patients through educational materials required as a part of a risk mitigation strategy for extended-release and long-acting opioids.
• Using the agency’s expedited review programs to advance development of new non-opioid medications to treat pain with the goal of bringing new non- or less-abusable products to market.
• Working with other federal agencies and scientists to advance our understanding of the mechanisms for pain and how to treat it, including the search for new non-opioid medications for pain.
• Recommending that hydrocodone-containing combination products have additional restrictions on their use by rescheduling them from Schedule III to Schedule II.
• Strengthening surveillance efforts to actively monitor the changing nature of prescription opioid abuse and to identify emerging issues.
• And, importantly, encouraging the development of medications to treat opioid abuse, such as buprenorphine for use in medication-assisted treatment, and to reverse opioid overdoses, such as naloxone.
 
Today’s FDA approval of Evzio (naloxone autoinjector) provides an important new tool in our arsenal to more effectively combat the devastating effects of opioid overdose, which is one part of our comprehensive work to support opioid safety. Reflecting the FDA’s commitment to encouraging important new therapies, the FDA’s review of Evzio was granted priority status, and the application was reviewed by the FDA in just 15 weeks.
 
This product is the first auto-injector designed to rapidly reverse the overdose of either prescription or illicit opioids. While the larger goal is to reduce the need for products like these by preventing opioid addiction and abuse, they are extremely important innovations that will help to save lives.
 
The FDA will continue to work to reduce the risks of abuse and misuse of prescription opioids, but we cannot solve this complex problem alone. A comprehensive and coordinated approach is needed; one that includes the White House Office of National Drug Control Policy, the Drug Enforcement Administration and many of our sister agencies within the Department of Health and Human Services, as well as state and local governments, public health experts, health care professionals, addiction experts, researchers, industry, and patient organizations.
 
I am confident that this can be accomplished, but we will all need to work together to invest in strategies and responsible approaches that deter or mitigate the effects of abuse while preserving access to pain medicines for the patients that need them the most.
Last Updated on Thursday, 03 April 2014 15:10
 
U. S. Government Recognizes Michigan Gay Marriages PDF Print E-mail
Federal Government
By Administrator   
Friday, 28 March 2014 10:52

DETROIT (AP) — Attorney General Eric Holder on Friday extended federal recognition to the marriages of about 300 same-sex couples that took place in Michigan before a federal appeals court put those unions on hold.

 
Holder's action will enable the government to extend eligibility for federal benefits to the Michigan couples who married Saturday, which means they can file federal taxes jointly, get Social Security benefits for spouses and request legal immigration status for partners, among other benefits.
 
The attorney general said the families should not be asked to endure uncertainty regarding their benefits while courts decide the issue of same-sex marriage in Michigan. Holder did the same thing in Utah, where more than 1,000 same-sex couples got married before the U.S. Supreme Court put those unions on hold in January after a federal judge overturned the conservative state's same-sex marriage ban in December.
 
Holder's decision came a week after U.S. District Judge Bernard Friedman in Detroit struck down the gay marriage ban and two days after Michigan Gov. Rick Snyder called last weekend's marriages legal but said Michigan won't recognize them.
 
Donna DeMarco and Lisa Ulrey were among the dozens of couples who married Saturday in Oakland County, northwest of Detroit.
 
DeMarco's reaction to Friday's federal recognition: "Cool."
 
"That's a major step," DeMarco said. "The federal government is making great strides with recognizing same-sex marriage. It's time for Michigan to get out of its prehistoric age and get with the times. When you have a state government that's full of hate and straddles political lines and doesn't recognize that people are people, it affects a lot of people."
 
DeMarco said she and Ulrey have not yet applied for joint Social Security benefits.
 
"I guess we can now," she said, adding that the couple will jointly file federal taxes next year.
 
Oakland County was one of four that took the extraordinary step of granting licenses Saturday just hours before the 6th U.S. Circuit Court of Appeals in Cincinnati ordered a temporary halt. The stay was extended indefinitely Tuesday.
 
The federal appeals court acted on a request from Michigan Attorney General Bill Schuette, who defended Michigan's same-sex marriage ban.
 
Friedman's ruling came in a federal lawsuit filed in 2012 by April DeBoer and Jayne Rowse, two Detroit-area nurses who are raising three children with special needs. DeBoer and Rowse have said they sued because they were barred from jointly adopting each other's children. Joint adoption is reserved for married heterosexual couples in Michigan.
 
"I think it's spectacular that our federal government has chosen to acknowledge the validity of these marriages, and accord the respect and dignity these couples and their families deserve," said attorney Dana Nessel, who represented DeBoer and Rowse.
 
Snyder, a Republican, acknowledged Wednesday that same-sex couples "had a legal marriage." But because of the court's stay, he added, the gay marriage ban has been restored. That closed the door, at least for now, to certain state benefits reserved solely for married couples. The American Civil Liberties Union has said more than 1,000 Michigan laws are tied to marriage.
 
Bill Freeman, pastor of Harbor Unitarian Universalist Congregation church in western Michigan's Muskegon, responded to Friday's news with a loud "Yeah!"
 
"I think it's great. I think it's wonderful. I think it's glorious," he said. "Even the governor of Michigan says the marriages are legal, but is not going to let them be enforceable in Michigan — and that's crazy.
 
"These guys ought to be able to get their Social Security cards and have the same benefits just like any other heterosexually married couple."
 
Freeman officiated dozen of weddings Saturday after marriage licenses were issued by the Muskegon County clerk's office.
 
Seventeen states and Washington, D.C., issue licenses for same-sex marriages. Since December, bans on gay marriage also have been overturned by courts in Texas, Oklahoma, Kentucky and Virginia, but appeals have put those cases on hold.
Last Updated on Friday, 28 March 2014 10:52
 
Unemployment Rates Fall In 29 States Last Month PDF Print E-mail
Federal Government
By Administrator   
Friday, 28 March 2014 10:48

WASHINGTON (AP) — Unemployment rates fell in most states in February and two-thirds of the states reported job gains, evidence that most of the country is benefiting from slow but steady improvement in the job market.

 
Unemployment rates dropped in 29 states, rose in 10 and were unchanged in the remaining 11, the Labor Department said Friday. Meanwhile, hiring rose in 33 states and fell in 17.
 
The rate declines occurred even though unemployment rose nationwide last month, to 6.7 percent from 6.6 percent in January. That increase occurred partly for a good reason: more Americans began looking for work, though most weren't immediately hired. But the fact that they started looking suggests they were optimistic about their prospects.
 
Employers added 175,000 jobs nationwide in February, close to the average monthly gains of the past two years. Those gains followed two meager months of hiring. Employers added only 129,000 jobs in January and just 84,000 in December. Harsh winter weather likely dragged on job gains in those months.
 
The biggest drop in unemployment occurred in South Carolina, where the rate fell to 5.7 percent from 6.4 percent. Ohio reported the next biggest decline, to 6.5 percent from 6.9 percent.
 
South Carolina actually lost jobs last month, so the big drop in its unemployment rate partly occurred because many of the unemployed stopped looking for work. The number of unemployed people in the state fell sharply. The government doesn't count those out of work as unemployed unless they are actively searching.
 
Another factor: The unemployment rate and job counts come from different surveys that can produce disparate results. The number of jobs in each state is calculated from a survey of employers, while the unemployment rate stems from a separate survey of households. The number of people in South Carolina who said they had jobs rose, even though the survey of employers found fewer overall positions.
 
Rhode Island reported the highest unemployment rate, at 9 percent, followed by Illinois at 8.7 percent and California with 8 percent.
 
North Dakota had the lowest rate, 2.6 percent, followed by South Dakota and Nebraska at 3.6 percent each.
Last Updated on Friday, 28 March 2014 10:48
 
President Obama To Propose Ending NSA's Phone Call Sweep PDF Print E-mail
Federal Government
By Administrator   
Tuesday, 25 March 2014 09:46

WASHINGTON (AP) — The White House wants the National Security Agency to get out of the business of sweeping up and storing vast amounts of data on Americans' phone calls.

 
The Obama administration this week is expected to propose that Congress overhaul the electronic surveillance program by having phone companies hold onto the call records as they do now, according to a government official briefed on the proposal. The New York Times first reported the details of the proposal Monday night. The official spoke on condition of anonymity because the official was not authorized to discuss the plan.
 
The White House proposal would end the government's practice of sweeping up the phone records of millions of Americans and holding onto those records for five years so the numbers can be searched for national security purposes. Instead, the White House is expected to propose that the phone records be kept for 18 months, as the phone companies are already required to do by federal regulation, and that it be able to preserve its ability to see certain records in specific circumstances approved by a judge.
 
According to a senior administration official, the president will present "a sound approach to ensuring the government no longer collects or holds this data, but still ensures that the government has access to the information it needs to meet the national security needs his team has identified." The administration official spoke late Monday on condition of anonymity because he was not authorized to publicly discuss the proposal before it was officially announced.
 
The president's plan, however, relies on Congress to pass legislation — something that has so far seemed unlikely.
 
Details of the government's secret phone records collection program were disclosed last year by former NSA systems analyst Edward Snowden. Privacy advocates were outraged to learn that the government was holding onto phone records of innocent Americans for up to five years. Obama promised to make changes to the program in an effort to win back public support.
 
In January, President Barack Obama tasked his administration with coming up with an alternative to the current counterterrorism program and suggested that the phone companies option was the most likely. However, he also said that option posed problems.
 
"This will not be simple," Obama said. An independent review panel suggested that the practice of the government collecting the phone records be replaced by a third party or the phone companies holding the records, and the government would access them as needed.
 
"Both of these options pose difficult problems," Obama said in January. "Relying solely on the records of multiple providers, for example, could require companies to alter their procedures in ways that raise new privacy concerns.
 
And the phone companies have been against this option, as well.
 
In several meetings with White House staff since December, phone company executives came out strongly opposed to proposals that would shift the custody of the records from the NSA to the telecoms. The executives said they would only accept such changes to the NSA program if they were legally required and if that requirement was spelled out in legislation.
 
The companies are concerned about the costs of retaining the records and potential liability, such as being sued by individuals whose phone data was provided to intelligence or law enforcement agencies, these people said. The discussions with the White House ceased earlier this year. Industry officials said they had not been in contact with the administration as new options were being considered. The executives have continued to discuss the issue with lawmakers, however.
 
The administration's proposed changes won't happen right away. The government plans to continue its bulk collection program for at least three months, the Times said.
 
But it's unlikely that Congress would pass legislation in the next three months, as the NSA surveillance has proved to be a divisive issue, even within political parties.
 
The chairwoman of the Senate Intelligence Committee, Dianne Feinstein, has advocated for the program to continue to operate as it does. The California Democrat said she would be open to other options if they met national security and privacy needs.
 
It is unclear whether the White House proposal will meet those needs.
 
Leaders of the House intelligence committee are expected to introduce legislation Tuesday that would call for a similar option to the Obama administration's.
 
Under the administration's pending legislative proposal, officials would have to obtain phone records by getting individual orders from the Foreign Intelligence Surveillance Court, the Times report said. The new court orders would require companies to provide those records swiftly and to make available continuing data related to the order when new calls are placed or received.
Last Updated on Tuesday, 25 March 2014 09:47
 
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