Posts Tagged ‘U.S. Food and Drug Administration’

How America Got Hooked On A Deadly Drug

Friday, June 15th, 2018

By Fred Schulte
Kaiser Health News
Purdue Pharma left almost nothing to chance in its whirlwind marketing of its new painkiller OxyContin. From 1996 to 2002, Purdue pursued nearly every avenue in the drug supply and prescription sales chain — a strategy now cast as reckless and illegal in more than 1,500 federal civil lawsuits across the country.
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First Amendment claims seen as Rx for drug makers, headache for consumers

Saturday, October 14th, 2017

By Paul Raeburn
Off-label promotion has long been considered a serious white-collar crime. The FDA has fined drug companies billions of dollars for off-label violations. The aim: to prevent them from overstating the benefits and understating the risks of their products, a practice known as misbranding – and one that sometimes leads to patients getting drugs that prove harmful or even deadly.
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Scientists urge tighter scrutiny of germ-fighting chemicals

Friday, June 30th, 2017

By Paul Feldman
More than 200 scientists and public health advocates are urging regulators to take a closer look at the potential dangers of antimicrobial chemicals including triclosan, an additive that has been banned from hand soaps but remains an active ingredient in products ranging from building materials to Colgate’s Total toothpaste.
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Under Donald Trump, Florida’s premium cigar industry could escape job-killing FDA regulations

Tuesday, December 27th, 2016

On the verge of being snuffed out by Obama administration regulators, Florida’s traditional and culturally distinct premium cigar industry has a chance at new life.
Late last week, U.S. Rep. Mark Meadows, R-N.C., the incoming chairman of the conservative House Freedom Caucus, met with President-elect Donald Trump and submitted a list of 232 items that could be repealed immediately after Trump’s Jan. 20 inauguration.
“We must undo Obama’s harmful regulatory regime that has hurt hardworking Americans across the nation,” the group said in language akin to Trump’s campaign rhetoric.
One item in the report entitled “First 100 Days: Rules, Regulations and Executive Orders to Examine, Revoke and Issue” recommends stripping the U.S. Food and Drug Administration of its authority to regulate tobacco products.
The move could save at least 2,600 Florida jobs currently at risk and spare many businesses, according to Mark Pursell, CEO of the International Premium Cigar and Pipe Retailers Association.
Progressive-liberal firebrand U.S. Rep. Alan Grayson, D-Fla., who’s no fan of Republicans, urged the executive branch agency to back off premium cigars when it first began targeting the industry through a proposed administrative rule in 2014, but to no avail.
In a letter to FDA Commissioner Margaret Hamburg, Grayson said that “the premium cigar industry is responsible for employing an estimated 20,000 Americans, and realizes almost $2 billion in annual revenue.”
The incoming Trump administration could extinguish the economic hardship on Day One, according to Meadows.
Under Obama, the FDA launched an aggressive crackdown on tobacco and began treating cigars the same as cigarettes.
According to the agency, the restrictions are necessary to reduce “death and disease” from tobacco products, and the “dramatic rise in youth and young adult use of tobacco products such as e-cigarettes, waterpipe tobacco, and continued youth and young adult use of cigars (mainly cigarillos).”
Others see it differently.
“Premium cigar retailers already institute a wide range of controls to prevent youth access

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Mary Elizabeth Elliott: Pilot project to make medication disposal safer, more effective

Friday, September 25th, 2015

Prescription drug misuse has been identified as Florida’s “fastest-growing and deadliest public safety issue,” according to Attorney General Pam Bondi’s Prescription Drug Diversion and Abuse Roadmap. Prescription painkiller overdoses have more than tripled in the past two decades, killing more than 15,500 people in the United States in 2009 according to the CDC.
On Saturday, Community Anti-Drug Coalitions of America (CADCA) and Mallinckrodt Pharmaceuticals launch a pilot project in Hillsborough, Collier, and Seminole counties to aid in the safe and effective disposal of prescription medications.
Prescription drugs and other medicines that are no longer needed often remain in medicine cabinets or other locations in the home. In 2012, health care providers wrote 259 million prescriptions for painkillers, enough for every American adult to have a bottle of pills.
Such wide access and availability has contributed to our nation’s overdose crisis.  The proper disposal of unused and expired medications is something every American should know about. Unfortunately, the public information is confusing and sometimes contradictory.
The U.S. Food and Drug Administration has a list of medications recommended to be flushed. However, our state partners at Florida Rural Water Association tell us that drugs disposed by flushing enter the environment, and may cause harm to fish and other aquatic life.
The U.S. Drug Enforcement Administration advises that if you cannot get to an approved drug take-back site, an individual should dispose of medicines in their own trash, mixing pills with kitty litter or used coffee grounds and sealing them in a bag.
So there are definitely differing views, even at a government level. One thing we can all agree upon: We must expand options to help guide people to proper disposal of their pharmaceutical controlled substances.
To explore solutions, CADCA will begin working with local coalitions on a pilot grounded in research. That approach – which we call a

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