GNC Drops as U.S. to Announce Action on Supplement Makers


GNC Holdings Inc. and Vitamin Shoppe Inc. plunged Tuesday on plans by the Justice Department, the Food and Drug Administration and other U.S. agencies to announce criminal and civil enforcement actions over the advertising and sale of dietary supplements.

Source: GNC Drops as U.S. to Announce Action on Supplement Makers

Hot Startup Theranos Dials Back Lab Tests at FDA’s Behest – By JOHN CARREYROU Updated Oct. 16, 2015 3:17 p.m. ET


 Under pressure from regulators, laboratory firm Theranos has stopped collecting tiny vials of blood drawn from finger pricks for all but one of its tests. WSJ's John Carreyrou explains on Lunch Break With Tanya Rivero. Photo: Martin E. Kilmek


Under pressure from regulators, laboratory firm Theranos has stopped collecting tiny vials of blood drawn from finger pricks for all but one of its tests. WSJ’s John Carreyrou explains on Lunch Break With Tanya Rivero. Photo: Martin E. Kilmek

Under pressure from regulators, laboratory firm Theranos Inc. has stopped collecting tiny vials of blood drawn from finger pricks for all but one of its tests, according to a person familiar with the matter, backing away from a method the company has touted as it rose to become one of Silicon Valley’s hottest startups.

The move is a setback to the Palo Alto, Calif., company’s ambition to revolutionize the blood-testing industry. As a result of the halt, Theranos is operating more like a traditional lab that draws blood with needles from patients’ arms. Theranos is valued at $9 billion, or about as much as each of the industry’s two largest companies in the U.S.

Food and Drug Administration inspectors recently showed up unannounced at Theranos, the person familiar with the matter said. The inspection was triggered by concerns the agency had about data Theranos had voluntarily submitted to the FDA in an effort to win approval for its proprietary testing methods, this person said.

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The Dangerous Rise of K2: America’s Cheapest High – Vice News Published on Oct 14, 2015


K2 — the street name for plant matter sprayed with synthetic chemicals, designed to mimic the effects of marijuana’s active ingredient — is currently America’s cheapest way to get high. The drug is often sold at corner stores, labeled as potpourri and unfit for human consumption. A bag of K2 sells for $5 to $10, while a joint goes for just $1.

But the drug’s dangerous side effects have taken a toll on a wide variety of communities across the country, particularly in New York City. US poison control centers received more than 6,000 K2 calls in the first nine months of 2015, around a quarter of those calls came from NYC.

VICE News gets a glimpse of the challenges New York City is facing with K2 through the lens of volunteer ambulance corps and harm reduction specialists in its outer boroughs.

Watch “Back from the Brink: Heroin’s Antidote” – http://bit.ly/1X0DX8W

California enacted the strictest law yet on antibiotic use in farms – Updated by Julia Belluz on October 11, 2015, 3:20 p.m. ET


Polarpx/Shutterstock

Antibiotic resistance is now considered a catastrophic threat to public health, as more and more deadly, drug-resistant bacteria have been appearing in our cities, farms, and hospitals. In theory, the solution should be simple: We need to stop overusing antibiotics. Yet nearly every attempt to do so thus far has failed.

Now California is taking drastic measures. This weekend, Gov. Jerry Brown signedthe toughest restrictions yet on antibiotic use in the United States, banning the state’s livestock producers from using certain antibiotics for routine disease prevention and growth promotion.

“The science is clear that the overuse of antibiotics in livestock has contributed to the spread of antibiotic resistance and the undermining of decades of lifesaving advances in medicine,” Brown said in a statement.

This is, potentially, a huge deal. Across the United States, more than 70 percent of medically important antibiotics are sold for use in animals, so curbing overuse in this area has always been a priority for public health reformers. And California’s new law could push other states to follow suit.

Why curbing antibiotic use on farms is so controversial

The science behind drug resistance is straightforward enough. The more we use antibiotics to kill off disease-causing bacteria, the more likely those bacteria are to evolve resistance, developing random mutations to outwit our drugs. And overuse has become a huge problem. In the United States alone, antibiotic-resistant infections are now associated with 23,000 deaths and 2 million illnesses every year.

So public health experts have been looking for places to curtail misuse. It would help, for instance, if doctors stopped prescribing unnecessary antibiotics. But another key place to look is on farms, where the vast majority of medically important antibiotics are sold.

Antibiotics on farms are typically used in three ways: to treat sick animals, to prevent infections, and to fatten up animals. The first use is uncontroversial: Everyone agrees that it’s okay to use antibiotics to treat animals that come down with disease. But public health experts have criticized the latter two uses. They argue that many livestock producers needlessly overuse antibiotics to prevent infections and promote growth — essentially relying on them as an alternative to hygiene and good nutrition. These are considered “nontherapeutic” uses.

And experts argue this overuse has real consequences. Both the Food and Drug Administration and the Centers for Disease Control and Prevention have told Congress that there’s a link between the routine, nontherapeutic use of antibiotics on farms and the superbug crisis in humans.

 

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2 new studies show the FDA is rushing more drugs to market based on shoddy evidence – Updated by Julia Belluz on September 24, 2015, 5:39 p.m. ET


There was a time when the Food and Drug Administration was so sluggish and conservative in approving new drugs that people who desperately needed access to medicines would die waiting.

But by the early 1990s, Congress had created four programs to expedite the development and approval process for new pharmaceuticals (the breakthrough drug designation, priority review, fast track and accelerated approval). These pathways were intended to push innovative new drugs — drugs to treat rare, serious, or life-threatening diseases — through the FDA more quickly.

Since these medicines were sorely needed, the idea was that rushing them through, often on the basis of more limited and preliminary clinical trials data, would help patients languishing with unmet medical needs.

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(Javier Zarracina)

 

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http://www.vox.com/2015/9/24/9387987/fda-expedited-drug-approvals

Nine Obama regulations to watch – By Lydia Wheeler – 09/06/15 02:31 PM EDT


The window is already closing on President Obama’s regulatory agenda, and agencies across the federal government are moving to crank out a slew of new rules before election year politics bring business in Washington to a virtual standstill.

Obama has made no bones about using the power of his office to accomplish his policy goals in lieu of congressional action, presiding over numerous controversial regulations in the energy, healthcare and financial sectors, among many others.

With more than a year left, the administration will continue to promulgate regulations until the clock runs out.

However, controversial rules in any administration tend to stall in election years. And proponents of stronger heath and safety protections fear that a GOP-controlled Congress could overturn rules issued at the tail end of the Obama administration, in the event that a Republican wins the White House next year.

They are instead hoping for a flurry of action this fall on regulations, many of which they see as long overdue.

Here are ten of the most highly anticipated rules likely to come down the pipeline in the remainder of 2015:

Tobacco: The Food and Drug Administration (FDA) is expected to finalize its tobacco “deeming rule” to regulate all tobacco products under the Tobacco Control Act, including electronic cigarettes and cigars.

Industry and advocacy groups have been pushing FDA to finalize the rule by the end of the summer, but with two weeks left in August all bets are now on September.

The agency has been slow from the start on issuing the rule, which would expand the FDA’s reach to a host of new products over which it has not previously asserted authority.
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Why President Obama and Congress turned their backs on food safety – By HELENA BOTTEMILLER EVICH July 2015


Congress passed a landmark law. Then everyone walked away.

Mario Wagner for Politico

Mario Wagner for Politico

The bacteria-tainted apple that probably killed Shirlee Frey traveled hundreds of miles from an orchard to a packinghouse and then to a factory that coated it in caramel. It never came anywhere close to being examined or tested by a food-safety inspector.

The California woman died in December, about a month after she ate some of the Halloween treats she bought for her grandchildren. At the end, her brain was so swollen she couldn’t breathe on her own. Frey, 81, was one of seven fatalities in a listeria outbreak caused by caramel apples that spread to 12 states. Common bacteria such as listeria, salmonella and E. coli kill several thousand people each year and sicken some 48 million Americans. Brad Frey believes his mother and hundreds of others might still be alive if a sweeping law hailed as a complete revamp of the nation’s broken food-safety system had been put into action.

“This didn’t have to happen,” Frey said.

He may well be right.

According to a POLITICO investigation, the Obama administration and Congress have all but squandered an opportunity to give the anemic Food and Drug Administration, which is responsible for the safety of 80 percent of the nation’s food supply, a level of oversight the public long assumed it already had.

On paper, the law that Congress passed in late 2010 — known as the Food Safety Modernization Act — was bigger than anything since Teddy Roosevelt cleaned up the meatpacking industry. The law mandated more inspections and much tougher anti-contamination standards for everything from peaches to imported pesto sauce, and it placed more emphasis on preventing outbreaks than on chasing them down after people become sick.

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http://www.politico.com/story/2015/07/sickness-in-the-system-120057.html?hp=t4_r