Archive for the ‘fda’ Category

After pushing addictive OxyContin, Purdue now pursuing overdose antidote

March 15th, 2019
If approved, Purdue's new drug would compete with opioid overdose antidote, naloxone.

Enlarge / If approved, Purdue's new drug would compete with opioid overdose antidote, naloxone. (credit: Getty | Steve Russell)

Notorious OxyContin-maker Purdue Pharma—which has been widely criticized for deceptively marketing its highly addictive painkiller and for its role in spurring the current nationwide epidemic of opioid abuse and overdose deaths—is moving ahead with a new, potent drug, one said to be an antidote to opioid overdoses.

The company announced this week that the US Food and Drug Administration has granted fast-track status to its investigational drug nalmefene hydrochloride (HCl), an injectable, emergency treatment intended to rescue people suspected of having an opioid overdose. Purdue suggests that nalmefene HCl’s effects last longer than the similar emergency opioid antagonist naloxone. As such, the company hopes nalmefene HCl will out-compete naloxone at reversing overdoses from the most highly potent opioid, namely fentanyl, which is currently driving the alarming numbers of opioid overdose deaths. The FDA’s fast-track status will speed the development and regulatory review of the drug.

“Opioid antagonists like naloxone have played an important role in the emergency treatment of opioid overdose,” John Renger, Purdue’s head of Research & Development and Regulatory Affairs, said in a statement. “However, because of the increasing number of deaths due to fentanyl and its even more potent analogues, we are focusing on a potentially more potent and longer-lasting rescue option specifically intended to work in those overdose situations.”

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Posted in addiction, drug abuse, drug development, fda, opioid, overdose, purdue, science | Comments (0)

Citing parental freedom, Arizona lawmakers move ahead with anti-vaccine bills

February 25th, 2019
 A single dose of MMR (for Measles, Mumps, and Rubella) at Kaiser Permanente East Medical offices in Denver.

Enlarge / A single dose of MMR (for Measles, Mumps, and Rubella) at Kaiser Permanente East Medical offices in Denver. (credit: Getty | Joe Amon)

Lawmakers in Arizona are moving forward with three bills that will make it easier for parents to opt out of getting life-saving vaccinations for their children—and may even encourage them to do so, according to a report in The Arizona Republic.

The brazen legislative move comes as the country grapples with six outbreaks of measles, an extremely contagious, vaccine-preventable disease that can be disabling and even fatal to young children. One of those outbreaks is occurring in Washington state's Clark County, where rampant anti-vaccine views and similarly lax vaccination laws fueled the spread of disease. Since the start of the year, officials have tallied 65 cases, mostly in children under the age of 10 (47 of the 65 cases) and nearly all unvaccinated (57 cases of the 65 cases, with six others cases unverified, and two cases with only one out of the recommended two vaccine doses).

Hoping to prevent future outbreaks, Washington state lawmakers are now advancing legislation that would eliminate vaccination exemptions on personal and philosophical grounds. But Arizona lawmakers seem to have taken no heed of the efforts of their Washington counterparts, even as public health experts condemned Arizona's proposed legislation.

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Posted in Arizona, fda, Infectious disease, measles anti-vaccine, science, vaccine, vaccine exemptions | Comments (0)

Blood of the young won’t spare rich old people from sadness and death, FDA says

February 19th, 2019
Still image from a Hammer horror film in which a vampire (Christopher Lee) sucks blood from an attractive female victim.

Enlarge / Not so fast, says the FDA. (credit: Getty | Silver Screen Collection)

The US Food and Drug Administration issued an alert Tuesday, February 19, warning older consumers against seeking infusions of blood plasma harvested from younger people. Despite being peddled as anti-aging treatments and cures for a range of conditions, the transfusions are unproven and potentially harmful.

In a statement, FDA Commissioner Scott Gottlieb and the director of FDA's Center for Biologics Evaluation and Research, Peter Marks, wrote:

Simply put, we're concerned that some patients are being preyed upon by unscrupulous actors touting treatments of plasma from young donors as cures and remedies.

Establishments in several states are now selling young blood plasma, which is the liquid portion of blood that contains proteins for clotting. The sellers suggest that doses of young plasma can treat conditions ranging from normal aging and memory loss to dementia, Parkinson's disease, multiple sclerosis, Alzheimer's disease, heart disease, or post-traumatic stress disorder, according to the FDA.

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Posted in Aging, blood, fda, Health, mouse studies, science | Comments (0)

Drug companies are sitting on generics—43% of recently approved aren’t for sale

February 8th, 2019
Drug companies are sitting on generics—43% of recently approved aren’t for sale

Enlarge (credit: Getty | Ute Grabowsky )

Of the more than 1,600 generic drugs approved by the Food and Drug Administration since January of 2017, more than 700—or 43 percent—are not for sale in the US, according to a new analysis by Kaiser Health News.

The finding means that many pricy, brand-name drugs are not facing the competition that could help drive down soaring prices. Among the drugs missing in action are generic versions of the expensive blood thinner Brilinta and the HIV medication Truvada. Moreover, of the approved drugs that would offer a brand-name drug its first competition, 36 percent are being held off the market, the analysis found.

Experts told KHN that the reasons drug makers may withhold an approved generic from the market are varied. Industry consolidation has made buying, manufacturing, and distributing generics more difficult in recent years. Generic drug makers also, as always, face patent litigation from brand-name makers. Then there’s potentially anti-competitive deals, in which brand-name drug makers simply pay generic makers to keep their product off the market for a while—a so-called “pay for delay” tactic.

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Posted in drug prices, fda, generics, Pharmaceutical industry, science | Comments (0)

Infamous pharma company declares bankruptcy after 3,900% price hike

February 6th, 2019
Man wipes really expensive cream from his face.

Enlarge / Man wipes really expensive cream from his face. (credit: Getty | Boston Globe)

The Chicago-based pharmaceutical company that made headlines in 2016 for dramatically raising the price of cheap skin creams has now filed for bankruptcy. The filing cites, in part, profit-scorching backlash from the price increases, the Chicago Tribune reports.

In September of 2016, Ars reported that the company, Novum Pharma, had repeatedly raised the price of an old, cheap skin cream, bringing its list price from $241.50 to $9,561 a tube—a 3,900 percent increase total. The cream, called Aloquin, is “possibly effective” for treating eczema and acne, according to the Food and Drug Administration. It’s composed of a generic antibiotic and extracts from the aloe vera plant.

Novum raised Aloquin’s price after acquiring the rights to it from Primus Pharmaceuticals in May of 2015. The company similarly raised the price of another skin cream, Alcortin A, to $7,142, the Financial Times reported at the time.

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Posted in drug pricing, fda, generic medicines, Novum, Pharmaceutical industry, science | Comments (0)

Family behind OxyContin called addicts “criminals” while pushing pills

January 19th, 2019
Family behind OxyContin called addicts “criminals” while pushing pills

Enlarge (credit: Getty | Bloomberg)

With the opioid epidemic raging, you may at this point be familiar with Purdue Pharma. It makes the powerful painkiller OxyContin and has been widely blamed for igniting the current crisis.

After debuting OxyContin in 1996, Purdue raked in billions using aggressive and deceptive sales tactics, including ratcheting up dosages of the addictive opioid while lying about its addictiveness. As OxyContin prescriptions soared, opioid overdose deaths increased six-fold in the US, killing more than 400,000 people between 1999 and 2017. Of those deaths, around 200,000 involved prescription opioids specifically.

In 2007, Purdue and three of its executives pleaded guilty in federal court to misleading doctors, regulators, and patients about the addictiveness of OxyContin. The company has seen a flurry of lawsuits making similar allegations since then.

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Posted in drug abuse, drug addiction, fda, opioid epidemic, opioids, overdose, oxycontin, Pharmaceutical industry, purdue pharma, science | Comments (0)

Healthcare industry spends $30B on marketing—most of it goes to doctors

January 11th, 2019
Healthcare industry spends $30B on marketing—most of it goes to doctors

Enlarge (credit: Getty | Media for Medical)

Talk with your doctor… It’s a common refrain at the end of any drug advertisement or disease awareness campaign. Ostensibly, it seems like a responsible suggestion. Talking with your own, trusted doctor can help determine if a new drug really is right for you, or if you may be suffering from an undiagnosed disease. You shouldn’t just take the word of the drug company behind that drug ad or awareness campaign, of course.

But the suggestion to consult with your doctor may not be as innocent as it seems. The drug company likely got to your doctor first.

Of the nearly $30 billion health companies now spend on medical marketing each year, around 68 percent (or about $20 billion) goes to persuading doctors and other medical professionals—not consumers—of the benefits of prescription drugs. That’s according to an in-depth analysis published in JAMA this week. The study broke down exactly how health companies convinced us to spend enormous sums on our care between 1997 and 2016. In that time, health companies went from spending $17.7 billion to $29.9 billion on medical marketing. Meanwhile, US healthcare spending hit $3.3 trillion, or 17.8 percent of the GDP, in 2016.

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Posted in drug advertisements, drug prices, fda, Health policy, medical marketing, Pharmaceutical industry, science | Comments (0)

Halted inspections amid gov’t shutdown “puts our food supply at risk”

January 9th, 2019
A man shops for vegetables beside Romaine lettuce stocked and for sale at a supermarket in Los Angeles, California, on May 2, 2018, where the first death from an E coli contaminated Romaine lettuce outbreak was reported.

Enlarge / A man shops for vegetables beside Romaine lettuce stocked and for sale at a supermarket in Los Angeles, California, on May 2, 2018, where the first death from an E coli contaminated Romaine lettuce outbreak was reported. (credit: Getty | FREDERIC J. BROWN)

After a year plagued by deadly E. coli outbreaks linked to widely distributed romaine lettuce, 2019 is off to an anxiety-inducing start.

With hundreds of food inspectors furloughed in the ongoing government shutdown, the Food and Drug Administration has suspended all routine inspections of domestic food processing facilities. That’s according to FDA Commissioner Scott Gottlieb, who revealed the news in an interview with the Washington Post published Wednesday.

Gottlieb said that the agency, which oversees about 80 percent of the food supply, is continuing to surveil foreign manufacturers and imported food, as well as any domestic producers involved in a current recall or outbreak.

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Posted in E. coli, fda, food safety, foodborne illnesses, romaine, science | Comments (0)

“Scary” reality: Meds tainted with germs, glass, carcinogens, mystery particles

January 7th, 2019
What else is in there?

Enlarge / What else is in there? (credit: Getty | Bloomberg)

An investigation by Kaiser Health News into thousands of recent drug recalls reveals a frightening record of medicines in the US being tainted with dangerous bacteria, mold, glass shards, rubber bits, cancer-causing chemicals, mysterious powders, and worrying metal particles. There were also cases of medications with too much or too little ingredients—or simply the wrong ingredients entirely.

Digging deeper, the investigation discovered that a startling number of the drug makers who issued the recalls had received an all-clear from Food and Drug Administration inspectors within a year of their recalls. FDA records and lawsuits suggest that drug makers can easily game the inspection system, mislead inspectors, lie about where drugs are manufactured, or outright sabotage inspections.

For instance, FDA enforcement documents reveal that employees at one drug-making facility in Japan stood “shoulder-to-shoulder” to physically block an FDA inspector from looking around, and another drug maker in India faked a worker strike and cut the lights at its facility to foil an inspection. In a different case, whistleblowers alleged in a lawsuit that Gilead Sciences told the FDA that it used a facility in South Korea to make an ingredient for HIV drugs Truvada and Atripla, but in reality, Gilead was using an unregistered facility in China. The civil suit claimed that the Chinese ingredient contained “glass-like shards,” “black rubber-like particles,” “plastic-like particles,” “small stone or pebble-like particles” and “metal shards.”

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Posted in bacterial infection, contamination, Drug Safety, fda, kaiser health news, Pharmaceutical industry, science | Comments (0)

FDA slams more homeopaths for playing fast and loose with toxic chemicals

August 17th, 2017

Enlarge / Contains belladonna, aka deadly nightshade. (credit: Homeolab)

The Food and Drug Administration sent a sharp letter this month to a Canadian-based homeopathic pharmaceutical manufacturer named Homeolab USA. The letter warned of “significant violations” the agency found during a recent inspection and poor quality control of the company’s infant teething products that contain the deadly poison, belladonna, aka deadly nightshade.

The letter, dated August 2 and posted on the agency’s website Wednesday, includes a lengthy list of quality and manufacturing process failures that renders Homeolab’s products “adulterated,” the agency concluded. These include failing to test the quality of ingredients or ensuring consistent levels of belladonna in the products.

Homeolab is just the latest homeopathic company slammed by the FDA for problems related to belladonna-containing products. For years, the agency has been investigating reports of infants having seizures, losing consciousness, and, in some cases, dying after using such products. The symptoms were all consistent with belladonna poisonings. Last September, the FDA warned consumers to avoid the homeopathic teething gels and tablets distributed by Hyland’s, CVS, and others.

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Posted in fda, homeopathy, science, teething | Comments (0)