Wednesday, January 29, 2020

Health Tech Company Resolves Allegations It Helped Set Up System To Encourage Opioid Prescriptions

Kentucky pharmacist who was one of the US' largest opioid buyers is charged Sarah Ladd, Louisville Courier JournalPublished 3:06 p.m. ET Jan. 28, 2020 | U

Feds: Casper pharmacy will pay $1M settlement in connection with doctor convicted of drug dealing Shane Sanderson Jan 28, 2020

A Secret Reason Rx Drugs Cost So Much: A Global Web of Patent Laws Protects Big Pharma

A Secret Reason Rx Drugs Cost So Much: A Global Web of Patent Laws Protects Big Pharma

5 recent pharmaceutical, devicemaker bankruptcies Alia Paavol

Still time to comment on FDA drug compounding guidance Industry survey on FDA’s Draft GFI 256 shows veterinarians not happy with restrictions these “regulations” would enact. Alan Newport | Jan 28, 2020

Recent Developments in False Claims Act Pleading Standards

2 Arrested in $20M Workers’ Comp Fraud And Kickback Scheme January 28, 2020

Monday, January 27, 2020

6 days ago - Amazon has filed to trademark “Amazon Pharmacy” in Canada, the U.K. and Australia, signaling a potential move into selling prescription drugs outside of the ...
4 days ago - Glowing Green Pharmacy Sign. Getty. Pharmaceutical distribution vary from country to country, but all of them are subject factors that make genuine competition .
14 hours ago - The grocery store pharmacy counter seems to slowly be nearing its expiration date. Hundreds of grocery stores nationwide are closing their pharmacies as ..

Despite an industry crackdown, certain prescription drugs could still be dangerous

CNBC· 5 days ago
Following the NECC catastrophe, Congress overhauled the law that governs compounding pharmacies and...

Call For FDA To Withdraw Preterm Birth Drug Divides Doctors and Insurers

A study ordered by the Food and Drug Administration failed to prove that Makena, the only drug approved to prevent premature birth, is effective. While a panel of experts has recommended withdrawing the drug’s approval, many doctors are wary.

Read in Kaiser Health News:

Sunday, January 26, 2020

Cases in Arizona, California push US tally of new virus to 5

Cases in Arizona, California push US tally of new virus to 5

Las Vegas Review-Journal· 2 hours ago
The three previously reported cases were a patient in Orange County, California; a man in his 30s in...

Virus death toll in China rises to 56 with about 2,000 cases

Virus death toll in China rises to 56 with about 2,000 cases

Associated Press· 22 hours ago
The death toll from a new virus in China has risen to 56 with 1,975 total cases reported, as China’s...

China virus spread is accelerating, Xi warns

BBC News· 17 hours ago
The spread of a deadly new virus is accelerating, Chinese President Xi Jinping warned, after holding a special government meeting on the Lunar New Year...

Virus death toll in China rises as US prepares evacuation· 2 hours ago
Consulate in the city at the epicenter announced it will evacuate its personnel and some private..

Wednesday, January 22, 2020

GlaxoSmithKline halts Excedrin production over manufacturing stumble

Cardinal Health recalls 9.1 million surgical gowns

Nearly 8 million of the recalled surgical gowns were distributed to 2,807 facilities worldwide over the course of more than a year.

Trump says U.S. in 'great shape' with plan for coronavirus

Trump says U.S. in 'great shape' with plan for coronavirus

Wuhan coronavirus death toll rises to 17 with 547 infected says China, sparking fears of wider spread By James Griffiths, Nectar Gan, Tara John and Jack Guy, CNN Updated 12:48 PM ET, Wed January 22, 2020

FDA In Brief: FDA expands youth e-cigarette prevention campaign to include stories from teenagers addicted to nicotine

The following quote is attributed to FDA Commissioner Stephen M. Hahn, M.D.:

“The troubling epidemic of youth vaping threatens to erase years of progress in combatting tobacco use among youth. We are working tirelessly to tackle this concerning trend, including through our recently released compliance policy focusing on, among other priorities, unauthorized flavored cartridge-based e-cigarettes most popular with youth. We also know it is imperative to continue to educate our nation’s youth about the dangers of these products, so they can make the smart, well-informed choice to not use these products.

“The new videos that launch this week as part of our youth e-cigarette prevention campaign feature real stories from teens who have become addicted to e-cigarettes. These powerful narratives from youth show their peers the disastrous impact of e-cigarette addiction, like the teens who developed severe anxiety and depression after using e-cigarettes or the high school athlete who could no longer compete.

“We will continue to spearhead these highly successful public education efforts to warn and inform youth about the dangers of all tobacco products, including e-cigarettes, and we are committed to supporting research into therapies for youth who are trying to quit e-cigarettes or any other tobacco product. We will also remain diligent in our vigorous compliance and enforcement actions to hold manufacturers and retailers accountable when they illegally market or sell these products to minors.”
  • Starting this week, the U.S. Food and Drug Administration’s  “The Real Cost” Youth E-Cigarette Prevention Campaign will release videos featuring teenagers sharing cautionary tales about their e-cigarette addiction. The campaign will include a series of four videos called “My Vaping Mistake” with teenagers describing the physical and emotional effects of vaping addiction. The videos will be released on youth-focused channels and amplified on social media throughout the year.
  • Studies have reported that youth who use a tobacco product, such as e-cigarettes, are more likely to go on to use other tobacco products, such as cigarettes. This evidence is particularly concerning given that over the past several years, e-cigarettes were the most commonly used tobacco product by youth in the U.S. In fact, more than 5 million middle and high school students across the country were current (within the past 30 days) e-cigarette users in 2019, according to the National Youth Tobacco Survey conducted by the FDA and the U.S. Centers for Disease Control and Prevention.
  •  “The Real Cost” Youth E-Cigarette Prevention Campaign educates youth that using e-cigarettes, just like cigarettes, puts them at risk for addiction and other health consequences. Most e-cigarettes contain the highly addictive chemical nicotine and vaping delivers nicotine to the brain in as little as 10 seconds. A teen’s brain is still developing, making it more vulnerable to nicotine addiction, and nicotine exposure during the teen years can disrupt normal brain development.
  • Since its launch in 2017, “The Real Cost” E-Cigarette Prevention Campaign is showing positive results for reach and engagement. The campaign, which originally focused on digital and social media sites popular among teens and has since expanded to TV advertisements, has generated significant viewership, including more than 2 billion teen views in just over a year. Across social media platforms, the FDA has engaged teen audiences with more than 882,00 likes, 121,000 shares and 50,000 comments.

 The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

New vertical merger guidelines disappoint antitrust experts

Some experts hoped the Justice Department and Federal Trade Commission would signal tougher scrutiny on vertical merger deals in the future.

In Oval Office Meeting, Trump Expresses Regret on Vaping Policy

Thursday, January 16, 2020

Statement from Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health on quality issues with certain Cardinal Health surgical gowns and packs

FDA working with manufacturer to assess scope of potential contamination risk, possible supply chain disruptions
On Jan. 11 and again on Jan. 15, 2020, medical device manufacturer Cardinal Health alerted its customers to potential quality issues affecting some of its Level 3 surgical gowns and PreSource procedural packs that contains these gowns. Cardinal Health recommends, and the FDA agrees, that customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include these surgical gowns because the manufacturer cannot provide assurance the products are sterile. The FDA is working to assess the cause and full impact of these concerns.

Surgical gowns are commonly used in health care facilities during surgical procedures and/or to provide moderate to high risk barrier protection. Gowns are classified into four levels of barrier protection based on their liquid barrier performance. Level 3 gowns provide moderate risk protection and are used in a wide-range of surgical procedures, such as open heart surgery and knee replacements. They are ...

Wednesday, January 15, 2020

USP 800 Presents Significant Compliance Challenges for Long-Term Care Providers 2020-01-14 16:18:00 Jill Murphy, Assistant Editor
15 hours ago - The Pharmacy Board of Australia's Guidelines on. Compounding Medicines2 specify that medicines may be compounded only if an appropriate registered ...

Monday, January 13, 2020

DPL XXXI Seminar
November 5 - 8, 2020
Naples Grande Beach Resort
Naples, FL
5 days ago - Prosecutors had charged the group of doctors, pharmacy owners and marketers with plotting to defraud the Tricare military health care program by conspiring to .