Friday, January 31, 2020

Teens find a big loophole in the new flavored vaping ban
The policy allows mint, dessert and fruit flavors to continue to be sold in disposable e-cigarettes, prompting many teens to switch from Juul to those devices.

Read in The New York Times: https://apple.news/AktAXmXwFSCqaTX2aeXtsfg

CDC quarantines Americans evacuated from center of China virus outbreak
Americans who were evacuated from the epicenter of the China coronavirus outbreak will be quarantined for 14 days at a U.S. military base to prevent any spread of the infectious disease, authorities said.

Read in The Wall Street Journal: https://apple.news/Aq6tyAbD4QHSJkUGVMTcdgA

FDA In Brief: FDA Warns Maker of Nicotine-Containing Toothpicks of Several Violations, Including Illegal Sales

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

“The FDA has made it clear, we will not tolerate violations of federal tobacco regulations designed to protect the American public – especially underage tobacco sales to youth. In this case, the FDA was prompted to take action because Smart Toothpicks LLC ignored the laws.

“The FDA has been holding retailers and manufacturers accountable for marketing and sales practices that have led to increased youth accessibility and appeal of tobacco products. We’re especially concerned about novel nicotine-containing products, such as...

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Wednesday, January 29, 2020

Coronavirus: 110 people in 26 states 'under investigation' for disease; 5 U.S. cases so far

MSN News· 2 days ago

U.S. officials are in 'very close communication' with China as that nation grapples with a deadly.

Filing: Emails raise questions of execution drugs access

ABC News· 2 hours ago

The emails mention the state's “difficult time” getting its hands on the paralytic used as the s

Department of Justice

U.S. Attorney’s Office

Eastern District of Kentucky

FOR IMMEDIATE RELEASE

Friday, January 10, 2020

Jackson Woman Pleads Guilty to Soliciting Kickbacks, Making False Statements to Law Enforcement Agents, and Tampering with Records

LEXINGTON, Ky.- A Jackson, Kentucky, woman admitted in federal court today she solicited kickbacks from a toxicology laboratory in exchange for urine drug testing referrals, lied to law enforcement agents about the kickback she received, and then attempted to cover up the kickback by requesting the alteration of certain financial records.

Theresa C. Merced, 80, pleaded guilty today to one count of violating the Eliminating Kickbacks in Recovery Act (EKRA), 18 U.S.C. § 220; one count of making false statements, 18 U.S.C. § 1001; and one count of attempted tampering with records, 18 U.S.C. § 1512, before U.S. District Court Chief Judge Danny C. Reeves.

Merced, the office manager of a substance abuse treatment clinic in Jackson, Ky., admitted that between December 2018 and August 2019, she solicited kickbacks from the CEO of a toxicology lab in exchange for urine drug test referrals. According to the plea agreement, in August 2019 the CEO delivered to Merced a $4,000 check as part of a larger package of promised inducements. Merced caused the check to be cashed. When Merced was questioned about the check by law enforcement agents in September 2019, she denied knowledge of it, and stated that the $4,000 was probably a loan from the lab CEO to her husband. Shortly after her interview with the agents concluded, Merced called the lab CEO and asked that he alter the lab’s financial records so that the entry for the $4,000 check would say “rent/loan,” consistent with the lie she told the agents.

EKRA, enacted by Congress in October 2018 as part of a broader package of legislation aimed at combatting the opioid crisis, prohibits, among other things, the solicitation or receipt of kickbacks in exchange for the referral of urine drug testing services. Merced’s EKRA conviction is believed to be the first in the nation.

Robert M. Duncan, Jr., United States Attorney for the Eastern District of Kentucky, Derrick L. Jackson, Special Agent in Charge at the U.S. Department of Health and Human Services, Office of Inspector General, Atlanta Field Office, and Kentucky Attorney General Daniel Cameron jointly announced the guilty plea.

The investigation was conducted by the U.S. Department of Health and Human Services, Office of Inspector General, and the Kentucky Office of Attorney General, Medicaid Fraud Control Unit. The U.S. Attorney’s Office was represented by Assistant U.S. Attorney Paul McCaffrey.

Merced is scheduled to be sentenced on May 1, 2020. She faces up to 20 years in prison and a maximum fine of $250,000. However, any sentence will be imposed by the Court after consideration of the U.S. Sentencing Guidelines and the federal statutes.

— END —

Attachment(s):

Download 2020-01-10_merced_guilty_plea.pdf

Component(s):

USAO - Kentucky, Eastern

Contact:

CONTACT: Gabrielle Dudgeon PHONE: (859) 685-4887 E-MAIL: gabrielle.dudgeon@usdoj.gov

Updated January 10, 2020

01/28/2020	01/13/2020	Wave Miami LLC	Division of Pharmaceutical Quality Operations I	Unapproved New Drugs/Misbranded

Trump says US is improving vaccines, drug prices and opioid issues

Trump says US is improving vaccines, drug prices and opioid issues
President Trump discusses health care issues, including drug prices, the opioid crisis and vaccines, while speaking to supporters at a 'Keep America Great' rally in Wildwood, New Jersey.

Read in Fox Business: https://apple.news/Ao3ryCdvoRga-lhllv9IEUA

The dangers you should know about before taking probiotics
Over the past decade or two, there's been a lot of talk around probiotics, with many publications reporting on the benefits of taking them daily. However, there are also arguments of the potential harm they could cause, and certain dangers you should know about before taking probiotics.

Read in The List: https://apple.news/AEHjZNJv9RMqoeQrrJPr58Q

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

https://khn.org/morning-breakout/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

https://www.courier-journal.com/story/news/local/2020/01/28/kentucky-pharmacist-pleads-guilty-charges-drug-distribution-us-attorney-says/4599541002/

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

https://trib.com/news/local/crime-and-courts/feds-casper-pharmacy-will-pay-m-settlement-in-connection-with/article_dc008cc3-5354-5b18-9646-a83c8876faa9.html

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

5 recent pharmaceutical, devicemaker bankruptcies Alia Paavol

https://www.beckershospitalreview.com/pharmacy/5-recent-pharmaceutical-devicemaker-bankruptcies.html

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

https://www.beefmagazine.com/animal-health/still-time-comment-fda-drug-compounding-guidance

Recent Developments in False Claims Act Pleading Standards

https://www.jdsupra.com/legalnews/recent-developments-in-false-claims-act-62041/

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

https://www.insurancejournal.com/news/west/2020/01/28/556746.htm

Monday, January 27, 2020

www.cnbc.com › 2020/01/21 › amazon-files-trademarks-for-amazon-...

Amazon files trademarks for 'Amazon Pharmacy' in UK ...

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 ...

www.forbes.com › sites › enriquedans › 2020/01/24 › why-pharmaci...

Why Pharmacies Are About To Be Hit Hard By Disruption

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 .

www.linkedin.com › feed › news › grocery-pharmacies-being-phased-o...

Grocery pharmacies being phased out | LinkedIn

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: https://apple.news/AaInQo_WgTRihYJFlmmFk_A

Sunday, January 26, 2020

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

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

seattlepi.com· 2 hours ago

Consulate in the city at the epicenter announced it will evacuate its personnel and some private..

Friday, January 24, 2020

Court: Insurer Cannot Refuse Payment for Pain Cream Without Utilization Review By Jim Sams | January 24, 2020

https://www.claimsjournal.com/news/east/2020/01/24/295096.htm

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

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

https://www.cnn.com/2020/01/22/asia/china-wuhan-coronavirus-deadly-intl-hnk/index.html

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.

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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.

Read M

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.

01/21/2020	01/09/2020	Cosmelab Co Ltd	Center for Drug Evaluation and Research \| CDER	CGMP/Finished Pharmaceuticals/Adulterated

01/21/2020	01/17/2020	GOJO Industries Inc	Division of Pharmaceutical Quality Operations III	Unapproved New Drugs/Misbranded

1/21/2020	01/09/2020	Zhuhai Aofute Medical Technology Co., Ltd.	Center for Drug Evaluation and Research	CGMP/Finished Pharmaceuticals/Adulterated/Failure to Register/Unapproved or Misbranded

01/21/2020	01/07/2020	Swagath Home Foods LLC	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)

01/21/2020	12/19/2019	CGA Limited	Center for Drug Evaluation and Research \| CDER	CGMP/Finished Pharmaceuticals/Adulterated

01/21/2020	12/12/2019	Dinamix Distribution, LLC.	Division of Southeast Imports	Foreign Supplier Verification Program (FSVP)

01/21/2020	12/12/2019	Hazetown Vapes Inc.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
01/21/2020	12/12/2019	Vapetrunk Company Inc	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

01/21/2020	12/05/2019	Tismor Health and Wellness Pty Limited	Center for Drug Evaluation and Research \| CDER	CGMP/Finished Pharmaceuticals/Adulterated

01/22/2020	08/20/2019	Inter-Continental Trading USA, Inc. d/b/a E-Luminate E-Cig LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

In Oval Office Meeting, Trump Expresses Regret on Vaping Policy

https://www.nytimes.com/2020/01/17/us/politics/trump-vaping-azar.html

Sunday, January 19, 2020

What's going on at the FDA? 10 agency updates Maia Anderson - Friday, January 17th, 2020

https://www.beckershospitalreview.com/pharmacy/what-s-going-on-at-the-fda-10-agency-updates.html

7th Circ. Says Science Must Back Up Aloe Buyers' Label Suit

https://www.law360.com/classaction/articles/1234748/7th-circ-says-science-must-back-up-aloe-buyers-label-suit

San Antonio pharma rep gets 2-plus years in prison, must pay $1.7 million in national health fraud case By Diana R. Fuentes, Staff Writer Updated 8:24 pm CST, Thursday, January 16, 2020

https://www.mysanantonio.com/news/local/article/San-Antonio-pharma-rep-gets-more-than-2-years-in-14981498.php

Court orders fee determination for $5K compound cream Angela Childers January 17, 2020

https://www.businessinsurance.com/article/20200117/NEWS08/912332637/Court-orders-fee-determination-for-$5K-compound-cream

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 ...