Wednesday, February 27, 2019

Statement from FDA Commissioner Scott Gottlieb, M.D. as prepared for oral testimony before the U.S. House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, Committee on Appropriations

Chairman Bishop, Ranking Member Fortenberry, and members of the subcommittee. I want to thank you today on behalf of the FDA for your continued support of our public health mission. We’re witness to a period of historic scientific advance. The opportunities we have, across our entire portfolio, to advance health and wellbeing, far exceed any comparable period of rapid technological change. Simply put, we’re in a period of unparalleled medical progress.

Your support is helping us seize these opportunities to improve the lives of Americans. The FDA’s Fiscal Year 2019 budget includes one of the most substantial increases for the FDA in recent years. The initiatives that Congress supported will help uncover new treatment options for patients suffering from debilitating conditions, improve competition to ...

BREAKING: Cohen drops testimony on Novartis deal: They wanted ‘access’ to Trump

BREAKING: Cohen drops testimony on Novartis deal: They wanted ‘access’ to Trump

Tuesday, February 26, 2019

Pasadena pharmacy owner gets 4 years in prison for running ...

LA Daily News-20 hours ago
LOS ANGELES — A Pasadena pharmacy owner was sentenced Monday to four years behind bars for running a Medicare fraud scheme involving more than ...

US Senators rip pharmacy executives on high prescription drug prices hours ago
AbbVie Inc. Chairman Richard A. Gonzalez, far left, testifies about drug pricing Tuesday before the Senate Finance Committee. Also in the photo are executives ...

Man pleads guilty in pharmacy fraud scheme

WLOX-7 hours ago
Prosecutors charged that “pharmacy owners bribed healthcare providers to ... Many of the prescriptions were for “compounded medications,” with some running ..

Co-owner, ex-employee of pharmacy in meningitis outbreak seek ...

Reuters-5 hours ago
A co-owner and ex-employee of a Massachusetts compounding pharmacy on Tuesday urged a judge to grant them an acquittal after a jury found they conspired ...

NECC Execs Say Conspiracy Convictions 'Legally Impossible'

Law360-4 hours ago
Law360, Boston (February 26, 2019, 5:58 PM EST) -- Two former executives at the New England Compounding Center asked a Massachusetts federal judge ..
02/20/2019Pure Source LLCDallas District OfficeCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
02/13/2019Proandre SLCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *

Monday, February 25, 2019

Amazon takes steps to grow PillPack's national distribution

DigitalCommerce360-11 hours ago
Amazon is revealing more on how it intends to grow its nearly $800 million acquisition of digital pharmacy In September Amazon closed its $753 ...

Kentucky officials: PBMs earned $123M last year through spread ...

FierceHealthcare-13 hours ago
Pharmacy benefit managers earned millions through spread pricing in Kentucky's ... a PBM charges Medicaid more for a drug than the pharmacy paid, leading t

Big Pharma heads to Capitol Hill Feb 26: 6 things to know

Becker's Hospital Review-10 hours ago
Big Pharma is likely to deflect the blame onto pharmacy benefit managers or insurers. A drug policy expert told Politico that executives will likely attack the rebate ...

Online and hospital pharmacies steal a march on independents

Pharmacy Business-10 hours ago
Online pharmacies and hospital pharmacies are seeing exponential growth in volume and value respectively, while community pharmacies fail to even realise .

Federman & Sherwood Announces Filing of Securities Class Action ...

Business Wire (press release)-7 hours ago
Plaintiff seeks to recover damages on behalf of all Diplomat Pharmacy, Inc. shareholders who purchased common stock during the Class Period and are .

Drug industry defense for high prices: Blame insurance companies

Washington Post-7 hours ago
Sanofi argues that the discounts it gives insurance companies, and the pharmacybenefit manager divisions they own, are not being passed down to consumers.

Diplomat Pharmacy Misled Investors About New Venture: Suit

Law360-6 hours ago
Law360 (February 25, 2019, 4:59 PM EST) -- Diplomat Pharmacy misled investors about the success of a new business venture, causing a 56 percent plunge in ...

Pharmacy discount card company fined for violations

The Hutchinson News-11 hours ago
TOPEKA – A pharmacy discount drug card company has been ordered to pay $10,000 for marketing prescription discount cards in Kansas without registering ..

Pasadena Pharmacy Owner Sentenced to 4 Years for Medicare Fraud ...

NBC Southern California-5 hours ago
A Pasadena pharmacy owner was sentenced Monday to four years behind bars for running a Medicare fraud scheme involving more than $1.3 million in phony 

In-office Rx dispensing fills care gap

Dermatology Times (press release) (blog)-10 hours ago
In revisiting compounding regulations, says Dr. Werschler, the new section of the law known as the Drug Quality and Security Act created new opportunities for ...

Michigan attorney general pursues new murder charges in fungal ...

WDIV ClickOnDetroit-6 hours ago
Barry Cadden, the founder of the compounding pharmacy at the center of the outbreak, and pharmacist Glenn Chin, each face 11 counts of second-degree
11 hours ago - A Tulsa doctor and a Texas marketer implicated in an illegal kickback scheme involvingcompounding prescriptions have agreed to pay the government about ...

Saturday, February 23, 2019

Public Hearing on New Formulary Set for Friday

WorkCompCentral-Feb 21, 2019
It would require that expensive compounded medications and other non-preferred drugs be pre-approved by employers or insurance carriers. A draft of the rules 

Ex-pharmacy rep from San Antonio pleads guilty in $8.8 million fraud ... 22, 2019
Compounding pharmacies create their own drugs by combining two or more ... including Tricare, for compounded medications based on the prescriptions.

Jon Lender: Doctor's husband found guilty on 2 counts involving fraud ...

Hartford Courant-Feb 22, 2019
The phenomenon became a national issue, as other state and federal drug .... After the 3,000 percent cost increase in compounded drugs in 2015, Lembo ...

Texas Pharma Sales Rep Pleads Guilty To $8M Fraud in compounding medication case

Texas Pharma Sales Rep Pleads Guilty To $8M Fraud

Law360-Feb 22, 2019
... would prescribe compounded medications to patients who didn't need them. ... Medical Devices and used it to market and sell drugs including pain and scar ..

Jury Reaches Verdict In Stamford Health Care Fraud Trial: Feds

Jury Reaches Verdict In Stamford Health Care Fraud Trial: Feds hours ago
Advantage Pharmacy was a compounding pharmacy located in Hattiesburg, Mississippi. As a compounding pharmacy, Advantage created compound ...

Stamford man convicted in drug compounding case that cost health ...

FOX 61-Feb 22, 2019
Advantage Pharmacy was a compounding pharmacy located in Hattiesburg, Mississippi. As a compounding pharmacy, Advantage created compound ..

As Theranos trial, documentary and movie near, Elizabeth Holmes ...

Silicon Valley Business Journal-Feb 21, 2019
While government officials comb through millions of pages of documents to prepare for Theranos founder Elizabeth Holmes' expected fraud trial and the last 

Elizabeth Holmes bought dog she claimed was 'wolf' as Theranos ...

Fox News-Feb 22, 2019
As her company was facing serious trouble, the then-CEO of Theranos reportedly jetted off across the U.S. to purchase a Siberian husky -- that she later claimed ...

Theranos Founder Elizabeth Holmes Thinks She Has a Chance at ...

Fortune-Feb 21, 2019
The founder of blood-testing startup Theranos, who raised more than $700 million from investors for technology that was little more than a pipe dream, has ...
When Theranos' remarkable blood-test claims began to unravel
WABC-TV-Feb 20, 2019

“SHE NEVER LOOKS BACK”: INSIDE ELIZABETH HOLMES’S CHILLING FINAL MONTHS AT THERANOS At the end, Theranos was overrun by a dog defecating in the boardroom, nearly a dozen law firms on retainer, and a C.E.O. grinning through her teeth about an implausible turnaround.

Wednesday, February 20, 2019

House of pain: Feds detail alleged 'pill mill' scheme at Warren pain ...

The Detroit News-25 minutes ago
Warren — Pain pill scalpers roamed the parking lot at a Macomb County clinic embroiled in one of the nation's largest health care fraud cases, chugging booze, 

Judge: Convicted pharmacist Kim Jones must stay in jail pending ...

The News Journal-12 hours ago
A federal judge has denied a Williamsburg pharmacist's request to be released from jail as she awaits sentencing on charges of unlawfully dispensing controlled

Kentucky Medicaid releases report on pharmacy benefit program

Ohio County Monitor-18 hours ago
Get full access to the Ohio County Monitor and support quality local journalism with a $5 monthly subscription, or SAVE with a longer subscription. It costs less

Ohio AG says state owed $15.8M from pharmacy benefit manager

Dayton Daily News-18 hours ago
The Ohio Attorney General is arguing the state is owed $15.8 million from a company that manages pharmacy benefits for Ohio Bureau of Workers' ...

Hope Thomley pleads guilty in compounding pharmacy fraud scheme

Mississippi woman pleads guilty in massive pharmacy fraud

Minneapolis Star Tribune-3 hours ago
Prosecutors have said Advantage Pharmacy, partly owned by Hope Thomley, took in $192 million in revenue from TRICARE alone over several years.

Welch unveils legislation to allow importation of cheap insulin from ... hours ago
... the importation of insulin from countries like Canada, where the drug comes at a ... The problem is compounded, he said, with the middlemen — the insurance ..

United States: DOJ Expands New Enforcement Tactic – Obtains TRO ...

Mondaq News Alerts-19 hours ago
"Pharmacies and pharmacists have a legal obligation to dispense controlled substances properly, so as not to put patients' health at risk," said Assistant Attorney .

Attorney General Dave Yost seeks $16 million repayment from ...

The Columbus Dispatch-19 hours ago
After nearly a year of investigating, Ohio is taking its first steps to recover money from pharmacy middlemen who do billions of dollars worth of business with state

Report cracks open 'black box' of Kentucky's Medicaid pharmacy system

Courier Journal-7 hours ago
FRANKFORT — A long-awaited state report appears to confirm legislators' suspicions that industry middlemen, known as pharmacy benefit managers, are ...

FDA Milestones

Quality Digest-14 hours ago
Requires drug wholesalers to be licensed by the states; restricts reimportation ... more authority to regulate and monitor the manufacturing of compounded drugs.

BakerHostetler FDA and Pharmacy Weekly Digest - February 19, 2019

Lexology-1 hour ago
FDA Finalizes Compounding Rule – The FDA announced the finalized rule setting out six bulk drug substances that can be compounded and four that cannot be .

Tulsa doctor pays fine for alleged kickback scheme

KRMG-4 hours ago
TULSA - Federal prosecutors in Tulsa say a physician will pay the government nearly $85,000 to settle allegations he was involved in a kickback scheme.

Express Scripts seeking $20 million won in court judgment against compounding pharmacy

Express Scripts seeking $20 million won in court judgment against ... hours ago
ST. LOUIS • A compounding pharmacy that sued Express Scripts more than four years ago has paid nearly $367,000 in attorney's fees and costs for misconduct, 

Sarasota pharmacy pays $775000 to settle kickback claims

Sarasota Herald-Tribune-10 hours ago
The owners of a Sarasota compounding pharmacy will pay at least $775,000 to resolve claims that they engaged in an illegal kickback scheme. The U.S. 

Oklahoma doctor to pay $84666 in alleged kickback scheme

KTUL-12 hours ago
Shores says the settlement resulted from an investigation into health care providers who wrote prescriptions for pain creams compounded and sold by OK ...
02/11/2019Bella Pharmaceuticals, Inc.Detroit District OfficeCompounding Pharmacy/Adulterated Drug ProductsNot Issued *
02/11/2019United PharmacyDallas District OfficeCompounding Pharmacy/Adulterated Drug ProductsNot Issued *
01/29/2019Hangzhou SunKing Nonwovens Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
1/29/2019Vipor Chemicals Private Ltd.Center for Drug Evaluation and ResearchVipor Chemicals Private Ltd., CGMP/Active Pharmaceutical Ingredient (API)/AdulteratedNot Issued *

Monday, February 18, 2019

Pharmacy reprimanded over opioid prescriptions

Northern Virginia Daily-18 hours ago
The Virginia Board of Pharmacy recently reprimanded a Front Royal pharmacy for what the board stated was a failure “to take appropriate steps to determine the ...

Sarasota pharmacy owners agree to pay $775,000 settlement

Sarasota pharmacy owners agree to pay $775,000 settlement: A Sarasota pharmacy and its owners are out at least $775,000 to settle a federal lawsuit.

New Hazardous Waste Pharmaceuticals Rule: Significant Changes ...

JD Supra (press release)-Feb 14, 2019
Dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act; ... drugs;; Homeopathic drugs;; Compounded drugs;; Investigational new drug