Friday, April 20, 2018


The warrant to search Dr. James Kauffman's office gives insight into a multimillion dollar prescription fraud case that involved several public employees. There is also information about kickbacks Kauffman may have

Drug industry facing onslaught from frustrated states

The Hill-7 hours ago
Pharmacy benefit managers (PBM)s are essentially middlemen — companies that administer prescription drug coverage. State lawmakers are attacking contracts preventing a pharmacist form telling their customers they could buy the medication cheaper if they paid for it out of pocket rather than through their insurance plan

Amazonising pharmacy — reality or just a rumour?

The Pharmaceutical Journal-5 hours ago
Shares in major online drug stores and healthcare services all dropped after the announcement. Although Amazon already supplies vitamins and supplements, UBS analysts suggest the purchase could provide the online retailer with brick-and-mortar locations that could be used to establish a physical pharmacy, which .

Amazon Withdrawals Plans for Medication Distribution

Pharmacy Times-Apr 19, 2018
I wrote about how Amazon was interested in pharmacy space last year, and had blogged about how such a service could hypothetically roll out if they ever got involved. Ultimately, my concern has always been that Amazon would need to overcome regulatory hurdles in order to get into the space. After all, for a company that ...

GPhC maintains that staffing levels are best set by pharmacy owners

The Pharmaceutical Journal-5 hours ago
The General Pharmaceutical Council (GPhC) has reaffirmed its view that setting staffing levels is best done by those responsible for managing the pharmacy, according to papers discussed at its council meeting on 12 April 2018. Instead, the regulator said its role was to ensure that pharmacy owners have taken account of .

Biloxi pharmacy kept quiet after recall of some of its meds, FDA says

The Sun Herald-22 hours ago
The U.S. Food and Drug Administration alerted the media and other health care professionals about the recall of injections from a Biloxi pharmacy after the business did not inform the public about the recall. Coastal Meds initiated a voluntary recall on its sterile, injectable drug products on April 5 but did not tell the public, ...

First Opioid Lawsuit Targeting Pharmacy Benefit Managers

Monthly Prescribing Reference-6 minutes ago
HealthDay News — A first opioid lawsuit is targeting pharmacy benefit managers (PBMs), according to a report published in Managed Healthcare Executive. Noting that until now, PBMs have not been sued for the opioid crisis, in February, a south Texas county included the three largest PBMs in a nationwide lawsuit, which ..

Iowa lawmaker/pharmacist literally calls 'BS' on CVS rationale for ...

The Columbus Dispatch-14 hours ago
Pharmacy giant CVS has for months ignored questions in Ohio about a controversial pricing practice, but an Iowa legislative committee on Wednesday got the executive in charge to describe it. He came after a lawmaker threatened a subpoena. Rich Ponesse, senior director of trade finance for CVS Caremark, appeared ..

Health Care Enforcement Quarterly Roundup - April 2018

JD Supra (press release)-13 hours ago
15-CV-62617 (S.D. Fla.). The case involves allegations that Patient Care America (PCA), a Florida compounding pharmacy, paid illegal kickbacks to induce prescriptions for drugs reimbursed by TRICARE. While DOJ routinely targets company executives—particularly in recent years—the addition of a private equity sponsor ..

Former KC Chief sentenced to prison for fraud

hays Post-21 hours ago
Grow was convicted earlier this year on 17 counts of health care fraud and money laundering in a kickback scheme from Patient Care America, a South Florida compounding pharmacy. Prosecutors say Grow got millions in illegal payments for recruiting patients who were covered by the Tricare health insurance program for .

Why Counterfeit Drugs Are A Global Problem With No Foolproof ...

WBUR-4 hours ago
Zaman began investigating the problem of substandard and fake drugs in his native Pakistan. But he quickly realized it was a problem of global proportions. That same year, more than 800 Americans were sickened and 76 killed in a meningitis outbreak caused by the New England Compounding Center in Framingham.

THV11.com KTHV

Federal judge enters consent decree against Cantrell Drug Company

Longview News-Journal-13 hours ago
the Drug Quality and Security Act for compounded drugs set forth by. Congress that helps ensure compounded drugs are made under appropriate. production standards," said FDA Commissioner Scott Gottlieb, M.D.. "We'll continue to take action against compounders who produce drugs. under substandard conditions and ...

Details of compounding drug fraud case and blood-collection ...

breakingac.com/details-compounding-drug-fraud-case-blood-collection-kickbacks-fo...
6 hours ago - There is also information about kickbacks Kauffman may have gotten from a blood collection operation. To date, 19 people have pleaded guilty in federal court to compounding fraud, including firefighters from Margate and Atlantic City, and a Margate doctor. The compounding cases represent about $50 million in fraudulent ...

MEDISCA Announces First-Ever World Congress of Compounding ...

www.newschannel10.com/.../medisca-announces-first-ever-world-congress-of-compoun...
17 hours ago - MONTREAL --(BUSINESS WIRE). MEDISCA, the industry leader in providing high qualitycompounding solutions and services to pharmacists worldwide, announced today that it will host the first-ever World Congress of Compounding on October 27-28, 2018 in Las Vegas, NV. The conference is sponsored by MEDISCA ...

High Importance! District Court Enters Permanent Injunction Against Arkansas Compounding Pharmacy and its CEO to Prevent Distribution of Adulterated Drugs

Department of Justice
Office of Public Affairs

FOR IMMEDIATE RELEASE
Thursday, April 19, 2018

District Court Enters Permanent Injunction Against Arkansas Compounding Pharmacy and its CEO to Prevent Distribution of Adulterated Drugs

The U.S. District Court for the Eastern District of Arkansas entered a consent decree of permanent injunction against defendants Cantrell Drug Company (Cantrell), and James L. McCarley Jr., Cantrell’s co-owner and Chief Executive Officer.  The injunction permanently enjoins the defendants from distributing adulterated drugs in violation of the federal Food, Drug, and Cosmetic Act.  
The entered permanent injunction stems from a complaint the Department filed in the U.S. District Court for the Eastern District of Arkansas on Feb. 28, at the request of the U.S. Food and Drug Administration (FDA).  That complaint alleged, among other things, that the defendants distributed adulterated drugs in interstate commerce.  
As part of the permanent injunction, defendants cannot resume manufacturing, processing, or distributing drugs until they comply with specific remedial measures.  Those measures include submitting a remedial plan to FDA, which will provide for an independent expert to conduct inspection(s) of defendants’ facility, ensure defendants implement all recommended corrective actions, and ensure that defendants’ manufacturing and distributing of drugs will be in conformity with current good manufacturing practice.  The permanent injunction provides that defendants cannot resume manufacturing, processing, or distributing drugs until FDA notifies them in writing that defendants appear to be in compliance with the ordered remedial measures.  
“Compounding pharmacies have a responsibility to ensure that they process drugs in a manner that meets the legal standards necessary to ensure the safety and quality of such drugs,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division.  “The Department of Justice will continue to work with FDA to ensure that doctors and patients can rely on the protections in the Food, Drug, and Cosmetic Act.”  
According to the complaint filed by the Department on Feb. 28, defendants’ drugs were adulterated because they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated or may have been rendered injurious to health.  The complaint also alleged that defendants’ drugs were adulterated because defendants failed to comply with current good manufacturing practice regulations. 
Cantrell initiated voluntary recalls of drug products in 2016 and 2017.  The 2016 recall, initiated due to lack of sterility assurance, involved 29 lots of unexpired sterile drug products.  The 2017 recall, also due to a lack of sterility assurance, encompassed all lots of unexpired sterile drug products that Cantrell had compounded and distributed between Feb. 16, 2017, and July 19, 2017.
“The Food, Drug, and Cosmetic Act is designed to protect the public health,” said U.S. Attorney Cody Hiland for the Eastern District of Arkansas. “This enforcement action demonstrated our commitment to ensuring that when deficiencies are identified, they are properly addressed.” 
“As a public health agency, the FDA is committed to fully implementing the regulatory framework set forth by Congress that helps ensure compounded drugs are made under appropriate production standards,” said FDA Commissioner Scott Gottlieb, M.D. “FDA is committed to taking action against compounders who do not comply with the requirements set forth in federal law.”
The government is represented by Trial Attorney Raquel Toledo of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Shannon S. Smith of the U.S. Attorney’s Office for the Eastern District of Arkansas, with the assistance of Associate Chief Counsel, Litigation, Jennifer Kang of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Eastern District of Arkansas, visit its website at https://www.justice.gov/usao-edar
Topic(s): 
Consumer Protection
Press Release Number: 
18-511

Tuesday, April 17, 2018

Miami Sues Drug Makers Over Opioid Epidemic

WLRN-45 minutes ago
In 2016, the city of Miami saw 641 opioid-related overdoses, a 20 percent increase from the year before. Now, attorneys for the city have filed a lawsuit in Miami-Dade County circuit court alleging that drug manufacturers violated Florida law by aggressively and deceptively marketing opioids as safe. The 134-page suit filed

Confronting the Opioid Epidemic and Litigation Risk

BRINK-22 hours ago
The United States—along with much of the world—is confronting an opioid epidemic. According to the Centers for Disease Control and Prevention, 115 Americans die every day from an opioid overdose, and the CDC states that overdoses from prescription opioids “are a driving factor” in the increase in overdose deaths.

France had a big heroin epidemic in the 1980s and '90s. Here's how ...

Vox-11 hours ago
The biggest solution to America's opioid epidemic is no mystery: a major expansion of proven addiction treatment programs. There is not only research backing up the approach but historical precedent too. Over at the Atlantic, Olga Khazan provided a brief overview of what happened when France responded to its ow

Pets, Vets, and Opioids

American Veterinarian-14 hours ago
Today's nationwide opioid epidemic is turning families and entire communities upside down. The most recent report from the American Society of Addiction Medicine states that prescription medication overdose is the leading cause of accidental death among people under 50. The group also noted that opioid addiction is ...

Bernie Sanders introduces bill to impose jail time for execs behind ...

STAT-13 hours ago
ASHINGTON — Sen. Bernie Sanders (I-Vt.) will introduce a bill Tuesday that would impose jail time for pharmaceutical executives whose companies engage in manipulative practices when marketing opioids. The legislation would impose a 10-year minimum prison sentence and fines equal to an executive's compensation ..

Doctor found guilty of prescribing opioids without seeing patients

News & Observer-6 hours ago
Donovan Dave Dixon, 51, of Fayetteville was found guilty of 20 counts of unlawfully distributing oxycodone, as well as conspiracy to distribute the opioid. At trial, prosecutors contended that Dixon worked with a local drug dealer to provide prescriptions in the names of certain people in exchange for cash. Witnesses testified ...
Doctor guilty in opioids case
The Robesonian-4 hours ago

Sessions proposes plan to limit amount of opioids manufacturers ...

Washington Post-4 hours ago
Attorney General Jeff Sessions proposed a change to national drug policy Tuesday by limiting the amount of opioids that certain companies can manufacture each year in an effort to fight what has become a nationwide epidemic. Under Sessions's proposal, the Drug Enforcement Administration, which sets opioid production ...

GOP Rep. Roskam: Corporate Drug Pricing “Outrageous”

IVN News-10 hours ago
While you may assume that your pharmacist is working in your best interests, if her pharmacy's contract with its pharmacy benefits manager (PBM) has a gag clause, she is not. A gag clause puts your pharmacist in violation of that contract if she informs you of cheaper alternatives to the high-priced prescription drugs you are

Pharmacist Sentenced For Giving Painkillers To Addicts: USAO

Patch.com-8 hours ago
A Burlington County pharmacist has been sentenced to two years, three months in prison after he admitted to his role in a long-running scheme to illegally ... Goldfield worked for Ludwikowski at Olde Medford Pharmacy and Medford Family Pharmacy, according to documents filed in the case and statements made in court.

Kmart Corporation inked a settlement of a False Claims Act investigation in which the qui tam relator initially alleged systematic pharmacy billing fraud across twenty-seven states for $525,000.

In Case Alleging Nationwide Pharmacy Fraud, Kmart Scores Narrow ...

The National Law Review-6 hours ago
On Thursday, March 8, Kmart Corporation inked a settlement of a False Claims Act investigation in which the qui tam relator initially alleged systematic pharmacy billing fraud across twenty-seven states for $525,000. Brought by a pharmacist formerly employed at a Kmart in Lakeport, California, the original complaint alleged ...

Pharmacy settles prescription pain pill suit

KWTX-4 hours ago
(AP) A pharmacy accused of dispensing millions of prescription pain pills in West Virginia has agreed to a $550,000 settlement with the state. In a news release, Attorney General Patrick Morrisey says the settlement of a lawsuit involving Lar

Second druggist gets prison term for pill-mill scheme

Cherry Hill Courier Post-5 hours ago
CAMDEN - A second pharmacist has received a prison term in connection with a pill mill run from two Medford drug stores. David Goldfield, 60, of Medford Lakes was sentenced to 27 months in federal prison Tuesday for conspiring to illegally distribute and dispense oxycodone and other prescription drugs, said the U.S. ...

West Virginia Pharmacy Settles Prescription Pain Pill Suit

U.S. News & World Report-13 hours ago
pharmacy accused of dispensing millions of prescription pain pills in West Virginia has agreed to a $550,000 settlement with the state. ... In a news release, Attorney General Patrick Morrisey says the settlement of a lawsuit involving Larry's Drive-In Pharmacy in Madison resolves allegations that it helped fuel the state's ...

Baltimore health commissioner latest to warn about bleeding from ...

Baltimore Sun-10 hours ago
The products are usually herbs and spices with a synthetic compound similar to the psychoactive ingredient in marijuana. They're often ... She joins officials from the Maryland Health Department and the Maryland Poison Center at the University of Maryland School of Pharmacy in advising against taking the drugs. “We want ..

2 local doctors plead guilty to fraud

Cleveland Daily Banner-8 hours ago
San Diego news outlets have been reporting the cost of claims to the program for compounded drugsrose to more than $1 billion, which led investigators to a pharmacy in Utah which had issued prescriptions to patients in Southern California. Most of those prescriptions were authorized by the two Cleveland doctors, who ...

Remarks from FDA Commissioner Scott Gottlieb, MD on Fiscal Year ...

FDA.gov-9 hours ago
It advances a new effort to help more compounding pharmacies expand and grow their businesses. It promotes programs to modernize generic drug review as a way to increase competition and address high drug costs. And it advances new approaches to support the development of treatments for rare pediatric diseases.

Former NFL football player gets 22 years in prison for compounding pharmacy fraud after receiving nearly $20 million in kickbacks from Patient Care America

BC-FBO--Ex-Football Player-Fraud

Hickory Daily Record-4 hours ago
Grow was convicted earlier this year on 17 counts of health care fraud and money laundering in a kickback scheme from Patient Care America, a South Florida compounding pharmacy. Prosecutors say Grow got millions in illegal payments for recruiting patients who were covered by the Tricare health insurance program for ...

Monty Grow gets 21-year term in fraud case

Gainesville Sun-8 hours ago
Court documents say Grow received nearly $20 million in kickbacks from Patient Care America, a Broward County compounding pharmacy, in exchange for recruiting and referring patients to the pharmacy who were covered by the Tricare health care insurance program. Andrew Caplan @AACaplan. Former Florida Gator ...

FDA takes step to protect consumers against dietary supplements containing dangerously high levels of extremely concentrated or pure caffeine

03/29/2018Hanbul Cosmetics Co., LtdCenter for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
04/02/2018ARJ Infusion Services IncDetroit District OfficeDrug Product/AdulteratedNot Issued *
04/04/2018Amerigo Labs LLCKansas City District OfficeDietary Supplement/New Drug/MisbrandedNot Issued 
04/04/2018Puget Sound Drug Corporation dba Key Pharmacy and Compounding CenterLos Angeles District OfficeDrug Product/AdulteratedNot Issued