Wednesday, December 13, 2017

Speculation continues surrounding Amazon, UPS, and pharmacy

Pharmacy Today, American Pharmacists Association, pharmacist.com-Dec 12, 2017
On October 27, 2017, the St. Louis Post-Dispatch reported that Amazon had received approval from 12 state boards of pharmacy for wholesale pharmacy licenses. The article has fueled media speculation about Amazon potentially entering the pharmacy market, but a spokesperson for Amazon told Pharmacy Today, “We ...

Tuesday, December 12, 2017

Attorney blasts Barry Cadden, wife: 'Do you have no shame?'

Boston Herald-19 hours ago
A total of 753 people were sickened by the 2012 outbreak, caused by shoddy conditions in Cadden's now-defunct Framingham based lab, the New England Compounding Center. The deaths of 64 patients were attributed to the outbreak. Cadden was acquitted on second-degree murder charge
11/28/2017Fagron Compounding Services LLC dba Fagron Sterile ServicesDetroit District OfficeCompounding Pharmacy/Adulterated Drug ProductsNot Issued *
11/28/2017RC Outsourcing LLCDetroit District OfficeCompounding Pharmacy/Adulterated Drug ProductsNot Issued 
12/05/2017Aphena Pharma Solutions-Tennessee, LLCCenter for Drug Evaluation and ResearchFailure to Comply with Drug Listing Requirements/MisbrandedNot Issued *
12/05/2017Seindni Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
12/05/2017Seindni Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
12/11/2017Arco Globus Trading LLCCenter for Drug Evaluation and ResearchUnapproved New Drugs/MisbrandedNot Issued *
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Lewis Brisbois Bisgaard & Smith LLP
Yesterday, the Kings County District Attorney's office indicted 20 New York-area doctors for participating in a scheme to defraud Medicare, Medicaid, and other publicly funded insurance 

Insider trading case against Ackman, Valeant approaches trial: report

FDA warns companies for promoting alternatives to street drugs

Coco Loko and Legal Lean Syrup found to be unapproved drugs
The U.S. Food and Drug Administration today posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and misbranded drugs. Continue reading.

Monday, December 11, 2017

IACP Submits Comments to Massachusetts State Board of Registration in Pharmacy/Sterile Compounding - International Academy of Compounding Pharmacists

IACP Submits Comments to Massachusetts State Board of Registration in Pharmacy/Sterile Compounding - International Academy of Compounding Pharmacists

FDA takes new steps to help ensure clear presentation of health ...

https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm588419.htm
11 hours ago - The first Federal Register notice announces the FDA's final guidance on product name placement, size, prominence, and frequency in promotional labeling and advertisements for human prescription drugs, including prescription biological products, and for animal prescription drugs. The disclosure of the product name in ...

Fentanyl is so potent doctors don't know how to fight it

PBS NewsHour-10 hours ago
If this trend holds true, it would mirror what scientists have found in animal models of drug addiction, Comer said. Whereas buprenorphine can completely block the response to drugs like morphine or heroin in animals, the therapy only marginally dulls the influence of fentanyl. Though it's not always the case for 

Say it Ain't So: Supplement Companies Actually Claim Their ...

CSPI Newsroom-15 hours ago
Experts say that the supplements make no difference in relieving opioid withdrawal. “There's no credible evidence that dietary supplements can help with the prevention of opioid addiction, detoxification, or relapse prevention and recovery,” says Bachaar Arnaout, an addiction psychiatrist and assistant professor at the Yale ...

CSPI to FDA and FTC: Crack Down on Supplements Marketed for ...

Natural Products INSIDER (blog)-7 hours ago
Last week, a watchdog group urged FDA and the Federal Trade Commission (Commission) to crack down on eight dietary supplements marketed as opioid withdrawal aids. The Center for Science in the Public Interest (CSPI) emailed the companies, requesting scientific studies to establish their products were more effective ...

Arkansas prescription monitoring program streamlined

Pharmacy Today, American Pharmacists Association, pharmacist.com-14 hours ago
Pharmacists say the new website is easier to log into and accesses information more quickly. However, Arkansas still faces vulnerability at its northern border, with Missouri lacking a statewide monitoring program. Gov. Asa Hutchinson of Arkansas noted that prescription drugs and opioid abuse have been approaching ...

PBM Acquisition Allows Diplomat Pharmacy Inc. to Expand Patient ...

Specialty Pharmacy Times-13 hours ago
Joel Saban, president of Diplomat, told Specialty Pharmacy Times that NPS offers the capabilities and economics of a big-box provider, the services and flexibility of a small provider, and the mentality of a partner, all of which are valuable in today's health care landscape. This acquisition will provide Diplomat with numerous ..

The Drug Topics 2017 Pharmacist Salary Survey

ModernMedicine-9 hours ago
The good news is that the majority of pharmacists got a pay raise in 2017, but it came with a downside: a rise in stress levels. That's the bottom line from an exclusive Drug Topics' 2017 Salary Survey. More than half of pharmacists who responded to the survey reported receiving a raise this year. Although the salary ..

Pharmacy Is Dead

Pharmacy Is Dead

ModernMedicine-12 hours ago
The deal will merge the largest pharmacy, the third largest PBM, and the third largest insurer. Perhaps most significantly, the deal represents a shift in pharmacy and in its value to health care. The deal is still subject to antitrust scrutiny, but many analysts believe the deal will go through without a hitch. The merger would fall ...

Why Are Women Choosing Bioidentical Hormone Therapy?

ModernMedicine-13 hours ago
An estimated one in three women are currently treating menopause symptoms by using compoundedbioidentical hormone therapy (CBHT) rather than conventional FDA-approved hormone therapy (HT). A recent study explored the reasons why a woman might choose this alternative to FDA-approved hormone therapy and ...

KSU study demonstrates loss of compounded drug potency

VeterinaryPracticeNews.com-12 hours ago
A new Kansas State University (KSU) study funded by Morris Animal Foundation (MAF) shows a commonly compounded antimicrobial drug used in veterinary medicine may be losing potency over time. The study recently was published in the Journal of the American Veterinary Medical Association. The KSU research team

meningitis-etc: NECC, Ameridose Profits Topped $200 Million

meningitis-etc: NECC, Ameridose Profits Topped $200 Million: By Walter F. Roche Jr. The company blamed for a deadly fungal meningitis outbreak and a closely related firm earned over $200 million in ...

FDA head favours generics as remedy for high drug prices Scott Gottlieb says he aims to encourage competition and exert a deflationary effect

Supplements Claiming to Ease Opioid Addiction Come Under Scrutiny

'You'll get profitable pharmacies to the detriment of the community.'

Australian Journal of Pharmacy (blog)-7 hours ago
Last week, the AJP covered questions put to pharmacy stakeholders appearing before the Senate Inquiry into the effect of red tape on pharmacy. The committee is chaired by libertarian Senator David Leyonhjelm, who asked the Pharmacy Guild's David Quilty, “What would be the problem with more Chemist Warehouses ...

Scottish government must stop 'lagging behind' England and Wales ...

Pharmacy Business-2 hours ago
Alex MacKinnon, the director for the Royal Pharmaceutical Society in Scotland, has said the country has been left “lagging behind” following the Welsh government's decision to hand its pharmacies access to the general practice record. 

The CVS-Aetna Merger Will Be a Disaster for Small Drugstores

The CVS-Aetna Merger Will Be a Disaster for Small Drugstores

Slate Magazine-28 minutes ago
Big corporate mergers in the health care industry tend to work out poorly for customers. When hospitals combine, they raise prices. When insurers get together, premiums can leap. But when pharmacy giant CVS announced last week that it planned to buy Aetna, the nation's third largest insurer, in a deal worth $69 billion, ...

Update in Lawsuit for Investors in Diplomat Pharmacy Inc (NYSE ...

GlobeNewswire (press release)-34 minutes ago
On November 10, 2016, a lawsuit was filed against Diplomat Pharmacy Inc over alleged securities laws violations. The plaintiff alleged that the defendants made false and/or misleading statements and/or failed to disclose that Diplomat Pharmacy Inc lacked adequate internal controls over its financial reporting, that as a ...

Lisa Cadden, wife of convicted NECC pharmacy executive begs to keep mansion

Wife of convicted pharmacy executive begs to keep mansion ...

Boston Herald-6 hours ago
Lisa Cadden, 50, and her three children have filed petitions asking U.S. District Court Judge Richard G. Stearns to hear arguments on what they contend is their legal right to the assets Stearns has preliminarily ordered be forfeited in a $7.5 million restitution judgment to help the New England Compounding Center's victims ...

How can FDA improve compounding rules? AHA weighs in Healthcare Dive · 2 mins ago

How can FDA improve compounding rules? AHA weighs in

Healthcare Dive · 2 mins ago

Saturday, December 9, 2017

Drug companies sue to block California drug price law

New Haven Register-15 hours ago
FILE - In this Friday, July 8, 2016, file photo, a prescription is filled at Pucci's Pharmacy, in Sacramento, Calif. Pharmaceutical companies are suing to block a new California law that would require them to give advance notice for big price increases. The Pharmaceutical Research and Manufacturers of America file suit Friday, ...

Drug Culture: Picturing Pharmaceuticals Since 1850

Hyperallergic-15 hours ago
Interestingly, there's a lot of street photography in the book, such as an interior shot of a New York pharmacy in 1936 by Berenice Abbott, and Barry Frydlender's 2008 panoramic “57th Street and Sixth Avenue,” where a Duane Reade sign pops from the urban noise. Often a drugstore or advertisement just appears in the ...

CVS-Aetna deal casts chilling shadow over pharmacy landscape

HME News-19 hours ago
YARMOUTH, Maine – If a planned merger between CVS Health and Aetna goes through, community pharmacists say it could flatten the industry. “It's going to have a terrible negative impact on privately-owned pharmacies,” said Steve Nelson, CEO and president of Okeechobee Discount Drugs in Okeechobee, Fla. “They've ...
The CVS-Aetna Merger
Opinion-New York Times-18 hours ago

Specialty pharmacy scrutiny hits again with state's focus on Horizon ...

FiercePharma-22 hours ago
In its 2015 and 2016 formularies, top pharmacy benefits manager Express Scripts excluded the pills, saying they were pricey substitutes for readily available, off-patent products. That's essentially Lembo's contention, and that's one reason he's calling for the health plan to reconsider its coverage. Obviously, the individual ...

California Workers' Comp Division to Adopt a Drug Formulary, Host ...

Insurance Journal-22 hours ago
The California Division of Workers' Compensation will adopt an evidence-based drug formulary for medical providers treating injured workers beginning Jan. ... regarding physician dispensing, generic versus brand name drugs, off-label use, special-fill, peri-operative fill, compounded drugs and access to unlisted drugs.
Department of Justice
U.S. Attorney’s Office
Northern District of Texas

FOR IMMEDIATE RELEASE
Monday, December 4, 2017

Austin Man Admits Role in $4.8 Million TRICARE Fraud Conspiracy

DALLAS, Texas — Jody Sheffield, 44, of Austin, Texas, pleaded guilty today, before U.S. District Judge Sidney A. Fitzwater, to one count of conspiracy to commit health care fraud stemming from a scheme to defraud TRICARE through the submission of unnecessary toxicology and DNA cancer screening tests. The announcement was made today by Criminal Chief Chad Meacham of the Northern District of Texas.
Sheffield faces a maximum penalty of not more than five years in federal prison, a $250,000 fine, and may be ordered to pay restitution. Sheffield will remain on bond pending sentencing, which is scheduled for May 18, 2017.
According to the plea agreement factual resume filed in the case, , Sheffield was the operations manager for ADAR Group, LLC (ADAR Group), an outpatient toxicology testing facility. Erik Bugen owned and operated ADAR Group. Britt Hawrylak and Matthew Hawrylak were marketers for Xpress Laboratories, Inc. (Xpress Laboratories) and Progen Lab Systems, LLC (Progen Labs), and financiers of ADAR Group.

Starting in May 2015 and continuing through May 2016, ADAR Group collected urine and saliva samples from TRICARE, a healthcare program of the United States Department of Defense (DoD) Military Health System that provided coverage for DoD beneficiaries world-wide, including active duty service members, National Guard and Reserve members, retirees, their dependents, and survivors. The samples were sent to Xpress Laboratories and Progen Labs and billed to TRICARE and private insurance for unnecessary toxicology and DNA cancer screening tests.

Sheffield and Bugen induced TRICARE beneficiaries to provide urine and saliva samples with $50.00 Wal-Mart gift cards. Sheffield and his co­defendants disguised the kickback payments as a food assistance program for low income soldiers. They also paid monthly fees to doctors to sign test forms. Ultimately, Bugen obtained signature stamps from the doctors and Sheffield and other ADAR Group employees stamped the testing order forms. Beneficiaries did not see these doctors prior to obtaining the testing, did not receive test results, and did not know the purpose of their samples.

As a result of the scheme, TRICARE was billed approximately $36 million for tests that were not needed, not legitimately prescribed, and which were the product of kickbacks. For these claims, TRICARE paid approximately $4.8 million.

The Defense Criminal Investigative Service, Veteran’s Affairs- Office of Inspector General, and Federal Bureau of Investigation, are investigating. Assistant U.S. Attorney Adrienne Frazior is prosecuting. 
# # #
Topic(s): 
Health Care Fraud
Component(s): 
Contact: 
Lisa Slimak 214-659-8600 Lisa.Slimak@usdoj.gov

2 Investigators: 4-Ounce Prescription Cream Costs $645

CBS Chicago-10 hours ago
(CBS) — The costs for custom-made drugs from compounding pharmacies have skyrocketed, according to federal investigators who are raising questions about possible fraud, abuse and patient safety. Now, one of those patients wants to warn others not to fall into the same trap that she did. Shirley Fox had sticker shock

Friday, December 8, 2017


New study funded by Morris Animal Foundation demonstrates loss of drug potency
DENVER/December 7, 2017 - Drugs work best when their potency remains stable or consistent, but a new study funded by Morris Animal Foundation shows a commonly compounded antimicrobial drug used in veterinary medicine may be losing potency over time. The study recently was published in ..

Loss of Drug Potency Found for Commonly Compounded Drug
Results showed that the compounded formulations of doxycycline lost potency within 21 days of receipt, with many dropping to sub-therapeutic content in that time, as defined by United States Pharmacopeia standards. The complete report was recently published in the Journal of the American Veterinary ...

Compounding Exec Pleads Guilty Amid FDA Concern With Outsourcers
In recent months three compounding executives have been criminally charged after producing harmful medicines, including morphine for infants that was over 2,000 percent more potent than labeled, and FDA's top lawyer said Wednesday (Dec. 6) that the agency is dedicating significant resources to ...

US Compounding develops compound to manage equine ulcers
Adamis Pharmaceuticals Corp. announced that its subsidiary, US Compounding, has developed a compound to manage ulcers in horses. A study, utilizing US Compounding's drug formulation, was conducted in approximately 50 racehorses. Gastric endoscopy was performed at Day 0 and any time ..

Thursday, December 7, 2017

Toxicology testing plays a pivotal role in ensuring the safety of FDA-regulated products. During the development and evaluation of almost all FDA-regulated products, testing is performed on people or animals to identify any potential risk from chemical, physical, or biological agents.
Today, novel methods such as organs on a chip or mathematical modeling are being developed for toxicity testing that are generating unique opportunities to improve our ability to quickly and more accurately predict potential toxicities and reduce associated risks.   
This week the agency’s Toxicology Working Group laid out FDA’s Predictive Toxicology Roadmap, a six-part framework for integrating predictive toxicology methods into safety and risk assessments. Among other recommendations, it calls for FDA research to identify data gaps and to support intramural and extramural research to ensure that the most promising technologies are developed, validated, and integrated into the product pipeline. The roadmap also identifies toxicology issues that need addressing for FDA-regulated products and toxicology areas that could benefit from improved predictivity.


...
FDA Voice blog
Drugs are approved by FDA based upon substantial evidence from clinical trials that the medicine will be both effective and safe for use if prescribed according to its labeling. However, there may be issues that need additional evaluation after approval. 
FDA’s ability to require post-approval studies, referred to as post-marketing requirements (PMRs), has evolved over time. Prior to 2007, FDA could require post-approval studies for the few drugs approved under the accelerated approval pathway, for the rare drugs approved based solely on animal studies and, in certain cases, for drugs that may be used in pediatric populations. If FDA wanted other types of post-approval studies, it would seek an agreement with the manufacturer, called a post-marketing commitment or PMC. The FDA Amendments Act of 2007 (FDAAA) was a major step forward for drug safety in the United States. It gave FDA authority to require safety-related PMRs when the agency becomes aware of new safety information.
FDA is committed to making sure industry fulfills their PMRs and PMCs and that the post-market studies are transparent to the public.  Certain information about PMRs and PMCs is made available to the public in a searchable database on the agency’s website.  Additionally, the FDA monitors the progress of PMRs and PMCs to ensure they are conducted in a timely manner.  Each year, FDA issues a report via a Federal Register (FR) Notice on the status of PMRs and PMCs.  Our most recent FR report shows that, overall, the majority of PMRs and PMCs are progressing toward completion according to the original agreed-upon schedule (85 percent of PMRs and 77 percent of PMCs).