Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Sunday, March 15, 2020

Tales Of The New Crown: Food Banks Are Banks, Too

Feeding America came into existence for a reason.

That reason was to run fraud schemes.

There are multiple food bank fraud schemes.

Why is there even a need for a food bank?

Why are children being raised in poor families?

Poverty is manufactured for the purposes of maximizing revenues because a non profit cannot generate profit.

Poverty is just part of the industry of trafficking tiny humans because you have to feed your chattel <===(pun intended).

In the mean time, here is the link to find some food.

Actually, I must admit, the food banks have kicked their game up as of recent.

https://www.feedingamerica.org/find-your-local-foodbank
Feeding America

Feeding America Establishes COVID-19 Response Fund to Help Food Banks During the Coronavirus Pandemic

Funds will be Used to Aid the Most Vulnerable People Throughout the Country

Feeding America, the nation’s largest domestic hunger-relief organization with a network of 200 member food banks across the country, today announced the establishment of the COVID-19 Response Fund to help food banks across the country as they support communities impacted by the pandemic. The $2.65 million fund will enable food banks to secure the resources they need to serve the most vulnerable members of the community during this difficult time. Still, it is impossible for the Feeding America network to address this pandemic without public and government support, so that food banks can do what they do best — feed people in need within their communities.

While the media has reported greater at-risk factors for COVID-19 among the general population, such as age and pre-existing health conditions, many may not realize food-insecure households are likely more susceptible to the virus. This is believed to be due to lesser access to adequate health care, lower resistance or compromised immune systems, stigma or bias, or lack of information about proper prevention and care.

In addition, school closures, job disruptions, lack of paid sick leave and the coronavirus’ disproportionate impact on adults age 60 and older and low-income families further contribute to the demands placed on food banks. Lost wages or sudden expenses due to illness will be increasingly burdensome for the millions of people in America who live paycheck to paycheck, especially when, according to the Federal Reserve, 40 percent of Americans don’t have enough cash on hand to cover a $400 emergency expense.

In the face of these challenges, the Feeding America network of food banks is uniquely positioned to help people who need it most. Per the most recent USDA food security report, more than 37 million people, 11 million of whom are children, face hunger. As the largest provider of charitable food assistance in the U.S., including in disaster and emergency situations, Feeding America provides more than 4.2 billion meals to people facing hunger each year.

“Our first priority is the millions of individuals, families and seniors who rely on food banks for help,” said Feeding America CEO Claire Babineaux-Fontenot. “Our member food banks are always there to help throughout the year and in times of disaster. This fund will advance their ability to respond efficiently and effectively in their communities so that food is not added to the list of worries for families during this pandemic.” Babineaux-Fontenot added, “We cannot do it alone.”

Using the COVID-19 Response Fund, Feeding America is launching national food- and fund-raising efforts to support people facing hunger and the food banks who help them. This includes building an inventory of emergency food boxes and distributing them to member food banks across the country, as well as working to get incremental funding to support other anticipated costs. Feeding America is also working with government leaders to ensure the emergency response includes strong supports in food, funds, and flexibility for federal nutrition programs.

Member food banks have started shifting operations, adding more mobile or “drive-thru” distributions wherever possible. In addition, food banks are working with partner food pantries and meal programs to minimize the risk of spreading the disease by scheduling appointments and suggesting that only one member of the household visit the pantry or distribution site in order to decrease the number of people congregating in one place.

To learn more and support efforts at the national level, visit feedingamerica.org. To support your community or affected communities directly, you can use the Feeding America food bank locator at https://www.feedingamerica.org/find-your-local-foodbank.

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Wednesday, March 11, 2020

Tales Of The New Crown: Trump Addresses The Nation

All U.S - Europe travel suspended.

Insurance providers to waive co-pays.

Nursing homes encouraged to suspend visitation.

SBA will provide low interests loans and deferment of certain business taxes.



Banks are strong where Emergency Manager Emperor Pence and the Secret Procurement Consortia Task Force worked really hard on this speech given from the Oval Office.


The banking industry was very helpful advising Trump on fighting for the health of individuals with recommendations of the great opportunity to refinance mortgages with suggestions of another bailout, like TARP.



We are behind South Korea in testing.

Still no datasets.

Fauci is NIH, just remember that in dealing with tiny human lab rats.
 Office of Global Health was shuttered in the National Security Council which is why there is chaos.

College basketball games are being shutdown. "Why not the NBA?" Asked by the committee.

White House called for a meeting of all panelists in committee but never notified committee.
Emergency Manager Emperor Pence is hot mess.




It seems the health care industry, along with many, many others in congress, including Procurement Consortia Task Force still wants to put profits over people.



Dougie still just does not get it.

*routing for you*

#maytheheavensfall

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Thursday, July 11, 2019

DOJ: $1.4 Billion Conjugal Collabortive With The Virginia Medicaid Fraud Control Unit

“This historic resolution is the product of a continued partnership with the Virginia Medicaid Fraud Control Unit, FDA, HHS, and the U.S. Postal Service.”
First Assistant United States Attorney Daniel P. Bubar of the Western District of Virginia

49 more States Medicaid Fraud Control Units to go!

Justice Department Obtains $1.4 Billion from Reckitt Benckiser Group in Largest Recovery in a Case Concerning an Opioid Drug in United States History

Global consumer goods conglomerate Reckitt Benckiser Group plc (RB Group) has agreed to pay $1.4 billion to resolve its potential criminal and civil liability related to a federal investigation of the marketing of the opioid addiction treatment drug Suboxone. The resolution – the largest recovery by the United States in a case concerning an opioid drug – includes the forfeiture of proceeds totaling $647 million, civil settlements with the federal government and the states totaling $700 million, and an administrative resolution with the Federal Trade Commission for $50 million.
Suboxone is a drug product approved for use by recovering opioid addicts to avoid or reduce withdrawal symptoms while they undergo treatment. Suboxone and its active ingredient, buprenorphine, are powerful and addictive opioids. 
“The opioid epidemic continues to be a serious crisis for our nation, and I’m proud of the work the Department of Justice and our partners are doing to address this epidemic,” said Principal Deputy Associate Attorney General Claire Murray.
 “We are confronting the deadliest drug crisis in our nation’s history. Opioid withdrawal is difficult, painful, and sometimes dangerous; people struggling to overcome addiction face challenges that can often seem insurmountable,” said Assistant Attorney General Jody Hunt for the Department of Justice’s Civil Division. “Drug manufacturers marketing products to help opioid addicts are expected to do so honestly and responsibly.”
Resolution of the Criminal Investigation
Until December 2014, RB Group’s wholly owned subsidiary, Indivior Inc. (then known as Reckitt Benckiser Pharmaceuticals Inc.) marketed and sold Suboxone throughout the United States. In December 2014, RB Group spun off Indivior Inc., and the two companies are no longer affiliated. On April 9, a federal grand jury sitting in Abingdon, Virginia, indicted Indivior for allegedly engaging in an illicit nationwide scheme to increase prescriptions of Suboxone. The United States’ criminal trial against Indivior is scheduled to begin on May 11, 2020, in the United States District Court in Abingdon, Virginia. Indivior is presumed innocent until proven guilty.
To resolve its potential criminal liability stemming from the conduct alleged in the indictment of Indivior, RB Group has executed a non-prosecution agreement that requires the company to forfeit $647 million of proceeds it received from Indivior and not to manufacture, market, or sell Schedule I, II, or III controlled substances in the United States for three years. In addition, RB Group has agreed to cooperate fully with all investigations and prosecutions by the Department of Justice related, in any way, to Suboxone.
“Today’s announcement demonstrates that this office will work tirelessly to address all facets of the opioid epidemic,” First Assistant United States Attorney Daniel P. Bubar of the Western District of Virginia said. “This historic resolution is the product of a continued partnership with the Virginia Medicaid Fraud Control Unit, FDA, HHS, and the U.S. Postal Service.”
“This is a landmark moment in our fight to hold drug companies responsible for their role in the opioid crisis,” said Virginia Attorney General Mark Herring. “We will not allow anyone to put profits over people, or to exacerbate or exploit the opioid crisis for their own benefit. The Virginia Medicaid Fraud Control Unit’s expertise, capacity, and diligent investigation, combined with strong relationships with local, state, and federal partners, helped make this resolution possible.”
“Opioid addiction and abuse is an immense public health crisis and taking steps to address it is one the FDA’s highest priorities,” said Acting FDA Commissioner Ned Sharpless, M.D. “Providing misleading information about product benefits puts the public at risk. We also are particularly concerned with schemes to game the drug approval process to prevent generic competition for important medicines. The FDA, including criminal investigators in our Office of Regulatory Affairs and the lawyers in our Office of Chief Counsel, will continue to work with the Department of Justice to investigate and hold accountable those who devise and participate in schemes to the detriment of the public health.”
“The U.S. Postal Service spends billions of dollars per year in workers compensation-related costs, most of which are legitimate,” said Kenneth Cleevely, Special Agent in Charge of the Eastern Field Office for the U.S. Postal Service Office of Inspector General. “However, when medical providers or companies choose to flout the rules and profit illegally, special agents with the USPS OIG will work with our law enforcement partners to hold them responsible. To report fraud or other criminal activity involving the Postal Service, contact our special agents at www.uspsoig.gov or 888-USPS-OIG.”
According to the indictment, Indivior—including during the time when it was a subsidiary of RB Group—promoted the film version of Suboxone (Suboxone Film) to physicians, pharmacists, Medicaid administrators, and others across the country as less-divertible and less-abusable and safer around children, families, and communities than other buprenorphine drugs, even though such claims have never been established.
The indictment further alleges that Indivior touted its “Here to Help” internet and telephone program as a resource for opioid-addicted patients. Instead, however, Indivior used the program, in part, to connect patients to doctors it knew were prescribing Suboxone and other opioids to more patients than allowed by federal law, at high doses, and in a careless and clinically unwarranted manner.
The indictment also alleges that, to further its scheme, Indivior announced a “discontinuance” of its tablet form of Suboxone based on supposed “concerns regarding pediatric exposure” to tablets, despite Indivior executives’ knowledge that the primary reason for the discontinuance was to delay the Food and Drug Administration’s approval of generic tablet forms of the drug.
The indictment alleges Indivior’s scheme was highly successful, fraudulently converting thousands of opioid-addicted patients over to Suboxone Film and causing state Medicaid programs to expand and maintain coverage of Suboxone Film at substantial cost to the government.
The Civil Settlement
Under the civil settlement, RB Group has agreed to pay a total of $700 million to resolve claims that the marketing of Suboxone caused false claims to be submitted to government health care programs. The $700 million settlement amount includes $500 million to the federal government and up to $200 million to states that opt to participate in the agreement. The claims settled by the civil agreement are allegations only and there has been no determination of liability.
The civil settlement addresses allegations by the United States that, from 2010 through 2014, RB Group directly or through its subsidiaries knowingly: (a) promoted the sale and use of Suboxone to physicians who were writing prescriptions without any counseling or psychosocial support and for uses that were unsafe, ineffective, and medically unnecessary and that were often diverted for uses that lacked a legitimate medical purpose; (b) promoted the sale or use of Suboxone Film to physicians and state Medicaid agencies using false and misleading claims that Suboxone Film was less susceptible to diversion and abuse than other buprenorphine products and that Suboxone Film was less susceptible to accidental pediatric exposure than tablets; and (c) submitted a petition to the Food and Drug Administration on Sept. 25, 2012, claiming that Suboxone Tablet had been discontinued “due to safety concerns” about the tablet formulation of the drug and took other steps to delay the entry of generic competition for Suboxone in order to improperly control pricing of Suboxone, including pricing to federal healthcare programs.
“With the nation continuing to battle the opioid crisis, the availability of quality addiction treatment options is critical. When treatment medications are used, it is essential they be prescribed carefully, legally, and based on accurate information, to protect the health and safety of patients in federal healthcare programs,” said Gary L. Cantrell, Deputy Inspector General for Investigations at the U.S. Department of Health and Human Services. “Along with our federal and state law enforcement partners we will continue working to protect these vulnerable beneficiaries.”
“Opioid manufacturers – like all drug manufacturers – have a duty to market their products both truthfully and safely,” said Craig Carpenito, U.S. Attorney for New Jersey. “Opioid manufacturers have an additional and critically important duty to maintain effective controls to prevent their highly dangerous products from being abused and diverted.”
“The opioid crisis has caused devastation throughout the country, including in the lives of Federal employees, annuitants, and their families,” said Thomas W. South, Deputy Assistant Inspector General for Investigations for the Office of Personnel Management. “The OPM OIG is committed to working with the Department of Justice and our other law enforcement partners to combat this epidemic. As always, patient safety is our number one priority.”
The civil settlement resolves the claims against RB Group in six lawsuits pending in federal court in the Western District of Virginia and the District of New Jersey under the qui tam, or whistleblower provisions of the False Claims Act, which allow private citizens to bring civil actions on behalf of the United States and share in any recovery.
FTC Resolution
Under a separate agreement with the Federal Trade Commission (FTC), RB Group has agreed to pay $50 million to resolve claims that it engaged in unfair methods of competition in violation of the Federal Trade Commission Act, 15 U.S.C. § 53(b). The FTC is filing a complaint in the United States District Court for the Western District of Virginia alleging anticompetitive activities by RB Group designed to impede competition from generic equivalents of Suboxone. RB Group no longer manufactures or markets drug products. As part of a consent decree, RB Group agreed that it would notify the FTC if it began marketing drug products in the United States. RB Group further agreed that if it filed a Citizen Petition with the FDA in connection with a drug product, it would simultaneously disclose to both the FDA and the FTC all studies and data relevant to that Citizen Petition. RB Group further agreed not to withdraw a drug from the market or otherwise disadvantage a drug after obtaining approval to market another drug containing the same active ingredient.
“Buprenorphine products are approved for use in the treatment of Americans struggling to overcome opioid addiction, and, in the middle of the nation’s opioid crisis, RB Group allegedly sought to deny those consumers a lower-cost generic alternative to maintain its lucrative monopoly on the branded drug,” said Gail Levine, a Deputy Director of the FTC’s Bureau of Competition.
A Multilateral Effort
The criminal resolution with RB Group was handled by the U.S. Attorney’s Office for the Western District of Virginia and the Department of Justice’s Consumer Protection Branch based on an investigation by the Virginia Attorney General’s Medicaid Fraud Control Unit; FDA - Office of Criminal Investigation; United States Postal Service – Office of Inspector General; and Department of Health and Human Services - Office of Inspector General. The civil settlement was handled by the Civil Division’s Commercial Litigation Branch, the U.S. Attorney’s Office for the Western District of Virginia, and the U.S. Attorney’s Office for the District of New Jersey. Assistance was provided by representatives of the HHS Office of Counsel to the Inspector General; the HHS Office of the General Counsel, CMS Division; FDA’s Office of Chief Counsel; the U.S. Department of Agriculture Office of the General Counsel; the National Association of Medicaid Fraud Control Units; the Defense Criminal Investigative Service; the Office of Personnel Management - Office of Inspector General; the Department of Veterans’ Affairs Office of Inspector General; the Department of Labor - Office of Inspector General; and TRICARE Program Integrity.

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Saturday, April 13, 2019

DOJ: FORMER CEO CONVICTED OF DEFRAUDING FOOD AND DRUG ADMINISTRATION AND DISTRIBUTING ADULTERATED DRUGS

And people wonder why infant mortality is so high in geographic regions with highly sought after land and resources.


Image result for paul elmer
Paul J. Elmer, former CEO
Pharmakon
     WASHINGTON – A jury yesterday convicted Paul J. Elmer, the former CEO and owner of Pharmakon Pharmaceuticals Inc. (Pharmakon), of conspiracy to defraud the Food and Drug Administration (FDA) and nine counts of adulterating drugs, the Department of Justice announced today. Pharmakon was a Noblesville, Indiana, drug compounding facility.
     The verdict came after an eight-day trial before U.S. District Judge James R. Sweeney II in Indianapolis, Indiana.
     Elmer, 67, formerly a licensed pharmacist and a resident of Fishers, Indiana, was charged by grand jury in a superseding indictment on Feb. 7, 2019. The superseding indictment charged that, from 2013 to 2016, Elmer and Caprice R. Bearden, Pharmakon’s former director of compliance, caused Pharmakon ─ which compounded sterile, intravenous drugs ─ to distribute approximately 70 lots of over- and under-potent drugs to military and civilian hospitals throughout the country.
     “As these convictions show, the Department of Justice takes very seriously conduct that unlawfully undermines the safety of compounded drugs,” said Assistant Attorney General Jody Hunt of the Civil Division. “We will not tolerate actions that impede the FDA’s efforts to ensure the safety of products. With its law enforcement partners, the Department of Justice will thoroughly investigate and prosecute those who knowingly prevent the FDA from protecting patients and ensuring compounded drugs are safe.”
     “The jury’s findings in this case resonate with citizens of every age,” said Josh J. Minkler, United States Attorney. “Specifically, hospitals and patients from every walk of life rely on the integrity of pharmaceutical manufacturers like Pharmakon to make safe drugs. This defendant prioritized profit over safety and the jury’s verdict demonstrates the government’s resolve to protect our citizens. Good pharmaceutical manufacturers who work with the FDA achieve that goal.”
     “Producing unsafe drugs puts patients at risk and is particularly concerning when they reach already vulnerable populations such as premature infants. This conviction demonstrates that those, including drug compounders, who distribute harmful drugs will be held accountable under the law,” said Director Catherine A. Hermsen, FDA Office of Criminal Investigations. “The FDA continues to play an important role in protecting patients—including young children—and we will continue to work with our law enforcement partners to pursue and bring to justice those who place profits before the health of U.S. patients.”
     “When drug compounders disregard safety standards and violate the law, patient health can be put at significant risk. In this case, we saw unacceptable behavior from the defendant whose company distributed dangerous products that led to serious adverse events in infants,” said Stacy Amin, FDA Chief Counsel. “The FDA is fully committed to working with the Department of Justice to stop these bad actors and protect patients from potential public health risks.”
     Bearden pleaded guilty to all the charges in the original indictment on Nov. 21, 2017.  Her sentencing date has not been scheduled.
     Evidence at Elmer’s trial showed that, from 2013 to 2016, Pharmakon routinely shipped compounded drugs at Elmer’s direction to customers without having received laboratory test results that verified the drugs were the strength they were supposed to be. Furthermore, evidence showed that, despite receiving test results showing potency failures, Elmer did not recall the drugs, notify the customer, notify the FDA of the potency failures, or conduct any root cause investigation to determine the cause of the failure. 
    

 FDA consumer safety officers testified about two inspections of Pharmakon they conducted in 2014. One inspection was prompted by Pharmakon’s distribution of 200 percent potent midazolam, a sedative that was used to treat premature infants, to an Indianapolis hospital.  They observed numerous violations of FDA regulations during each inspection, and informed Elmer. But former Pharmakon employees testified that Elmer and Bearden misled and interfered with these first two FDA inspections, in order to prevent the FDA from knowing about the potency failures as well as other aspects of the business. Former employees also testified that certain changes in process that Elmer and Bearden told the FDA Pharmakon would enact, never happened.
     According to evidence at trial, in February 2016, the multiple potency failures culminated in Pharmakon’s distribution of 2,460 percent super potent morphine sulfate, an opioid pain medication, to hospitals in Indianapolis and Chicago. Nurses at the Indianapolis hospital administered the morphine, not knowing that it was 2,460 percent super potent, to infants in the pediatric unit.  Three infants suffered adverse effects from the narcotic overdose. One infant needed to be revived through the administration of Naloxone (commonly known as Narcan) and sent by helicopter to a nearby hospital with a neo-natal intensive care unit. These adverse events led to a final FDA inspection in which FDA consumer safety officers testified that they discovered evidence of multiple previous potency failures that had been concealed by Bearden during the first two inspections. Former employees testified that Elmer and Bearden misled and interfered with this final FDA inspection as well.
     Elmer was convicted of one felony count of conspiracy to defraud the FDA and to obstruct FDA inspections, carrying a maximum punishment of five years in prison and a fine of up to $250,000. He was also convicted of three misdemeanor counts of introducing adulterated drugs into interstate commerce and six misdemeanor counts of adulterating drugs while held for sale after shipment of a drug component in interstate commerce. Each of the adulteration counts is punishable by up to one year in prison and a fine of $100,000.
     Elmer’s sentencing date has not been scheduled.
     Assistant Attorney General Jody Hunt and U.S. Attorney Minkler commended the FDA’s Office of Criminal Investigations, which conducted the investigation. The case was prosecuted by Assistant U.S. Attorney Cindy J. Cho of the U.S. Attorney’s Office for the Southern District of Indiana and Trial Attorney David A. Frank of the Department’s Consumer Protection Branch and, with assistance from Paul Joseph of the FDA’s Office of Chief Counsel.
     For more information about the Consumer Protection Branch, visit its website at http://www.justice.gov/civil/consumer-protection-branch.  For more information about the U.S. Attorney’s Office for the Southern District of Indiana visit its website at https://www.justice.gov/usao-sdin.


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Wednesday, May 16, 2018

DOJ: United States Intervenes In False Claims Act Lawsuits In Opioids

The United States has intervened in False Claims Act Lawsuits through a consolidation of multiple cases.

This is an historic moment in civil rights.

Happy Birthday, Sweetie.


United States Intervenes in False Claims Act Lawsuits Accusing Insys Therapeutics of Paying Kickbacks and Engaging in Other Unlawful Practices to Promote Subsys, A Powerful Opioid Painkiller

On April 13, 2018, the United States intervened in five lawsuits accusing Insys Therapeutics Inc., of violating the False Claims Act in connection with the marketing of Subsys, an opioid painkiller manufactured and sold by Insys, the Department of Justice announced today.  Subsys is a sublingual spray form of fentanyl, a powerful, but highly addictive, opioid painkiller.  In 2012, Subsys was approved by the Food and Drug Administration for the treatment of persistent breakthrough pain in adult cancer patients who are already receiving, and tolerant to, around-the-clock opioid therapy. 
As stated in the complaint, which was unsealed today, the United States alleges that Insys, headquartered in Arizona, paid kickbacks to induce physicians and nurse practitioners to prescribe Subsys for their patients.  Many of these kickbacks took the form of speaker program payments for speeches to physicians that were, in fact, shams; jobs for the prescribers’ relatives and friends; and lavish meals and entertainment.  The United States also alleges that Insys improperly encouraged physicians to prescribe Subsys for patients who did not have cancer, and that Insys employees lied to insurers about patients’ diagnoses in order to obtain reimbursement for Subsys prescriptions that had been written for Medicare and TRICARE beneficiaries.
“Improper financial relationships between physicians and drug companies can distort a physicians’ best judgment for their patients, in addition to undermining patient health and trust. This is especially troubling when the drugs are opioids,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division.  “Lying to federal health programs about patients’ medical diagnoses is also completely unacceptable. The Justice Department will pursue these illegal actions and continue to hold drug companies and doctors accountable for their roles in contributing to this deadly epidemic.”  
"Insys allegedly bribed doctors who are more concerned with profits than patients," said Christian J. Schrank, Special Agent in Charge for the Office of Inspector General of the U.S. Department of Health and Human Services.  "Encouraging the inappropriate use of this too-often deadly opioid is intolerable enough, but the abuse is compounded when taxpayers are forced to pick up the bill."  
"I applaud the Civil Division and the U.S. Attorney for their untiring efforts to hold health care providers accountable to the American taxpayer," said Vice Adm. Raquel Bono, director of the Defense Health Agency.  "The Department of Justice's efforts safeguard the health care benefit for American service members, veterans and their families. The Defense Health Agency continues to work closely with the Justice Department, and other state and federal agencies to investigate those who participate in fraudulent practices."
“Our intervention in these cases is just one part of the Justice Department’s multi-pronged efforts to combat the opioid crisis,” said United States Attorney Nicola T. Hanna. “The illegal marketing activities alleged in the government’s case helped fuel the crisis by improperly introducing opioids into the market. We are committed to hold accountable corporations and individuals who use kickbacks, off-label promotions and other illegal activities to sell lethal and highly addictive narcotics. Our goal is bring about an end to the tragic epidemic that is harming untold numbers of people across the United States.”
The qui tam provisions of the False Claims Act allow whistleblowers to file lawsuits on behalf of the United States when they believe that a party has submitted false claims for government funds, and to receive a share of any recovery.  The United States has the right to intervene and take over responsibility for litigating these cases.  Here, the United States has intervened in five separate lawsuits that have been consolidated together in the Central District of California.  They are: United States, et al., ex rel. Guzman v. Insys Therapeutics, Inc., et al., 13-cv-5861; United States ex rel. Andersson v. Insys Therapeutics, Inc., 14-cv-9179; United States ex rel. John Doe and ABC, LLC v. Insys Therapeutics, Inc., et al., 14-cv-3488; United States ex rel. Erickson and Lueken v. Insys Therapeutics, Inc., 16-cv-2956; and United States ex rel. Jane Doe, et al. v. Insys Therapeutics, et al., 16-cv-7937.
The United States has separately pursued a number of criminal cases against Insys employees and Subsys prescribers.  Some of these cases have resulted in criminal convictions or guilty pleas, while others are currently pending.
These cases are being handled by the Justice Department’s Civil Division, the United States Attorney’s Office for the Central District of California, the Office of Inspector General of the Department of Health and Human Services, and the Defense Health Agency. The claims asserted against Insys are allegations only, and there has been no determination of liability.


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Monday, January 29, 2018

Day 102.3 Chief Petty Awan To Navy Intel Kingsman


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Thursday, December 28, 2017

Congressional Candidate Shaun Brown Indicted For Child Welfare Fraud

Having previously recognized the bottom up pattern of investigation, I recalled a previous post on the targets of child welfare smaller programs by the FBI.

FBI Begins To Take Down Child Welfare Fraud Programs In Collaborative Conjugations 

I have been pontificating on the use of child welfare funding going into political campaigns for the tenure of my blog.

As always, I had to analyze the original documents.

The FEC issued a letter calling for disavowment of using funds from a third party to fund a politcal campaign.

She probably charged food for campaign events to the USDA program.

Looking at her campaign committee funding for the 2016 cycle, below, she did not raise very much money, but did nake an odd contribution herself, in the FEC filing, below.

I will bet anything she was what I like to call a prop candidate.

The DNC is notarious for this type of surrogate action.

They pick someone out the blue who they know will be fully complicit to whatever the party tells them to do because they will be elevated to the ranks of a community queen, finally achieving being chosen to go to the promised land of a better financial lifestyle.

In order to be recognized and blessed by the party, you must first demonstrate that you can raise money.

I call it distraction of the pretty shiney trinkets because all I found was a facebook page for the campaign, making this a low budget hustle.

This woman did not have the financial acumen to raise money.

She was used as a patsy.

Then, as she is busy studying her DNC talking points, like a good little girl, the operatives come out the cyber woodwork and set up money laundering operations because they know the FEC is ill-equipped to do very much.

I wonder how much they raised behind her back and not even report.

All I am saying is that there is more to this story than just ripping off sandwiches from the kids.

Come to Detroit.

Congressional candidate Brown indicted for fraud, theft
Shaun Brown, Democratic Candidate for the U.S. House
of Representatives, Virginia, District 2, 2012 

A federal grand jury has indicted Democratic congressional candidate Shaun Brown on charges of fraud and theft of government property.

The indictment alleges that Brown and others with JOBS Community Outreach Development Corp. filed fraudulent claims with the Summer Food Service Program in 2012, the U.S. Attorney’s Office for the Eastern District of Virginia said.

Brown, meanwhile, has gone to court herself, accusing the U.S. Department of Agriculture, the state Department of Health and several officials of discriminating against her and the organization she co-founded with her mother, Jenever Brown, which ran the summer feeding program for children.
“This is about making sure there are no hungry children in Hampton Roads,” she said.

Brown ran for Congress in 2016, losing to Rep. Scott Taylor, R-Virginia Beach, by nearly 23 percentage points.

She is again seeking the Democratic nomination for the 2018 race.

The indictment says that Brown directed JOBS staff to inflate the number of children actually fed and to falsify documents in order to obtain additional money, according to the U.S. Attorney’s Office.

She has been charged with wire fraud and theft of government property, and faces a maximum penalty of 20 years in prison if convicted.

“We will vigorously defend. She maintains her innocence,” said her attorney, Jimmy Ellenson.
He said there’s been “a longstanding dispute between her and the feds about this whole thing,” adding that the timing of the criminal complaint seems unusual, given Brown’s own recent lawsuit.

“And why would they do this right before Christmas?” he asked.

In the lawsuit, which she filed without a lawyer, Brown says she and her mother filed a civil rights complaint against USDA alleging the agency’s summer food program discriminated against them.

The lawsuit says the USDA, state health department and five officials unlawfully delayed payments, and falsified reimbursements and claims for reimbursements.

Brown alleged that USDA officials in 2016 derailed JOBS’ efforts to secure financing to “satisfy its prior financial commitments for 2012, outstanding bills from the summer of 2012 and $625,000 to purchase” a restaurant that the company hoped to use as a central kitchen for its summer feeding programs. Her lawsuit says that calls from state health officials to a funding group and to her supplier upset agreements JOBS hoped to arrange. It adds that the state’s designation of JOBS as a “high risk auditee” after 2012 cut it out of the summer program. The lawsuit says the state has falsely claimed JOBS was involved in fraud.

The suit seeks $10 million in damages.

Brown asked the U.S. District Court in Alexandria to appoint an attorney for her, but Judge Liam O’Grady denied the request, saying that the exceptional circumstances that allow judges to do so in civil lawsuits did not exist in her case.

Her campaign finance reports with the Federal Election Commission show she’s raised $713,491 as of the end of October, all but $2,750 of which came from her. She said most of that was in the form of stock in her company. The FEC report shows she has no cash on hand in her campaign account.

Democratic Candidate for U.S. House of Representatives, Virginia, District 2, 2012 Shaun Brown, FEC Disavow... by Beverly Tran on Scribd


BROWN, SHAUN DENISE

Candidate Details
From: 03/01/2016  To: 12/31/2016
CANDIDATE INFORMATION
BROWN, SHAUN DENISE
Office: HOUSE
Party: DEMOCRATIC PARTYElection: 2016
State: VIRGINIADistrict: 02

FINANCIAL SUMMARY
From: 03/01/2016   To: 12/31/2016
I. RECEIPTS
Itemized Individual Contributions$16,052
Unitemized Individual Contributions$12,261
Party Committees Contributions$0
Other Committees Contributions$1,750
Candidate Contributions$102
TOTAL CONTRIBUTIONS$30,166
Transfers from Authorized Committees$0
Candidate Loans$2,480
Other Loans$0
TOTAL LOANS$2,480
Operating Expenditure Offsets$0
Other Receipts$0
TOTAL RECEIPTS$32,646
II. DISBURSEMENTS
Operating Expenditures$23,428
Transfers to other Authorized Committees$0
Candidate Loan Repayments$2,480
Other Loan Repayments$0
TOTAL LOAN REPAYMENTS$2,480
Individual Refunds$2,674
Political Party Refunds$0
Other Committee Refunds$0
TOTAL CONTRIBUTION REFUNDS$2,674
Other Disbursements$5,266
TOTAL DISBURSEMENTS$33,849
III. CASH SUMMARY
Ending Cash On Hand$4
Net Contributions$27,491
Net Operating Expenditures$23,428
Debts Owed By$3,050
Debts Owed To$0

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Wednesday, July 12, 2017

CONYERS Statement for the Markup of H.R. 2851, the “Stop the Importation and Trafficking of Synthetic Analogues Act of 2017” by the Committee on the Judiciary

Dean of the U.S. House
of Representatives
John Conyers, Jr.
H.R. 2851, the “Stop the Importation and Trafficking of Synthetic Analogues Act of 2017,” is intended to address the problem of the illicit use of analog synthetic drugs. 

This bill involves important issues concerning public health and safety, and also fairness in our criminal justice system. 

While I appreciate the desire to protect our citizens from dangerous drugs, I must oppose this flawed bill. 

I recognize that analogs to some synthetic drugs are dangerous and are harming our citizens – particularly young people. 

Some of these modified, man-made substances are more potent, more dangerous, and oftentimes more deadly than the substances they are designed to mimic.

However, in addressing the dangers these drugs pose, I believe Congress must be careful in advancing any legislative response. 

Unfortunately, H.R. 2851, although well-intended, is ultimately unwise for several reasons.

To begin with, this measure would give the Attorney General almost unfettered authority over the regulation of these substances. 

While much of the conversation surrounding synthetic analogues focuses on the chemistry of the substances – from the process of manufacturing them to their effect on the human body – H.R. 2851 would eliminate vital scientific and medical evaluations normally undertaken by the Department of Health and Human Services and the Food and Drug Administration and do away with binding recommendations provided by the Department of Health and Human Services in scheduling drugs.

There are already statutory mechanisms in place to provide for the scheduling and regulation of new drugs that may be dangerous if misused.  Those mechanisms require an appropriate degree of collaboration among the Justice Department, the Department of Health and Human Services, and the Food and Drug Administration in scheduling synthetic analogues.

This is because each of these agencies are equally important to the scheduling process.

And under this bill, not only would the Attorney General hold the sole authority to schedule these substances, but he or she would also have the power to shape sentencing policy – without the input of the U.S. Sentencing Commission that is currently studying the issue of synthetic drugs and penalties.
Secondly, we must be cautious in our response to synthetic drugs and heed the lessons we learned from the fear-driven legislation enacted in response to crack.  

For example, H.R. 2851 would establish lengthy, and sometimes mandatory minimum, penalties for certain offenses involving these analog drugs. 

While mandatory minimum sentences give the appearance that we are taking strong action to address a problem, they are patently unjust as a matter of sentencing policy and are unnecessary to the imposition of appropriate sentences.  

Indeed, extremely lengthy sentences are sometimes appropriately imposed by judges, but over-penalization through mandatory minimums is counterproductive and only contributes to our crisis of over-incarceration. 

Also, this bill has the potential to chill medical research into substances that may be beneficial, or into alternative treatments for drug addiction. 

We must be careful not to harm innovation and exploration into the development of new drugs that can actually help us. 

In closing, I want to note that the Committee has received a letter from more than 65 advocacy organizations opposing this bill – including the ACLU, the Leadership Conference on Civil and Human Rights, and Families Against Mandatory Minimums. 

Furthermore, we received a letter yesterday from a number of conservative groups opposing the bill.  The signatories included Freedom Works, the American Conservative Union Foundation, and the Taxpayers Protection Alliance.

We must not ignore their concerns as we consider approaching this issue through legislation. 

Therefore, I must oppose this bill, and I ask my colleagues from both sides of the aisle to do the same today. 

I yield back the balance of my time.

Voting is beautiful, be beautiful ~ vote.©

Saturday, May 20, 2017

Day 209 - Hillary/s Hackers, Awan Brothers Saga Deepens

My Interrogation and Near Arrest at NSA, Ctaig Murray's Thumbdrives Handouts in May and September


 What do you do when the FBI is hiring Pakistani isi to spy on you? 

How the fentanyl cab works with the propofol interview


Silver spring, MD, FDA, and Doctor Testing

Seth Rich Really Lived at 1222 Euclid Be Because I Walked It. - You Can Too Right Now

"Friends" in the Ambulance With Seth Rich at 4:20AM? Yellow Oval Room at White House.

No Substitute for Hard Work

Where Did Craig Murray Get the Braverman Drop in September? May Drop From Seth Rich?

Voting is beautiful, be beautiful ~ vote.©

Wednesday, April 19, 2017

DOJ Is Creatively Conjugating To Stop Public Corruption

It just warms the cockles of my heart when I see multiple, state and federal agencies come together and perform the sensual dance of taking out these nefarious fraud schemes.

These innovative, multi-jurisdictional task forces are able, through conjugal agency partnerships, to circumvent intentionally constructed statutory barriers by decentralizing investigative authority, to collaborate and bring forth criminal indictments to what have been traditionally known as civil penalties.

Monmy is so proud of her babies.


Owners of Two Los Angeles-Area Drug Wholesale Companies Arrested in $20 Million Federal ‘Structuring’ Conspiracy

          LOS ANGELES – The owners of two local drug wholesale companies were among four defendants taken into custody this morning on federal “structuring” charges that allege they made millions of dollars in cash deposits designed to circumvent federal reporting requirements.

          Law enforcement authorities this morning arrested Richard Kayseryan, 41, of Burbank, the owner of Burbank-based TriMed Medical Wholesalers, Inc. Kayseryan is the lead defendant in a 20-count indictment returned on April 6 by a federal grand jury that charges four individuals and TriMed in relation to two separate schemes to structure millions of dollars in proceeds through “funnel” bank accounts set up in the names of shell companies.

          Two other defendants – Derou Biglari, 31, and Jivani Markarian, 33, who own the Glendale-based drug wholesale business JD Pharmaceutical Wholesaler, Inc. – and the fourth defendant – Rafik Mesropyan, 56 – surrendered this morning. These three co-conspirators, all Glendale residents, are charged with depositing millions of dollars of TriMed checks for Kayseryan, and returning the funds to him in the form of cash.

          The four individuals and TriMed are expected to be arraigned on the indictment this afternoon in United States District Court.

          As part of the scheme, TriMed collected millions of dollars from business activities and Kayseryan prepared checks that he delivered to his co-defendants. The co-conspirators deposited the checks into the funnel accounts and immediately withdrew the funds in cash in amounts at or under $10,000 per transaction, according to the indictment. These transactions were designed to prevent banks from reporting the cash withdrawals to the federal government, which is required for every cash transaction of more than $10,000.

          The indictment also charges Kayseryan with lying to federal agents about the funds during an interview in June 2016. Kayseryan allegedly falsely claimed that “he issued TriMed checks payable to the shell businesses,…for the purpose of making interest-bearing ‘investments’ in the shell businesses” and that he “did not receive ‘one cent’ of the funds from the TriMed checks back.” In fact, the businesses did not exist at all, and Kayseryan received millions of dollars in funds back from the checks in the form of cash.

          Finally, the indictment charges Kayseryan with filing false tax returns that fraudulently overstated TriMed’s business expenses.

          Investigators believe that Kayseryan wrote checks to the shell companies from 2010 through 2015 totaling more than $20 million and that Kayseryan claimed these checks were to pay business expenses. In fact, most of the shell companies did not actually exist other than on paper.

          This indictment marks the third phase of Operation “Psyched Out.” The investigation previously resulted in convictions against 17 defendants connected with the operators of a fraudulent medical clinic, Manor Medical Imaging. A medical doctor employed at the location, Kenneth Johnson, and two owners of a San Marino pharmacy, Phic Lim and Theanna Khou, were convicted in that case. In the second phase, the owner of a Glendale pharmacy, Peter Bagdasarian, was convicted of prescription drug misbranding connected to the scheme.

          An indictment contains allegations that a defendant has committed a crime. Every defendant is presumed innocent until and unless proven guilty.

          If convicted of the 20 counts in the indictment, Kayseryan would face a statutory maximum of 94 years in prison. Biglari and Markarian, if convicted, would each face 45 years, and Mesropyan could be sentenced to as much as 35 years in prison.

          Two other conspirators, identified in the indictment by initials as M.F. and S.G., previously pled guilty to federal structuring charges.

          The investigation was conducted by IRS Criminal Investigation, the California Department of Justice Tax Recovery and Criminal Enforcement Task Force, the Department of Health and Human Services – Office of Inspector General, the Federal Bureau of Investigation, and the United States Food and Drug Administration’s Office of Criminal Investigations.

          The case is being prosecuted by Assistant United States Attorneys Benjamin R. Barron and Christopher Kendall of the Organized Crime Drug Enforcement Task Force.

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