Friday, April 30, 2021

Citizen Petition DATED April 13, 2021 calls for FDA to act on issues relating to compounded drugs

 

Citizen Petition Date: April 13, 2021 Division of Dockets ...

Apr 13, 2021 — promptly amend FDA regulations at 21 C.F.R. § 216.24 — the list of drug ... FDA must convene and consult with an advisory committee on compounding before ...

 

MEDISCA Pledges $100,000 to Alliance for Pharmacy ...

Apr 9, 2021 — MEDISCA, a global leader in the pharmacy compounding industry, pledged up to ... the most recent FDA threat to compounded hormone replacement therapies.

 

FDA Compounding MOU Project | NABP

Mar 12, 2021 — The Compounding Pharmacy Information Sharing Project was created in partnership with FDA to improve data sharing related to compounding pharmacies as ...

 

Iowa Board of Pharmacy - Iowa.gov

Dec 21, 2020 — 19 patients which aren't showing on the FDA drug shortage list. ... The Board has been alerted that PCCA has a formulation that is slightly different than the FDA.

 

Agency Information Collection Activities ... - Federal Register

1 day ago — Guidance documents applicable to animal drug compounding regulated by our Center for Veterinary Medicine would also be returned if no FDA Organization is ...
1 day ago — Drug Compounding, Repackaging, and Related Activities Regarding Sections ... Although compounded drugs can serve an important medical need for certain ...

 

FDA-funded report on compounded hormones is ... - BioSpace

25 mins ago — The Food and Drug Administration (FDA) touted the NASEM report, which recommended restrictions on compounded hormone therapy, as "independent" and 

 

Prisoner disputes shelf life of Arizona's execution drug

20 hours ago — His lawyers contend the drug is unusable 45 days after it's compounded. ... within the 45-day shelf life to request an execution warrant, compound the 

Multiple Defendants Sentenced in a Major Compounding Pharmacy Fraud Conspiracy

 Department of Justice

U.S. Attorney’s Office
Northern District of Alabama

FOR IMMEDIATE RELEASE
Thursday, April 29, 2021

Multiple Defendants Sentenced in a Major Compounding Pharmacy Fraud Conspiracy

TUSCALOOSA, Ala. – This week, Chief U.S. District Judge L. Scott Coogler sentenced two dozen defendants who were part of a major conspiracy to commit health care fraud, announced U.S. Attorney Prim F. Escalona, Federal Bureau of Investigation Special Agent in Charge Johnnie Sharp, Jr., U.S. Department of Health and Human Services, Office of Inspector General, Special Agent in Charge Derrick L. Jackson, Defense Criminal Investigative Service Special Agent in Charge Cynthia Bruce, United States Postal Inspector in Charge, Houston Division, Adrian Gonzalez, and Internal Revenue Service Criminal Investigation Special Agent in Charge James E. Dorsey. 

The defendants sentenced included an array of company executives and managers, a prescriber, billers, and sales representatives.  Among those sentenced this week were:

John Jeremy Adams, 40, of Panama City Beach, Florida, the president and CEO of Global Compounding Pharmacy (Global), who directed the fraud and made millions from it, was sentenced to 170 months in prison on one count of conspiring to commit health care fraud and mail fraud, 19 counts of health care fraud, one count of conspiring to pay kickbacks to a prescriber, and 8 counts of spending the proceeds of health care fraud.  Adams pleaded guilty to the charges in May 2020.

James A Mays, III, 45, of Winfield, Ala., was sentenced to 102 months in prison on one count of conspiring to commit health care fraud and mail fraud, twelve counts of health care fraud, and three counts of money laundering based on spending the proceeds of health care fraud.  Mays was the pharmacist who handled Global’s compounding operation and made millions during the conspiracy. Mays pleaded guilty to the charges in February 2021.

Jessica Linton, 38, of Clearwater, Florida, was sentenced to 132 months in prison on one count of conspiracy, thirteen counts of health care fraud, three counts of mail fraud, and seven counts of aggravated identity theft.  Linton was the manager in charge of Global’s billing center; she altered and added prescriptions, billed insurers for medically unnecessary prescriptions, and helped hide the fraud from auditors. In February 2021, a federal jury convicted Linton of these charges.

John Gladden, 51, of Tallahassee, Florida, was sentenced to  64 months in prison on one count of conspiracy, six counts of health care fraud, one count of mail fraud, and one count of aggravated identity theft. Gladden, a district manager for Global during most of 2015, directed his sales representatives to get medically unnecessary prescriptions for themselves and their family members and profited from the scheme.  In February 2021, a federal jury convicted Gladden of these charges.  

Phillip Marks, 52, of St. Augustine, Florida, was sentenced to 36 months in prison on one count of conspiracy and twelve counts of health care fraud.  Marks served as a manager of the sales managers and, in 2015, pressured subordinates to get unnecessary prescriptions for themselves and their family members.  Marks made more than $400,000 during his time at Global.  He pleaded guilty to the charges in September 2018. 

“The health care fraud conspiracy and scheme executed by these defendants caused health insurance companies to lose millions of dollars,” U.S. Attorney Escalona said.  “These defendants manipulated the system for their own personal gain without regard for patient need or medical necessity. I applaud our prosecutors and law enforcement partners for their commitment and hard work on this complex investigation and prosecution.”

The sentencings came after an extensive investigation into a prescription drug billing scheme involving a Haleyville, Ala.-based pharmacy, Northside Pharmacy, doing business as Global Compounding Pharmacy.  More than two dozen defendants pleaded guilty to charges, and two additional defendants went to trial in February 2021. 

From 2013 to 2016, this large-scale conspiracy billed insurers for massive quantities of medically unnecessary prescription drugs.  The scheme involved directing employees to get medically unnecessary drugs for themselves, family members, and friends, changing prescriptions to add non-prescribed drugs because insurance would pay for them, automatically refilling prescriptions regardless of patient need, routinely waiving and discounting co-pays to induce patients to get and keep medically unnecessary drugs, and billing for drugs without patients’ knowledge.  When prescription drug administrators attempted to police this conduct, the conspirators hid their fraud and obstructed detection efforts—including by lying to auditors and diverting their billing through affiliated pharmacies.  The scheme targeted multiple health insurance plans, including the pharmacy’s Blue Cross Blue Shield of Alabama plan, as well as plans providing health insurance to the elderly, disabled, members of the military, and veterans—Medicare, TRICARE, and CHAMPVA, among others. 

The scheme resulted in pharmacy benefit managers paying Global nearly $50 million in claims in just a two-year period.  Global received more than $13 million from prescriptions written by prescribers who were either paid cash to write them or whose spouses worked as Global sales reps.  One nurse practitioner who wrote prescriptions was paid kickbacks in paper bags filled with thousands of dollars in cash and left in her car.  Global also received over $8.4 million for prescriptions Global employees got for themselves—including from doctors they had never seen as patients. In some cases, Global was paid as much as $30,000 or more for a single tube of compounded cream. 

The FBI, HHS-OIG, DCIS, USPIS, and IRS-CI investigated the cases.  Assistant U.S. Attorneys J.B. Ward, Edward Canter, and Don Long prosecuted the case.  The U.S. Department of Veterans Affairs Office of Inspector General, Criminal Investigations Division, aided in the investigation.

Topic(s): 
Health Care Fraud

Wednesday, April 28, 2021

 

FDA Issues Warning Letter to North Carolina Outsourcing ...

9 hours ago — In addition, the labeling for the compounded drugs lacked adequate directions ... “You compound drug products that are intended for conditions not amenable

 

FAQs - Regulation and Licensing Department

1 day ago · 8 posts
Emergency Dispensing Declaration (Compounding Certain Drugs for ... Allows a hospital to obtain compounded sterile preparation from a pharmacy, under ...

Tuesday, April 27, 2021

California Board of Pharmacy: Enforcement and Compounding Committee Meeting -- April 22, 2021

https://www.youtube.com/watch?v=2v3eRLqVwts 

 

 

High Importance! Animal Drugs

 As part of the FDA’s effort to protect animals, the agency issued a warning letter to Group Cyrenne Inc. dba HomeoAnimal. The company sells a “Virus Defense Kit” containing “Immunopet,” “Silverpet,” and “Cordyceps,” and misleadingly represents that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in pets. The company also markets unapproved drugs for conditions such as cancer, epilepsy, heartworm, parvovirus, and anemia. The FDA requested the company take action to cease the sale of any unapproved and unauthorized products for the treatment or prevention of COVID-19. Pet owners concerned about COVID-19 should consult with their veterinarians

High Importance!

 

  • As part of the FDA’s effort to protect consumers, the agency issued a warning letter to an operator of one website, www.pharmacygeoff.md for marketing unapproved drugs for multiple diseases, including COVID-19. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether. Consumers can visit BeSafeRx to learn about how to safely buy medicine online. Consumers concerned about COVID-19 should consult with their health care provider.

Monday, April 26, 2021

Owner Of Illegal Racehorse Doping Websites Pleads Guilty In Manhattan Federal Court Scott Mangini Peddled Performance-Enhancing Drugs Including “Blast Off Red Blood Builder,” “Extreme Explosion,” “Oral Epo,” and “Green Speed”

 

Owner Of Illegal Racehorse Doping Websites Pleads Guilty In Manhattan Federal Court

Scott Mangini Peddled Performance-Enhancing Drugs Including “Blast Off Red Blood Builder,” “Extreme Explosion,” “Oral Epo,” and “Green Speed”

Audrey Strauss, the United States Attorney for the Southern District of New York, announced that SCOTT MANGINI pled guilty today to conspiring to unlawfully distribute adulterated and misbranded drugs with the intent to defraud and mislead, in connection with the charges filed in United States v. Robinson et al., 20 Cr. 162 (JPO). MANGINI pled guilty before U.S. District Judge J. Paul Oetken, and will be sentenced on September 10, 2021, before Judge Oetken.

U.S. Attorney Audrey Strauss said: “Scott Mangini created and flooded the supply side of a market of greed that continues to endanger racehorses through the sale of performance-enhancing drugs. Mangini designed and created dozens of products intended for use by those engaged in fraud and animal abuse. His products were manufactured with no oversight of their composition, in shoddy facilities, despite prior efforts by state and federal regulators to shut down Mangini’s operation and strip his license. Mangini’s guilty plea underscores that our Office and our partners at the FBI are committed to the prosecution and investigation of corruption, fraud, and endangerment in the horse racing industry.”

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Sunday, April 25, 2021

 Department of Justice

U.S. Attorney’s Office
District of New Jersey

FOR IMMEDIATE RELEASE
Wednesday, April 21, 2021

Morris County Man Admits Role in Health Care Fraud Conspiracy, Conspiring to Obstruct Justice

CAMDEN, N.J. – A Morris County man today admitted defrauding New Jersey county health benefits programs and obstructing justice by seeking to provide false information to federal agents and the grand jury investigating the scheme, Acting U.S. Attorney Rachael A. Honig announced.

Rocco Cammalleri, 49, of Budd Lake, New Jersey, pleaded guilty by videoconference before U.S. District Judge Robert B. Kugler to an information charging him with one count of conspiracy to commit health care fraud and one count of conspiracy to obstruct justice. 

According to documents filed in this case and statements made in court:

Compounded medications are specialty medications mixed by a pharmacist to meet the specific medical needs of an individual patient. Although compounded drugs are not approved by the Food and Drug Administration (FDA), they are properly prescribed when a physician determines that an FDA-approved medication does not meet the health needs of a particular patient, such as if a patient is allergic to a dye or other ingredient.

In 2015, the conspirators learned that certain New Jersey local government employees, including county prison guards, had insurance coverage for these compounded medications. An entity referred to as the “Pharmacy Benefits Administrator” provided pharmacy benefit management services for the Bergen County Prescription Benefits Program (BCPBP), which covered certain local government employees, including county prison guards. The Pharmacy Benefits Administrator paid prescription drug claims and then billed the BCPBP for the amounts paid.

The conspirators learned that certain compounded medication prescriptions – including vitamins and pain, scar, antifungal, migraine, and libido creams – reimbursed thousands of dollars for a one-month supply. From September 2015 through April 2017, the conspirators – a including Cammalleri and an individual referred as Individual 2 – recruited local government employees and others to obtain medically unnecessary compounded medications. Cammalleri, who had no medical or sales background or training, recruited several individuals to receive medically unnecessary compound medications. Cammalleri and Individual 2 directed the recruits to an unnamed doctor – referred to as Individual 1 – to obtain his authorization for the compounded prescription medications. The recruits agreed to receive the very expensive compounded medications not because they needed them, but rather because they were paid to do so.  Cammalleri received $175,467 in payments for the prescriptions he arranged and agreed to receive, and caused $2.98 million in fraudulent claims for compounded medications.

In 2017, Individual 2 informed Cammalleri that a federal grand jury was investigating the health care fraud conspiracy. Individual 2 and Cammalleri conspired to obstruct the federal investigation by providing and seeking to provide false information to federal agents and the grand jury. 

The health care fraud conspiracy count to which Cammalleri pleaded guilty carries a maximum potential penalty of 10 years in prison and a $250,000 fine, or twice the gain or loss from the offense, whichever is greater. The obstruction of justice conspiracy count carries a maximum penalty of five years in prison and a $250,000 fine, or twice the gross gain or loss from the offense, whichever is greater. Sentencing is scheduled for Nov. 18, 2021.

Acting U.S. Attorney Rachael A. Honig credited special agents of IRS - Criminal Investigation, under the direction of Special Agent in Charge Michael Montanez in Newark; special agents of the FBI’s Atlantic City Resident Agency, under the direction of Special Agent in Charge George M. Crouch Jr. in Newark; and special agents of the U.S. Department of Labor Office of Inspector General, New York Region, under the direction of Special Agent in Charge Michael C. Mikulka, with the investigation leading to today’s guilty plea.

The government is represented by Assistant U.S. Attorneys Christina O. Hud and R. David Walk Jr. of the U.S. Attorney’s Office in Camden.

Topic(s): 
Health Care Fraud
Component(s): 
Press Release Number: 
21-145
Updated April 21, 2021

A pharmacist-driven Food and Drug Administration incident surveillance and response program for compounded drugs Ashlee N Janusziewicz 1, Shannon N Glueck 1, Sophia Y Park 1, Dien N Nguyen 1, Susan C Rimmel 1, Laurelle A Cascio 1, Gina Y Doh 1, Garrette F Martin-Yeboah 1

https://pubmed.ncbi.nlm.nih.gov/33889929/ 

Tuesday, April 20, 2021

 

Northern Virginia pharmacy owner, employees sentenced in ...

10 hours ago — In addition, Abdalla and employees at his pharmacies conspired to defraud federal, state, and private health care benefit programs by engaging in numerous other

 

  • The Eleventh Circuit Issues Important Opinion on the ...

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    Apr 08, 2021 · On April 7, 2021, in Gil v. Winn-Dixie, Case No. 17-13467, the U.S. Court of Appeals for the Eleventh Circuit issued an important decision on whether Title III of the Americans with Disabilities Act (“ADA”), 42 U.S.C. § 12101 et seq., is violated when a place of public accommodation (there, a grocery store) offers valuable in-store benefits to customers through a website that is ...

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