Friday, July 31, 2020

Ohio pharmacy board backtracks, withdraws rule barring use of hydroxychloroquine to treat coronavirus BY JUSTIN WISE - 07/30/20 08:43 AM EDT

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2 days ago - Starting on Thursday, Ohio pharmacies, clinics and other medical facilities will be prohibited from dispensing or selling the malaria drug Hydroxychloroquine, ...
4 days ago - Compounded medications are specialty medications mixed by a pharmacist to meet the ... Although compounded drugs are not approved by the Food and Drug .

Nurse practitioner admits to kickbacks

Nurse practitioner admits to kickbacks: A federal judge Tuesday accepted a nurse practitioner's guilty plea to a charge of violating the federal anti-kickback statute after she admitted scheming with her daughter and others to defraud Tricare, the military's health insurer.

Rx fraud case nets 4th plea of guilty

Rx fraud case nets 4th plea of guilty: A North Little Rock man on Wednesday became the fourth person since late June to plead guilty to conspiring to defraud Tricare, a federal health-care program, of more than $12 million by generating fake prescriptions for expensive compounded drugs.

N.J. Fraud Scheme Milked ‘Exorbitant’ Rates for Compounded Drugs

Glycolic acid, TCA among FDA's proposed additions to 503B bulk drugs list

New Jersey Public University Employee Admits Role in $5.3 Million Compounded Prescription Drug Scheme

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

Wednesday, July 29, 2020

New Jersey Public University Employee Admits Role in $5.3 Million Compounded Prescription Drug Scheme

NEWARK, N.J. – An employee of a public university in New Jersey today admitted his role in a scheme to defraud public and private health benefits programs of at least $5.3 million for the billing of medically unnecessary compounded prescriptions, U.S. Attorney Craig Carpenito announced. 
John Cuffari, 58, of Cedar Grove, New Jersey, pleaded guilty by videoconference before U.S. District Judge John Michael Vazquez to an information charging him with conspiracy to commit health care fraud.
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 ingredients in the prescription.
Between November 2014 and July 2016, Cuffari participated in a conspiracy that involved the submission of fraudulent prescriptions for compounded medications to public and private insurance plans. The scheme centered on the discovery that certain insurance plans paid for prescription compounded medications – including scar creams, wound creams, and metabolic supplements/vitamins – at exorbitant reimbursement rates.
Cuffari exploited this opportunity through working as a sales representative for several compounding pharmacies. In order to profit as a sales representative, Cuffari targeted individuals who had insurance plans that covered compounded medications and then convinced those individuals to obtain prescriptions for compounded medications, regardless of medical necessity, often by providing them with cash payments. In order to obtain prescriptions for compounded medications for some of the recruited individuals, Cuffari caused payments to be made to a New Jersey-based physician.
Once the prescriptions were written, they were filled by the compounding pharmacies with which Cuffari worked. The compounding pharmacies would then receive reimbursement from the insurance plans, and would pay Cuffari a percentage of the reimbursement amount.
As part of his plea agreement, Cuffari must forfeit $539,580 in criminal proceeds he received for his role in the scheme and pay restitution of at least $5,392,214. He faces a statutory maximum of 10 years in prison and a $250,000 fine, or twice the gross gain or loss from the offense. Sentencing is scheduled for Dec. 9, 2020.
U.S. Attorney Carpenito credited special agents of the FBI, under the direction of Acting Special Agent in Charge Joe Denahan in Newark, with the ongoing investigation leading to today’s guilty plea.
The government is represented by Assistant U.S. Attorney Sean M. Sherman of the United States Attorney’s Office, Opioid Abuse Prevention and Enforcement Unit in Newark.
Health Care Fraud
Press Release Number: 

Mobile-Area Doctor Charged in Prescription Drug Billing Scheme

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

Friday, July 31, 2020

Mobile-Area Doctor Charged in Prescription Drug Billing Scheme

BIRMINGHAM, Ala. – A Mobile-area Alabama doctor was indicted on Tuesday in a long-running investigation into a prescription drug-billing scheme involving a Haleyville, Ala.-based pharmacy, Northside Pharmacy doing business as Global Compounding Pharmacy.  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 announced the charges. 
An 11-count indictment charges Dr. Michelle Martine Jackson, 53, of Fairhope, Alabama, with a conspiracy to receive kickbacks, a conspiracy to commit health care fraud and mail fraud, health care fraud, and aggravated identity theft.  According to the indictment, Dr. Jackson, who worked out of two clinics in Mobile, Alabama, received kickbacks in exchange for issuing medically unnecessary compounded drug and other prescriptions to be filled by Global Compounding Pharmacy.  Dr. Jackson issued medically unnecessary prescriptions to a Global employee Bonita Amonett, and her family and friends, to individuals with whom Jackson did not have a doctor-patient relationship, and to individuals with whom she had a doctor-patient relationship, but who did not need the drugs in question.   Ms. Amonett paid the kickbacks in the form of cash and free offices services to Dr. Jackson and a nurse practitioner, Brandy Lunsford.  According to court documents, both Ms. Amonett and Ms. Lunsford previously entered guilty pleas to paying and receiving kickbacks and health care fraud. 
Dr. Jackson’s indictment brings the total number of individuals who have been charged in this long-running investigation to 30, 24 of whom have previously entered guilty pleas.  Those who have previously pled guilty include two nurse practitioners and various Global employees, including its CEO, COO, a vice president of sales, an operations manager, a district manager, and multiple sales representatives. 
The maximum punishment for the 18 U.S.C. § 371 kickback conspiracy is 5 years in prison and a $250,000 fine.  The maximum punishment for the 18 U.S.C. § 1349 health care and mail fraud conspiracy charge is 20 years in prison and a $250,000 fine. The maximum penalty for health care fraud is 10 years in prison and a $250,000 fine.  The minimum and maximum penalty for the 18 U.S.C. § 1028A aggravated identity theft charge is 2 years in prison and a $250,000 fine. 
The FBI, HHS-OIG, DCIS, USPIS, IRS-CI, and a United States Attorney’s Office investigator investigated the cases, which Assistant U.S. Attorneys Chinelo Dike-Minor, Don Long, and Edward Canter are prosecuting.  The Veteran Affairs Office of Inspector General Criminal Investigations Division provided assistance in the investigation.
An indictment is merely an allegation and the defendant is presumed innocent until proven guilty beyond a reasonable doubt.

Updated July 31, 2020
23 hours ago - “While compounded drugs do not undergo premarket review for safety, effectiveness and quality, we recognize they can serve an important role for patients whose
The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

  • As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to one company for selling fraudulent COVID-19 related products. The company, Vapore, LLC, dba Mypurmist, sells Mypurmist with misleading claims that the product can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. There are currently no FDA-approved products to prevent or treat COVID-19. FDA requested that Vapore, LLC, immediately cease selling this unapproved and unauthorized product. Consumers concerned about COVID-19 should consult with their health care provider.
  • Testing updates:
  • To date, the FDA has currently authorized 194 tests under EUAs; these include 159 molecular tests, 33 antibody tests, and 2 antigen tests
Resources for Animal Food Producers in Puerto Rico and the Southeastern U.S. Affected by Hurricane Isaias
As Hurricane Isaias approaches Puerto Rico and the Southeastern United States, the U.S. Food and Drug Administration’s Center for Veterinary Medicine reminds those who may be affected about resources available for animal food producers who may be harvesting, mixing, storing or distributing grains and other foods for animals.

The FDA reminds harvesters that crops harvested from flooded fields are often unacceptable because of contamination. Flood waters, which are different from pooled rain water, may contain sewage, pathogenic organisms, pesticides, chemical wastes, or other toxic substances. Mold growth is another serious concern for flood impacted crops intended for use in animal food. Some molds produce mycotoxins, which are toxic to certain animals and people.

Wednesday, July 29, 2020

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

  • On July 28, the FDA updated the Molecular Diagnostic templates. The Molecular Diagnostic templates include recommendations for laboratories and commercial manufacturers who may use the templates to help facilitate the preparation and submission of requests for emergency use authorizations (EUAs). The updates are regarding diagnostic tests for use with sample pooling, at the point of care, and in the detection and differentiation of SARS-CoV-2 and other respiratory pathogens such as viruses that cause influenza.
  • Today, the FDA posted a new template for commercial manufacturers to help facilitate the preparation and submission of emergency use authorization (EUA) requests for prescription or non-prescription COVID-19 diagnostic tests that can be performed entirely outside of a laboratory, such as at home, in schools or in other non-lab settings.
  • Testing updates:
  • To date, the FDA has currently authorized 193 tests under EUAs; these include 158 molecular tests, 33 antibody tests, and 2 antigen tests.

FDA Warns Companies Illegally Selling Hangover Remedies

Today, the U.S. Food and Drug Administration announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: Double Wood LLC; Ebnsol Inc.; Vita Heaven LLC (doing business as Hangover Heaven); Happy Hour Vitamins; LES Labs; Mind, Body & Coal LLC; and Purple Biosciences LLC.

“Dietary supplements that claim to cure, treat, mitigate or prevent hangovers could potentially harm consumers, especially young adults,” said Steven Tave, director of the FDA's Office of Dietary Supplement Programs. “Consumers may get the false impression that using these products can prevent or mitigate health problems caused by excessive drinking. Dietary supplements are not a substitute for responsibly limiting one’s alcohol consumption.”

Under the FD&C Act, products intended to cure, treat, mitigate or prevent disease are drugs and are subject to the requirements that apply to drugs. Unlike drugs approved by the FDA, there has been no FDA evaluation of whether these unapproved products are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs, or...

Tuesday, July 28, 2020

Kodak Shifts Into Drug Production With Help of a $765 Million U.S. Loan

Kodak Shifts Into Drug Production With Help of a $765 Million U.S. Loan

Wall Street Journal· 7 hours ago
The photography pioneer won a government loan under the Defense Production Act to help expedite...

Kodak stock triples on $765 million government loan — for ...
Jul 28, 2020 · Kodak stock soared Tuesday morning after it won a a $765 million U.S. government loan to help produce pharmaceutical ingredients — part of an effort to reduce dependence on foreign drug makers ...

Monday, July 27, 2020

Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products

Agency Urges Consumers, Health Care Professionals Not to Use Certain Products, Citing Serious Adverse Events and Death
The U.S. Food and Drug Administration continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol, or wood alcohol – a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin as well as life-threatening when ingested. The agency has also taken additional action to help prevent certain hand sanitizers from entering the United States by placing them on an import alert. The FDA is proactively working with manufacturers to recall products and is encouraging retailers to remove products from store shelves and online marketplaces. As part of these actions, a warning letter has been issued to Eskbiochem S.A. de C.V. regarding the distribution of products labeled as manufactured at its facilities with undeclared methanol, misleading claims –including incorrectly stating that FDA approved these products—and improper manufacturing practices. 

Friday, July 24, 2020

Trump issues drug pricing executive orders on 340B, international drug pay

President Donald Trump signed four executive orders to advance policies on passing through some 340B discounts, tying Medicare payment for outpatient drugs to international prices, passing drugmaker rebates to patients and importation.
The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

Recall Alert: FDA MedWatch Safety Alert: Dexmedetomidine Hydrochloride Injection by Fresenius Kabi

CVM is sharing this recall announcement because these products may be used in veterinary settings.

TOPIC: Dexmedetomidine Hydrochloride Injection by Fresenius Kabi: Recall - Due to Cross - Contamination of Lidocaine

AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy

ISSUE: Fresenius Kabi is recalling two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg/mL), 50 mL fill in a 50 mL vial due to the possible presence of trace amounts of lidocaine in these two lots based on FDA investigation. Administration of Dexmedetomidine HCl containing trace amounts of lidocaine to a patient with lidocaine allergy could result in anaphylaxis, a potentially life-threatening condition.

To date, no adverse drug experience reports have been received for either of the lots being recalled by Fresenius Kabi.

BACKGROUND: Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is approved for intravenous use and indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

List of recalled lots and product photos below:
RECOMMENDATION: Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the form, or submit by fax to 1-800-FDA-0178.

Thursday, July 23, 2020

FDA Proposes New Rule on Reporting Requirement Under Right to Try Act

FDA Proposes New Rule on Reporting RequirementUnder Right to Try Act

Today, the U.S. Food and Drug Administration published the proposed rule, Annual Summary Reporting Requirements Under the Right to Try Act, that when finalized, will implement a statutory requirement for sponsors and manufacturers to provide an annual summary to the FDA for any eligible investigational drug they provide to eligible patients under the Right to Try Act.

“The FDA is dedicated to achieving the goals that Congress set forth in the Right to Try Act, so that patients facing terminal conditions have another avenue to access investigational medicines,” said Anand Shah, M.D., Deputy Commissioner for Medical and Scientific Affairs. “Today’s proposed rule builds on the FDA’s long-standing dedication to enhancing access for patients who are facing life-threatening diseases or conditions and our continued commitment to transparency.”

The Right to Try Act, or the Trickett Wendler, Frank Mongiello, Jordan McLinn and Matthew Bellina Right to Try Act of 2017, provides a pathway for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in a clinical trial, to access certain unapproved treatments. Ultimately, the sponsor or manufacturer who is developing the drug or biologic, not the FDA, is responsible for determining whether to make their product available to patients who qualify for access under the Right to Try Act.