Friday, June 28, 2019

FCA Decision Tracker: More Interpretations Of Escobar

Law360-3 hours ago
Allegations that pharmacies overcharged Medicaid for generic drugs that ... unnecessary prescriptions for expensive compounded drugs did not include any ...

Pharmaceutical wholesaler sues owner of Lovelace Drugs in Ocean ...

Biloxi Sun Herald-18 hours ago
When Clark Levi, the owner of Lovelace Drugs, bought out his partners at Alvix ... Federal investigators say conspirators in the scheme compounded drugs for 

Court dismisses 4 counts against former Nephron Pharmaceuticals employee in trade secrets case

Court dismisses 4 counts against former Nephron Pharmaceuticals employee in trade secrets case: ORLANDO — A federal court granted a former Nephron Pharmaceuticals employee who is being sued for allegedly giving trade secrets her motion to dismiss four counts relating to the Florida Uniform Secrets Act (FUTSA).
13 hours ago - ... series, Non-binding Guidance, highlights two recent federal district court decisions implicating enforcement efforts in the stem cell and compounding arenas.

FDA warns patients and health care professionals not to use sterile products from Pacifico National Inc., dba AmEx Pharmacy

FDA is warning patients and health care professionals not to use products intended to be sterile produced by Pacifico National Inc., doing business as AmEx Pharmacy, Melbourne, Florida, due to a lack of sterility assurance. These drugs may pose a safety risk to patients.

Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening infections or death.

Health care professionals should immediately check their medical supplies, quarantine any drugs prepared by AmEx Pharmacy, and not administer or provide them to patients. FDA urges health care professionals, who obtained products from AmEx Pharmacy, to make alternative arrangements to obtain medications from sources that adhere to proper quality standards. Patients who have received any drug produced by AmEx Pharmacy and have concerns should contact their health care professional.

FDA investigators recently inspected AmEx Pharmacy’s facility in May 2019 and observed conditions that could cause AmEx Pharmacy’s drugs to become contaminated or otherwise pose risks to patients.

On June 25, 2019, FDA recommended that AmEx Pharmacy voluntarily recall all unexpired drugs intended to be sterile and cease sterile operations until the company takes adequate corrective actions. However, AmEx Pharmacy has not initiated the recall.

For more details on the alert, please visit: Pacifico National Inc., dba AmEx Pharmacy
For more information, please visit FDA's Human Drug Compounding web site

Thursday, June 27, 2019

How many United States Attorney's Offices will be filing Qui Tam Litigation against Compounding Pharmacies in the future and how much money will be recovered?

21 hours ago - The complaint alleges that the pharmacies improperly included the drug aripiprazole, an atypical antipsychotic drug, in compounded pain creams in order to boost the pharmacies' reimbursement for the prescriptions and that the pharmacies routinely waived patient copayment 
17 hours ago - ... Immediately After Global Settlement Triggers Powerful Remedies · OIG Report Finds a Small Percentage of Hospitals Do Not Obtain Compounded Drugs from ..
18 hours ago - The drugs Roberts prescribed include Adderall, a drug used to treat attention deficit hyperactivity disorders, Suboxone, a drug used to treat opioid addiction, and oxycodone, an opioid.
11 hours ago - FDAnews Announces — Pharmacy Compounding Regulation: A Fresh Look at Guidance, Compliance, Enforcement Webinar, July 11, 2019, 2019 ...

FDA In Brief: FDA takes new step to help advance the transition of certain biological products

Today the U.S. Food and Drug Administration issued a proposed rule to amend its regulations on the use of master files for biological products. The proposed rule, if finalized, would allow certain applications for biological products approved under the Federal, Food, Drug, and Cosmetic Act to continue incorporating by reference information on drug substances, drug substance intermediates, or drug products contained in drug master files (DMF) after the approved applications for those products are deemed to be licenses under the Public Health Service Act (PHS Act) on March 23, 2020. The proposed rule would also codify the FDA’s existing practice that an application for ...

Tuesday, June 25, 2019

Case activity for Pentec Health Inc. vs Bond Pharmacy Inc. on June 20

The Pennsylvania Record-Jun 23, 2019
The U.S. District Court for the Eastern District of Pennsylvania reported the following activities in the suit brought by Pentec Health Inc. against Bond Pharmacy 

Longs pharmacy fined for alleged violations of the Controlled ...

WMBF-Jun 24, 2019
HORRY COUNTY, S.C. (WMBF) – A Longs pharmacy was fined $50,000 and agreed to surrender its DEA registration to resolve alleged violations of the ...

Former hospital pharmacy director gets 4 years for fraud hours ago
OMAHA, Neb. (AP) — A former pharmacy director has been sentenced to four years in prison for stealing more than $4.6 million from an Omaha hospital.

Here's why an Horry County pharmacy will pay a $50000 fine to the feds

Myrtle Beach Sun News-10 hours ago
A Longs pharmacy filled prescriptions without confirming required information and will now have to pay a $50,000 fine and surrender its DEA registration, ...

Feds: Ocean Springs pharmacy at center of $7 million prescription ... hours ago
The indictment accuses Pharmacy 1 of formulating "compounded ... but an employee at Lovelace Drugs said Tuesday that owner Levi had been in the store and .

Recall reinforces role of newly updated compounding regulations

Recall reinforces role of newly updated compounding regulations 22, 2019
The recent recall of nearly two dozen drugs manufactured by Premier Pharmacy Labs reinforces the importance of the newly updated compounding regulations

Area experts say medically treating exotic pets can be challenging

WCBI-4 hours ago
“It's a wonderful thing to have your local compounding pharmacist and be able to talk to that pharmacist and let them know what you're trying to achieve


FDA plans to institutionalise drug compounding The FDA has told its staff that it will be assigning drug compounding to the Office of Compliance.

FDA issues warnings to companies selling illegal, unapproved kratom drug products marketed for opioid cessation, pain treatment and other medical uses

For Immediate Release:
June 25, 2019
The U.S. Food and Drug Administration issued warning letters to two marketers and distributors of kratom products – Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina – for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. The companies also make claims about treating pain, as well as other medical conditions like depression, anxiety and cancer.
“We have issued numerous warnings about the serious risks associated with the use of kratom, including warnings about the contamination of kratom products with high rates of salmonella that put people using kratom products at risk, and resulted in numerous illnesses and recalls. As part of our efforts to assess kratom for contamination in the products tested, we also found high levels of heavy metals in kratom products. Despite our warnings, companies continue to sell this dangerous product and make deceptive medical claims that are not backed by science or any reliable scientific evidence,” said Acting FDA Commissioner Ned Sharpless, M.D. “As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions.”
The FDA continues to warn consumers not to use Mitragyna speciosa, commonly known as kratom, a plant that grows naturally in Thailand, Malaysia, Indonesia and Papua New Guinea. Kratom is not legally marketed in the United States as a drug or dietary supplement, and while it is important to gather more evidence, data suggest that certain substances in kratom have opioid properties that expose users to the risks of addiction, abuse and dependence. There are no FDA-approved uses for kratom, and the agency has received concerning reports about the safety of kratom. The FDA is actively evaluating available scientific information on this issue and continues to warn consumers not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine. The FDA encourages more research to better understand kratom’s safety profile, including the use of kratom combined with other drugs.
The companies receiving warning letters use websites and social media to illegally market kratom products, making unproven claims about the ability of the kratom drug products they distribute to cure, treat or prevent disease. Examples of claims being made by these companies include:
  • “Kratom acts as a μ-opioid receptor-like morphine.”
  • “In fact many people use kratom to overcome opiate addiction.”
  • “Of course, people who are using kratom to overcome a preexisting opiate addiction may need to use kratom daily to avoid opiate withdrawal.”
  • “Usage: It is for the management of chronic pain, as well as recreationally.”
  • “Kratom is frequently used as a natural alternative to treat depression, anxiety, addiction, diabetes, chronic pain and fatigue…Kratom has been reported to have taken the place of brand name drugs like Hydrocodone or Oxycodone for individuals, all the way to weaning people off of Heroin.”
  • “Some researchers have even claimed that kratom can protect you against cancer!”
  • “Kratom is used for energy, to increase attention/focus, to relax, and also to treat pain and addiction. Here is just some of what our customers have used kratom to treat . . . Chronic Pain, Migraines, Opiate Addiction, ADHD/ADD, Anxiety, Depression, Arthritis, Insomnia and much more!”
Health fraud scams like these can pose serious health risks. These products have not been demonstrated to be safe or effective for any use and may keep some patients from seeking appropriate, FDA-approved therapies. Selling these unapproved products with claims that they can treat opioid addiction and withdrawal and other serious medical conditions is a violation of the Federal Food, Drug, and Cosmetic Act.
The FDA requested responses from both companies within 15 working days. The companies are directed to inform the agency of the specific actions taken to address each of the agency’s concerns. The warning letters also state that failure to correct violations may result in law enforcement action such as seizure or injunction.
Reducing the number of Americans who are addicted to opioids and cutting the rate of new addiction is one of the FDA’s highest priorities. This work includes promoting more widespread innovation and access to opioid addiction treatments for the more than 2 million of Americans with an opioid use disorder. The FDA is taking new steps to make safe and effective medication assisted treatments (MAT) available to those who suffer from opioid use disorder and to reduce the stigma that is sometimes associated with use of these therapies. Using products with unsubstantiated claims may prevent those addicted to opioids from seeking treatments that have been demonstrated to be safe and effective. Reliance on products with unsubstantiated claims may delay their path to recovery and put them at greater risk of addiction, overdose and death. In fact, patients receiving FDA-approved MAT cut their risk of death in half, according to the Substance Abuse and Mental Health Services Administration.
Health care professionals and consumers are encouraged to report any adverse events related to these products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed formcan be submitted online or via fax to 800-FDA-0178.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


 FDA Office of Media Affairs

Statement by Acting FDA Commissioner Ned Sharpless, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on stem cell clinic permanent injunction and FDA’s ongoing efforts to protect patients from risks of unapproved products

Today, U.S. District Judge Ursula Ungaro of the Southern District of Florida issued an order that stops US Stem Cell Clinic LLC, of Weston, Florida, and US Stem Cell Inc., of Sunrise, Florida, and their Chief Scientific Officer Kristin Comella, Ph.D., from manufacturing or distributing any and all stromal vascular fraction (SVF) products, which are adipose (fat) tissue derived stem cell products, until they come into compliance with the law.

The U.S. Department of Justice, on FDA’s behalf, initiated this action against US Stem Cell Clinic LLC and US Stem Cell Inc., and Comella in May 2018, seeking a permanent injunction after they failed to come into compliance with the law, including FDA regulations intended to ...