Friday, May 5, 2023

 From the FDA:

  • On Tuesday, the U.S. Department of Justice announced the United States Marshals, acting with investigators from the FDA, seized nearly 250,000 bottles of liquid product containing kratom, 1.0 tank of liquid product containing kratom, more than 1,200 cartons of capsules containing kratom, and over 1000 kilograms of bulk powder kratom. The seized articles containing kratom were manufactured by Botanic Tonics, LLC of Broken Arrow, Oklahoma and are marketed under the brand name “Feel Free Plant Based Herbal Supplement.” The seized products are estimated to be worth more than $3 Million. The bulk kratom and articles containing kratom were seized after the U.S. Attorney’s Office in the Northern District of Oklahoma filed a civil forfeiture complaint on behalf of the FDA. The complaint alleges that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that it does not present a significant or unreasonable risk of illness or injury. The complaint further states that dietary supplements containing kratom are adulterated under the Federal Food, Drug, and Cosmetic Act.

 

SC passes shield law in effort to resume executions. What ...

1 day ago — The SC Senate passed legislation to hide identities of pharmaceutical companies ... pharmacists or compounding pharmacies that may provide lethal injection ...

 

Becker's Hospital Review
4 states take aim at Ozempic, Wegovy copycats
1 day ago

 

Home - WV Board of Pharmacy

4 days ago — UPDATED 5-2-23: WVBOP Statement on Semaglutide Compounding The West ... Semaglutide is, of course, a commercially available drug product marketed as ...

 

SB 970 STAFF MEASURE SUMMARY

3 days ago — Provisions of federal Drug Quality and Security Act. EFFECT OF AMENDMENT: No amendment. ... regulate and monitor the manufacturing of compounded drugs.

 

Guidelines for the Use of Non-Pharmaceutical Grade ...

3 days ago — Pharmaceutical Compounding-sterile preparations) used to compound a needed ... If the drug will be administered directly to the animal, as supplied by the.

 

Experts raise concern over compounded weight loss drugs

3 hours ago — Compounding pharmacies creating weight-loss drugs could be dangerous, expert

Some states are cracking down on compounding pharmacies making versions of Ozempic and Wegovy

 

Versions of Ozempic and Wegovy weight-loss drugs face ...

2 days ago — Some compounding pharmacies are using a different form of an active ingredient, semaglutide, that is not approved by the FDA, state regulators say.

Thursday, April 27, 2023

AVMA members press Congress for illicit xylazine, dog importation laws

AVMA members press Congress for illicit xylazine, dog importation laws: Nearly 120 veterinarians and veterinary students attended the 2023 AVMA annual legislative fly-in, held April 17-19 in Washington, D.C. They urged Congress to support two AVMA-backed bills aimed at ensuring dogs are healthy when imported into the United States and to combat trafficking of the animal sedative xylazine without hindering veterinary access to the drug.

Physician and pharmacy settle claims for unnecessary medications Monday, April 24, 2023

 HOUSTON – A 61-year-old doctor and a compounding pharmacy he operates paid the United States $7,963,246 to resolve claims they improperly billed the Department of Labor, Office of Workers’ Compensation Program (DOL-OWCP), announced U.S. Attorney Alamdar S. Hamdani.

Dr. Ajay Kumar Aggarwal and Medley Compounding Pharmacy LLC knowingly and willfully submitted, or caused the submission of, false claims to DOL-OWCP. The claims for payment were for compounding creams, gels and pain patches that were neither medically necessary nor medically beneficial to the patients. The investigation revealed DOL-OWCP beneficiaries were receiving excessive and unnecessary medication through the U.S. mail. 

“It is particularly egregious when providers who participate in federally funded programs like OWCP violate their responsibility to the public to provide legitimate, necessary and safe treatment,” said Hamdani. “We are not going to stand by when such people take advantage of federal employee health insurance programs and dispense unnecessary medications and services to the federal workforce. The significant penalty announced today is an example of that effort.”

Aggarwal owned and operated A.A. Texas Anesthesiology Back Pain Center where he allegedly wrote and issued prescriptions for compound pain medications to injured federal employees with federal worker’s compensation benefits. Medley filled the prescriptions.

Aggarwal’s wife owned Medley on paper. Medley began billing DOL in 2013, a year after it opened.

The investigation began when an individual employed at Medley filed a qui tam aka whistleblower lawsuit under seal Oct. 10, 2017. During his term of employment, the whistleblower allegedly witnessed patients being sent unnecessary, unwanted medications through the United States mail despite the fact they did not need and could not benefit from the medications. In a few instances, patients did not see, or ever meet, Aggarwal. Medley employees were allegedly instructed to auto-fill medications on a monthly basis and to use pre-printed prescription pads to submit the prescriptions to DOL-OWCP without consideration of medical need. 

“This settlement is a testament to the dedication and determination of the investigative and legal teams,” said Special Agent in Charge Jonathan Ulrich, U.S. Postal Service - Office of Inspector General (USPS-OIG). “USPS-OIG, along with our law enforcement partners, will continue to vigorously investigate these types of cases in order to root out fraud, waste and abuse.”

“Protecting the integrity of the programs administered by OWCP is an important part of the mission of DOL-OIG. We will continue to work with OWCP and the Department of Justice to vigorously pursue allegations of fraud involving these programs,” said Special Agent-in-Charge Steven Grell, Central Region, DOL-OIG.

Under the False Claims Act, a private party known as a relator can file an action on behalf of the United States and receive a portion of the recovery. In this case, the relator will receive a total of $1,353,752.

DOL-OIG and USPS-OIG conducted the investigation. Assistant U.S. Attorney Jill O. Venezia handled the matter.

Updated April 24, 2023