18 hours ago — We have many important and exciting priorities for 2021. ... This is compounded by many of the merger factors listed in s50(3), which can be ...
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, February 23, 2021
Review: New book spotlights rogue lab and a shadow industry of compounding pharmacies
1 day ago — And those drugs can blind or kill you, due in large part to an almost total absence of ... The story centers on the New England Compounding Center, which in 2012 ... Relying on transcripts, interviews, FDA inspection reports and other sources, ...
IN THE UNITED STATES DISTRICT COURT FOR THE ...
a4pc.org › 2021-02_Amicus-Brief-Wellness-v-Cochran
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7 days ago — Pursuant to Local Civil Rule 7(o), the Alliance for Pharmacy Compounding, ... on behalf of millions of patients who benefit from compounded medications. APC's ... FDA published a Final Memorandum of Understanding (“MOU”) on October 27,.
Former Sales Representative Indicted in Compounded Prescription Drug Scheme
Department of Justice
U.S. Attorney’s Office
District of New Jersey
FOR IMMEDIATE RELEASE
Tuesday, February 23, 2021
Former Sales Representative Indicted in Compounded Prescription Drug Scheme
NEWARK, N.J. – A former sales representative was arrested today for his role in a scheme to defraud public health benefits programs by billing for medically unnecessary compounded prescriptions, Acting U.S. Attorney Rachael A. Honig announced.
Matthew Puccio, 38, of Randolph, New Jersey, was indicted by a federal grand jury on Feb. 17, 2021, for conspiracy to commit health care fraud. He will be arraigned at a date to be determined.
According to the indictment returned yesterday:
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 March 2016, Puccio participated in a conspiracy that involved the submission of fraudulent prescriptions for compounded medications to public health benefits programs. The scheme centered on marketing companies recruiting and paying sales representatives, such as Puccio, to obtain compounded medications for themselves and others regardless of medical necessity, and by specifically targeting health plans that reimbursed for compounded medications at high rates.
Puccio exploited this opportunity through working as a sales representative for several compounding pharmacies. He targeted individuals who had health plans that covered compounded medications and then convinced those individuals to obtain prescriptions for compounded medications, regardless of medical necessity. Puccio and others induced two New Jersey based physicians to sign medically unnecessary prescriptions for beneficiaries that he and others had recruited.
Once the prescriptions were written, they were filled by the compounding pharmacies with which Puccio worked. The compounding pharmacies would then receive reimbursement from the health plans and would pay Puccio a percentage of the reimbursement amount.
The charge of conspiracy to commit health care fraud carries a maximum sentence of 10 years in prison and a $250,000 fine, or twice the gross gain or loss from the offense.
Acting U.S. Attorney Honig credited special agents of the FBI, under the direction of Acting Special Agent in Charge George M. Crouch Jr. in Newark, with the investigation leading to today’s indictment.
The government is represented by Assistant U.S. Attorneys Emma Spiro and Sean M. Sherman of the U.S. Attorney’s Office’s Opioid Abuse Prevention and Enforcement Unit in Newark.
The charge and allegations contained in the indictment are merely accusations, and the defendant is presumed innocent unless and until proven guilty.
Attachment(s):
Topic(s):
Health Care Fraud
Component(s):
Press Release Number:
21-068
Updated February 23, 2021
| 02/19/2021 | 02/18/2021 | Mountain Peak Nutritionals | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded | ||
| 02/19/2021 | 02/18/2021 | Native Remedies dba Silver Star Brands | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded | ||
| 02/17/2021 | 02/16/2021 | Dr. Paul's Lab | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
| 02/23/2021 | 02/12/2021 | CooperSurgical, Inc. | The Office of Prescription Drug Promotion (OPDP) | False & Misleading Claims/Misbranded | ||
| 02/23/2021 | 02/18/2021 | Absara Cosmetics S.A.P.I DE C.V. | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated | ||
| 02/19/2021 | 02/18/2021 | Blossom Nature, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded | ||
| 02/19/2021 | 02/18/2021 | ProHealth Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded | ||
| 02/19/2021 | 02/18/2021 | Dr. Garber’s Natural Solutions | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded | ||
| 02/19/2021 | 02/18/2021 | FDC Nutrition Inc. | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded | ||
| 02/19/2021 | 02/18/2021 | SANA Group LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded | ||
| 02/19/2021 | 02/18/2021 | Lifted Naturals | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded | ||
| 02/19/2021 | 02/18/2021 | Enlifta, LLC | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded | ||
| 02/19/2021 | 02/18/2021 | Wholesome Wellness | Center for Food Safety and Applied Nutrition (CFSAN) | New Drug/Misbranded |
Thursday, February 18, 2021
Wednesday, February 17, 2021
FDA issues warning to AcelRx for making false and misleading claims about the risks and benefits of Dsuvia
[2/16/2021] As part of the FDA’s ongoing commitment to combat inappropriate opioid use, the agency’s Center for Drug Evaluation and Research has issued a warning letter to AcelRx Pharmaceuticals, Inc. (AcelRx) for the false and misleading promotion of Dsuvia (sufentanil sublingual tablet), a potent opioid analgesic.
AcelRx has disseminated promotional communications that undermine key prescribing conditions required for the safe use of this opioid product. Dsuvia was approved with special restrictions requiring that it only be prescribed in a certified medically supervised setting by health care practitioners trained to properly administer it. The promotional communications at issue, however, promote the product as simple to administer -- just “Tongue and Done.” This promotion dangerously undercuts FDA-required conditions on the proper administration of the drug, which requires particular diligence to minimize the risk of serious or even fatal adverse events.
Dsuvia is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. It is of particular use in certain special circumstances where adult patients may not be able to swallow oral medication and where access to intravenous pain relief is not possible.
Dsuvia was approved with a Risk Evaluation and Mitigation Strategy (REMS), which reflects the serious risks associated with this product. The REMS limits distribution to certified, medically-supervised health care settings where health care professionals are trained in the proper use and administration of the product. Such settings include hospitals, surgical centers and emergency departments that are certified in the requirements outlined in the REMS. The FDA continues to carefully monitor the implementation of the REMS associated with Dsuvia and compliance with its requirements.
Critical conditions for the safe use of Dsuvia are not appropriately conveyed in the promotional communications cited in the warning letter. In particular, the claim “Tongue and Done” severely detracts from these important conditions for safe use. Because of the potency and the small size of the tablet, the prescribing information outlines multiple administration steps including a separate, distinct step to visually confirm tablet placement in the patient’s mouth. These prescribed steps are designed to minimize the serious risk that misplaced tablets could cause to patients and others. The promotional communications at issue also omit other important risk information, further minimizing the serious risks associated with Dsuvia. For example, the materials state that patients may retake the drug in one-hour intervals but fail to state that the maximum daily dosage is 12 tablets in 24 hours. This omission is concerning due to the serious risks associated with overdose of Dsuvia, including respiratory depression and death.
It is vitally important that promotional communications be truthful and non-misleading. Opioid products are highly addictive controlled substances and there are serious public health risks associated with their use, including addiction, abuse, and misuse, that can lead to overdose and death. False and misleading claims can negatively impact prescriber awareness and understanding about approved opioid drugs, their risks, and the actions and precautions necessary for the safe use of these products.
FDA requests that AcelRx cease any violations of the Food, Drug and Cosmetic Act and submit a written response within 15 days from the date of receipt of the letter addressing the concerns in the letter, listing all other promotional communications that contain statements such as those described in the letter, and explaining any plan for discontinuing use of such communications or for ceasing distribution of Dsuvia. If AcelRx fails to adequately address the concerns outlined in the warning letter, the FDA may take further regulatory action. The FDA is also requesting that AcelRx submit a comprehensive plan of action to distribute truthful, non-misleading, and complete corrective communications about the concerns discussed in the warning letter to the audience(s) that received the promotional communications.
The FDA encourages healthcare providers and consumers to report potentially false or misleading prescription drug promotion to FDA’s Bad Ad program.
The FDA also encourages health care professionals and consumers to report adverse events, medication errors, and quality problems experienced with the use of any medical product to MedWatch: The FDA Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
The FDA remains focused on reducing the rate of new addictions by decreasing exposure to opioids while still enabling appropriate access for those patients who have legitimate medical need for these medicines. Dsuvia, when used in a manner consistent with the FDA-approved labeling, including the REMS, can play an important role in the management of pain. The agency will continue to actively confront the opioid crisis, while also paying careful attention to the needs of patients experiencing pain and their health care providers.
Tuesday, February 16, 2021
Office of Manufacturing Quality
Company/Individual | Product/Issue | Issue Date |
|---|---|---|
Precision Analitica Integral S.A. de C.V. | CGMP/Adulterated - Hand Sanitizer Products | 2/5/2021 |
AAA Cosmetica, SA de CV | CGMP/Adulterated - Hand Sanitizer Products | 2/3/2021 |
Botanicals Internacional S.A. de C.V. | CGMP/Adulterated - Hand Sanitizer Products | 2/3/2021 |
Professional Compounding Centers of America dba PCCA | CGMP/Active Pharmaceutical Ingredients (APIs)/Adulterated | 1/27/2021 |
Grupo Yacana Mexico, S.A.S. de C.V. | CGMP/Adulterated - Hand Sanitizer Products | 1/26/2021 |
Laboratorios Jaloma S.A. de C.V. | CGMP/Adulterated - Hand Sanitizer Products | 1/25/2021 |
Grupo Plast-Y-Kosas, SA de CV | CGMP/Adulterated - Hand Sanitizer Products | 1/25/2021 |
Ignacio Reyes Gonzalez | CGMP/Adulterated - Hand Sanitizer Products | 1/25/2021 |
Yuyao YiJia Daily Chemical Co., Ltd. | CGMP/Finished Pharmaceuticals/Adulterated | 1/22/2021 |
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