"After Roe, Autoimmune Patients Lose Access to "Gold-Standard" Treatment
Patients with rheumatic illnesses may lose access to methotrexate, a cheap drug prescribed to millions of Americans each year, since the Supreme Court overturned Roe v. Wade, according to an investigation by the Los Angeles Times."
quoting Med Page Today, July 13, 2022
Damian Williams, the United States Attorney for the Southern District of New York, announced that defendant SETH FISHMAN, DVM, received a sentence of 11 years in prison today for his role at the helm of an approximately twenty-year scheme to manufacture, market, and sell to racehorse trainers and others in the racehorse industry “untestable” performance enhancing drugs for use in professional horseracing. FISHMAN was one of over thirty defendants charged in four separate cases in March 2020, each arising from this Office’s multi-year investigation of the abuse of racehorses through the use of performance enhancing drugs.
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Today, the U.S. Food and Drug Administration (FDA) issued warning letters to four companies for illegally selling honey-based products that may pose a significant health risk to consumers. The FDA’s laboratory testing found that product samples contained active drug ingredients not listed on the product labels, including the active drug ingredients found in Cialis (tadalafil) and Viagra (sildenafil), which are FDA approved drugs used to treat men with erectile dysfunction. Sildenafil and tadalafil are restricted to use under the supervision of a licensed health care professional. These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
“Tainted honey-based products like these are dangerous because consumers are likely unaware of the risks associated with the hidden prescription drug ingredients in these products and how they may interact with other drugs and supplements they may take,” said FDA Associate Commissioner for Regulatory Affairs Judy McMeekin, Pharm.D., “Products marketed with unidentified ingredients may be dangerous and, in some cases, deadly to consumers. We encourage consumers to remain vigilant when shopping online or in stores to avoid purchasing products that put their health at risk, and instead seek effective, FDA-approved treatments.”
Today’s warning letters outline how companies violated federal law by selling active drug ingredients in products marketed as foods, like honey, and by making unauthorized claims that their products treat disease or improve health. These products are promoted and sold for sexual enhancement on various websites and online marketplaces, and possibly in some retail stores.
The warning letters were issued to:
Companies marketing food products containing tadalafil and/or sildenafil violate federal law. Some of the products cited in the warning letters are also unapproved new drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and they lack FDA approval. In some cases, product claims reference diseases that can only be diagnosed or treated under medical supervision. Additionally, some products cited in the warning letters are represented as dietary supplements even though tadalafil and sildenafil products are excluded from the dietary supplement definition.
The FDA has requested responses from the companies within 15 working days stating how they will address these issues or providing their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to promptly address the violations may result in legal action, including product seizure and/or injunction.
Consumers using or considering using any over-the-counter product marketed for sexual enhancement should talk to a health care professional first, as some ingredients may interact with medications or dietary supplements. The FDA’s health fraud products database can help consumers identify nearly 1,000 of these potentially dangerous products.
The FDA previously warned consumers about more than 10 honey-based products containing hidden drug ingredients. The FDA’s laboratory testing found that product samples contained undeclared active ingredients, including sildenafil and tadalafil. The agency also previously warned consumers to avoid products with hidden drug ingredients sold through Amazon, eBay, Walmart and other retailers. The FDA is committed to protecting consumers by identifying and removing these potentially dangerous products from the market and urges stores, websites, and online marketplaces to stop selling these products.
If a consumer thinks that a product might have caused a reaction or an illness, they should immediately stop using the product and contact their health care provider. The FDA also encourages health care providers and consumers to report adverse reactions associated with FDA-regulated products to the agency using MedWatch or the Safety Reporting Portal.
Department of Justice
A federal court permanently enjoined a Colchester, Vermont, compounding pharmacy from distributing drugs unless they are manufactured in compliance with the Federal Food, Drug and Cosmetic Act (FDCA), the Justice Department announced.
In a complaint filed May 20, the United States alleged that Edge Pharm Inc., and its owners and operators Marc Chatoff and Kurt Radke, violated the FDCA by manufacturing and distributing adulterated and misbranded drugs, by causing drugs to become adulterated and misbranded while held for sale, and by introducing new unapproved drugs into interstate commerce. According to the complaint, the defendants manufactured injectable drugs intended to be sterile under conditions that fell short of the minimum requirements to ensure sterility. The complaint further alleged that U.S. Food and Drug Administration (FDA) inspections of the Edge facility between 2014 and 2021 revealed record-keeping violations, labelling inadequacies, improper airflow, structural disrepair and the presence in cleanroom suites of mold species that can cause diseases in humans which may be deadly to immunocompromised patients.
“Compounding pharmacies must ensure that their products are safe,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will continue to work closely with the FDA to ensure that drugs are compounded in compliance with the law.”
“Edge Pharma LLC has put patients’ lives at risk by repeatedly producing drugs under insanitary conditions and failing to follow good manufacturing practice requirements,” said Director Donald Ashley of the Center for Drug Evaluation and Research (CDER) Office of Compliance. “While compounded drugs are not FDA-approved, all drug firms must prioritize patient safety, which Edge Pharma has been unable to do. This consent decree ensures that Edge Pharma will be held accountable, and FDA will continue to take all necessary steps within our regulatory authority to protect the health of the American public.”
The defendants did not admit or deny the allegations in the government’s complaint, but agreed to settle the suit and be bound by a consent decree of permanent injunction. The consent decree requires, among other things, that the defendants stop manufacturing and distributing drugs until they take specific remedial measures and demonstrate to the FDA that they will comply with federal law. Judge Chief Judge Geoffrey W. Crawford of the U.S. District Court for the District of Vermont entered the order against the defendants.
The government was represented by Trial Attorney David G. Crockett of the Civil Division’s Consumer Protection Branch, with the assistance of Claudia Zuckerman of the FDA’s Office of Chief Counsel. The U.S. Attorney’s Office for the District of Vermont provided valuable assistance.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.
Citing an “immediate danger” to the public, state licensing officials have issued an emergency order restricting a Fort Dodge pharmacy’s ability to compound certain drugs for customers.
According to the Iowa Board of Pharmacy, Daniel Pharmacy of 1114 Central Ave., Fort Dodge, has “had ample time to comply with applicable standards for compounding with hazardous drugs, but continues to be non‐compliant” with state regulations and industry standards.
Department of Justice
ATLANTA - Brett Sabado has been sentenced for his role in a scheme to defraud Tricare and Medicare by submitting fraudulent claims for compound medications and durable medical equipment (DME). Sabado also agreed to pay $950,000 as part of an “ability to pay” civil settlement in order to resolve violations of the False Claims Act for causing false claims for DME to be submitted to the Medicare Program. This resolution is the result of a global investigation involving the criminal and civil divisions of the Northern District of Georgia and the Southern District of California.
“Instead of putting patient care first, the defendants decided their best interests were more important,” said U.S. Attorney Ryan K. Buchanan. “Healthcare providers and pharmacies who use their positions of trust to game the system, specifically designed to maximize their profits, put their patients at risk and divert scarce government resources.”
“Through federal healthcare programs like Medicare and TRICARE, the United States provides essential medical care for the elderly and disabled, and to service members and their families,” said U.S. Attorney Randy Grossman of the Southern District of California. “It is crucial that the American people know that taxpayer funds are being used for these important purposes and not diverted through the schemes of fraudsters. I am proud of the coordination and cooperation among districts and agencies reflected in this outcome,” he added, commending the work of the attorneys and agents in the SDCA and NDGA U.S. Attorneys’ Offices, and at DCIS, FBI, and HHS-OIG, in employing the range of criminal and civil remedies to reach this resolution.”
“This sentence will hold Sabado accountable for the damage he caused to Medicare and every taxpayer in this country,” said Keri Farley, Special Agent in Charge of FBI Atlanta. “Government subsidized programs like Medicare help protect the healthcare needs of deserving Americans and the FBI is determined to work with our partners to prevent people from illegally profiting off of them.”
“HHS-OIG is committed to protecting beneficiaries of federal health care programs from fraud and safeguarding valuable taxpayer dollars,” said Tamala E. Miles, Special Agent in Charge with the Department of Health and Human Services, Office of Inspector General (HHS-OIG). “We will continue to investigate and hold accountable any providers who egregiously take advantage of their patients for illegitimate financial gain.”
“Compounding pharmacy fraud bilked the Defense Health Agency of over a billion dollars and exploited not only the military, but all citizens,” said DoD Inspector General's Defense Criminal Investigative Service (DCIS) Southeast Field Office Special Agent in Charge Cynthia A. Bruce. “I thank the U.S. Attorney's Office and our investigative team for their tireless effort to untangle this web of crime, trace the assets, and hold these individuals accountable.”
According to U.S. Attorney Buchanan, the charges, and other information presented in court: Sabado and his co-conspirators received illegal kickbacks for Tricare referrals and prescriptions of compound medication formulations including pain creams, scar creams, and multi-vitamins that they specifically devised to maximize profits.
Sabado operated NHS, a pharmaceutical company that caused compounding pharmacies to submit false claims for these prescriptions to Tricare. The compounding pharmacies paid NHS a portion of the Tricare reimbursement, and NHS paid a portion of its proceeds to healthcare marketing companies that pushed providers into prescribing these unnecessary compound medications.
Sabado further executed the scheme by creating an online portal database used by NHS to facilitate the referral of prescriptions through NHS to the compounding pharmacies. Sabado and others at NHS used claims data to track the referrals made to compounding pharmacies and to invoice those pharmacies for the illegal kickbacks owed to NHS for the referrals. Sabado ultimately caused a loss of $4.5 million to Tricare.
Sabado also conspired with the owners of DME supply companies to submit false and fraudulent claims for medically unnecessary DME such as arm, leg, back, wrist, and neck braces to Medicare. Specifically, Sabado warehoused, packaged, and shipped thousands of fraudulent DME orders to Medicare beneficiaries. Sabado knew that the DME orders were supported by sham prescriptions written by telemedicine physicians who, in many instances, never spoke with or examined the Medicare beneficiaries for whom the physicians ordered DME. Nonetheless, Sabado continued to package and ship DME that Medicare beneficiaries neither requested nor needed.
For his part in this scheme, Sabado received between $5 and $15 for each medically unnecessary brace he shipped. Sabado also received a percentage of all Medicare reimbursement for the braces. Sabado ultimately caused a loss of almost $70 million to Medicare.
Sabado further engaged in similar conduct involving the submission of false and fraudulent claims to Tricare, the New Jersey State Health Benefits Program, and private health care benefits programs for expensive and medically unnecessary compounded medication in other states.
Brett Sabado, 34, of Sandy Springs, Georgia, was sentenced by U.S. District Judge Thomas W. Thrash, Jr., to five years in prison to be followed by three years of supervised release.
This case was investigated by the U.S. Attorney’s Office for the Northern District of Georgia, the U.S. Department of Health and Human Services - Office of Inspector General, the Federal Bureau of Investigation, and the Defense Criminal Investigative Service.
The civil resolution was reached by Assistant U.S. Attorney Mellori Lumpkin-Dawson. The criminal case was prosecuted by Assistant U.S. Attorneys Angela Adams and Bernita Malloy in the Northern District of Georgia. A related case in the Southern District of California, United States v. Charles Ronald Green and Melinda Elizabeth Green, Case No. 3:20-cr-01566-DMS, SDCA (San Diego)), was prosecuted by Assistant U.S. Attorneys Valerie Chu and Kevin Larsen.
For further information please contact the U.S. Attorney’s Public Affairs Office at USAGAN.PressEmails@usdoj.gov or (404) 581-6016. The Internet address for the U.S. Attorney’s Office for the Northern District of Georgia is http://www.justice.gov/usao-ndga.