Tag: FDA

FDA Coronavirus Disease (COVID-19) Update: Foreign Inspections


On Tuesday, the FDA provided an update on the status of U.S. Food and Drug Administration inspections outside of the U.S. in response to the COVID-19 outbreak.

After careful consideration, the FDA is postponing most foreign inspections through April, effective immediately.

Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.

The FDA based this decision on a number of factors, including State Department Level 4 travel advisories in which travel is prohibited for U.S. government employees, Centers for Disease Control and Prevention travel recommendations, access restrictions being imposed on foreign visitors by certain countries, guidance from the Office of Personnel Management and the importance of the health and safety of our employees.

Another critical factor in taking this action is the confidence we have in our ability to maintain oversight over international manufacturers and imported products using alternative tools and methods.

We are aware of how this action may impact other FDA responsibilities, including product application reviews. We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible.

When we are temporarily not able to physically inspect foreign produced FDA-regulated products or manufacturers, as an interim measure we employ additional tools to ensure the safety of products imported to the U.S., which have proved effective in the past.

These include denying entry of unsafe products into the U.S., physical examinations and/or product sampling at our borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements and requesting records “in advance of or in lieu of” on-site drug inspections.

For example, we began exercising this authority when we postponed on-the-ground inspections of manufacturers of FDA-regulated products in China earlier in the outbreak. This is all part of the FDA’s multi-pronged and risk-based approach to ensuring quality, as well as compliance, with applicable federal laws and regulations.

The FDA will continue working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first-time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law.

The FDA has the ability through our risk-based import screening tool (PREDICT) to focus our examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce. The PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak.

We are keeping a close eye out for indications of port shopping or cargo diversion and will continue our oversight of shipments through potentially higher-risk venues such as International Mail Facilities. We can refuse admission of products that fail sample testing or may violate other applicable legal requirements.

Americans can rest assured the FDA is diligently monitoring this outbreak and the impact to our operations.

Our leadership team meets daily to talk about the myriad of urgent issues facing us as we actively facilitate efforts to diagnose, treat and prevent the disease; survey the medical product supply chain for potential shortages or disruptions and help to mitigate such impacts, as necessary; and leverage the full breadth of our public health tools, including enforcement tools to stop fraudulent COVID-19 activity.

As this remains a dynamic situation, we will continue to assess and calibrate our approach as needed to help advance federal response efforts in the fight against this outbreak.

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FDA.gov (March, 2020) Coronavirus Disease 2019 (COVID-19) Update: Foreign Inspections

FDA Informs Patients, Providers and Manufacturers About Potential Cybersecurity Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy


On Wednesday, the U.S. Food and Drug Administration is informing patients, health care providers and manufacturers about a set of cybersecurity vulnerabilities, referred to as “SweynTooth,” that – if exploited – may introduce risks for certain medical devices.

SweynTooth affects the wireless communication technology known as Bluetooth Low Energy (BLE). BLE allows two devices to “pair” and exchange information to perform their intended functions while preserving battery life and can be found in medical devices as well as other devices, such as consumer wearables and Internet of Things (IoT) devices.

These cybersecurity vulnerabilities may allow an unauthorized user to wirelessly crash the device, stop it from working, or access device functions normally only available to the authorized user.

To date, the FDA is not aware of any confirmed adverse events related to these vulnerabilities. However, software to exploit these vulnerabilities in certain situations is publicly available. Today, the FDA is providing additional information regarding the source of these vulnerabilities and recommendations for reducing or avoiding risks the vulnerabilities may pose to a variety of medical devices, such as pacemakers, glucose monitors, and ultrasound devices.

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“Medical devices are becoming increasingly connected, and connected devices have inherent risks, which make them vulnerable to security breaches. These breaches potentially impact the safety and effectiveness of the device and, if not remedied, may lead to patient harm,” said Suzanne Schwartz, M.D., MBA, deputy director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health. “The FDA recommends that medical device manufacturers stay alert for cybersecurity vulnerabilities and proactively address them by participating in coordinated disclosure of vulnerabilities as well as providing mitigation strategies. An essential part of the FDA’s strategy is working with manufacturers, health care delivery organizations, security researchers, other government agencies and patients to address cybersecurity concerns that affect medical devices in order to keep patients safe.”

The FDA is currently aware of several microchip manufacturers that are affected by these vulnerabilities: Texas Instruments, NXP, Cypress, Dialog Semiconductors, Microchip, STMicroelectronics and Telink Semiconductor. Their microchips may be in a variety of medical devices, such as those that are implanted in or worn by a patient (such as pacemakers, stimulators, blood glucose monitors and insulin pumps) or larger devices that are in health care facilities (such as electrocardiograms, monitors and diagnostic devices like ultrasound devices).

Medical device manufacturers are already assessing which devices may be affected by SweynTooth and are identifying risk and remediation actions. In addition, several microchip manufacturers have already released patches. For more information about SweynTooth cybersecurity vulnerabilities – including a list of affected devices, see ICS-ALERT-20-063-01 SweynTooth Vulnerabilities, Department of Homeland Security Cybersecurity Infrastructure Security Advisory.

The agency is asking medical device manufacturers to communicate to health care providers and patients which medical devices could be affected by SweynTooth and ways to reduce associated risk. Patients should talk to their health care providers to determine if their medical device could be affected and to seek help right away if they think their medical device is not working as expected.

The FDA takes reports of vulnerabilities in medical devices very seriously and today’s safety communication includes recommendations to manufacturers for continued monitoring, reporting and remediation of medical device cybersecurity vulnerabilities.

The FDA is recommending that manufacturers conduct a risk assessment, as described in the FDA’s cybersecurity postmarket guidance, to evaluate the impact of these vulnerabilities on medical devices they manufacture and develop risk mitigation plans.

Medical device manufacturers should work with the microchip manufacturers to identify available patches and other recommended mitigation methods, work with health care providers to determine any medical devices that could potentially be affected, and discuss ways to reduce associated risks.

The FDA will continue to assess new information concerning the SweynTooth vulnerabilities and will keep the public informed if significant new information becomes available.

Furthermore, the FDA will continue its ongoing work with manufacturers and health care delivery organizations—as well as security researchers and other government agencies—to help develop and implement solutions to address cybersecurity issues throughout a device’s total product lifecycle.

FDA.gov (March, 2020) FDA Informs Patients, Providers and Manufacturers About Potential Cybersecurity Vulnerabilities in Certain Medical Devices with Bluetooth Low Energy

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Coronavirus Update: FDA steps to ensure quality of foreign products


Today, we are providing updated and more detailed information about the status of FDA inspections in China and the agency’s oversight of imported products from China, which have been impacted by this outbreak.

While we are not able to conduct inspections in China right now, this is not hindering our efforts to monitor medical products and food safety. We have additional tools we are utilizing to monitor the safety of products from China, and in the meantime, we continue monitoring the global drug supply chain by  prioritizing risk-based inspections in other parts of the world.

The FDA is not currently conducting inspections in China in response to the U.S. Department of State’s Travel Advisory to not travel to China due to the novel coronavirus outbreak. We will continue to closely monitor the situation in China so that, when the travel advisory is changed, we will be prepared to resume routine inspections as soon as feasible.

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We already use other tools to help complement our inspections, including import screening, examinations, sampling, and import alerts, relying on a firm’s previous compliance history, and we use information from foreign governments as part of mutual recognition agreements. Thus, at this time, we can rely on these other tools to give us comprehensive oversight of FDA-regulated products entering this country. This is all part of our agency’s risk-based approach to ensuring quality, as well as compliance with applicable FDA requirements.

It is important to reiterate that inspections are one of many tools that the agency uses to inform our risk strategy for imported FDA-regulated products and to help prevent products that do not meet the FDA’s standards from entering the U.S. market.  A wide variety of FDA-regulated products are imported from China, which makes it important to assure the public of the quality of these products. At this time, over 60% of FDA-regulated products imported from China are medical devices and 20% are housewares (like food packaging).  

In response to the COVID-19 outbreak, the FDA will utilize, where appropriate, our authority to request records from firms “in advance or in lieu of” drug surveillance inspections in China. The Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act (FDASIA) of 2012, gives the FDA authority to request records “in advance of or in lieu of” on-site drug inspections.

Congress enacted this provision to improve the effectiveness and efficiency of inspections, given the increasing globalization of drug production.  Along with other FDASIA provisions, this inspection record request authority was viewed as a way to “level the playing field” between foreign and domestic drug inspections by allowing the FDA to review records ahead of time and take a more risk-based approach to conducting both domestic and foreign inspections. These records will help the agency when we resume drug inspections in China.

By applying the use of paper records in our risk-based inspection framework, we can prioritize our early inspections on those deemed most needed, based on the records . By doing so, we hope to rapidly assess what could become a backlog number of on-the-ground surveillance inspections this fiscal year if travel restrictions persist.

In addition to records requests, the FDA will continue working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law. FDA has the ability through our risk-based import screening tool (PREDICT) to focus our examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce. The PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak.  

We are keeping a close eye out for indications of port shopping or cargo diversion and will continue our oversight of shipments through potentially higher-risk venues such as International Mail Facilities. We can refuse admission of products that fail sample testing or may violate other applicable legal requirements.

Fortunately, currently, we are not seeing the impacts of this outbreak resulting in an increased public health risk for American consumers from imported products. There is no evidence to support transmission of COVID-19 associated with imported goods and there have not been any cases of COVID-19 in the United States associated with imported goods. As noted, this remains a dynamic situation and we will continue to assess, and update guidance as needed. 

We also continue to aggressively monitor the market for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA can and will use every authority at our disposal to protect consumers from bad actors who would take advantage of a crisis to deceive the public, including pursuing warning letters, seizures, or injunctions against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.

We know the public may have questions or concerns for the FDA as a result of this outbreak, including you and your family’s risk of exposure, or whether your critical medical products are safe and will continue to be available in the future.

We assure you that the FDA is working around the clock to monitor and mitigate emerging coronavirus issues through collaborative efforts with U.S. regulators, international partners, and medical product developers and manufacturers to help advance response efforts to combat the COVID-19 outbreak. 

FDA.gov (February, 2020) FDA steps to ensure quality of foreign products

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Collegeville Man Indicted for Scheme to Sell Fraudulent Canine Cancer-Curing Drugs to Pet Owners


The defendant promised to restore the health of terminally ill dogs and allegedly defrauded pet owners of hundreds of thousands of dollars

United States Attorney William M. McSwain announced that Jonathan Nyce, 70, of Collegeville, PA, was charged by Indictment with wire fraud and the interstate shipment of misbranded animal drugs. The charges arise from a years-long scheme to defraud pet owners of money by falsely claiming to sell canine cancer-curing drugs.

The Indictment alleges that the defendant created several companies beginning in 2012, including “Canine Care,” “ACGT,” and “CAGT,” through which he purported to develop drugs intended to treat cancer in dogs. Using various websites for these companies, the defendant marketed these “cancer-curing” medications to desperate pet owners, using the drug names “Tumexal” and “Naturasone.”

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The websites made numerous allegedly false and fraudulent claims regarding the safety and efficacy of these supposed drugs, including that “Tumexal is effective against a wide variety of cancers,” and, “[i]n fact, Tumexal will almost always restore a cancer-stricken dog’s appetite, spirit and energy!” As alleged, these drugs were nothing more than a collection of bulk ingredients from various sources, which the defendant blended together himself at a facility on Arcola Road in Collegeville.

Further, through email and telephone conversations, Nyce allegedly induced the owners of terminally ill dogs to pay him hundreds or thousands of dollars for these drugs by touting the effectiveness of his products in treating a host of canine cancers. He also told prospective customers that their pets could become part of clinical trials, but in order to do so, they had to pay him large sums of money.

The defendant’s marketing, sale, and shipment of these drugs in interstate commerce is alleged to have violated the Food and Drug Administration’s Federal Food, Drug, and Cosmetic Act because the drugs were not approved by the FDA. The defendant even falsely claimed in promotional materials that his company’s research was “funded in part by the U.S. Food and Drug Administration.”

“The defendant’s alleged conduct here is shameful,” said U.S. Attorney McSwain. “As any dog owner will tell you – myself included – pets quickly become part of the family. And when they become sick, caring owners look for hope, often doing everything they can to keep their beloved pets alive and well. The defendant is charged with taking advantage of that nurturing instinct in the worst way possible by defrauding pet owners and giving them false hope that they might be able to save their dying pet. That is both cruel and illegal, and now the defendant will face the consequences.”

“American pet owners rely on the FDA to ensure their pets’ drugs are safe and effective,” said Special Agent in Charge Mark McCormack, FDA Office of Criminal Investigations’ Metro Washington Field Office.  “We will continue to investigate and bring to justice those who ignore or attempt to circumvent the law.”

If convicted, the defendant faces a maximum possible sentence of 32 years imprisonment and a fine of up to $1,250,000.

The case was investigated by the Food and Drug Administration’s Office of Criminal Investigation, and is being prosecuted by Assistant United States Attorney Christopher E. Parisi.

An indictment, information, or criminal complaint is an accusation. A defendant is presumed innocent unless and until proven guilty.

FDA.gov (February, 2020)  Collegeville Man Indicted for Scheme to Sell Fraudulent Canine Cancer-Curing Drugs to Pet Owners

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