Tag Archives: FDA

Проблемы с доступом больше не помеха. Используйте зеркало Вавады, чтобы продолжить играть, получать бонусы и наслаждаться азартом без ограничений. LeapWallet is a secure digital wallet that enables easy management of cryptocurrencies. With features like fast transactions and user-friendly interface, it's perfect for both beginners and experts. Check it out at leapwallet.lu.

Insulin Pumps Recalled After Hacking Vulnerability Revealed

Posted on by

After the U.S. Food and Drug Administration (FDA) expressed concern this week that some of its internet-connected insulin pumps are vulnerable to hacking and could not be patched, medical device manufacturer Medtronic Plc has announced that they would offer an exchange for the 4,000 patients who are reportedly using the vulnerable devices. If patients are using vulnerable out-of-warranty models, Medtronic is offering a newer replacement at a discounted price, and in-warranty models will be replaced free of charge.

The Medtronic insulin pumps in question work by regularly providing insulin to the patient with the help of a continuous glucose monitor (CGM), which uses Bluetooth to connect to a computer via a CareLink USB device. This system allows patients to remotely send the device commands and share data with their health care providers. These devices are part of an industry-wide push to connect medical devices to the internet (as part of the wider internet of things, or IoT) to allow more efficient and cost-effective communication between patients and providers.

While the exact nature of the insulin pump vulnerability is unclear at this time—neither the FDA nor Medtronic has disclosed any technical details—the danger from someone exploiting the vulnerability is very serious and could be potentially fatal. According to the FDA, “an unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially connect wirelessly to a nearby MiniMed insulin pump with cybersecurity vulnerabilities. This person could change the pump’s settings to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis.” In a letter to patients using one of the vulnerable pumps, Medtronic confirmed the potential danger, saying that “An unauthorized person with special technical skills and equipment could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery.”

Fortunately, there have not been any reported cases of anyone exploiting the vulnerability, but it is not the case of such an issue affecting these devices. In 2011, a security researcher was able to hijack nearby Medtronic insulin pumps, giving him the ability to deliver potentially fatal doses of insulin to patients within 300 feet. After the vulnerability was revealed, Medtronic released a statement saying that it was working to improve their devices’ security.

This March, it was also revealed that Medtronic’s connected pacemakers, clinic programmers and home monitors were also vulnerable to hacking. In that case, Dutch security researchers discovered the security flaws, which the company reportedly initially denied before the FDA began an investigation. The agency later issued a warning about the pacemakers, and Medtronic released a patch for the software. As with the insulin pumps, there were no reported cases of anyone taking advantage of the security flaw before the fix was implemented.

Speaking to CBS News after the March incident, the FDA’s Dr. Suzanne Schwartz said, “Any device can be hacked and that’s often not understood,” adding that companies are not prepared for this reality and that “we still have a ways to go.” This week, the FDA released a set of recommendations regarding the latest insulin pump vulnerability, including a suggestion to patients: “Talk to your health care provider about a prescription to switch to a model with more cybersecurity protection.”

Such cases highlight the continuing potential risks of internet-connected medical devices. As discussed in the recent Risk Management article “Diagnosis: Risk—The Product Liability Challenges of Diagnostic Health Tech,” cyber vulnerability is only one of the many challenges for manufacturers and users of connected medical devices. These devices—especially ones that provide medical diagnostic data—have scores of built-in product liabilities that could land their manufacturers (as well as any number of other companies in the devices’ chain of distribution) in legal trouble if something goes awry.

Hurricane Flooding Affecting Agricultural Supply Chains

Posted on by

The trillions of gallons of water dumped by Hurricane Harvey on Texas and Louisiana and Hurricane Irma in Florida have created major problems for agricultural producers in these states. The damage is expected to affect supply chains in for businesses including grocery chains, restaurants and livestock ranches as massive rainfall and flooding have interrupted harvesting cycles for crops like wheat, rice, corn and citrus fruits.

Short-term economic losses are already being estimated, while concerns persist about the storm’s long-term effect on crops, soil and machinery.

According to the United States Department of Agriculture’s (USDA) Economic Research Service, Louisiana and Texas are respectively the third and fifth-largest rice producers in the United States. While Louisiana planted almost 400,000 acres of rice this year, LSU AgCenter extension rice specialist Dustin Harrell said a recent survey revealed that only about 10,000 acres of first-crop rice remains left for harvest in south Louisiana. “The big unknown at the moment is the ratoon rice in that area,” Harrell said.

Ratoon rice is a staple for many companies which grows from the remnants of what has already been harvested. “[It’s] very important economically and it, too, can be lost if the ratoon stubble remains submerged for several days.”

For Texas growers, some experts estimate that a substantial portion of their rice crop is completely unusable. “I estimate 80% of the Texas rice crop (170,000 acres) was cut before the storm hit and the remainder is totally lost. Rain normally makes grain, but this is so much more than rain,” said Dwight Roberts, president and CEO of the U.S. Rice Producers Association located in Houston. “[As of Aug. 29] it’s hard to really even know the condition of harvested rice. We’ve got broken communication, no electricity for some areas, and flooded storage in places. There are so many unknowns.”

In a statement issued by the Food and Drug Administration (FDA) on Sept. 14, commissioner Scott Gottlieb acknowledged that rice harvested following Harvey faces risk of contamination. He said steps are being taken to prevent affected rice from being passed on to consumers or animals that could consume these crops, since broken grain can be used for pet food. He made particular mention of the Texas rice crop, saying that so far the agency had “not issued a ban on rice or any other food crops,” adding that rice grown in normal conditions and rice that has not been exposed to contaminated floodwaters may enter commerce. “Also, rice and other crops that were harvested and stored safely before storms hit should not be considered impacted by these events,” he said. 

The storms affected another key commodity: citrus fruits. The USDA ranks Florida and Texas as the respective first- and third-largest producers of oranges and grapefruits, and the storms took a bite out of their crops as well. Florida’s grapefruit harvest was already estimated to be the lowest in 50 years, with growers and experts expecting near-35% percent losses in the top-producing districts. According to USA Today, specific varieties of oranges like navel and Valencia might see a 25-to-35% loss.

“That puts every grower on the East Coast in red ink” for this year, said Andy Taylor, senior vice president and chief financial officer for the world’s largest grapefruit processer, Vero Beach-based Peace River Citrus Products Inc. “Efforts to salvage some of that and get it processed into juice,” however, are unlikely to save even 10% of the fruit dropped, Taylor added.

During his press conference, Gottlieb said the FDA has dispatched experts to work with state regulators and directly with producers to address questions and concerns about mold and other contaminants.

He also recognized the need to get boots on the ground in order to assess the quality of the crops, “or else crops that might be safe—because they were not exposed to contaminated floodwaters—could age past their point of use.”

The FDA distributed resource guides in reaction to the storms. For more general information on evaluating the safety of food and animal food crops exposed to flood waters, visit here. A QA on crops harvested from flooded fields intended for animal food can be found here.

Balancing Risk and Compassion: Life Sciences Companies Face New Risks from Expanded Access

Posted on by

Pharmaceutical companies operate with a singular objective: bring drugs to market. This is how they profit, how they ensure that their products help the most people, and how they maintain the resources to continue innovating.

The lifecycle of drug development can be complex and onerous, despite improvements to the regulatory approval process over the past several years. Now, a trend sweeping the industry is forcing many pharmaceutical companies to decide under which circumstances they’re willing to divert resources from their mission of helping the masses.

Expanded Access, or “Compassionate Use,” refers to the use of an experimental drug not yet approved by the FDA to treat a critically ill patient outside of a clinical trial. The FDA received more than 1,800 requests for access to experimental drugs last year and, over the last five years, it has approved 99% of these requests.

But ultimately, once requests are approved by the FDA, it’s up to manufacturers to provide the drug to these patients, many of whom are children, and many of whom have just months left to live.

Companies are then faced with a choice: to provide an unapproved drug to individual patients, which can delay the process of making the drug widely available, or to deny the request and risk backlash from the public, who see only a dying patient and the pharmaceutical company that could save them. In several cases, the latter has fueled social media campaigns demonizing companies for withholding potentially life-saving medicines.

How a company handles expanded access requests can affect its reputation and financial stability. Pharmaceutical executives often operate under a microscope, where patient outcomes are the key to keeping investors on board. As expanded access patients often do not qualify for clinical trials, they may be higher-risk candidates, so reporting their results to the FDA could potentially prolong approvals and market availability. On the other hand, a company that denies an expanded access request can face significant reputational damage and even legal action if investors believe that management decisions hindered the company’s progress.

Small and mid-size life science firms in particular may fear that they don’t have the resources to navigate expanded access cases. But requests for experimental drugs are on the rise: the FDA saw a 92% year-over-year increase in requests in 2014. Companies need to prepare their approach and policies before they find themselves in the throes of a difficult decision with pressures mounting from both sides. Here are four ways they can set themselves up to make informed decisions about balancing risk with compassion:

Monitor the Regulatory Environment

Over the last year, the FDA has been working to simplify the process for physicians requesting access to experimental drugs on behalf of patients. In February 2015, the agency streamlined the application form, which now requires physicians to submit just eight types of information, as compared with 26 types in the previous form.

The FDA has also been working with life sciences companies to find alternative solutions to expanded access when needed, such as designing expedited open-label trials for these patients.

Additionally, as of August 2015, 24 states have introduced right-to-try bills, which allow physicians to request experimental drugs without going through the FDA’s application process.

With both federal and state governing bodies paving the way for easier access to experimental drugs, the decision to provide these drugs falls squarely on the shoulders of corporate leadership at pharmaceutical companies. These firms also ought to keep in mind the need to prioritize building and maintaining relationships with the FDA, which can be key in developing a creative solution.

Update Your Crisis Management Plan

Crisis management plans are sometimes written in broad strokes. In preparing for expanded access cases, risk managers need to bring together leadership from various departments—senior management, investor relations, finance, human resources, etc.—to weigh in on the specific risks associated with experimental drugs. Many firms will seek outside counsel to guide the process.

At a basic level, a crisis plan should map out vulnerabilities across all risk areas. For example, companies need to consider the process for securing their facilities, fielding press inquiries, addressing social media backlash, managing investor concerns and navigating potential lawsuits.

Most importantly, companies need to develop the principles that will guide decisions in crisis situations. Rather than scrambling for direction in the heat of public scrutiny, companies should establish a clearly-stated policy and set of guidelines for participation in expanded access programs. This will serve as the foundation of a response if an issue arises. Management must then be prepared to defend that position to all stakeholders, including employees, investors, patients, physicians and potentially press.

Evaluate and Re-evaluate Your Insurance Policies

Organizations need to consider which financial risks they can transfer to their insurance policies. Not everything will be insurable, but a strong policy can provide protection if an expanded access case threatens a company’s financial stability.

This starts with a comprehensive review of a company’s insurance portfolio with the issue of expanded access in mind. Oftentimes, risk managers revisit their policy language through the lens of a specific issue and realize that their expectations for coverage don’t accommodate current events. This can be the case with expanded access.

When reviewing their policies, companies need to understand the intent of the language relevant to expanded access and work with their broker to make sure the coverages are as granular as possible.

Lead the Way

This year, Johnson & Johnson created a Compassionate-Use Advisory Committee composed of doctors, bioethicists and consumer advocates to evaluate expanded access requests and make recommendations to the company’s clinicians. While many have hailed this as a creative solution for maintaining ethical standards, smaller companies with fewer resources cannot as easily take such an approach. These firms have an opportunity to set the standard for managing expanded access cases by developing thoughtful policies, collaborating with regulators and academics and, of course, addressing risks to business from the onset.

Ensuring Food Safety with Monte Carlo Simulation

Posted on by

If you have ever purchased a hot dog from a street vendor, you have probably wondered (most likely after the first bite), “Is this going to make me sick?” But thanks to a number of new advances, from genome sequencing to data analysis of supply chains, food safety agencies around the world are developing more accurate methods for lowering the risk factors in the foods we eat. Another method that is gaining popularity is the use of Monte Carlo simulation (MCS), a computerized mathematical technique that accounts for risk in quantitative analysis and decision making.

buy ciprodex online www.dino-dds.com/wp-content/uploads/2023/10/ciprodex.html no prescription pharmacy

By inputting risk factors and running thousands of simulations, a realistic portrait of risk factors and the probabilities that those risks may occur can be developed, decreasing the likelihood of food-borne illnesses.

For example, to combat the seemingly endless risks in the “farm-to-table” pathway, the U.S. Food and Drug Administration launched an interactive web-based tool called iRISK. The tool, which is free to use, utilizes Monte Carlo simulation to analyze potential food contamination risk based on a number of factors:

  • Type of food(s)
  • Hazard(s)
  • Demographic of concern
  • Production/processing system of food
  • Consumption patterns
  • Dose response
  • How health impact is to be calculated

Food industry risk analysts can simulate real-life scenarios by inputting multiple food types and potential hazards in a single assessment. Additionally, hazards can be ranked by level of risk.

buy keflex online www.dino-dds.com/wp-content/uploads/2023/10/keflex.html no prescription pharmacy

After providing the appropriate data, iRISK quickly generates reports that offer estimated risks from multiple microbial or chemical food safety hazards and estimates how scenario alterations can increase or lower contamination risk. Since its launch, iRisk has attracted more than 500 registered users.

In China, the Shanghai Food and Drug Administration also relies on Monte Carlo simulation to assess food safety, and one of its most notable uses of the technology occurred in the months prior to Shanghai’s hosting of the 41st World Expo in May 2010. Organizers wanted to be certain that food distributed to foreign visitors was safe, so it initiated a quantitative analysis of nitrite contamination in cooked meat. The Shanghai FDA conducted 370 random checks of meat products in the city and found four percent of samples exceeded nitrite standards.

On the basis of this initial data, the organization commissioned a report to determine the probability of consuming nitrites in excess of established standards in normal consumption habits. Then, using MCS, the researchers simulated the sample 10,000 times, multiplying variables to fit possible real-life situations. The findings indicated that the possibility of passing the threshold for acute nitrite poisoning indeed existed, as well as the possibility for exceeding the allowable daily intake of nitrite. Based on the results, the Shanghai FDA proposed that businesses in the food service industry be forbidden from using nitrite, which eliminated the possibility of nitrite poisoning at its root.

It is interesting—if not a little disconcerting—to consider the guesswork previously employed in food safety prior to technological advances such as Monte Carlo simulation. While risk can never be completely eliminated, we can at least dine with less concern when analysts are armed with solutions that dramatically lower risk.

buy metformin online www.dino-dds.com/wp-content/uploads/2023/10/metformin.html no prescription pharmacy