Investigation of Listeria monocytogenes

Welcome to FWQRC Regulatory focus news LetterHere we are going to review on the Outbreak Investigation of Listeria monocytogenes Linked to Hard-Boiled Eggs, December 2019FDA, CDC, and state and local partners are currently investigating a multistate outbreak of Listeria monocytogenes infections linked to foods that contain hard-boiled eggs. On December 20, 2019, Almark Foods recalled and suspended production of hard-boiled and peeled eggs in pails due to the potential for contamination with Listeria monocytogenes. These hard-boiledand peeled eggs were sold in pails under the following names: Rainbow Select Hard-cooked Eggs, Rainbow Select Hard-cooked Eggs in Vinegar, Nic’s Salad Hard-boiled Eggs, Almark Hard-cooked Eggs, and Sutherland Select Hard-cooked Eggs. A full list of recalled products is included below.RecommendationFood processors, restaurants, and retailers should not sell or serve any of the recalled hard-boiled and peeled eggs in pails from Almark Foods. These products were not sold directly to consumers.Additionally, FDA recommends that food processors, restaurants and retailers who have received Almark Foods bulk, fresh hard-boiled eggs, use extra vigilance in cleaning and sanitizing any surfaces that may have come in contact with these products, to reduce the risk of cross-contamination.Background:As of December 17, 2019, a total of seven people infected with the outbreak strain of Listeria monocytogenes have been reported from five states. In interviews, ill people answered questions about the foods they ate and other exposures in the month before they became ill. Of the five people for whom information was available, four reported eating products containing eggs. Three of these people reported eating hard-boiled eggs in deli salads purchased from grocery stores and in salads eaten at restaurants. Illnesses started on dates ranging from April 10, 2017 to November 12, 2019.Additionally, based on whole-genome sequencing, the Listeria monocytogenes found in environmental samples collected at the firm’s processing facility during an FDA inspection conducted in February 2019 is a genetic match to the outbreak strain. FDA is conducting additional inspections and sampling. Almark Foods has been cooperating with the ongoing investigation and announced a voluntary recall of hard-boiled and peeled eggs in pails on December 20, 2019.This outbreak strain was found during environmental sampling in 2017 of one other food facility. That facility is not currently handling food and ceased operation in 2018.Thank you for viewing FWQRC blogs….

USFDA Class I Recall,the most serious type of recall

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Smiths Medical ASD, Inc. Recalls Medfusion® 4000 Syringe Pumps Due to Malfunctioning Alarms and Potential Interruption of Therapy

The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death.

Recalled Product

• Medfusion® 4000 Syringe Pump with Firmware Version 1.7.0
• Model numbers 4000-0107-01 and 4000-0106-01
• Manufacturing Dates: June 25, 2019
• Distribution Dates: September 27, 2019 to October 31, 2019
• Devices Recalled in the U.S.:  627
• Date Initiated by Firm: October 28, 2019
• Device Use

The Smiths Medical ASD Medfusion 4000 Syringe Pump is used to deliver blood, blood products or prescribed drugs into a patient’s body in a controlled manner.  Syringe pumps are primarily used in the neonatal and pediatric populations and in operating rooms and intensive care units for the adult population.

Reason for Recall

Smiths Medical has become aware of a software issue in the most recently updated Medfusion® 4000 Syringe Pump Firmware, Version 1.7.0, that could potentially cause the low battery alarms to stop working. If the battery alarms do not work, the healthcare provider using the pump will not receive audible or visual notification that the battery is shutting down. This may lead to an interruption of therapy which may lead to serious injury, adverse events, or death.

Smiths Medical has received 74 complaints related to the software update. No injuries or deaths have been reported.

• Who May be Affected
• Healthcare providers using the Smiths Medical ASD, Inc.  Medfusion® 4000 Syringe Pump
• Patients who receive therapy delivered by the Smiths Medical ASD, Inc. Medfusion® 4000 Syringe Pump

What to Do

On October 28, 2019, Smiths Medical sent a Recall Notice to customers informing them of the affected models and instructing them to immediately return all affected products.

The Recall Notice from Smiths Medical advised customers to:

• Locate all Medfusion® 4000 Syringe Pumps with Firmware Version 1.7.0 in their possession. The firmware version of the pump can be identified by powering on the unit and observing the firmware version displayed on the screen.
• Determine the number of affected devices in their possession and complete the provided Recall Notice Response Form within 10 days of receipt, returning it to fieldactions@smiths-medical.com even if they do not have any affected product in their possession. All affected product must be returned to Smiths Medical for processing.
• Upon returning the Response Form, Smiths Medical will provide a shipping label to return the affected product. Include a copy of the completed Response Form inside each box of returned product to facilitate processing. Ensure boxes are sealed and labeled with the facility name prior to shipping.
• If they distributed any of the potentially affected products identified in this Recall Notice, they should immediately notify the recipients of the potentially affected products by forwarding them a copy of this Recall Notice.

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National Drug Code(NDC)

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Here we are going to review the historic step taken by Trump Administration to lower U.S. prescription drug prices

Proposed rule could allow certain prescription drugs to be imported from Canada; draft guidance explains how manufacturers could import drugs, biological products originally intended for sale in another country

Today, President Trump, along with the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration, issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow for the importation of certain prescription drugs from Canada. In addition, the Administration is announcing the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.
The NPRM issued today is the first step in implementing a provision of federal law that would allow for the importation of certain prescription drugs from Canada under specific conditions that ensure the importation poses no additional risk to the public’s health and safety while achieving a significant reduction in the cost of covered products to the American consumer. The draft guidance issued today describes procedures for a drug manufacturer to submit documentation that demonstrates that the product offered for import from any foreign country is, in fact, an FDA-approved drug product, including that it is manufactured in accordance with the FDA-approved application.

“Today’s announcement outlines two pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients,” said Health and Human Services Secretary Alex Azar. “These are historic actions by HHS and the FDA, and they represent the bold nature of President Trump’s agenda for lowering drug costs. The President has recognized the opportunity to lower costs for American patients through safe importation, and we at HHS and FDA are delivering on that possibility through a safe, commonsense approach.”

The NPRM would allow states and certain other non-federal government entities to submit importation program proposals to the FDA for review and authorization. An importation program could be co-sponsored by a pharmacist, a wholesaler, or another state or non-federal governmental entity. Referred to as Section 804 Importation Programs, these programs would be authorized by the FDA to manage the importation of certain prescription drugs that are approved in Canada and also meet the conditions in an FDA-approved drug application. Eligible prescription drugs would have to be relabeled with the required U.S. labeling prior to importation and undergo testing for authenticity, degradation, and to ensure that the drugs meet established specifications and standards. Notably, these programs would also have to demonstrate significant cost reductions to the American consumer.

“The FDA continues to assess and act on multiple opportunities to promote competition that can, in turn, help reduce drug prices and improve access to medicines for Americans,” said Assistant Secretary for Health Brett Giroir. “The proposed rule and draft guidance include procedures intended to protect the public’s health and safety. We look forward to receiving public comment on these draft policies, and we will take timely comments into account as we work to finalize the rule and guidance. Our ultimate goal is to provide a robust program that clearly lays out procedures to import drugs that could provide lower prices while also maintaining the high quality Americans expect.”

Of note, the draft guidance describes procedures drug manufacturers could follow to obtain an additional National Drug Code (NDC) for certain FDA-approved prescription drugs, including biological products, that were originally manufactured, and intended to be marketed, in a foreign country. The use of an additional NDC would allow greater flexibility for drug companies to offer these products at a lower price than what their current distribution contracts require.

The draft guidance also recommends that the drug manufacturer include a statement on the product’s label and in the prescribing information to assist pharmacists to accurately identify, dispense and bill for these products. Prescription drugs, including biological products, imported under the pathway described in the draft guidance could be available to patients in a variety of settings, including hospitals, health care providers’ offices, or licensed U.S. pharmacies, and would include the FDA-approved labeling (including prescribing information).

Comments on the NPRM are being accepted for 75 days after publication in the Federal Register and comments on the draft guidance are being accepted for 60 days after publication in the Federal Register

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Some Medicines and Driving Don’t Mix

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Here we are going to review on medicines that might affect driving

Although most medications won’t affect your ability to drive, some prescription and nonprescription medicines can have side effects and cause reactions that may make it unsafe to drive, including:

• sleepiness/drowsiness
• blurred vision
• dizziness
• slowed movement
• fainting
• inability to focus or pay attention
• nausea
• excitability

Additionally, we know that CBD can cause sleepiness, sedation and lethargy, based on data from the approved prescription CBD drug. Because of these side effects, consumers should use caution if planning on operating a motor vehicle after consuming any CBD products.

Medicines That Might Affect Driving

Knowing how your medications — or any combination of them — affect your ability to drive is a safety measure. Some drugs that could make it dangerous to drive include:

• opioid pain relievers
• prescription drugs for anxiety (for example, benzodiazepines)
• anti-seizure drugs (antiepileptic drugs)
• antipsychotic drugs
• some antidepressants
• products containing codeine
• some cold remedies and allergy products, such as antihistamines (both prescription and OTC)
• sleeping pills
• muscle relaxants
• medicines that treat or control symptoms of diarrhea
• medicines that treat or prevent symptoms of motion sickness
• diet pills, “stay awake” drugs, and other medications with stimulants (e.g., caffeine, ephedrine, pseudoephedrine)
• Taking Cannabidiol (CBD) Products and Driving Can Be Dangerous

Last year the agency approved a prescription CBD drug, Epidiolex, for the treatment of two rare and life-threatening seizure disorders in children. The FDA has not approved any other CBD products. Unlike drug products approved by the FDA, unapproved CBD drug products have not been subject to any FDA review. 

Moreover, there has been no FDA evaluation regarding whether unapproved CBD drug products are safe and effective to treat a particular disease or condition, what the proper dosage is, how they could interact with other drugs, foods or cosmetics, or whether they have dangerous side effects or other safety concerns.

But we do know that CBD can cause sleepiness, sedation and lethargy, based on data from the approved prescription drug. Because of these side effects, consumers should use caution if planning on operating a motor vehicle after consuming any CBD products.

We urge you to obtain more information about CBD by visiting: What You Need to Know About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD.

Some Sleep Medicines Can Impair You, Even the Next Morning

People with insomnia have trouble falling or staying asleep. Many take medicines to help sleep. Come morning, though, some sleep medicines could make you less able to perform activities for which you must be fully alert, including driving.

A common ingredient in a widely prescribed sleep medication is zolpidem, which belongs to a class of medications called sedative-hypnotics. The FDA has found that medicines containing zolpidem, especially extended release forms, can impair driving ability and other activities the next morning.

Zolpidem immediate and extended-release forms are marketed as generic drugs and under these brand names:

• Ambien and Ambien CR (oral tablet)
• Edluar (tablet placed under the tongue)
• Intermezzo (tablet placed under the tongue)
• Zolpimist (oral spray)

People who take sleep medicines should talk to their health care professional about ways to take the lowest effective dose. Don’t assume that non-prescription sleep medicines are necessarily safer alternatives. The FDA is also evaluating the risk of next-day impairment with other insomnia drugs, both prescription and OTC versions.

Allergy Medicines Can Affect Your Ability to Drive

For allergy sufferers, medications containing antihistamines can help relieve many different types of allergies, including hay fever. But these medicines may interfere with driving and operating heavy machinery (including driving a car).External Link Disclaimer Antihistamines can slow your reaction time, make it hard to focus or think clearly, and may cause mild confusion even if you don’t feel drowsy.

Read the OTC Drug Facts label of your medicine and understand the warnings before using it. Also, avoid drinking alcohol or taking sleep medications while using some antihistamines. Those combinations can increase the sedative effects of antihistamines.

How to Avoid Driving Impaired

You can still drive safely while taking most medications. Talk to your health care provider about possible side effects. For example, some antihistamines and sleep medications work for longer periods than others. You might feel the sedating effects of these medications for some time after you’ve taken them, and maybe even into the next day.

Doctors and pharmacists can tell you about known side effects of medications, including those that interfere with driving. You can also request printed information about the side effects of any new medicine.

To manage or minimize side effects while driving, your health care provider may be able to adjust your dose, adjust the timing of when you take the medicine, or change the medicine to one that causes fewer side effects for you.

Here are some more tips:

• Always follow directions for use and read warnings on medication packaging, or handouts provided by the pharmacy.
• Don’t stop using your medicine unless your prescriber tells you to.
• Tell your health care provider about all the products you are taking, including prescription, OTC, and herbal products. Also, let them know about any reactions you experience.

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FDA Finalizes Rule to Go From Paper to Electronic Devices Submissions

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Here we are going to discuss about the finalised rule for the submission process.

As part of an effort to improve the US Food and Drug Administration’s (FDA) medical device submission process, the agency on Friday issued a final rule to remove the requirements for multiple paper copy submissions and replace them with a single electronic submission.

The agency said the rule, proposed in September 2018 and will take effect in 30 days, is in response to an executive order from the Trump Administration in 2017 made famous as the “one-in, two-out” order. FDA’s rule is meant to improve the device premarket submission program and create a more efficient submission system.

“The requirement for a single submission in electronic format applies to all submission types that fall within the provisions listed in section 745A(b) of the FD&C Act; under this final rule, FDA is only amending those regulations that specifically mention paper and/or multiple copies of such regulatory submissions and are not consistent with this final rule,” FDA said.

The agency responded to four comments on the proposal but did not update the rulemaking. The agency noted that the final rule will produce cost savings for firms without imposing any additional regulatory burdens for submissions or affect the agency’s ability to review submissions.

“Firms will incur minimal administrative costs to read and understand the rule. We expect the economic impact of this regulation to be a total net costs savings yielding positive net benefits,” FDA said.

The agency also noted that submissions in electronic format can include those created and submitted on CD, DVD or flash drive and mailed to FDA.

For premarket approval applications (PMAs), the final rule changes one section to take out a section requiring an applicant to submit three copies of any updated safety and effectiveness report for pending applications.

FDA also previously required that PMAs be submitted in six copies, each bound in one or more numbered volumes, but that language has been removed with this final rule.

In another section, FDA removes the requirement that a PMA applicant has to provide copies of information that it believes to be trade secret or confidential commercial or financial information in the PMA.

FDA in September also published a draft guidance with “both binding and nonbinding provisions”

Please contact FWQRC for electronic submissions. (+91 8072483812)