FDA Final Guidance for [Industry]

If a firm disseminates HCEI to this audience, FDA does not intend to consider such information false or misleading.

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FDA recently announced the availability of an important guidance for industry. The document, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers,” updates an Obama era-draft that outlines how companies can communicate off-label health care economic information about their products to drug purchasers like a health plan or a hospital.

Guidance

The guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities–Questions and Answers,” provides answers to common questions regarding firms’ communications of HCEI (healthcare economic information) about their approved prescription drugs to payors. The guidance also provides answers to common questions regarding firms’ communications of HCEI about their approved or cleared medical devices to payors. In addition, the guidance addresses common questions relating to firms’ dissemination to payors of information about medical products that are not yet approved or cleared for any use and about unapproved uses of approved/cleared medical products.

There are two changes of note in the document. First, the guidance is expanded and includes medical devices along with drugs. Additionally, the guidance applies to communication about unapproved products or unapproved uses of already clearly drugs or devices.

According to FDA Commissioner Scott Gottlieb: “Taking into consideration the many thoughtful comments from stakeholders on our draft guidance, our final guidance now includes recommendations that are designed to enable truthful, non-misleading and appropriate company communications with insurers across a product’s lifecycle. The goal is to advance public health benefits such as increased cost savings from informed and appropriate coverage and reimbursement decisions. In this way, we can help ensure patients have more timely access to cutting-edge medical technologies. We can facilitate access by helping to reduce the overall cost of providing these benefits to patients. And in promoting access, we will advance important public health goals.”

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The guidance specifically addresses how the FDA intends to implement its language for HCEI disseminated in accordance with section 502(a) of the FD&C Act. In particular, FDA notes that an appropriate audience under this section of the law is HCEI that relates to an approved indication and is based on competent and reliable scientific evidence. If a firm disseminates HCEI to this audience, FDA does not intend to consider such information false or misleading.

Furthermore, HCEI should clearly and prominently present the information discussed in the guidance, including study design and methodology, generalizability, limitations, sensitivity analyses, and information relevant to providing a balanced and complete presentation. If HCEI includes material differences from the FDA approved labeling (e.g., new or increased risks, different dosing/use regimens, different endpoints, more-limited/targeted patient populations), it must present “a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug”.

You Can Check the Restaurant’s FDA Rating on Hygiene!

The aim is to reduce the incidence of food-borne illnesses and associated costs to the economy.

In the first phase, the FDA carried out the rating for 30 restaurants. These included 15 in Mumbai, 10 in Pune and five in Nagpur, which got their star ratings at a public function by officials on Thursday.

Pallavi Darade, Commissioner, FDA, spoke to The Times of India, highlighting the purpose of the unique rating system.

She said, “The food hygiene rating given will reflect our inspection findings. The purpose of this scheme is to allow consumers to make informed choices about the places where they eat out. The aim is to reduce the incidence of food-borne illnesses and associated costs to the economy.”

So how does this system help you and me? Let’s find out!

  • The restaurants will have to complete an online self-assessment for hygiene, which would be later followed by FDA inspectors inspecting the restaurants.
  • The parameters that these restaurants will be rated on include cleanliness, design and facilities, availability of water and soap, non-toxic fittings, walls free of flakes, window nets, sufficient light and air, food thawed hygienically, proper reheating, use of good oil etc.
  • The FDA will also use a scoring system to rate how well a food business is run. While the best restaurant will get five stars, the worst will get none.
  • Another unique way these assessments will benefit restaurants is the opportunity to earn a tag that identifies them as a “responsible place to eat”. The only way to be rated on this parameter is if the staff maintains hygiene and undergoes periodic health checks, every six months.
  • The staff will also have to ensure that the surplus food at the restaurant is not wasted but donated and that their beverages are made in potable water, and cooking methods are hygienic.
  • These eateries and joints will also be rated on the advice they give out to customers, whether it is about maintaining a balanced diet or minimising their sugar and salt intake. They can create awareness through posters, display screen, menu etc.
  • Restaurants will also receive brownie points if their kitchens are open to consumers who want to check if the food handlers and cooks wear protective gear.
  • Eateries that have an effective consumer redressal mechanism in place including WhatsApp numbers and emails will be considered too.
  • These are some of the 20 parameters that will be used to examine restaurants.

 

Food Fraud in the Organic Industry

Organic food fraud and prevent potential pesticide cross contamination from previously carried loads.

A recent admission by The U.S. Department of Agriculture’s Office of the Inspector General of its failure to review required documents for products labeled as “organic” indicates a lack of controls at U.S. borders, increasing the likelihood of nonorganic products entering the U.S. under false “organic” labels.

This opens the floodgates for the entry of dubious products into the market and getting passed off as organic, without being that. In fact, many imported products that carry the organic label are not only completely non-organic; they contain GMO and pesticides.

There is no guarantee that those who consume what are labeled as organic food are consuming food that is free of adulteration by pesticides, cross contaminants, and other hazards. This, despite the establishment in 2002 of the National Organic Program (NOP) standards, which prohibit the use of sewage sludge, GMO, ionizing radiation, synthetic pesticides, synthetic fertilizers, antibiotics, growth hormones, artificial preservatives, flavors, and dyes, and cover specific labeling rules or products labeled as organic.

Whopping food fraud costs

Globally, food fraud losses are put at between $10 and $15 billion a year. As thousands of U.S. companies buy, process and sell organic products and with the organic food industry expanding in a big way by the day; there is a pressing need to protect the consumer, the industry and brand identity investment and curb pricing variations and food fraud. With organic sales jumping 23% in 2016 according to a report from Packer; the need for stopping fraudulent practices is greater than ever before.

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One of the actions taken by The US Department of Agriculture is punishing violating companies with fines up to $11,000 and encouraging reporting complaints. The USDA also lists fraudulent organic certificates and all companies legally certified as organic. There is an urgent need for food companies to review and develop new tools and technology designed to provide data that tracks and traces organic product through all processes in order to build a preventive supply chain.

Learning on how to handle organic food fraud

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will explain these aspects in detail and will show what steps a food industry company can take to handle organic food fraud and prevent potential pesticide cross contamination from previously carried loads.

John Ryan, a highly regarded senior Quality professional, whose quality system career has spanned the manufacturing, food, transportation and Internet industries over the past 30 years, will be the speaker at this webinar. Dr. Ryan brings the rich experience of working and living extensively throughout Asia and the U.S. at the corporate and facility levels for large and small companies as a turn-around specialist. His company, Ryan Systems, works with some of the world’s leading equipment, hardware, software, training and integration companies in the business.

Please visit http://bit.ly/2JdiRHi to enroll for this valuable session.

At this webinar, Dr. Ryan will cover the following areas:

  • NOP Standards
  • Verifying the Source Organic Food Shipments
  • Controls Over Transportation of Fresh Organic Foods
    • Cross Contaminants – Sanitation Specifications
    • Procedures and Controls
    • Control over Previous Loads
    • Lack of Border Controls
    • Temperature Controls
    • Inspection
    • Food Security
    • Farmers’ Markets
  • A tracking solution that allows shippers, carriers and receivers to record and review data focused on
    • Tracking organic shipments from the source
    • Checking the shipment source against the NOP approved data base
    • Checking to assure the container or trailer for organic shipment has been cleaned according to shipper/receiver specific requirements
    • Assuring the container has been properly sealed
    • Assuring the temperature has been maintained throughout all shipment handoffs
    • Verifying conditions at the receiving end
    • Maintaining a complete record of all transactions
  • The NOP site to help you assure you are dealing with organic certified suppliers.

Food Safety and Quality in Home Food Delivery

Food suppliers have to take a relook at their strategy if they have to gain a reputation in the market as providers of hygiene.

Among the many conveniences that technology has ushered into our lives is the facility of ordering food online and eating whenever we want to, instead of having to necessarily visit hotels or restaurants. Coupled with another recent phenomenon that has changed our lives forever-globalization-the home delivery market is growing at a terrific rate. It is pegged at between $45 and $50 billion annually, and is expected to grow at a rate of more than 50% by 2022.

This huge industry, part of the wider and bigger food supply chain industry, which involves many players and activities in meeting its demand; is often characterized by ignorance about the most vital aspect of food: hygiene. This is an industry, like say, healthcare, whose efficiency depends more on the last mile provider, than on planners and high-level managers and strategists. It is this foot soldier on whom the industry actually runs, in a sense. Yet, the home food delivery market is characterized by a shocking lack of knowledge about food hygiene on the part of these delivery personnel. If this is the story of a hygiene-obsessed country such as the US; one can imagine how appalling the situation must be globally.

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One can attribute a twofold reason for this situation: the diverse and fragmented nature of the food delivery business, and the near total absence of regulation in it. It is thus an irony of the food delivery business that while the business continues to grow in terms of attractive numbers; the core aspect of food delivery, cleanliness, continues to suffer.

Regulatory controls lack teeth

Many consequences result from the lack of hygiene standards. Lack of hygiene affects products of daily use, such as poultry products, meat and other related foods. Consumers, most of whom are in the productive age group, fall sick often. When this happens, the economy’s productivity levels drop. Plus, it puts a heavy burden on the already overstretched healthcare sector.

There is the existence of a law on food safety: the FDA’s Food Safety Modernization Act (FSMA), which has rules relating to areas of the food supply chain such as distribution from the point of produce, documentation -especially for imported and exportable items- and supply chains. This fact notwithstanding, the FSMA is not potent or comprehensive enough to ensure hygiene at the critical source at which food is most vulnerable: the last mile supplier, or the food delivery point.

Get to understand the elements of food delivery hygiene

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering a course in which the core areas of safety and sanitation aspects of home food delivery will be explained. Dr. John Ryan, a highly acclaimed expert on food safety, will be the speaker at this very high value webinar. Dr. Ryan is the Founder of John Ryan Systems, which he founded after gaining expertise in all the areas of the food safety industry for three decades, during which he worked in sectors such as manufacturing, food, transportation and Internet industries.

Please log on to http://bit.ly/2HxZTdK to enroll for this webinar and to gain insights into Dr. Ryan’s vast knowledge of the food supply industry.

Understanding the reasons for which food gets harmed

The ambit of this webinar is an explanation of the vulnerabilities that food in the food home delivery industry is exposed to. Dr. Ryan will explain the regulations that need to be complied with to ensure the safety of food, as well as the consequences of lack of compliance. Complying with regulations apart, food suppliers have to be more knowledgeable about how activities on their part can prevent disease outbreaks. Food suppliers have to take a relook at their strategy if they have to gain a reputation in the market as providers of hygiene. This is one of the major discussions of this webinar.

Dr. Ryan will explain how food supply companies that seek to get away from the reach of the law by deceptive and escapist recourses such as disclaimers can be hauled up.

food

At this webinar, Dr. Ryan will cover the following areas:

  • The issues of food safety and quality
  • Basic food sanitation and temperature controls
  • Appropriate dunnage
  • Evolving home food delivery Technology
  • Types of foods in the home food delivery market
  • Ordering models
  • Recall requirements
  • Integrated Online Ordering Companies
  • Call in or online orders
  • Some of the industry players.

When coliform bacteria are detected in drinking water

The feces of humans as well as other warm-blooded animals are a source of these bacteria. Coliforms are primarily used as a method for indicating water quality.

For over a hundred years, the western world has used coliform as a method of testing water contamination. A quick understanding of this method of testing the level of water contamination:

Coliforms belong to a broad class of bacteria. These bacteria are found freely in our environment. The feces of humans as well as other warm-blooded animals are a source of these bacteria. Coliforms are primarily used as a method for indicating water quality. When coliform bacteria are detected in drinking water; it may be indicative of the potential presence of other harmful, disease-causing organisms. The belief is that wherever coliform bacteria are present, there are chances that other more harmful bacteria could reside with them.

coliform

Used as a first step

Pathogens, or disease causing organisms -namely virus, bacteria and protozoa -have to be eliminated from water, or they could cause a range of waterborne diseases such as dysentery, hepatitis, and giardiasis and related ones.

Since it is difficult to physically test every sample of water for specific harm-causing bacteria, protozoa and viruses, testing water for coliform is considered. This makes sense, because it is easier to further test samples that have coliform than to test every sample.

Laboratories have been adapting this method because this is relatively much, much less expensive and less time consuming to implement this method rather than look for every specific pathogen.

Moreover, most laboratories are ill equipped to handle mass testing of huge samples of water. Coliform as a method of testing water contamination is thus a useful tool, because it prevents the incurrence of huge expenses.

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Effectiveness of coliform as a method of testing water contaminationThe practical advantages of using coliform as a method of testing water contamination notwithstanding; its effectiveness is open to debate. Some scientists believe that this method is too antiquated. Later methods have been proven to be more effective methods. The Environmental Protection Agency (EPA) for instance, draws up plans for containing water contamination from time to time. Using coliform as a method of testing water contamination is just one small part of these. The agency looks more to methods such as addressing contaminants as groups, which is believed to be more effective. It encourages the development of new technologies that tackle contaminants better, faster and more economically.

However, it is too early to say if these developments will signal the discontinuation of using coliform as a method of testing water contamination in the near future.

Irish shopping basket contains 45.9% ultra-processed foods.

The food industry has been “very clever at making food actively less satiating.

Future generations will look at today’s food consumption in the same way we view sending children up chimneys, obesity expert Prof Donal O’Shea has said. “Wind on 50 years and people will look back on current consumption and say, ‘really?’”

O’Shea, consultant endocrinologist at St Vincent’s Hospital, was responding to a recent study ranking Ireland third highest in the consumption of ultra-processed foods among 19 European countries. The study in the Journal of Public Health Nutrition said the Irish shopping basket contained 45.9 per cent ultra processed foods, making Ireland the third highest consumer after Britain (50.7 per cent) and Germany (46.2 per cent). Portugal and Italy had the lowest consumption levels at 10.2 per cent and 13.4 per cent respectively.

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“Historically, Ireland has a very poor system of regulating the kind of foods that are marketed and the food industry is doing huge amounts of work marketing these hyper-convenient foods,” O’Shea said.

Our embracing of ultra-processed foods like cereals, sugary and savoury snacks, highly processed bread and ready meals and sauces, was down to “something in the Irish psyche”, he said. “We see it in our pattern of drinking, especially in our young people. We’re very much an all or nothing society.”

These foods were incredibly attractive from a food producer point of view, O’Shea said. “Darina Allen has this lovely phrase and I’ve used it in talks. She says: ‘when you go to the supermarket buy food, not ‘food-like products.’” Highly processed foods are calorie dense but not filling, he said. The food industry has been “very clever at making food actively less satiating. The less satiating the better because then you grow your market.”

‘Bliss points’

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Food scientists had actively worked out “bliss points in terms of taste according to age, so it’s different for a three-year-old, an eight-year-old or a 50-year-old. This is not paranoia speaking on my part. It’s what they do. It’s what they have to do.”

He also said the food industry was “running amok” on social media aimed at young people “actively targeting ultra processed top shelf foods through social media,” an area that is “completely without regulation.”

Asked if the authors were overstating the damaging health effects of ultra processed foods he said the main problem with these foods was how full you felt after eating them.

“It is about total energy in and total energy out. If you get 150 kilocalories from an ultra processed food and 150 kilocalories from an apple and half a banana there is no difference to the effect on weight or your metabolic health. However an hour after eating your highly processed food you will need to have something else to eat, compared to two and a half hours after your banana and apple.”

O’Shea said the Government’s obesity policy action plan implementation group could look at calling for the reformulation of food products. We need “clearer language,” he said. Highly processed brown bread should be called “brown coloured bread,” he said to differentiate it from wholemeal brown soda bread. A socio-economic gulf was widening where the “better off and better educated are getting healthier,” while the worse off and poorly educated are becoming less healthy.

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ABP Food Group hosts Sustainability Best Practice event

It recognises good management and year-on-year improvements in sustainability performance.

ABP Food Group recently hosted a best practice Sustainability Summit for its beef and lamb sites. The aim of the event was to showcase and share examples of best practice and expertise from within the Group. All 120 attendees were encouraged to adopt innovations from other ABP Group locations across Ireland and the UK, and integrate to their local site. The bi-annual event, which took place in Dublin, has played a key part in ABP reaching many of its 2020 targets ahead of time.

Commenting at the event, Dean Holroyd, ABP’s Technical and Sustainability Director said: “This is an invaluable opportunity for the wider ABP team to share and learn. At the moment hundreds of innovative sustainability initiatives are taking place across all of our sites in Ireland and the United Kingdom, so it is important that all ABP sites benefit from these.

Today builds on the success of our 2015 event where 50 new sustainability projects were adopted and implemented, contributing significantly to progress against our 2020 targets.”

ABP Food Group is a founding member of Origin Green. Earlier this year the company became the first organisation globally to achieve Carbon Trust Triple Certification for the third time in a row.

The Carbon Trust Standard is the world’s leading independent certification awarded to organisations that can demonstrate they are taking effective action to tackle their environmental impact, verifying reductions in carbon emissions, water use and waste output.

It recognises good management and year-on-year improvements in sustainability performance.

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