Antibiotics sales for use in U.S. farm animals dropped in 2016: FDA

CHICAGO (Reuters) – The sale and distribution of antibiotics approved for use in food-producing animals in the United States decreased by 10 percent from 2015 to 2016, a U.S. Food and Drug Administration (FDA) report said on Thursday.

It was the first decline in year-to-year sales since the FDA began collecting the data in 2009, according to food and consumer health groups.

For years scientists have warned that the regular use of antibiotics to promote growth and prevent illness in healthy farm animals fuels dangerous, antibiotic-resistant “superbug” infections in people.Major U.S. food companies including McDonald’s and Tyson Foods have stepped up efforts to curtail, and in some cases eliminate, antibiotics in their products.

“Actions speak louder than words, and the most action we’ve seen on antibiotics has come from food companies,” said Matthew Wellington, Antibiotics Program Director of public interest campaigning group U.S. PIRG. “We’re cheering this good news.”

Last month, the World Health Organization urged farmers to completely stop using antibiotics to enhance growth and prevent disease in healthy animals.

An estimated 70 percent of the kinds of antibiotics that are also used to fight human infections and in surgery are sold in the United States for use in meat production.

In 2016, sales and distribution of those medically important antibiotics for food production fell 14 percent, the FDA said.

Medically important antimicrobials accounted for 60 percent of the domestic sales of all antimicrobials approved for use in farm animals in 2016, the agency said.

The FDA’s data show chicken accounting for 6 percent of medically important antibiotic sales, with swine at 37 percent and cattle at 43 percent.

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3D Printing: FDA Finalizes Guidance for Medical Devices

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The US Food and Drug Administration (FDA) on Monday finalized guidance on medical device additive manufacturing, also known as 3D printing.

The guidance finalizes the draft version from May 2016 and largely keeps intact the recommendations and considerations laid out in the draft.

FDA Commissioner Scott Gottlieb said Monday that the guidance “will help manufacturers bring their innovations to market more efficiently by providing a transparent process for future submissions and [ensures] our regulatory approach is properly tailored to the unique opportunities and challenges posed by this new technology.”

Gottlieb also said that FDA has now reviewed more than 100 3D printed medical device applications, including knee replacements and implants used for facial reconstruction, up from the 85 reviewed at the time the draft was released.

FDA describes the guidance as a “leap-frog” guidance in that it is meant to provide manufacturers about its initial thinking on manufacturing 3D-printed devices and how to characterize and validate such devices. The final guidance also emphasizes that the recommendations made will not be applicable to all 3D-printed devices due to the wide array of available additive manufacturing technologies and materials.

Some changes in the final guidance include new considerations for handling complex design files and cybersecurity considerations for patient-matched devices.

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How to free Indians from the medical poverty trap

India is the largest supplier of generic drugs in the world, and Indian pharmaceutical companies have famously succeeded in pushing down the cost of medication in many countries across the world. Yet, too many Indian citizens do not get access to medicines owing to high costs. The preferred solution of the government right now—price control—is suboptimal.

The problem starts with the thin insurance cover that leads to most patients paying for medical expenses out of their pockets after they have been diagnosed with an ailment. The latest National Sample Survey Office (NSSO) survey on healthcare, in 2014, shows that 86% of the rural population and 82% of the urban population were not covered under any scheme of health expenditure support, and that medicines are a major component of total health expenses—72% in rural areas and 68% in urban areas. Healthcare costs pushed 60 million Indians below the poverty line in 2011. Therefore, even a modest drop in drug prices will free hundreds of households from the widespread phenomenon of a medical poverty trap.

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The government is aware of the problem, which is why it has been fixing the prices of “essential medicines” for some time, and even medical devices such as stents and knee replacement caps from this year. As this newspaper has argued, price controls have their costs. First, investment in price-controlled medicines has fallen vis-a-vis non-price-controlled ones. Second, while stent manufacturers like Abbott have been denied permission to withdraw their high-end stents from the market, it is also unlikely that high-end, innovative products will be introduced in the market if they’re commercially unviable.

Generic medicines are affordable versions of the drug, introduced after a company loses patent over a medicine. These medicines are sold either by their salt-name or by a brand (called branded generics). For example, Crocin is a branded generic whose active ingredient is paracetamol. A study by the Indian Journal Of Pharmacology in 2011 revealed that the price to the retailer for the branded product of cetirizine was 11 times the price of branded generics by the same company—the price of the generic was Rs2.24 per strip of 10 tablets and that of the branded medicine, Rs27.16. These costs reveal the markup that companies charge for the research, reputation and marketing costs of branded medicines. However, doctors continue to prescribe branded medicines for rational reasons.

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The vital area of Pharmaceutical Process Engineering

Pharmaceutical Process Engineering is an often-overlooked area in the field of pharmaceutical manufacturing. It calls for a high degree of precision and coordinates technical expertise and communication between professionals involved at diverse levels of the manufacturing unit, such as pharmaceutical researchers, chemical engineers and industrial. It is concerned with how pharmaceutical development is related to the application of major concepts and important unit operations in the field of pharmaceutical engineering.

Development and adaption of technology is one of the major bottlenecks of pharmaceutical process engineering. The major changes that digitization has brought into areas such as say, education and automobiles are yet to be fully realized in pharmaceutical process engineering. The benefits of digitization are yet to be felt and fully put into use in the crucial areas of pharmaceuticals, such as manufacturing -which, being a high precision area, offers tremendous scope for the use of conceptualizations such as the Internet of Things (IoT)- supply chain management, and Quality Control.

Lack of integration between the core functions and regulatory pressures are often cited as major reasons for which pharmaceutical process engineering is yet to catch up with the drastic changes wrought by technology.

Full understanding of the area of Pharmaceutical Process Engineering

A complete assessment of the present scenario in the pharmaceutical process engineering field, along with the its prospects for the future will be made at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. At this session, Co-founder and CEO of CGMP University Inc. Training and consulting organization and well-known author of several books relating to GMP; David Muchemu, will be the speaker.

Want to understand the importance and the prospects of this very vital area of pharmaceutical process engineering? Then, please register for this webinar by visiting Choosing process variables to control

Preventing flare-up of issues

David will help participants understand how to avoid being in situations where issues arise after scale up. The main reason this happens is that process variables and their parameters are never established based on hard data and engineering realities. David will offer a solution that combines engineering factors and scientific data collected in the lab into process control to counter such problems. He will explain the following major topics relating to these:

o  The process concept

o  Design of Experiment: DOE

o  Choosing process variables to control

o  Process validation

o  Process scale-up

o  Batch reactors

Of high value to professionals in pharmaceutical process engineering, such as Quality Engineers, Manufacturing Engineers and Line Managers; this webinar will cover the following areas:

o  Quality Risk Management Defined

o  Compliance Requirements for Quality Risk Management

o  The Quality Risk Management Model

o  Quality Risk Management Life Cycle.

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Statement from FDA Commissioner Scott Gottlieb, M.D.

As we continue to confront the staggering human and economic toll created by opioid abuse and addiction, we’re focused on taking actions that reduce the scope of new addiction by decreasing unnecessary exposure to opioids. At the same time, we also must take steps to help those with acute and chronic pain who need access to medicines, including opioids, get access to improved alternatives. Until we’re able to find new non-opioid forms of pain management for those who need treatment for pain, it’s critical that we also continue to promote the development of opioids that are harder to manipulate and abuse, and take steps to encourage their use over opioids that don’t offer any form of abuse deterrence.

Opioids with abuse-deterrent formulations (ADFs) are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding. To date, the U.S. Food and Drug Administration has approved 10 opioid drugs with these properties. But their uptake has been slow among doctors who are treating patients in pain. The reason for their more limited use is likely multifold. We know there can be a learning curve that comes with new technologies. Some prescribers may not be aware of the existence of these drugs, or may be uncertain of when to prescribe the abuse-deterrent versions. But we also know a significant barrier to use can be price. Because these new formulations are currently only available as brand-name products, they’re inherently more expensive than the numerous non-abuse deterrent formulations that are also available in generic formulations.

Transitioning from the current market, dominated by conventional opioids, to one in which most opioids have abuse-deterrent properties, holds significant promise for a meaningful public health benefit. But to transition this market more quickly to the ADFs, and consider permanently withdrawing the older formulations that lack abuse-deterrent features in the event these products were judged to be less safe ‒ there are a number of factors we must consider. One of the factors that the FDA would consider relates to generic access. We must have the potential to improve access to the newer formulations, for appropriately selected and monitored patients, through the introduction of generic competitors.

In order to support this transition and encourage advancements in this area, today the FDA issued a final guidance to assist industry in their development of generic versions of approved ADF opioids. This guidance includes new recommendations about the type of studies companies should conduct to demonstrate that the generic drug is no less abuse-deterrent than its brand-name counterpart. We’re also taking additional steps beyond the new guidance to help developers of generic ADFs navigate the regulatory path to market as quickly as possible and make the review process more efficient and predictable. For example, we’re developing appropriate, improved testing methodologies for evaluating complex features like abuse deterrence for both brand name (innovator) and generic opioid drug products. In addition, we’re also taking a flexible, adaptive approach to the evaluation and labeling of ADF opioids.

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The role of Quality Agreements in Contract Manufacturing Organizations (CMO)

The role of contract manufacturing in the pharmaceutical and life sciences industries cannot be overlooked. It has gained favor with organizations in these industries, as it allows them the luxury of outsourcing their processes relating to manufacturing or other activities to a third party, saving them costs and hassles in the short and long terms. Entrusting their processes to Contract Manufacturing Organizations (CMO’s) enables them to concentrate on their core activities such as research and new drug discovery.

With the global economy more open than it perhaps has been at any other point of time in history, and with almost no economy of any country being isolated from the forces of globalization; CMO’s are a very viable option for pharmaceutical and related companies. As long ago as 2010; the global CMO size was put at over $26 billion, with a healthy CAGR of over 10 percent. With the global pharma market having crossed a trillion dollars in 2015; there is heavy optimism for the growth of CMO in the coming years.

While these figures look encouraging; a whole lot of issues need to be considered before embarking on contract manufacturing. The most important of these is quality. Ensuring that the supplier maintains the high quality standards set out by the contracting company is a major challenge for the client company.

The Quality Agreement

Quality Agreements are a very strong tool in addressing this issue. A Quality Agreement is a contract reached between a pharmaceutical firm and a GMP Contract Manufacturer, in which the responsibilities each of these parties has towards assuring the quality, safety and efficacy of the manufactured drug, are spelt out in detailed and clear terms. This is the only real means to ensure oversight of the processes and the quality of the products. Ensuring that they comply with the GMP regulations is at the core of these requirements and expectations.

How do contracting pharmaceutical and life sciences firms draft Quality Agreements that comply with the regulatory requirements and ensure the quality of products from the supplier? What are the elements of a Quality Agreement? What due diligence and scrutiny does the contracting organization need to keep in mind when drafting a Quality Agreement?

Complete learning on all aspects of the Quality Agreement

The nitty-gritty of these elements will be taught at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. This webinar’s speaker, Roger Cowan, is the founder and owner of R Cowan Consulting Services LLC, a consulting company specializing primarily in the area of pharmaceutical contract manufacturing. The experience he has gained in the industry after having worked in it for 37 years will be in full flow at this webinar.

Please register for this webinar by visiting Contract Manufacturing Arrangements for Drugs

In-depth look at the two recent FDA and EU guidelines

Roger will explain the dynamics of a CMO Quality Agreement at this webinar. He will discuss the two recent regulatory guidelines: the EU GMP Chapter 7 “Outsourced Activities” (Revised) issued by the EU, and the Draft Guidance for Industry – “Contract Manufacturing Arrangements for Drugs: Quality Agreements”, which was issued by the FDA in May 2013. These two guidelines are important from the CMO perspective, as they offer greater depth of understanding and clarity on quality contracts.

Roger will explain what aspects of Quality Agreements need to be taken care of from a regulatory perspective. Both the FDA and the EU have laid sufficient emphasis on the control of suppliers such as CMO’s. It is expected that these new these new regulatory documents will introduce written documentation of this control. Evidence of this kind of control can be presented to FDA/EU inspectors in the form of a Quality Agreement which is specific to a particular CMO.

Writing a Quality Agreement in line with the new guidelines

The speaker will help participants gain a thorough understanding of the Quality Agreement by fully analyzing each proposed section. He will suggest how to write it keeping the new guidelines in mind. He will also detail the comparisons between the two regulatory documents and will highlight their differences. Topics of critical importance in the Quality Agreement, such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc., will be examined. He will also present an analysis of the current status of the FDA draft guidance and will review the comments that this guidance has received from the industry.

Roger will cover the following areas at this session:

o  The Who and What of a good Quality Agreement

o  What a Quality Agreement is – and is not

o  Responsibilities of the owner vs. contract facility

o  GMP responsibilities

o  A comparison of the new guidelines from the FDA and the EU.

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The AAMI TIR 45 is invaluable in helping adapt Agile methods for medical device software

A report from the Association for the Advancement of Medical Instrumentation, namely, AAMI TIR 45, offers recommendations for how to comply with both international standards and guidance documents from the FDA when it comes to Agile practices for developing medical device software.

The AAMI TIR 45 is an attempt to align and synchronize Agile’s values, goals, principles and practices to medical device software development. It shows the ways of doing this. It seeks to remove the many misconceptions and myths surrounding the suitability and adaptability of Agile to medical device software and explains how to apply Agile methods for meeting the Quality System requirements set out for medical device software.

AAMI TIR 45 has been set out to help manufacturers of medical device software reap the benefits that Agile provides, while staying compliant with the regulatory expectations and requirements.

The AAMI TIR 45 was created because of the value that Agile can bring to medical device software. One of the reasons for which Agile was developed was to address concerns relating to the quality and efficiency present in the methods of software development that existed then. When its core features are adapted to the medical device software field, it brings enormous benefits, some of which include:

–       It allows for continuous and persistent focus on risk management, safety and delivering customer value through its method of prioritizing backlog work, and practices relating to planning and customer feedback

–       It uses continuous integration and testing to continuously and consistently assess quality

–       Through its methods of retrospective action and accountability; Agile brings in continuous improvement into the process of software development

–       By focusing on getting things done one stage at a time and thus ensuring timely and incremental completion of work and deliverables; Agile satisfies the demands and needs of the medical device company’s stakeholders in the management and quality areas.

A few reservations

Many experts in both medical device software and Agile fields have expressed reservations about the suitability that Agile has in an extremely stringently regulated area such as medical device software. They refer to the Agile Manifesto, which seems to contain value statements that seemingly contradict the values at the core of a Quality Management System.

They also draw attention to the fact that as Agile evolved at a time when there was no criticality attached to risk management and human safety; the controls needed for producing software to which safety is critical have not been embedded into Agile.

Requires proper understanding and implementation

These points notwithstanding; Agile comes with a fundamental adaptability to the context it is applied in. Implementing Agile principles and practices in a proper way makes it more than adequate in an area like medical device software, where safety is critical. It is perfectly well-suited to accomplishing the lifecycle steps prescribed in IEC 62304 and risk management under ISO 14971. It can also help achieve usability design as required under IEC 62366

A learning session on the AAMI TIR 45

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer thorough clarity on the area of the suitability of the Agile to medical device software. The speaker at this session, Brian Shoemaker, will unravel the elements of AAMI TIR 45 and explain how it can be applied to medical device software smoothly and effectively in a manner that meets regulatory requirements.

Please visit Agile Meets Software Standards to register for this webinar and derive the benefit of understanding how to apply Agile principles to medical device software.

At this webinar, Brian will help understand how the AAMI TIR 45 can be the ideal roadmap for facilitating and bettering development, which benefits everyone concerned, be they development teams, companies, patients, caregivers, or regulators.

He will put this in perspective by explaining the following topics:

o  Convergence: Agile principles and regulatory needs

o  Lifecycle: incremental development, design reviews, documentation

o  Key practices: planning, collective effort, product definition

o  Implementation: evolving architecture, emergent design, continuous testing, traceability

o  Managing your software: release, configuration management, third-party software, and CAPA

Brian will cover the following areas at this webinar:

o  TIR 45 comes at a much-needed time

o  TIR 45 stitches together the important high-level concepts

o  TIR 45 outlines key practices that are needed for flexibility and quality

o  Implementation issues are not ignored

o  This TIR is actually just a starting point.

For more updates and articles AAMI TIR 45