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FDA: Mitigation Strategies to Protect Food Against Intentional Adulteration

FDA

FDA takes new steps to protect food products from deliberate attacks

March 5, 2019

Media Inquiries

  Lindsay Haake
  301-796-3007

“The U.S. has one of the safest food supplies in the world. However, to keep it safe we must recognize that our foods can be vulnerable – not just from unintended contamination, but from those who would do us harm. We’ve taken steps to minimize the risk of an intentional attack on our food supply, and today we’re advancing new steps to help manufacturers implement additional activities that can help identify and mitigate the risk of intentional food adulteration. To secure these goals, in 2016 we put forth a rule outlining smart, risk-based steps food production facilities must implement to help protect our foods from acts of intentional adulteration. This is a serious issue that warrants serious attention and is why today we’re taking some additional steps to help ensure food facilities will implement the rule as effectively as possible,” said FDA Commissioner Scott Gottlieb, M.D. “When it comes to modernizing our approach to food safety, our core aim is to shift the FDA’s focus from reacting to food safety problems to preventing them from occurring in the first place. To help secure this goal when it comes to the risk of intentional adulteration and acts of terrorism, today we’re providing additional draft guidance to help producers implement the rule’s protective standards, identify their biggest risks, and mitigate these risks from those who might try to use food products to cause deliberate harm to American consumers.”

The U.S. Food and Drug Administration today released a revised draft guidance, “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry,” to support compliance with the intentional adulteration (IA) rule set forth under the FDA Food Safety Modernization Act (FSMA).

The IA rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause widespread harm to public health. Unlike the other FSMA rules that address specific foods or hazards, the IA rule requires certain facilities – both domestic facilities and foreign facilities that export to the U.S. – to develop and implement food defense plans that assesses their potential vulnerabilities to such acts of deliberate contamination.

The draft guidance issued today outlines two, flexible methods for how facilities can conduct vulnerability assessments to identify their areas of highest risk and provides information about requirements for education and training. This installment of the draft guidance includes all of the information in the first installment, including information on the Key Activity Type method to conduct vulnerability assessments, mitigation strategies, and food defense monitoring procedures, released in June 2018.

In the near future, the FDA also intends to provide a third installment of this draft guidance that will include additional information on corrective actions, verification, records maintenance, reanalysis requirements, and how to calculate small and very small business sizes in order to determine what requirements of the rule are applicable. When finalized, this draft guidance is intended to be a resource that will help the food industry implement the IA rule’s provisions in a flexible and cost-effective manner. For more information on this guidance, as well as instructions on how to submit comments, please visit FDA.gov.

FDA

March 2019

Contains Nonbinding Recommendations

Draft-Not for Implementation

The FDA Food Safety Modernization Act (FSMA) added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) several new sections that reference intentional adulteration.  For example, section 418 of the FD&C Act (21 U.S.C. 350g) addresses intentional adulteration in the context of facilities that manufacture, process, pack, or hold food, and that are required to register under section 415 (21 U.S.C. 350d).  Section 420 of the FD&C Act (21 U.S.C. 350i) addresses intentional adulteration in the context of high-risk foods and exempts farms except for farms that produce milk [2].

We implemented these intentional adulteration provisions through a rule entitled “Mitigation Strategies to Protect Food Against Intentional Adulteration” (IA rule).We published the final rule in the Federal Register of May 27, 2016.  (81 FR 34166).

The rule, which includes the requirements for food defense measures against intentional adulteration, and related requirements, can be found in 21 CFR part 121, as shown in Table 1.

Table 1. Subparts Established in 21 CFR Part 121

 Subpart  Title
 A  General Provisions
 B  Reserved
 C  Food Defense Measures
 D  Requirements Applying to Records That Must Be Established and Maintained
 E  Compliance

As shown in Table 2 below, the amount of time we are allowing you to comply with the IA rule depends on your particular business.

Table 2. Compliance Dates for IA Rule Based on Size of Business

 Size of Business  Compliance Date
 Very Small  July 26, 2021
 Small  July 27, 2020
 Other businesses that do not qualify for exemptions  July 26, 2019

The IA rule applies to the owner, operator, or agent in charge of a domestic or foreign food facility that manufactures/processes, packs, or holds food for consumption in the United States and is required to register under section 415 of the FD&C Act, unless one of the exemptions provided in 21 CFR 121.5 applies.  (21 CFR 121.1).

Acts of intentional adulteration may take several forms: acts intended to cause wide scale public health harm, such as acts of terrorism focused on the food supply; acts of disgruntled employees, consumers, or competitors; and economically motivated adulteration (EMA).  Acts intended to cause wide scale public health harm are associated with intent to cause significant human morbidity and mortality. The other forms are typically not intended to cause wide scale public health harm, although some public health harm may occur because of the adulteration.  For example, acts of disgruntled employees, consumers, and competitors are generally intended to attack the reputation of a company, and EMA is intended to obtain economic gain.  In the spectrum of risk associated with intentional adulteration of food, attacks intended to cause wide scale public health harm to humans are ranked as the highest risk.  Therefore, the IA rule is focused on addressing those acts and not acts of disgruntled employees, consumers, or competitors, or acts of EMA [3].

This document is directed to those persons who are subject to the Intentional Adulteration (IA) requirements of 21 CFR part 121 (you).  Identifying significant vulnerabilities at your facility and implementing mitigation strategies and mitigation strategy management components enables you to apply a proactive and systematic approach to your food defense program to protect your food from intentional adulteration intended to cause wide scale public health harm.

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

Download the Draft Guidance for Industry

[1] This guidance has been prepared by the Office of Analytics and Outreach, Food Defense and Emergency Coordination Staff, in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.

[2] The IA rule did not include any requirements for farms that produce milk. As such, farms that produce milk are not covered under this draft guidance.

[3] As we noted in the final rule, the protections required by the rule will help minimize the likelihood of success of a disgruntled employee, consumer, or competitor who attempts an act of intentional adulteration at an actionable process step—even if that act is not intended to cause wide scale public health harm. (81 FR at 34183).


FDA’s Critical Role in Ensuring Supply of Influenza Vaccine

FDA

The flu vaccine you get at your doctor’s office or pharmacy is the year-round work of highly skilled microbiologists, epidemiologists, physicians and other public health experts.

Sound complicated? It is.

The U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS) are working toward developing new and better technologies for producing flu vaccines. As new strains of flu viruses emerge, the FDA works in close coordination with sister agencies, such as the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH), encouraging manufacturers to develop vaccines that will successfully protect us from influenza disease, which can be a very serious illness.

The more diverse the influenza vaccine supply, the better we can respond to flu public health emergencies in a timely manner. All U.S. licensed flu vaccines have been evaluated and determined to be safe and effective by the FDA.

There is often more than one type of influenza virus circulating each season, so influenza vaccines are formulated to target three or four of the most likely influenza viruses of the season: two influenza A types (H1N1 and H3N2) and one (trivalent vaccine formulation) or two (quadrivalent vaccine formulation) types of influenza B.

Influenza Vaccines and How They Are Made

Influenza (flu) vaccine works by triggering your immune system to produce antibodies that help the body prevent the flu.

Most of the U.S. influenza vaccine supply is made using an egg-based production process. In this method of making influenza vaccines, manufacturers use fertilized eggs to grow flu viruses. After about six months of laboratory work and manufacturing, those viruses are incorporated into that season’s flu vaccine. While this method produces safe and effective vaccines, FDA, HHS, and manufacturers have been working on different technologies to increase the influenza vaccine supply, making sure to still maintain safety and effectiveness. Some technologies have the potential to produce these vaccines faster and less labor-intensively.

For example, more recent approvals include influenza vaccines that do not use an egg-based production process for manufacturing. In addition, quadrivalent vaccines, which protect against two influenza A strains and two influenza B strains, have been available for several years. Quadrivalent vaccines provide protection against the two lineages of influenza B strains, both of which circulate each flu season. This is important, particularly for preschool and school-age children who get Influenza B more often than adults do. Influenza B also causes more complications and fatalities in children than adults.

In addition, the FDA has approved a high-dose and an adjuvanted vaccine specifically for people ages 65 and older, who typically bear the greatest burden of severe influenza disease and account for most of influenza-related hospitalizations and deaths. Adjuvants are incorporated into some vaccine formulations to enhance the immune response of the vaccinated individual.

Making the Flu Vaccine: A Year-Round Effort

The job of producing a new vaccine for the next flu season starts well before the current flu season ends. For the FDA, it’s a year-round initiative.

The composition of vaccines for the prevention of other infectious diseases stays the same year after year. In contrast, flu viruses are constantly evolving. And the flu viruses that circulate causing disease in people, often change from one year to another. So, every year, there is a need for a new flu vaccine. To that end, FDA, World Health Organization (WHO), CDC, and other partners collaborate by collecting and reviewing data on the circulating strains of influenza from around the world to identify those likely to cause the most illness in the upcoming flu season.

In late February/early March — well before the new flu season begins — an FDA advisory committee reviews data about which flu viruses have caused disease in the past year, how the viruses are changing, and disease trends so they can recommend the three or four flu strains to include in the trivalent and quadrivalent influenza vaccines for the U.S in the upcoming flu season.

Once the strains are selected, vaccine manufacturers begin the manufacturing process to include the newly selected flu strains in their FDA-approved vaccines. The different flu virus strains are combined to formulate the vaccine into standard dosages. The vaccine is then filled into vials, syringes and, for the nasal vaccine, sprayers. Both egg-based and non-egg-based manufacturing methods for FDA-approved flu vaccines require high-tech processes and manufacturing facilities that have been inspected by the FDA. Vaccine manufacturers must submit applications to the FDA to include the new flu strains in their FDA-approved vaccines.

In its own laboratories, the FDA also produces materials that are critical for making the vaccine. These include generating candidate vaccine virus strains suitable for further vaccine manufacture and producing the critical potency reagents, which are materials needed to test the vaccines for potency and identity (to ensure standardization) before the FDA approves the new formulation of the approved seasonal influenza vaccines for U.S. distribution.

The FDA is also responsible for ensuring that released lots of influenza vaccines meet appropriate standards. Each vaccine undergoes quality control tests, including testing for sterility. Manufacturers submit the results of their testing, along with sample vials from each lot to the FDA for “lot release.” The FDA typically begins releasing lots of flu vaccines in late summer. Lot release can continue into early fall. Once lots are released, manufacturers distribute the vaccine throughout the United States for use by the public.

Flu seasons and severity are unpredictable. Annual vaccination is the best way to prevent the flu for people ages 6 months and older.

An annual immunization with flu vaccine is the most effective and safest way for most of us to reduce our risk of getting the flu and spreading it to others. When more people get vaccinated, it is less likely that the flu viruses will spread through a community, making us all healthier.

Updated: March 1, 2019


Summary of Process for Emergency Use Authorization (EUA) Issuance

The flow chart below provides a summary of the process for Emergency Use Authorization (EUA) issuance.

Flow chart providing a summary of the process for Emergency Use Authorization (EUA)

 

Description of chart:

Issuance of an EUA by the FDA Commissioner requires several steps under section 564 of the FD&C Act. First, one of the four following determinations must be in place:

  1. The Department of Defense (DoD) Secretary issues a determination of military emergency or significant potential for military emergency
  2. The Department of Homeland Security (DHS) Secretary issues a determination of domestic emergency or significant potential for domestic emergency.
  3. The Department of Health and Human Services (HHS) Secretary issues a determination of public health emergency or significant potential for public health emergency
  4. The DHS Secretary issues a material threat determination

After one of the above four determinations is in place, the HHS Secretary can issue a declaration that circumstances exist to justify issuing the EUA.  This declaration is specific to EUAs and is not linked to other types of emergency declarations.

The FDA Commissioner, in consultation with the HHS Assistant Secretary for Preparedness and Response (ASPR), Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH), can then issue the EUA, if criteria for issuance under the statute are met.  FDA publishes public notice of each EUA that is issued in the Federal Register.

The last step in the process is termination of declaration and EUA, if appropriate and needed.


Current Emergency Use Authorizations

Emergency Use Authorization, with Emergency sign

FDA

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), which was enacted in March 2013

Current EUAs

The tables below provide information on current EUAs:


How FDA helps make MCMs (medical countermeasures) available in emergencies

How FDA helps make MCMs available in emergencies
The first in an occasional series on the ways FDA helps prepare for and respond to public health emergencies
During public health emergencies, medical countermeasures (MCMs) may be needed to prevent or treat diseases or conditions caused by chemical, biological, radiological, or nuclear (CBRN) agents or emerging infectious diseases, like pandemic influenza or Ebola.
Depending on the emergency and public health need, MCMs may be provided by the Strategic National Stockpile (managed by the Office of the Assistant Secretary for Preparedness and Response (ASPR), in the U.S. Department of Health and Human Services (HHS)), or through state and local stockpiles or other supplies. When needed during a public health emergency, MCMs are usually dispensed or administered to impacted individuals by healthcare workers and public health responders under official federal, state, and local emergency response plans.
In some cases, MCMs might already be approved and will be used in approved ways during a response. In other cases, the best medical products available for a response might be unapproved or need to be used in unapproved ways. Because of our role in regulating medical products, FDA may need to use special authorities to allow the use of such MCMs in impacted populations during or in anticipation of emergencies.
 
Mechanisms FDA can use to allow the emergency use of MCMs include the Emergency Use Authorization (EUA) authority and several authorities related to the emergency use of approved MCMs.

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

FDA

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

For Immediate Release

November 9, 2018

Release

Today, the U.S. Food and Drug Administration announced that an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic results outside of laboratories and in areas where patients are likely to be treated.

The test, called the DPP Ebola Antigen System, is used with blood specimens, including capillary “fingerstick” whole blood, from individuals with signs and symptoms of Ebola virus disease (EVD) in addition to other risk factors, such as living in an area with large numbers of EVD cases and/or having contact with other individuals exhibiting signs and symptoms of EVD.

“The scourge of Ebola tragically demonstrates that we’re a global community when it comes to public health protection. Infectious disease doesn’t recognize nation states. Bacteria and viruses don’t respect territorial boundaries. It takes a sustained, robust and globally coordinated effort to protect our nation and the global community from various infectious disease threats. We’re all in this together. To that end, our FDA team of experts in drugs, vaccines and diagnostics continue to collaborate with our Federal, international and industry partners to employ our collective expertise, experiences from previous incidents, and resources to assist in the global response to the Ebola outbreak in the Democratic Republic of Congo,” said FDA Commissioner Scott Gottlieb, M.D. “This EUA is part of the agency’s ongoing efforts to help mitigate potential, future threats by making medical products that have the potential to prevent, diagnosis or treat available as quickly as possible. We’re committed to helping the people of the DRC effectively confront and end the current Ebola outbreak. By authorizing the first fingerstick test with a portable reader, we hope to better arm health care providers in the field to more quickly detect the virus in patients and improve patient outcomes.”

The FDA’s EUA authority allows the agency to authorize the use of an unapproved medical product, or the unapproved use of an approved medical product when, among other circumstances, there are no adequate, approved and available alternatives. When circumstances exist justifying authorization, the EUA becomes an important mechanism that allows broader access to medical products that have not been FDA cleared or approved and are instead only authorized for use for the duration of an emergency declaration. The FDA’s criteria for issuing an EUA for a diagnostic test includes making an assessment that it is reasonable to believe, based on the totality of evidence available to the agency, that the test may be effective and the known and potential benefits of using the test outweigh its known and potential risks.

In 2014, during the Ebola outbreak in West Africa, an emergency was declared by the Secretary of Health and Human Services. While that outbreak has ended, ongoing, smaller Ebola outbreaks have continued, and the emergency declaration is still in place. Recent outbreaks in remote areas with limited resources can benefit from rapid diagnostic tools, and the issuance of an EUA for the DPP Ebola Antigen System is an important step in addressing these outbreaks.

The DPP Ebola Antigen System provides rapid diagnostic results with tests that can be performed in locations where a healthcare provider does not have access to authorized Ebola virus nucleic acid tests (PCR testing), which are highly sensitive but can only be performed in certain laboratory settings that are adequately equipped. The DPP Ebola Antigen System has been authorized for use with capillary “fingerstick” whole blood, ethylenediaminetetraacetic acid (EDTA, an anticoagulant added to whole blood to prevent coagulation) venous whole blood and EDTA plasma. The DPP Ebola Antigen System should only be run in facilities, including treatment centers and public health clinics where patients are likely to be treated, and laboratories that are adequately equipped, trained and capable of such testing.

While today’s action will increase access to diagnostic tools for healthcare providers who may not have otherwise been equipped to perform tests, it is important to note that a negative result from the DPP Ebola Antigen System, especially in patients with signs and symptoms of EVD, should not be used as the sole basis for patient management decisions. The diagnosis of EVD must be made based on multiple factors such as, history, signs, symptoms, exposure likelihood and other laboratory evidence in addition to the detection of Ebola virus.

The FDA remains committed to using its authorities and resources to advance the development of countermeasures to address emerging threats and recently outlined its efforts to help address Ebola virus outbreaks. The FDA will continue to work with its federal partners and potential commercial product manufacturers in the most expedited manner to increase the availability of authorized diagnostic tests for Ebola virus disease for emergency use during this and any future outbreak.

With the issuance of the EUA for the DPP Ebola Antigen System to Chembio Diagnostic Systems Inc., the FDA has now issued EUAs for nine nucleic acid tests and two rapid diagnostic tests for Ebola virus detection in human specimens.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

FDA

September 5, 2018

Statement

Over the past 25 years, globalization of drug manufacturing has prompted the FDA to change its regulatory landscape. The shift to overseas production of U.S. goods, including some drugs and their components, predominantly occurred in the early 2000s. It added new complexities to our supply chain. This required the FDA to take different steps to ensure that our drug manufacturing surveillance program kept pace with the evolving landscape and make sure consumers continued to receive safe and effective drug products.

We’ve established a framework to help assure that drug products all meet the same high-quality standards, regardless of where they’re manufactured; and whether they’re brand name or generic products, or prescription or over-the-counter drugs. Today, we’re announcing several steps that improve on that effort.

Helping assure the quality and safety of globally produced products requires a variety of efforts at different times throughout the lifecycle of a drug’s manufacturing and finishing. Our inspections and surveillance of manufacturing facilities are an integral part of this oversight. We need to make sure that our inspections are prioritized based on potential risks to patients, and that we’re using our resources efficiently.

Today, to add greater transparency around our site selection model, we’re publishing our internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections. Our policy explains how a facility’s compliance history, recall trends, time since last inspection, inherent risk of the drug being manufactured, processing complexity and other factors are all weighed and considered.

The FDA prioritizes inspections of sites regardless of their location. For manufacturing facilities in other countries, inspections may be conducted by staff in foreign offices, those on temporary duty assignments, or staff that travel internationally to conduct the inspection. In addition, to maximize resources and efficiency, we’ve also pursued opportunities to collaborate with other countries. With our announcement last year concerning the Mutual Recognition Agreement with the EU, we’ve ensured that we can recognize the drug inspections conducted by foreign regulatory authorities that meet U.S. requirements. In doing so, we’re able to dedicate more of our investigators’ time to those sites that pose the greatest risk.

The FDA’s inspections program is a large-scale endeavor. As of Fiscal Year 2017, there were about 5,063 human pharmaceutical sites worldwide subject to routine surveillance inspection – 3,025 of those were foreign-based. For that year, the FDA conducted 1,453 drug surveillance inspections, including 762 on foreign soil, to ensure manufacturers were following Current Good Manufacturing Practice (CGMP) requirements and maintaining high quality standards. To accomplish this critical work, we need to maximize our resources around the globe, which is why the FDA uses a risk-based site selection model to ensure that inspectional resources are allocated in the most efficient and appropriate manner to protect patient health. The risk-based site selection model is structured so that the inspection frequency for all facilities, regardless of where the facility is located, prioritizes our inspections of sites where the drug being produced and the manufacturing processes used pose the greatest potential risk for problems that could harm patients.

In addition to identifying the facilities of greatest risk and prioritizing those inspections, the FDA has also made efforts to ensure our resources are effectively deployed to address inspection demands. Last year, for example, we modernized the structure of our field organization, including inspection operations, to direct our focus and organization around the types of programs we regulate. Previously, we had organized our field activities and resources based on geographic regions. The new structure, which focuses resources based on areas of specialization, allows us to better align the expertise of our staff with our commitments.

But it’s important to note that inspections are not the only way we work to ensure product quality. For example, we provide guidance documents on a range of quality issues, from pharmaceutical development through commercial manufacturing and quality control, on original application submissions and on making changes after approval, addressing active ingredients and finished product. We also obtain drug samples and test drugs from various sources each year to evaluate aspects of quality that can be analytically measured and verified. It’s also important that we’re transparent about inspection outcomes.

Following each inspection, the FDA assesses the significance of the findings leading to a final classification into one of three categories – no action indicated, which means the agency found no objectionable conditions during the inspection; voluntary action indicated, which means the agency found objectionable conditions, but we are not recommending regulatory action at this time; or official action indicated, which means the agency found objectionable conditions and may pursue regulatory action.

The agency recently updated its inspections classifications database, which provides the most recent classifications of inspections of manufacturing facilities conducted for routine CGMP surveillance purposes or inspections of sites conducting bioequivalence/bioavailability studies. The database provides transparency to the industry, the general public, and other regulators into the outcomes of recent observations. The database has also been updated to build on our progress implementing the Mutual Recognition Agreement with the European Union, and now supports inclusion of facility status based on classification of inspection reports from recognized foreign regulatory authorities.

FDA carried out these updates well ahead of our scheduled commitment under the reauthorized Generic Drug User Fee Amendments (GDUFA II) to perform the updates by 2019. The agency went beyond the commitment to provide timely updates regarding generic drug manufacturing facilities – as the database is updated every 30 days with classifications for inspections for all FDA regulated products, not just generic drugs. While we take effort to ensure transparency, it’s important to note that the numbers from our database don’t account for all of the inspections that the FDA conducts at any given time. These are a subset of inspections that have received a final classification. We classify inspections on a rolling basis after taking a thorough look at all the relevant information available. So there’s a lag between the performance of an inspection and the final classification. Communicating information from inspections in a timely way is a priority. We are continually seeking to refine this process.

Ensuring quality standards are met

When objectionable conditions are identified with manufacturing processes or controls, creating a risk of potentially producing an unsafe product, it’s important that the problems are quickly remedied.

What we find is that the majority of firms – both in the U.S. and overseas – are operating within the standards U.S. patients deserve and that meet our standards. When needed though, we exercise our regulatory authority commensurate with the assessed risk, including issuing import alerts, warning letters, and in the most serious cases, working with firms as they recall drugs, seizing drugs in commerce or enjoining manufacturers to prevent further violations. We will continue to remain vigilant in our compliance and enforcement work, and we’ve taken a number of actions already this year.

We’ve enhanced our communications about inspections to facility owners to enable quicker resolution of situations where quality standards are not being met. For example, efficiencies from a Concept of Operations agreement the FDA implemented last year have enabled us to communicate inspection classification information to facility owners within 90 days of the close of a surveillance inspection, a significant improvement from past timelines. We’ve also established procedures to notify applicants when we identify issues during our premarket inspections that could impact approvability of a new drug application by communicating through an information request, discipline review letter or complete response letter. By discovering issues before the production process commences, we’re able to assist companies to circumvent future issues before they occur and help get quality products to patients more efficiently.

Harmonization and fostering technological advancements

In addition to these efforts, cooperation and harmonization with other foreign regulators are critical to ensuring that the drug supply produced outside the U.S. meets our safety and efficacy standards. To advance these goals, we participate in the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), which focuses on harmonizing how inspections are conducted. We also participate in the International Council for Harmonisation (ICH), which is a global body established to facilitate international collaboration that’s been successful in standardizing and elevating drug development practices and quality standards throughout the world. The goal is to ensure companies maintain a level of quality throughout the product lifecycle.

Having the same standards across multiple regulatory agencies makes it easier for manufacturers to ensure compliance with quality standards. This approach reduces the burden from having to implement different sets of requirements. This is also an important role of our foreign offices – to establish relationships with foreign regulators and to build our intelligence regarding these markets so we can target higher risk firms.

We’re also committed to fostering more advanced manufacturing practices, such as continuous manufacturing, that encompass advanced manufacturing technologies, implemented in a way that leads to more innovative, consistent and dependable manufacturing of drug and biological products. These technologies have the potential to help establish more reliable supply of drug and biological products by reducing manufacturing failures that can cause supply disruptions and drug shortages. Just this month, we awarded grants to three research institutions in efforts to adopt this pioneering technology more widely. We’ll continue to advance efforts to support the effective utilization of these new platforms.

We’ll continue to take new steps to address the challenges posed by a globalized drug supply chain. These actions are key parts of our commitment to ensure high-quality manufacturing, and to make sure Americans have confidence in the quality of products sold in the U.S. regardless of where a drug is manufactured.


FDA issues final guidance for drug companies to use for developing pre-exposure prophylaxis for inhalational anthrax.

FDA

FDA In Brief: As part of a longstanding program encouraging the development of medical countermeasures; new FDA policy promotes innovation to thwart inhalational anthrax

May 23, 2018

Media Inquiries

  Tara Rabin
  240-402-3157

“The FDA has long played an important role preparing our nation for potential bioterrorism threats, providing guidance and support around the development of medical countermeasures that can be used safely, effectively and reliably during public health emergencies,” said FDA Commissioner Scott Gottlieb, M.D. “Since the 2001 anthrax attacks, the U.S. government’s efforts to protect the nation from bioterrorism threats have continued to evolve. We now know that a comprehensive preparedness plan for potential anthrax threats must account for both pre- and post-exposure scenarios. That’s why the FDA has taken steps to modernize its guidance on inhalational anthrax to advance the development of new drugs for prophylaxis, prior to exposure. This builds upon the treatments that are currently available for inhalational anthrax and advances the agency’s longstanding commitment to the development of a full suite of medical countermeasures as part of its established programs.”

The U.S. Food and Drug Administration today issued final guidance, Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax, which is designed to assist in the development of drugs for prophylaxis (prevention) of inhalational anthrax for individuals who may be potentially exposed to or have inhaled aerosolized Bacillus anthracis (B. anthracis) spores, but who have not yet displayed related signs and symptoms.

While there are FDA-approved drugs for treatment of anthrax and for post-exposure prophylaxis of inhalational anthrax, situations can arise where starting therapy immediately before the anticipated or potential exposure can reduce the risk of illness and death (for example, first responders who anticipate an imminent risk of exposure to B. anthracis spores).

The FDA’s final guidance is the result of a multi-year effort to advance its policy framework for the development of treatments targeting inhalational anthrax. The final guidance revises the indication to “prophylaxis of inhalational anthrax” for the reduction of disease risk in those who have inhaled, or are likely to inhale, aerosolized B. anthracis spores, but who do not yet have established disease.

Clinical trials in humans cannot be conducted since naturally occurring inhalational anthrax is extremely rare and it would be unethical to deliberately expose healthy human volunteers to B. anthracis spores. Therefore, the final guidance clarifies that drugs developed for the prophylaxis of inhalational anthrax can rely on evidence from animal studies (known as the Animal Rule) to support approval when the criteria under the Animal Rule have been met.

The FDA encourages drug developers to reference the final guidance issued today when designing studies to appropriately establish the safety and effectiveness of drugs for prophylaxis of inhalational anthrax.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


FDA: Information about E. coli O157:H7 Outbreak Likely Linked to Leafy Greens

FDA

January 10, 2018

The U.S. Food and Drug Administration is working with the Centers for Disease Control and Prevention (CDC), and state and local authorities in an investigation of an outbreak of Shiga toxin-producing Escherichia coli (E. coli) O157:H7 illnesses. The FDA has also been in contact with Canadian food safety authorities on this outbreak, since cases were first identified in Canadadisclaimer icon

Whole genome sequencing showed that the U.S. and Canadian E. coli O157:H7 strains are closely related, suggesting a common source of illness. Canadian health officials identified romaine lettuce as the likely source of their outbreak. CDC has been working to determine the source of the outbreak in the U.S., and today announced it believes that this outbreak is likely linked to leafy greens. Health officials have not identified a specific type of leafy greens that sick people ate in common.

The known illnesses in the U.S. had illness onsets in late November and early December. This suggests that suspect leafy greens linked to this outbreak are likely no longer in the food supply.

The FDA’s outbreak investigation team is working with CDC and state and local officials to determine what ill people ate, where they bought it, and the distribution chain — all with the goal of reaching where these foods were produced, to see if there’s any common food or point where the food might have become contaminated. At this point, we have not identified a common or single point of origin for the food that made people ill. We want to make sure the information we provide is accurate and when we have information that consumers can use – such as any foods to avoid – we will share it immediately.


FDA: Tips about Medical Devices and Hurricane Disasters

FDA Offers Tips about Medical Devices and Hurricane Disasters

General Safety

  • Keep your device and supplies clean and dry.
  • If you depend on your device to keep you alive, seek emergency services immediately. If possible, notify your local Public Health Authority to request evacuation prior to adverse weather events.
  • Always use battery powered flashlights or lanterns rather than gas lights or torches when oxygen is in use (to minimize the risk of fire).
  • If your device appears to be damaged, or if you need a back-up device, contact your distributor or device manufacturer.
  • Check all power cords and batteries to make sure they are not wet or damaged by water. If electrical circuits and electrical equipment have gotten wet, turn off the power at the main breaker.
  • Maintain your device only in a well lit area so you can assess your device’s performance (e.g., refilling your insulin pump, checking your glucose meter).
  • Keep your device in as clean and secure location as possible: off the ground, away from animals or crowded areas.
  • Always check your device for pests before you use it (e.g., syringes, mechanical devices).

 


Power Outage

  • Notify your electric company and fire department to let them know you have a medical device that needs power (e.g., ventilator, apnea monitor).
  • Read your user instructions or call your distributor or device manufacturer to find out if your device can be used with batteries or a generator.
  • Locate a generator if possible.
  • Make sure you check for water before plugging in your device. Do not plug in a power cord if the cord or the device is wet.
  • When the power is restored, check to make sure the settings on your medical device have not changed (often medical devices reset to a default mode when power is interrupted).

 


Warning about Potential Carbon Monoxide Problems when Using Generators

Since many medical devices used in the home require a source of electrical power, generators are often used to supply electricity during a general power outage. The following points should be followed to prevent carbon monoxide poisoning.

  • Never run a generator, pressure washer, or any gasoline-powered engine inside a basement, garage, or other enclosed structure, even if the doors or windows are open, unless the equipment is professionally installed and vented.
  • Never run a motor vehicle, generator, pressure washer, or any gasoline-powered engine outside an open window or door where exhaust can vent into an enclosed area.

 


Water Contamination

Some medical devices and equipment, such as dialyzers or IV pumps, require safe water in their use, cleaning, and maintenance.

Hurricanes, especially if accompanied by a tidal surge or flooding, can contaminate the public water supply. In the area hit by a hurricane, water treatment plants may not be operating; even if they are, storm damage and flooding can contaminate water lines.

Listen to and follow public announcements about the safety of the municipal water supply.

In an emergency situation, follow these steps to ensure that your water is safe for use with your medical device:

  • Use only bottled, boiled, or treated water until your supply is tested and found safe.
  • If you use bottled water, be sure it came from a safe source. If you do not know that the water came from a safe source, you should boil or treat it before you use it.
  • Boiling water, when practical, is the preferred way to kill harmful bacteria and parasites. Bringing water to a rolling boil for 1 minute will kill most organisms.
  • When boiling water is not practical, you can treat water with chlorine tablets, iodine tablets, or unscented household chlorine bleach (5.25% sodium hypochlorite). If you use chlorine tablets or iodine tablets, follow the directions that come with the packaging.
  • If you use household chlorine bleach, add 1/8 teaspoon (~0.75 mL) of bleach per gallon of water if the water is clear. For cloudy water, add 1/4 teaspoon (~1.50 mL) of bleach per gallon. Mix the solution thoroughly and let it stand for about 30 minutes before using it.

Note: Treating water with chlorine tablets, iodine tablets, or liquid bleach will not kill parasitic organisms.

Use a bleach solution to rinse water containers before reusing them. Use water storage tanks and other types of containers with caution. For example, fire truck storage tanks and previously used cans or bottles may be contaminated with microbes or chemicals.

For additional information on keeping water safe, see http://www.bt.cdc.gov/disasters/foodwater.asp.

 


Sterility

  • When performing medical procedures, maintain a clean environment by using bleach, alcohol, or a disinfectant in the area you are working (e.g., catheter changes, dressing changes, suctioning).
  • Check sterile packaging to make sure it is dry and intact (e.g., sterile gauze). If the packaging is wet or damaged, do not use the product inside.
  • When you purchase supplies, always check the packaging to make sure it hasn’t been damaged.

 


Re-use of Medical Devices

Do not reuse a medical device intended for single use.

If you find that you need additional single use products, contact a healthcare provider or emergency response personnel.

  • If you need to reuse a device that is intended for multiple uses (e.g., infusion tubing, syringes), the device must be cleaned and disinfected or sterilized according to the device manufacturer’s instructions. Devices should not be boiled unless explicitly allowed on the product label or instructions for use.
  • If you have supplies that are intended for multiple use with your medical device, follow the appropriate procedures for cleaning and disinfecting.
  • If you need sterile water for cleaning, disinfecting, or sterilizing your device or its components, follow the above procedures for ensuring that your water is safe.

 


Dealing with Heat and Humidity

Heat and humidity can have an effect on home diagnostic test kits (including blood glucose tests used by people with diabetes). Test results may not be accurate. Read your owner’s manual to make sure your test kit is performing properly.

Special Information about Using Blood Glucose Meters

Heat and humidity can damage blood glucose meters and test strips.

If you use a blood glucose meter, check the meter and test strip package insert for information on use during unusual heat and humidity. Store and handle the meter and test strips according to the instructions. Perform quality-control checks to make sure that your home glucose testing is accurate and reliable.

To protect your device from heat and humidity, follow the steps below:

  • Use a dry cloth to wipe off your device regularly (e.g., mechanical infusion pumps).
  • Keep your device out of direct sunlight.
  • Enclose your medical products in plastic containers to keep them dry (e.g., wound care supplies).
  • Do not use ice if there is a danger of water contamination; use dry ice or instant cold packs to keep your device cool (e.g., prefilled syringes).
  • Do not use disposable devices that are wet (e.g., wound dressings, disposable thermometers, tubing).


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