When I announced the Drug Competition Action Plan, or DCAP, in June 2017, I committed the FDA to a number of new steps to increase competition in the market for prescription drugs and to help facilitate the entry of lower-cost alternatives to improve patient access to affordable medicines.
This guidance is intended for firms that have registered with the Food and Drug Administration (FDA) under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as human drug compounding outsourcing facilities (outsourcing facilities). Under section 503B(b)(5) of the FD&C Act, an outsourcing facility must submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).”2 This guidance explains FDA’s current thinking on adverse event reporting for outsourcing facilities.
The U.S. Food and Drug Administration has received reports of dosing errors and confusion with the labeled strength expression for certain compounded injectable products. Conventional manufacturers label their injectable products with the strength per total volume as the primary and prominent expression of strength on the label, whereas some compounders label their injectable products differently. Below is a description of the case reports received by FDA. The case reports illustrate how differences in the product labels of conventional manufacturers and compounders may lead to dosing errors.
Good morning and welcome. I am Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis here at the Food and Drug Administration.
This week marks the official start of “flu season” for 2018-2019. The FDA, along with its partners across the Department of Health and Human Services, has been working throughout the year to prepare the development of a safe, effective flu vaccine for the season. I’ll be getting my flu shot this week at an event in Washington, along with the U.S. Surgeon General Jerome M. Adams. With the severity of last year’s flu season, I know that there are questions about the effectiveness and benefits of the flu vaccine.
FDA is announcing an agreement with the National Academies of Science, Engineering & Medicine (NASEM), and expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation (CERSIs). These institutions will conduct research to help inform the public and the agency’s policies regarding compounded drugs.
FDA has released the latest edition of the Director’s Corner Podcast. In this podcast, Dr. Woodcock discusses what the agency is doing to address the issue of drug shortages, and how it is working with industry to help lessen their impact.
Today, the FDA is finalizing two guidance documents and making available one draft guidance to help ensure that prescription drug products are identified and traced properly as they move through the supply chain in compliance with federal law. The goal of these documents laying out the FDA’s policies is to clarify for the pharmaceutical industry timing related to product identification, and verification, to reduce confusion in the supply chain and ensure compliance.
As we all work to confront the staggering human and economic toll created by the opioid crisis, we recognize the critical role that health care providers play in addressing this public health priority – both in reducing the rate of new addiction by decreasing unnecessary and/or inappropriate exposure to opioids and ensuring rational prescribing practices, while still providing appropriate treatment to patients who have medical need for these medicines. With millions of Americans misusing and abusing opioids and more than 40 people dying every day from overdoses involving prescription opioids, it’s clear that we need to do everything we can, including working with stakeholders, to get ahead of this crisis.
The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.
The U.S. Food and Drug Administration approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition. Potassium chloride is an oral treatment that is indicated for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible. Continue reading
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FDA has launched a new Medication Guide database to replace the current Medication Guide web page. Medication guides are provided with many prescription medicines. A Medication Guide is a form of patient labeling that is part of the FDA-approved prescription drug labeling. Medication Guides address issues that are specific to particular prescription drugs or biologic products and can help patients avoid serious adverse events.
Today, the FDA issued a compounding risk alert to warn health care providers, compounders and patients of the dangers of using the bulk drug substance cesium chloride. Cesium chloride is sometimes used by cancer patients despite never having been proven safe and effective for any use. Serious adverse events associated with the use of cesium chloride and other cesium salts include abnormal heart rhythms (arrhythmias), low potassium (hypokalemia), seizures, fainting (syncope), cardiac arrest and death.
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Today, FDA released the Biosimilars Action Plan (BAP) to provide information about the key actions the agency is taking to encourage innovation and competition among biologics and the development of biosimilars. The BAP is focused on four key areas:
We’ve seen the number of new drug shortages steadily decline since a peak in 2011 owing to the work of the FDA, industry and other groups. Despite these efforts, we continue to see ongoing shortages of medically necessary products. Even shortages of a small number of key drugs can place a serious burden on providers. While we’ve made progress to mitigate individual shortages, we haven’t firmly impacted the underlying structural concerns that give rise to these recurring challenges. When shortages occur, practitioners are forced to ration supplies or substitute alternate drugs that in some cases compromise patient care. We need to pursue more enduring solutions.
Addressing opioid addiction is one of the FDA’s highest priorities and supports the U.S. Department of Health and Human Services’ 5-Point Strategy To Combat the Opioid Crisis. The FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioids. The agency will also continue to evaluate how opioids currently on the market are used, in both medical and illicit settings, and take regulatory action where needed.
Among the biggest challenges health care providers and patients face are shortages of medically necessary medications. These shortages greatly impact patient treatment options and require practitioners to make difficult decisions that can compromise care, such as rationing supplies or using less desirable, but more readily available, alternative therapies. The FDA also understands the impact and concern these shortages may have on patients and we want to reassure them that their care will continue to be our priority.
More patients have more opportunities to benefit their health. But to realize the potential of these scientific advances, American patients must be able to gain access to these innovations. That means they must be able to afford the resulting medicines. And the rising list prices of drugs can create an obstacle to access. This is especially true for patients who find themselves underinsured or uninsured for medicines.
Scientific advances in biotechnology, such as genome editing and synthetic biology, hold enormous potential to improve human and animal health, animal welfare, and food security. And researchers and companies based in the United States helped pioneer these technologies. They position the U.S. as a global leader of this rapidly growing and highly promising field.
FDA has proposed an important series of new steps to modernize the organization and functions of CDER’s Office of New Drugs. These changes are intended to free up resources so that our scientists and physicians have more time to focus on drug development, particularly for unmet medical needs, and on the multiple collaborations needed to make sure candidate drugs are developed and assessed properly, with appropriate input from external scientists, expert physicians and patient communities. The proposals include regulatory and review process changes, as well as organizational restructuring.
Today the U.S. Food and Drug Administration launched a number of improvements to the FDA’s Adverse Event Reporting System (FAERS) dashboard. The FDA is committed to improving the FAERS dashboard and is implementing these changes based on user feedback received since the dashboard was launched in September 2017. The changes encompass a wide-range of items, such as enabling the selection of multiple products for a search and the downloading of search results, as well as enhancing display formats so more information is shown in one screen.
Our annual report, Drug Safety Priorities 2017, provides updates on our ongoing initiatives, discusses new work, and highlights last year’s safety-related milestones and achievements.
Today the U.S. Food and Drug Administration posted a newly revised drug disposal page. This site contains information for patients and health care providers to help encourage patients to properly get rid of unused, unwanted, or expired prescription medications. Getting rid of these medications is important. When medicines are no longer needed, they should be disposed of promptly, preferably via a drug take-back option, to help reduce the chance that others will accidentally take or intentionally misuse the unneeded medicine.
For more information, please visit drug disposal
The U.S. Food and Drug Administration today permitted marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining blood glucose (sugar) levels in children aged two and older and adults with diabetes. This is the first type of continuous glucose monitoring system permitted by the agency to be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management. Today’s authorization also classifies this new type of device in class II and subjects it to certain criteria called special controls. This enables developers of future iCGM systems to bring their products to market in the least burdensome manner possible.Read More
Today, we’re taking a key step forward in implementing the Drug Quality and Security Act (DQSA) and section 503B of the Federal Food, Drug, and Cosmetic Act. Among other things, these provisions limit the bulk drug substances that outsourcing facilities can use in compounding. It directs the FDA to develop a list of bulk drug substances for which there is a clinical need – the 503B bulks list. See more
Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)
OPQ has published its first public annual report which describes our accomplishments in 2017. OPQ occupies a unique space at the U.S. Food and Drug Administration (FDA) by reaching across all human drug User Fee programs: new drugs and biologics, generics, and biosimilars – and also over-the-counter drugs and compounded drug products. Further, we reach across the drug product lifecycle including development, premarket, and postmarket. Many drugs are currently available to patients and consumers due to OPQ accomplishments across assessment, inspection, surveillance, policy, and research.
Today, the Food and Drug Administration Office of Generic Drugs (OGD) posted their 2017 annual report. In 2017, the FDA approved and tentatively approved 1,027 generic drug applications, the most in the history of the United States Generic Drug program. Generic medicines benefit public health by providing access and more affordable, high quality treatments for patients.
FDA posts the annual edition of Approved Drug Products with Therapeutic Ratings, better known as the Orange Book
Today the U.S. Food and Drug Administration (FDA) is launching a new set of webpages that aims to provide a one-stop source for general information about Risk Evaluation and Mitigation Strategy (REMS) programs. These webpages organize general REMS information according to audience (i.e., patients, health care professionals and industry) and most pages are presented in a short question and answer format.
The U.S. Food and Drug Administration issued its 2018 Compounding Policy Priorities Plan, which outlines how the agency will implement certain key aspects of the Drug Quality and Security Act (DQSA) and other provisions of the law relevant to compounders. DQSA put in place more robust oversight of compounders and enabled closer federal and state collaboration. It also established a clear legal framework that provides for compounding to meet patients’ medical needs, while also giving the FDA tools to promote the quality of compounded products – which have not undergone FDA premarket review for safety, efficacy and manufacturing controls – and address unlawful compounding practices that threaten public health. Significantly, the law created a new category of compounders, called outsourcing facilities, which may engage in larger-scale, nationwide distribution under additional FDA oversight.
Today, the U. S. Food and Drug Administration released Advancing Health through Innovation: New Drug Therapy Approvals of 2017, a summary of the Center for Drug Evaluation and Research’s (CDER’s) 2017 important new drug approvals that serve to advance public health. These new approvals will benefit patients affected by a wide range of rare diseases, neurological conditions, infectious diseases, cancers, and many other medical conditions.
The FDA today announced additional steps to encourage generic competition as part of our continued implementation of the Drug Competition Action Plan. This plan has three main components: reducing gaming by branded companies that can delay generic drug entry; resolving scientific and regulatory obstacles that can make it difficult to win approval of generic versions of certain complex drugs; and improving the efficiency and predictability of the FDA’s generic review process to reduce the time it takes to get a new generic drug approved and lessen the number of review cycles undergone by generic applications before they can be approved.More
A U.S. Food and Drug Administration (FDA) review of four large clinical safety trials shows that treating asthma with long-acting beta agonists (LABAs) in combination with inhaled corticosteroids (ICS) does not result in significantly more serious asthma-related side effects than treatment with ICS alone. In 2011, we required the drug companies that market LABAs to conduct these trials to evaluate the safety of LABAs when used in combination with ICS, and we reviewed the results of these recently completed trials.Read more
Gene therapy holds the promise to transform medicine and create options for patients who are living with difficult, and even incurable, diseases.
U.S. Food and Drug Administration (FDA) published an update to the “List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic.”
The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act).
The list includes approved new drug applications (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA product. The methodology used to compile the first edition of the list (published June 2017) has been modified to reflect that the list is now based on drug products, not active ingredients. This means that an approved NDA in the active section of FDA’s Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book) for a particular active ingredient and dosage form is included on the list if there are no approved ANDAs for such an NDA, even if there are approved ANDAs that reference a different NDA with the same active ingredient.
U.S. Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to combat antimicrobial resistance. The agency created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. This approach is intended to aid health care professionals in making more informed prescribing decisions that will both benefit their patients and prevent the spread of resistant bacteria.Read more
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. Continue reading.
The U.S. Food and Drug Administration (FDA) is making available a free, one-hour continuing education (CE) lecture for healthcare providers on Leveraging Health Literacy and Patient Preferences to Reduce Hypoglycemic Events in Patients with Type 2 Diabetes.
The REMS Integration Initiative was built on stakeholder feedback, and leveraged activities such as public meetings, workshops, listening sessions and a pilot program to ensure comprehensive stakeholder representation. We are very grateful to all those who contributed their time and perspectives to this project. FDA has issued various reports and guidances over the course of this initiative describing what we heard and how we responded. A comprehensive list of work completed can be found on our REMS Integration Initiative website.
Today the Administration took a historic step to direct additional resources to help address the staggering human and economic toll created by the epidemic of opioid addiction. We thank President Trump for his leadership in further empowering public and private parties around the country to do everything possible to more forcefully address this complex public health crisis. read more
Talking with Issam Zineh, PharmD, MPH, FCP, FCCP, who is the director of the Office of Clinical Pharmacology, Office of Translational Sciences, CDER.
FDA is pleased to announce the release of new educational materials for health care professionals about biosimilar and interchangeable products. The agency developed these educational materials to help increase understanding about these important new types of medication among health care professionals.
FDA has released the latest edition of the Director's Corner podcast. Listen to Dr. Woodcock discuss the new FAERS public dashboard tool, which makes FAERS data easier to query and retrieve. She discusses the advantages of the tool as well as its limitations. Click on the following links to read a transcript and listen to the podcast.
The U.S. Food and Drug Administration launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The new FAERS public dashboard enables users to search for and organize data by criteria such as drug/biological product, age of the patient, type of adverse event, year the adverse event occurred, or within a specific timeframe.
For the first time, the FDA is posting a new report that provides a list of the drugs that entities registered as outsourcing facilities have produced. Under the Drug Quality Security Act (DQSA), outsourcing facilities are required to report to the FDA, upon initial registration and each June and December, the drug products that they compounded during the previous six months.
The FDA’s publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the “Orange Book,” includes information about patents or exclusivities that apply to a particular drug product approved under the Federal Food, Drug, and Cosmetic Act (the Act). Patents and exclusivities are two different forms of protection for qualifying drug products that may affect how and when certain generic versions of those drug products are approved.
To read more, please visit: CDER Conversations.
new efforts to encourage compounding of better quality drugs under DQSA and help health care professionals access compounded medications needed for patient care from outsourcing facilities. Read more
Manufacturing of drugs has become increasingly complex and global, requiring us to remodel our oversight of these tasks, to improve FDA’s efficiency and reach. As a step toward achieving these goals, FDA previously announced that we’re restructuring our field activities, to direct our focus and organization around the programs we regulate, instead of our previous structure, that organized our activities and resources based on geographic regions. This allows us to better align the expertise of our staff and make more efficient use of our resources.
FDA is announcing the availability of a revised draft guidance for industry entitled “Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products.” The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This revised draft guidance describes the conditions under which FDA does not intend to take action regarding required stability studies for these repackaged products and the expiration date to assign under those conditions. Through this notice, FDA is hoping to decrease the regulatory burdens of drug regulations on manufacturers of these products, while at the same time ensuring patient safety.
We’re at a point in science where new medical technologies hold out the promise of better treatments for a widening number of vexing conditions. Over the last few decades, science has enabled fundamental advances in our understanding of the genetic and protein bases of human disease. These developments are already being translated into new medicines. In more cases, these treatments target the underlying mechanisms that drive different diseases. These advances hold out the promise of arresting and even curing a growing number of diseases.
Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy Guidance for Industry
Today the FDA took two important new steps to encourage generic drug development and increase generic drug access:
These actions are part of Commissioner Gottlieb’s recently announced Drug Competition Action Plan, and follow the announcement of next month’s public meeting on administering the Hatch-Waxman Amendments. The agency plans to take additional, related actions in the near future, and will continue to communicate with stakeholders as these new elements are implemented.
As part of the work by the Federal Government to address the epidemic of prescription and illicit opioid abuse, the FDA is announcing a public workshop to obtain input on issues and challenges associated with Federal efforts to support training on pain management and the safe prescribing, dispensing, and patient use of opioids (safe use of opioids) for health care providers. As discussed in this document, the workshop has three main goals. First, participants will be asked to discuss the role that health care provider training plays, within the broader context of ongoing activities, to improve pain management and the safe use of opioids. Second, participants will be asked to comment on how best to provide health care providers, who prescribe or are directly involved in the management or support of patients with pain, appropriate training in pain management and the safe use of opioids. Finally, participants will be asked about the issues and challenges associated with possible changes to Federal efforts to educate health care providers on pain management and the safe use of opioids. More information
This LIVE extended webinar format, with Q&A sessions, is intended to provide a deeper look at REMS, focusing on two topics:
Reducing preventable harm from medications is a big part of FDA’s mission. It requires teamwork across all of health care and the medication manufacturing, distribution, and delivery system.Reducing preventable harm from medications is a big part of FDA’s mission. It requires teamwork across all of health care and the medication manufacturing, distribution, and delivery system.
Watch FDA’s new video, Definition of a Drug video.
Whether a product is regulated as a drug, a cosmetic, or both under the law is determined by a product's intended use. FDA Drug Info Rounds pharmacists discuss the key differences between a drug and a cosmetic.
Just over three years ago, Congress amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by enacting the Drug Quality and Security Act (DQSA). The first title of the DQSA, known as the Compounding Quality Act, was passed in response to numerous serious adverse events, including deaths, linked to poor quality compounded drugs. Since enactment of the DQSA, FDA has worked diligently to mitigate the public health risks associated with compounded drugs by conducting inspections and taking appropriate regulatory and enforcement actions, developing policies, convening advisory committee meetings, collaborating and coordinating with the states, and conducting stakeholder outreach.
The Food and Drug Administration’s Office of Generic Drugs (OGD) has now posted its 2016 annual report. 2016 marked the highest number of generic drug approvals and tentative approvals ever awarded by OGD–more than 800. These generic drug products have the potential to provide more affordable care to thousands of patients with serious and life-threatening diseases. OGD continues to improve its review infrastructure, meet all Generic Drug User Fee Amendments (GDUFA) commitments, and promote consistency across all applications.
Direct link to the report: https://go.usa.gov/xXqRz
The Food and Drug Administration will hold a public meeting of the Pharmaceutical Science and Clinical Pharmacology (PSCP) Advisory Committee. The committee will discuss strategies, approaches, and challenges in model-informed drug development for new and generic drugs.
The PSCP Advisory Committee meeting will be held at the Omni Shoreham Hotel, the Ballroom, 2500 Calvert St. NW, Washington, DC 20008 on March 15, 2017, from 7:30am to 3:45pm. The Advisory Committee meeting will be held in conjunction with the American Society for Clinical Pharmacology and Therapeutics 2017 Annual Meeting.
Meeting materials will be available prior to the meeting
Talking with Kathryn Aikin, Ph.D., who is a Senior Social Science Analyst and Research Team Lead in the Office of Prescription Drug Promotion, Office of Medical Policy, CDER.
In the past, prescription drug makers typically marketed their drugs only to health care professionals. In the 1980s and early 1990s, companies began to market their products to consumers through direct-to-consumer (DTC) ads, via both print and broadcast media. The Guidance for Industry on Consumer-directed Broadcast Advertisements (finalized in 1999), clarified how a company may fulfill the “adequate provision” obligation for broadcast ads. This obligation stated that, in addition to including important risk information, broadcast ads should describe the sources a consumer can use to find complete prescribing and risk information for the drug.
DDI Webinar Series: Collaborating with FDA - Get Involved with FDA’s MedWatch Adverse Event Reporting Program
Will be held on: February 7, 2017 Time: 1:00 pm to 2:00 pm (EST)
To register for the online meeting, please visit: https://collaboration.fda.gov/ddi020717/event/registration.html After registering, you will receive a calendar invitation with details on how to join the online meeting.
FDA announced the release of two guidances related to medical product communications and reopened the comment period for the off-label Public Hearing. For more information about this release, please see the Statement from FDA Commissioner Robert Califf, M.D.
The guidances and information on the comment period for the off-label public hearing can be found at:
FDA issued a document titled, “FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act.”
This report provides a brief overview of the history of drug compounding regulation, as well as FDA’s regulatory oversight of drug compounders, implementation of the compounding provisions of federal law, and state and stakeholder collaboration since enactment of the Drug Quality and Security Act on November 27, 2013. It also discusses the need for ongoing efforts to protect patients from the risks associated with compounded drug products that are not produced in accordance with applicable requirements of federal law, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.
The Food and Drug Administration released a summary of novel drugs approved by the agency’s Center for Drug Evaluation and Research (CDER) in calendar year 2016 as new molecular entities or as new therapeutic biologics. Novel drugs are often innovative products that serve previously unmet medical needs potentially adding significant clinical value to the care of thousands of patients – many with serious and life-threatening diseases. While the quantity of novel drug approvals decreased in 2016, our focus continues to be on the unique medical value of many of these new drugs, their contribution to enhanced patient care, and the various regulatory tools the Agency employed to ensure their safe and efficient development and approval.
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