Advisory Panel Recommendations Research Articles

Friends, Family, and Food: Development of a Food Allergy Intervention, F3-App, for Children.

Despite a marked increase in the prevalence of pediatric IgE-mediated food allergy (FA) in recent decades, there is a dearth of age-appropriate management education and support tools for youth with FA. The purpose of this report is to detail our methods for intervention design and refinement of an interactive educational software program for school-aged children with FA. Development of the "Friends, Family and Food Application (F3-App)" employed an iterative, user-centered design approach with input from children with FA, their caregivers, and other key experts. Phase 1 (Prototype Development/Pilot Evaluation) involved family input on key themes and educational messages, development of a prototype, and pilot testing. Phase 2 (Full F3-App Development/Open Trial) included refinement and expansion of the prototype per advisory panel and end-user recommendations, followed by an open trial with additional iterative refinement. Acceptability and credibility of the F3-App were rated highly by most participants. Relatively few technical challenges arose with F3-App installation or use. Follow up interviews with children and caregivers suggested that the F3-App was generally well-received, families found the content useful, and that it prompted family discussion about the child's FA management. User input is critical to developing family-friendly software to support management of pediatric chronic conditions. Interactive educational software can be a useful channel for children to practice skills and build confidence in disease self-management and to facilitate family communication regarding the stresses of FA management. ClinicalTrials.gov identifier: NCT05111938.

Advisory panel recommends accelerated approval for ALS drug

Advisory panel recommends accelerated approval for ALS drug

Creative Equity in practice: responding to extra-legal claims for the return of Nazi looted art from UK museums

Looted cultural objects taken from Jewish owners during the Nazi Era still reside in museums worldwide. The United Kingdom’s Spoliation Advisory Panel (the Panel) recommends solutions based on the moral strength of the claim where the original owner’s legal title is extinguished. Using the framework of Equity this article argues that the Panel’s work represents a modern, creative form of Equity. The Panel’s work plugs a gap left by the law, much as Equity aimed to do. Despite a wide discretion to recommend just and fair solutions, the Panel is developing settled principles rather than applying inconsistent concepts of morality. This article’s reconceptualisation of this process as firmly grounded in Equity enables the Panel’s work to be more fully appreciated as sui generis. It may also enable the Panel to serve as a model for resolving other disputes about cultural objects.

Early Clinical Experiences of Esketamine Nasal Spray in the UK in Adults with Treatment-Resistant Major Depressive Disorder: Advisory Panel Recommendations.

Treatment-resistant depression (TRD) is associated with profound morbidity for patients, placing a significant burden on those affected, the health service and wider society. Despite this, TRD remains chronically underserved in terms of viable treatment options. To address this gap, an advisory panel of psychiatrists and clinical researchers with experience in managing TRD convened to develop best practice statements on the use of esketamine nasal spray, one of the first TRD treatments to be licensed in 30 years. During a virtual meeting held on 12th November 2020, the advisory panel shared their experiences of using esketamine nasal spray in their clinical practice. The meeting focused on developing and refining recommendations for setting up and running an efficient esketamine nasal spray clinic for patients living with TRD. At the conclusion of the meeting, agreement was reached on all recommendation statements. In setting up an esketamine nasal spray clinic, it is important to consider the logistical requirements involved and put measures in place to ensure it runs as efficiently as possible. Educating patients about the treatment and maintaining their well-being is paramount for preventing discontinuation. Putting in place checklists can be a useful strategy for ensuring treatment appointments run smoothly and safely. Providing additional treatment options for the management of TRD, such as esketamine nasal spray, is likely to be key to improving the long-term outcomes of this underserved patient population.

Preventing Pressure Injury Related to Personal Protective Equipment.

One side effect of the COVID-19 pandemic was the increased need for personal protective equipment (PPE). At first, the biggest problem facing nurses was just having PPE available to care for these highly infectious patients. But the length of time wearing PPE has created its own new issue: PPE-related pressure injury. Bambi et al, in their small Italian study titled “Pressure Injuries Due to Personal Protective Equipment in COVID-19 Critical Care Units,” found that 77% of nurses had a device-related pressure injury (DRPI) develop, primarily on the nose, ears, or forehead, after an average of just 5 hours of wearing PPE.Another significant concern for nurses is the need to prevent infection while preventing PPE-related pressure injury using protective dressings or moisture barriers. The National Pressure Injury Advisory Panel (NPIAP) recommends 3 measures to minimize the risk of infection if you are using a dressing or moisture barrier to prevent pressure injury. The first is to do another fit test if possible. The second is to do a “seal check” after the application of a dressing or barrier. And finally, when removing the dressing, NPIAP recommends assuming that the dressings are contaminated and removing them with your eyes closed while holding your breath.

Land redistribution in South Africa’s land reform policy: a better way to select beneficiaries

ABSTRACT South Africa’s land reform policy might succeed better if it had clear criteria for selecting beneficiaries for land redistribution. The National Development Plan identifies the intended beneficiaries and states how they should be selected, but implementation of the plan is haphazard. A 2019 report by the Presidency’s Land Reform and Agriculture Advisory Panel recommends that the beneficiary selection process be clear and transparent. In this paper, we respond to the report and expand on a proposal in the 2020 draft Beneficiary Selection Policy. Our study is based on a review of the relevant policies and the literature on beneficiary selection, and a profile of 833 potential land redistribution beneficiaries randomly selected from three provinces in South Africa. We highlight the flaws in the existing selection methods. Building on the suggestion of Vink and Kirsten (2019) of a tender or job application process, we suggest improvements we suggest improvements that could reduce inefficiencies and make the selection process inclusive and transparent.

FDA Advisory Panel Recommends Nonopioid Lofexidine to Treat Opioid Withdrawal Symptoms, Despite Concerns

FDA Advisory Panel Recommends Nonopioid Lofexidine to Treat Opioid Withdrawal Symptoms, Despite Concerns

In the Corporate Interest: Fossil Fuel Industry Input into Alberta and British Columbia’s Climate Leadership Plans

Background This article examines the narrative strategies used by fossil fuel industries in responding to and shaping Alberta and BC’s climate leadership plans. Analysis This article makes inferences about fossil fuel industry influence by examining submissions of industry players to both regions’ public consultation processes. Conclusions and implications Key themes include: a need to take a leadership stance, a balance between environmental protection and economic growth, an appeal to protect industry competitiveness, and an emphasis on demand-side policies. These themes align with a policy discourse of weak ecological modernization and are central to advisory panel recommendations and subsequent subnational climate policies that facilitate market expansion and increased oil and gas production at a time when strong greenhouse gas (GHG) mitigation efforts are urgently required.

Civics and citizenship education in New Zealand: a case for change?

The 2013 Constitutional Advisory Panel recommendation for a national strategy for civics and citizenship education in schools, kura (Māori-medium schools) and communities provided the opportunity for an important conversation about building civic knowledge in Aotearoa New Zealand (Constitutional Advisory Panel, 2013, p.8). This article explores possible next steps for implementing this recommendation. It is broken up into two parts: a case for change, and potential next steps.

Society Advocacy Continues to Make Impact Amid Uncertainty

Society Advocacy Continues to Make Impact Amid Uncertainty

Advisory Panel Recommends $4.5 Billion for Brain Research

Advisory Panel Recommends $4.5 Billion for Brain Research

Zohydro™ Approval by Food and Drug Administration: Controversial or Frightening?

The actions and regulations of the Food and Drug Administration (FDA) are crucial to the entire population of the US, specifically the public who take a multitude of drugs and providers who prescribe drugs and devices. Further, the FDA is relevant to investors, specifically in regards to biotech and pharmaceutical companies involved in developing new drugs. The FDA has been criticized for a lack of independence on the one hand and excessive regulatory and expanding authority without evidence and consistency of the actions on the other hand. The FDA approved a single-entity, long-acting, hydrocodone product (Zohydro™, Zogenix, San Diego, CA) on October 25, 2013, against the recommendation of the FDA’s own appointed scientific advisory panel, which voted 11 to 2 against the approval of Zohydro. Subsequent to the approval, multiple consumer safety organizations, health care agencies, addiction treatment providers, professional organizations, and other groups on the frontline of the opioid addiction epidemic have expressed concern. In addition, the US Congress and various state attorneys general raised serious concerns about the approval of Zohydro, which is highly addictive and may enhance the opioid addiction epidemic. Supporters of Zohydro contend that it is necessary and essential to manage chronic pain and improve functional status with no additional risk. Over the past 15 years, prescriptions for opioids have skyrocketed with the United States consuming more than 84% of the global oxycodone and more than 99% of the hydrocodone supply. The sharp increase in opioid prescribing has led to parallel increases in opioid addiction and overdose deaths, surpassing motor vehicle injuries in the US. Recent studies assessing the trends of medical use and misuse of opioid analgesics from 2000 to 2011 have concluded that the present trend of the continued increase in the medical use of opioid analgesics appears to contribute to increasing misuse, resulting in multiple health consequences, despite numerous regulations enforced by multiple organizations. The approval of Zohydro and its defense from the FDA were based on a misunderstanding of the prevalence of chronic severe disabling pain. Based on inaccurate data from the Institute of Medicine, in part caused by conflicts of interest, 100 million persons have been described to suffer from severe pain -- the correct number is 22.6 million. This manuscript analyzes 3 important principles of drug approval and utilization based on safety, efficacy, and medical necessity. Based on the limited literature that the authors were able to review including that which was submitted to the FDA by the manufacturers, it appears the safety, efficacy, and medical necessity were not demonstrated. In fact, the study submitted to the FDA showed a 50% pain improvement in only 48% of the patients in the treatment group and 21% of the patients in the placebo group at 85 day follow-up. This is a statistically significant result but its clinical relevance is unknown. The FDA approval decision occurring against the backdrop of the advisory panel recommendation is concerning and may result in serious consequences in the future. Key words: Chronic non-cancer pain, Food and Drug Administration, opioids, Zohydro, misuse, tolerance, addiction, dependency, medical necessity

The Food and Drug Administration advisory committees and panels: how they are applied to the drug regulatory process.

Food and Drug Administration (FDA) advisory panels and committees play a critical role in advising the FDA on the safety and efficacy of medical devices and drugs marketed in the US. Advisory panel recommendations are used by the FDA to make decisions regarding medical products. Currently, the FDA utilizes over 50 advisory panels that serve the three major FDA centers, including the Centers for Biologics, Drugs and Device Products. Members of an advisory panel typically include academicians, clinicians, consumers, patients, and industry representatives. The FDA establishes the schedules for advisory panel meetings on an annual basis and a panel usually meets several times a year for two consecutive days in Washington, DC. Typically, the advisory panel discusses issues highlighted by the FDA and is then asked to vote a response to the questions posed in advance by the FDA. Advisory panel recommendations have a strong influence on FDA's decision to approve a product, as evidenced by the 214 Advisory Panels FDA convened between January 2008 to November 2012, during which advisory panel members voted to approve the product (or use of the product) ∼74% of the time, with FDA ultimately approving the medical product (or use of the product) ∼79% of the time. The ACG membership are encouraged to consider serving the public's interest by participating in an FDA advisory panel utilizing their expertise for the evaluation of a new drug or medical device, and providing advice about whether the product should be sold in the US.

Controversy surrounds FDA approval of Zohydro

On October 25, FDA approved hydrocodone bitartrate extended- release capsules (Zohydro ER—Zogenix), a single-ingredient opioid product with no abuse-deterrent features. The decision to approve Zohydro ER without such controls goes against the 2012 recommendation of the agency's own advisory committee and came just a day after FDA announced its intent to recommend that DEA move combination hydrocodone products from Schedule III to Schedule II (see page 72). "I was surprised FDA approved this agent despite the advisory panel recommendations," said Chris Herndon, PharmD, BCPS, CPE, Associate Professor at Southern Illinois University Edwardsville and guest editor of Pharmacy Today's September 2013 special section on pain. While noting that he believes that "any additional treatment options that we have available for our patients in pain are a good thing," Herndon added, "I personally would not recommend placing this medication into the community via prescribing until it is available with an abuse- deterrent formulation."■Zohydro ER is a single-ingredient opioid product with no abuse-deterrent features.■The opioid is an option for patients whose pain is severe enough to require daily, around-the-clock, long-term opioid treatment. ■Zohydro ER is a single-ingredient opioid product with no abuse-deterrent features.■The opioid is an option for patients whose pain is severe enough to require daily, around-the-clock, long-term opioid treatment. Abuse-deterrent formulations of opioid products take a number of approaches to prevent abuse by those seeking drug highs while maintaining efficacy for patients using the products for legitimate medical needs, Eric Lavonas, MD, told the annual meeting of the RADARS System earlier this year. Such approaches include addition of naloxone, compounds such as niacin, or other substances that cause adverse effects when injected or snorted but that are pharmacologically inert when absorbed from the gastrointestinal tract. Lavonas is Associate Director of the Rocky Mountain Poison and Drug Center in Denver and Associate Professor at the University of Colorado School of Medicine. Some products are prodrugs requiring hepatic or other activation, Lavonas said. Solid oral dosage forms can also include fillers that prevent a user from getting the active drug into the body quickly through snorting or injecting and thereby achieve a heroin-like high. In January 2013, FDA released draft guidance to assist manufacturers in developing abuse-deterrent opioids, 1 month after Zogenix presented Zo- hydro ER to the FDA advisory committee that advised against approval. On April 15—the day the patent for the original OxyContin was expiring—FDA approved new labeling for Purdue Pharma's 2010 reformulation of OxyContin and also rescinded its approval of the original OxyContin. This action had the effect of preventing generic pharmaceutical companies from getting generic copies of the non- abuse-deterrent version of OxyContin approved by FDA. When announcing FDA's April action, Purdue Pharma said in a news release that it was working on a once- daily formulation of hydrocodone bitartrate that is "in the final stages of clinical development and incorporates the same abuse-deterrence technology as reformulated OxyContin." FDA considers the development of opioid analgesics with abuse-deterrent properties to be a public health priority and is actively supporting product development in this area, FDA spokesperson Eric Pahon told Today when asked why the agency would send mixed signals on this important public health issue. The science is still in its early stages, he added, and abuse-deterrent formulations are not available for most extended-release/long-acting [ER/LA] analgesics. "Accordingly, FDA does not believe it is feasible at this time to require that all new solid oral dosage form opioids have abuse-deterrent properties," Pahon said.Information on FDA's recommendation to reclassify hydrocodone as Schedule II starts on page 72. Information on FDA's recommendation to reclassify hydrocodone as Schedule II starts on page 72. Zohydro ER is the first opioid to include FDA's updated labeling requirements for all ER/LA opioid analgesics. In addition, FDA approved Zohydro ER with a Risk Evaluation and Mitigation Strategy (REMS). The program requires health professionals to provide Medication Guides with each prescription and counsel patients on safe use, storage, and disposal. Zohydro also will be subject to the new postmarketing study requirements to evaluate its serious risks, including the risk of abuse with long-term use (past 12 weeks). Before Zohydro ER's approval, no single-entity or ER hydrocodone-containing products were available to patients. Prescribers may titrate Zohydro ER for individual patients without the limitations or toxicity concerns associated with nonopioid active ingredients, such as acetaminophen, in other approved hydrocodone products. With the updated labeling, REMS, and postmarketing study requirements, prescribers will better understand the risks of prescribing ER/LA opioid analgesics and will be better able to determine the patients who really need them, according to FDA. When there are no indications of abuse and a patient's pain is severe enough to require daily, around-the-clock, long- term opioid treatment, Zohydro ER provides an additional opioid option.

FDA Advisory Panel Recommends Approval of Drug for Preoperative Treatment of Breast Cancer

In a nearly unanimous vote, an advisory panel for the US Food and Drug Administration (FDA) voiced its support on September 12 for the approval of the drug pertuzumab for use in the neoadjuvant (preoperative) treatment of breast cancer. Pertuzumab, a monoclonal antibody targeting the HER2/neu receptor, was approved by the FDA in 2012 for use in combination with trastuzumab and docetaxel for the treatment of patients with HER2-positive metastatic breast cancer who had not received prior anti-HER2 therapy or chemotherapy. If the FDA takes its advisory panel�s advice, pertuzumab would also be approved for use as neoadjuvant treatment in early HER2-positive breast cancers.

Electroconvulsive Therapy Device Classification: Response to FDA Advisory Panel Hearing and Recommendations

Electroconvulsive therapy (ECT) is a safe and highly effective treatment for management of acute episodes of a variety of serious mental disorders, particularly for major depressive episodes that are resistant to multiple interventions with treatment alternatives. As such, the National Network of Depression Centers (NNDC), a consortium of major academic centers with interest and expertise in this area, believes there is an important public health need for ECT to remain available for clinical use. As with all medical devices, ECT is regulated by the US Food and Drug Administration (FDA), which is presently involved in formulating a proposed rule as to how such devices should be classified. Since such classification may have substantial effects on the availability of ECT to patients for whom it is clinically indicated, the NNDC has reviewed the information provided by the FDA to its Advisory Panel, as well as the subsequent deliberations of the Panel itself at a January 2011 public hearing. This review indicates that the FDA may have substantially underestimated the efficacy of ECT as a means to produce large clinical improvements for individuals suffering from severe major depressive disorders and that such an underestimate likely affected the Panel's willingness to recommend reclassification of ECT devices to a less restrictive category. In addition, the NNDC's review generates support for a variety of methods by which the safety of ECT can be ensured, which is an essential requirement for such reclassification.

No user fees, but perhaps user fees

Facing somewhat of a firestorm of nation-wide criticism, the Canadian Medical Association has stepped back from an advisory panel recommendation that Canada should consider the implementation of health care user fees, while simultaneously arguing that “all the options” should remain on the table

Evaluating ‘Success’ In Programme Budgeting and Marginal Analysis: A Literature Review

Programme budgeting and marginal analysis (PBMA) is a priority-setting toolkit which aims to assist decision-makers in identifying the most efficient use of resources. The last systematic literature review on PBMA was published in 2001 and evaluated success in applying PBMA using the criteria of 'reallocation of resources' or the 'setting of priorities'. Our objective was to re-evaluate applications of PBMA in terms of these criteria separately, summarize different evaluation methods of PBMA and extend the above review by considering all PBMA applications since 2001. Systematic literature review. Information was sought from four general medical electronic databases. Descriptive statistics and content analysis were used. PBMA was successful in 52% of cases when success was defined in terms of the participants gaining a better understanding of the area under interest; in 65% of cases when success was defined as 'implementation of all or some of the advisory panel's recommendations'; in 48% of the studies when success was defined in terms of disinvesting or resource reallocation; and in 22% when success was defined in terms of adopting the framework for future use. The rate of success is clearly influenced by how success is defined. There is a need for a broadly accepted definition of success to be used when evaluating PBMA applications so to enable direct comparisons of studies. This evaluatory component needs to be adjacent to PBMA and not a separate procedure.

By Narrow Vote, FDA Advisory Panel Recommends DBS Device for Epilepsy

By Narrow Vote, FDA Advisory Panel Recommends DBS Device for Epilepsy

Impact of cardiovascular outcomes on the development and approval of medications for the treatment of diabetes mellitus

All medications currently approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes mellitus are indicated to improve glycemic control. Since 1995, FDA has used HbA1c as the primary basis for approval of these therapies because a reduction in blood glucose lessens the symptoms of hyperglycemia and lowering of HbA1c has been shown to reduce the risk for some of the chronic complications of diabetes. Despite evidence of clinical benefit with therapies that reduce HbA1c, concerns have been raised that some diabetes medications may increase cardiovascular risk in a patient population that is already vulnerable to cardiovascular disease. Therefore, FDA convened a public advisory committee meeting to discuss the role of cardiovascular assessment in the pre-approval and post-approval settings for medications developed for the treatment of type 2 diabetes. After considering the advisory panel's recommendations and other data, FDA published a guidance document requesting evidence showing that new treatments for type 2 diabetes do not result in an unacceptable increase in cardiovascular risk. This review article begins by summarizing the events leading up to publication of this guidance. Subsequent sections discuss the guidance itself as well as general considerations for implementing the new cardiovascular recommendations. The new approach to developing medications for the treatment of type 2 diabetes will lead to evaluation in patients more representative of those who will use these therapies, if approved, and will help healthcare providers make informed decisions when choosing a medication within the growing treatment armamentarium for type 2 diabetes.