Food And Drug Administration Announcement Research Articles

Cancer Drug Price and Novelty in Mechanism of Action

Many economic theories point to regulatory issues and subsidization of research and development costs as the primary factor in the high cancer drug prices in the US. Even so, the association between the median annual cost and novelty of cancer drugs approved in the US remains unclear. To evaluate the association between the median annual cost and novelty of cancer drugs approved in the US over a 6-year period. This cross-sectional study included all cancer drugs approved by the US Food and Drug Administration (FDA) from January 1, 2015, to December 31, 2020. Drug names, indications, manufacturer, dosage, and measures of activity/efficacy were extracted from the FDA announcement. The search was performed in December 2021. Data were analyzed from January 2022 until April 2022. Annual cost of treatment was calculated based on average wholesale price collected from the 2021 Micromedex Red Book database. Mechanism of action was inferred from trial publication or its references. There were 224 cancer drug approvals across 119 individual drugs, with a median annual cost of $196 000 (IQR, $170 000-$277 000). Gene and viral therapies were the most expensive (median, $448 000 [IQR, $448 000-$479 000]), followed by small molecule therapy (median, $244 000 [IQR, $203 000-$321 000), and biologics (median, $185 000 [IQR, $148 000-$195 000]). There was no significant difference in cost between first-in-class, next-in-class, and subsequent approvals of an already approved drug. Findings of this study indicate that the median annual price of anticancer drugs in the US is not associated with the novelty of their mechanism of action.

Association of FDA Mandate Limiting Acetaminophen (Paracetamol) in Prescription Combination Opioid Products and Subsequent Hospitalizations and Acute Liver Failure

In January 2011, the US Food and Drug Administration (FDA) announced a mandate to limit acetaminophen (paracetamol) to 325 mg/tablet in combination acetaminophen and opioid medications, with manufacturer compliance required by March 2014. To assess the odds of hospitalization and the proportion of acute liver failure (ALF) cases with acetaminophen and opioid toxicity prior to and after the mandate. This interrupted time-series analysis used hospitalization data from 2007-2019 involving ICD-9/ICD-10 codes consistent with both acetaminophen and opioid toxicity from the National Inpatient Sample (NIS), a large US hospitalization database, and ALF cases from 1998-2019 involving acetaminophen and opioid products from the Acute Liver Failure Study Group (ALFSG), a cohort of 32 US medical centers. For comparison, hospitalizations and ALF cases consistent with acetaminophen toxicity alone were extracted from the NIS and ALFSG. Time prior to and after the FDA mandate limiting acetaminophen to 325 mg in combination acetaminophen and opioid products. Odds of hospitalization involving acetaminophen and opioid toxicity and percentage of ALF cases from acetaminophen and opioid products prior to and after the mandate. In the NIS, among 474 047 585 hospitalizations from Q1 2007 through Q4 2019, there were 39 606 hospitalizations involving acetaminophen and opioid toxicity; 66.8% of cases were among women; median age, 42.2 (IQR, 28.4-54.1). In the ALFSG, from Q1 1998 through Q3 2019, there were a total of 2631 ALF cases, of which 465 involved acetaminophen and opioid toxicity; 85.4% women; median age, 39.0 (IQR, 32.0-47.0). The predicted incidence of hospitalizations 1 day prior to the FDA announcement was 12.2 cases/100 000 hospitalizations (95% CI, 11.0-13.4); by Q4 2019, it was 4.4/100 000 hospitalizations (95% CI, 4.1-4.7) (absolute difference, 7.8/100 000 [95% CI, 6.6-9.0]; P < .001). The odds of hospitalizations with acetaminophen and opioid toxicity increased 11%/y prior to the announcement (odds ratio [OR], 1.11 [95% CI, 1.06-1.15]) and decreased 11%/y after the announcement (OR, 0.89 [95% CI, 0.88-0.90]). The predicted percentage of ALF cases involving acetaminophen and opioid toxicity 1 day prior to the FDA announcement was 27.4% (95% CI, 23.3%-31.9%); by Q3 2019, it was 5.3% (95% CI, 3.1%-8.8%) (absolute difference, 21.8% [95% CI, 15.5%-32.4%]; P < .001). The percentage of ALF cases involving acetaminophen and opioid toxicity increased 7% per year prior to the announcement (OR, 1.07 [95% CI, 1.03-1.1]; P < .001) and decreased 16% per year after the announcement (OR, 0.84 [95% CI, 0.77-0.92]; P < .001). Sensitivity analyses confirmed these findings. The FDA mandate limiting acetaminophen dosage to 325 mg/tablet in prescription acetaminophen and opioid products was associated with a statistically significant decrease in the yearly rate of hospitalizations and proportion per year of ALF cases involving acetaminophen and opioid toxicity.

FDA Approves Second Antibody Therapy for Alzheimer’s

FDA Approves Second Antibody Therapy for Alzheimer’s

An Analysis of Twitter Posts About the U.S. Food and Drug Administration's Menthol Ban.

Although the U.S. Food and Drug Administration (FDA) banned characterizing flavors in cigarettes in 2009, this initial ban exempted menthol. After examining numerous reports on the adverse health effects of menthol cigarettes, the FDA proposed a menthol ban in April 2022. This study analyzed Twitter data to describe public reaction to this announcement. Posts containing the word "menthol" and/or "#menthol" were collected from April 21, 2022 to May 5, 2022 from Twitter's Streaming Application Programming Interface (API). A random sampling procedure supplied 1041 tweets for analysis. Following an inductive approach to content analysis, posts were classified into one or more of 11 themes. Posts discussed the FDA announcement (n = 153, 14.7%), racial discrimination (n = 101, 9.7%), distrust in government (n = 67, 6.4%), inconsistencies between policies (n = 52, 5.0%), public health benefits (n = 42, 4%), freedom of choice (n = 22, 2.1%), and health equity (n = 21, 2.0%). Posts contained misinformation (n = 20, 1.9%), and discussed the potential for illicit markets (n = 18, 1.7%) and the need for cessation support (n = 4, 0.4%). 541 (52.0%) tweets did not fit into any of the prescribed themes. Twitter posts with the word "menthol" commonly discussed distrust in government and mentioned racial discrimination. Findings demonstrated the possibility of near real-time Twitter monitoring of public opinion on a menthol ban. These data may be valuable for designing tobacco control health communication campaigns in the future. The U.S. FDA proposed a ban on menthol cigarettes in April 2022. This study's content analyzed Twitter posts over a 2-week period to understand the public's response to the proposed menthol ban. Twitter posts with the word "menthol" often discussed distrust in government and mentioned racial discrimination. Findings demonstrated the possibility of near real-time Twitter monitoring of public opinion of regulatory action. Findings underscore the need to educate the public about the potential health benefits of banning menthol from cigarettes, particularly for populations that experience tobacco-related health disparities.

Awareness about FDA announcement on voluntary recall of ranitidine among physicians and pharmacists in and around Chennai, India: a cross-sectional study

BackgroundRanitidine is a histamine-2 (H2) blocker, which decreases the amount of acid created by the stomach. In September 2019, the drug was recalled due to impurities N-nitrosodimethylamine (NDMA) by the Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada. NDMA is a carcinogen based on results from laboratory tests. The objective of the study is to assess the awareness among the physicians and pharmacists in and around Chennai about the ranitidine recall notification and its related issues. A descriptive, cross-sectional study was carried out where a questionnaire was administered on 198 physicians and 113 pharmacists who were enrolled in the study. Awareness, knowledge, and issues related to recall notification were recorded from the participants.ResultsResults showed that only 75% of the study participants were aware of the notification and the issues related, with significantly more participants from the urban area compared with the rural area. When the notification was known by many, the reasons pertaining to the notification were not known.ConclusionOverall, the awareness assessed among physicians and pharmacists was not satisfactory. Physicians and pharmacists are the most responsible healthcare providers and to be updated with every notification on medication published by regulatory bodies.

Inaccuracies in News Media Reporting About the 2019 US Food and Drug Administration Ban on Transvaginal Mesh for Pelvic Organ Prolapse Repair

ObjectiveTo analyze inaccuracies in the news media reporting of the 2019 US Food and Drug Administration (FDA) ban on surgical mesh for transvaginal repair of pelvic organ prolapse (POP). MethodsWe queried the NexisUni media database for English-language news articles about “transvaginal mesh” or “FDA” published before and after the ban. Content analysis was based on discussion of the ban, indications for surgical mesh, and assessment of bias. We characterized public interest in transvaginal mesh using Google Trends. ResultsOf 290 news articles reviewed, 42 articles were included for analysis. Public interest in transvaginal mesh increased 4-fold after the FDA announcement. While 15 articles (38%) accurately reported that mesh was used in both POP and incontinence repairs, a plurality (18, 43%) only described using mesh for POP. The majority (30, 71%) of articles did not specify that the FDA ban applied to only transvaginal repair of POP and not to incontinence. Despite multiple professional societies affirming the use of mesh for incontinence, only 2 (5%) articles cited these evidence-based recommendations. About half of the articles had an overtly biased tone; articles with an anti-mesh bias were significantly less likely to identify the mesh indications relevant to the ban (P <.01). ConclusionSeventy percent of news reports about the 2019 FDA ban on transvaginal mesh for POP failed to distinguish between the clinical indications for mesh impacted by the ban. The findings raise concern about patient perceptions of and future access to mesh surgery, regardless of indication.

MP05-09 SOURCES OF CONFUSION: MEDIA COVERAGE OF THE 2019 UNITED STATES FOOD AND DRUG ADMINISTRATION BAN ON VAGINAL MESH FOR PELVIC ORGAN PROLAPSE

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Pelvic Prolapse (MP05)1 Apr 2020MP05-09 SOURCES OF CONFUSION: MEDIA COVERAGE OF THE 2019 UNITED STATES FOOD AND DRUG ADMINISTRATION BAN ON VAGINAL MESH FOR PELVIC ORGAN PROLAPSE Poone Shoureshi*, Wai Lee, Kathleen Kobashi, and Kamran P. Sajadi Poone Shoureshi*Poone Shoureshi* More articles by this author , Wai LeeWai Lee More articles by this author , Kathleen KobashiKathleen Kobashi More articles by this author , and Kamran P. SajadiKamran P. Sajadi More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000819.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: On April 16th, 2019, the United States Food and Drug Administration (FDA) announced a ban on transvaginal mesh for the treatment of pelvic organ prolapse (POP). The aim of this study was to asses online user behavior on pelvic-mesh related articles after the ban. METHODS: We used Google Trends© to identify the terms related to pelvic mesh that experienced increased activity after the FDA ban. The terms were analyzed for worldwide social media engagement (Facebook, Twitter, Pinterest, and Reddit) between April 16-19, 2019. The top ten lay press articles shared for each term were evaluated. We also examined the top ten Google search results for each term on June 6th, 2019 in the United States to evaluate what information was available after peak interest subsided. RESULTS: Thirty unique articles with peak activity after the FDA ban were identified. Two (6.7%) did not mention the April 2019 FDA announcement. Seven (23%) discussed mesh for stress urinary incontinence. Eighteen (69%) mentioned lawsuits or negative individual experiences without clarifying the type of pelvic mesh used. Twelve (40%) included a photo of mesh in the article, six (50%) were accurate in depicting a transvaginal POP mesh implant. The other six (50%) depicted photographs of slings for stress urinary incontinence (SUI) or abdominal wall mesh. Google identified 26 unique articles for the four terms when searched on June 6, 2019. Seven (27%) did not mention the FDA announcement, 3 (12%) mentioned mesh for incontinence, and 11 (42%) discussed lawsuits or negative individual experiences. Seven articles included a mesh photo, and three (43%) were of the correct type of mesh. The other 4 photographs were of mesh slings for SUI for abdominal wall mesh. CONCLUSIONS: Internet search patterns and social media behavior following the April 2019 ban on transvaginal mesh for pelvic organ prolapse reveal that some of the most disseminated information did not accurately or thoroughly distinguish the type of mesh discussed. This emphasizes the importance of preoperative counseling and focused educational materials for patients who may be or think they are affected by the FDA ban. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e44-e44 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Poone Shoureshi* More articles by this author Wai Lee More articles by this author Kathleen Kobashi More articles by this author Kamran P. Sajadi More articles by this author Expand All Advertisement PDF downloadLoading ...

MP05-10 ACCURACY OF MEDIA COVERAGE ABOUT THE 2019 US FOOD AND DRUG ADMINISTRATION BAN ON TRANSVAGINAL MESH FOR PELVIC ORGAN PROLAPSE

You have accessJournal of UrologyUrodynamics/Lower Urinary Tract Dysfunction/Female Pelvic Medicine: Pelvic Prolapse (MP05)1 Apr 2020MP05-10 ACCURACY OF MEDIA COVERAGE ABOUT THE 2019 US FOOD AND DRUG ADMINISTRATION BAN ON TRANSVAGINAL MESH FOR PELVIC ORGAN PROLAPSE Shagnik Ray*, Marisa Clifton, and Kevin Koo Shagnik Ray*Shagnik Ray* More articles by this author , Marisa CliftonMarisa Clifton More articles by this author , and Kevin KooKevin Koo More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000819.010AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: On 4/16/2019, the US Food and Drug Administration (FDA) banned the sale of surgical mesh for transvaginal (TV) repair of pelvic organ prolapse (POP). Given the clinical prevalence of POP and urinary incontinence (not included in the ban), we analyzed media coverage of the ban and its potential impact on patient perceptions of mesh surgery. METHODS: We queried the NexisUni database(>15000 news sources indexed), for English-language articles about TV mesh or the FDA, published between 1 week before the ban (4/8/19) and 7/1/19. We excluded news ticker results and articles about mesh without mentioning FDA. Content analysis was based on discussion of the ban, mesh use indications, quoted sources, and mesh complications. The extent of media coverage of TV mesh was tracked using Google Trends. RESULTS: Of 290 news articles retrieved, 57 articles met inclusion criteria. The volume of news reports about TV mesh increased ∼ 400% the week of the FDA announcement, equal to twice the coverage anytime during the preceding year. Most articles focused on the regulatory effect of the ban (51 articles, 89%) and the implications on manufacturers (25 articles, 44%). Relatively few articles discussed the FDA’s prior actions on TV mesh for POP; only 18 (31%) and 13 (22%) articles cited the 2011 FDA Public Health Notification and 2016 Update, respectively. Regarding the indications for mesh surgery, the majority of articles either did not mention an indication for mesh surgery (17 articles, 30%) or discussed both POP and incontinence (16 articles, 28%). However, 45 (79%) articles did not specify that the ban applied only to POP and not incontinence, while 1 (2%) article stated this distinction incorrectly. A plurality of articles (26 articles, 46%) cited mesh-related complications (most commonly pain, bleeding, “permanent injury”), but only 6 (11%) articles quoted surgeons who use TV mesh, compared to 16 (28%) articles quoting lawyers. Despite evidence-based statements on mesh by 3 professional organizations including the AUA, only 1 (2%) article cited 1 statement (American Urogynecologic Society). CONCLUSIONS: The 2019 FDA ban on transvaginal mesh for POP received extensive media coverage, but 80% of articles did not accurately distinguish between the banned use of mesh for POP versus urinary incontinence. Given the prevalence of both conditions, the findings raise concern about patients’ perceptions of and future access to mesh surgery regardless of indication. Source of Funding: None © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e44-e45 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Shagnik Ray* More articles by this author Marisa Clifton More articles by this author Kevin Koo More articles by this author Expand All Advertisement PDF downloadLoading ...

The FDA authorization of direct-to-consumer genetic testing for three BRCA1/2 pathogenic variants: a twitter analysis of the public's response.

ObjectivesIn March 2018, the Food and Drug Administration (FDA) announced its authorization of a direct-to-consumer (DTC) genetic test for three pathogenic BRCA1/2 variants. We sought to determine to whether social media discussion increased following the authorization, who was driving social media conversations, and what topics were discussed.MethodsUsing Crimson Hexagon, we described tweets before, during, and after the FDA announcement authorizing 23andMe to return BRCA1/2 results (3/4/18–3/10/18). We conducted qualitative coding of a subset of 605 tweets to better understand Twitter communication.ResultsWe identified 11 055 twitter posts across the week of FDA’s announcement. Twitter discourse about 23andMe and the FDA authorization peaked the day following the FDA’s press release. Most tweets (48.6%) were informational and 26.3% were either expressing opinions (about 23andMe and/or FDA authorization, 14.9%) or testimonials (personal experiences with genetic testing, 11.4%). The types of tweets varied over the week-long period (P < .001).DiscussionTwitter discussion about the FDA’s authorization of DTC for three pathogenic BRCA1/2 variants increased immediately following the announcement. As more genetic technologies are brought to the DTC market, social media sites, like Twitter, will play a role in disseminating this information, providing a platform for information exchange, consumer testimonials, opinion pieces, and research.

When an FDA Drug Approval Makes Mainstream News: The Announcement of Zulresso, A Media Case Study

Media coverage following U.S. Food and Drug Administration (FDA) drug approvals is generally found in two sectors: bioindustry news and the financial markets. The March 19, 2019 FDA announcement of its approval of the postpartum anti-depression biopharmaceutical Zulresso from Sage Therapeutics also elicited unusually high levels of media response in the mainstream media. This case study (1) details the total media news response following the FDA approval announcement regarding Zulresso, (2) compares that media response with the mainstream media coverage for Aimovig, a Novartis and Amgen treatment, which received the most mainstream coverage in the group of 2018 FDA novel drug approvals, and (3) compares the media coverage for three recent FDA drug approvals, Mayzent, Dovato and Evenity, to demonstrate a normative media response pattern. Findings include demonstration of Zulresso coverage across all major mainstream media outlets, well in excess of its mainstream media comparator, Aimovig. The three recently-announced comparators received the anticipated media coverage in the bioindustry and financial markets segments, while the two mainstream candidates, Zulresso and Aimovig, both received more and/or more timely media coverage in the bioindustry and financial markets media sectors three recent drug approval comparators. No determination could be made as to whether the mainstream media response to Zulresso was a singular incident, or the signaling of a sea change due to the maturation of the biotechnology industry.

FDA Clears App to Help Retain Patients in Treatment for OUD

Experts in addiction and in digital technology say the app for opioid use disorder is an exciting development, but it remains to be seen if the technology will be widely used.

Anesthesia Exposure in Children: Practitioners Respond to the 2016 FDA Drug Safety Communication.

In December 2016, the US Food and Drug Administration (FDA) issued a drug safety warning stating that 11 commonly used anesthetic and sedative medications had potential neurotoxic effects when used in children under the age of 3 years and in pregnant women during the third trimester. A panel presentation at the sixth biennial Pediatric Anesthesia Neurodevelopmental Assessment (PANDA) symposium addressed the FDA announcement in a session entitled "Anesthesia Exposure in Children During Surgical and Non-Surgical Procedures: How Do We Respond to the 2016 FDA Drug Safety Communication?" Panelists included representatives from pediatric anesthesiology, obstetrics, pediatric surgery, and several pediatric surgical subspecialties. Each panelist was asked to address the following questions: How has the FDA labelling change affected your clinical practice including patient discussions, timing, and frequency of procedures? Has your professional society provided any guidelines for this discussion? Has there been any discussion of this topic at your national meetings? The panelists provided important perspectives specific to each specialty, which generated a lively discussion and a detailed response from the Deputy Director of the Division of Anesthesia and Addiction of the FDA describing the FDA procedures that led to this drug safety warning.

Too Much Carrot and Not Enough Stick in New Stem Cell Oversight Trends.

Regulators are now more often distinguishing between perceived good citizens and "bad actors" in stem cell and regenerative medicine clinical research, resulting in relatively more polar, carrot-and-stick oversight approaches. Here, I discuss why there may be too much carrot and not enough stick by regulators for effective enforcement.

FDA Starts Rulemaking to Slash Nicotine in Cigarettes

FDA Starts Rulemaking to Slash Nicotine in Cigarettes

Transvaginal mesh in the media following the 2011 US food and drug administration public health notification update.

Prompted by patients' changing perceptions of transvaginal mesh, this study examines how mesh has been reported in the news following the 2011 US Food and Drug Administration (FDA) updated notification about the use of mesh in the treatment of pelvic organ prolapse. Two national newspaper databases were queried for articles discussing transvaginal mesh published within 3 years of the FDA announcement. Content analysis included headline subjects, mesh-related complications, quoted sources, and the FDA recommendations. To determine whether more widely read sources publish higher quality reporting, a subgroup analysis was conducted based on newspaper circulation. Ninety-five articles met inclusion criteria. Mesh-related litigation was the most common headline subject (36 articles, 38%), and 54% of all articles referenced legal action. Fifty-seven articles (60%) cited at least one mesh-related complication. Only 18 articles (19%) quoted surgeons who use transvaginal mesh. For the FDA update, 40% of articles that first reported the announcement accurately specified that it applies to mesh for prolapse, not incontinence. This ambiguity persisted: half of all articles cited the warning, but only 23% distinguished between prolapse and incontinence. Higher newspaper circulation did not significantly improve the quality of reporting about the content or context of the FDA's recommendations. Despite frequent media coverage of transvaginal mesh and its complications since 2011, very few news sources that cited the FDA warning distinguished between prolapse and incontinence. Given prevalent reporting of mesh-related litigation, the findings raise concern about how patients perceive the safety and efficacy of transvaginal mesh, regardless of indication. Neurourol. Urodynam. 36:329-332, 2017. © 2015 Wiley Periodicals, Inc.

Evaluation of Patients' Perceptions of Mesh Usage in Female Pelvic Medicine and Reconstructive Surgery

To evaluate if new patients presenting to a female pelvic medicine and reconstructive surgery clinic are aware of the US Food and Drug Administration (FDA) announcement regarding transvaginal mesh placement for pelvic organ prolapse repair and do they believe there is a mesh recall. A voluntary anonymous 25-question survey was administered to new-clinic patients. Participants were aged at least 18years and had either urinary incontinence or pelvic organ prolapse. Appropriate statistical tests were performed for continuous and categorical variables. Logistic regression was used for univariate and multivariable analysis. Significance was considered for Pvalues<.05. Two hundred fourteen surveys were included for final analysis. Of the 214 patients, 157 (73.4%) had urinary incontinence as their sole presentation. Of 204 patients, 126 (61.8%) were aware the FDA-released information regarding mesh use in transvaginal surgery, and 88 of 169 (52%) believed there is a "recall" on mesh being used for transvaginal surgery. Of 156 patients, 108 (69.2%) listed television as a source of information. On multivariable analysis, television as a source was significantly associated with awareness of the FDA announcement (odds ratio, 7.12; 95% confidence interval, 2.69-18.84; P= .0001) and belief in a "recall" (odds ratio, 3.01; 95% confidence interval, 1.28-7.06; P= .01). Although almost 2 of 3 participants were aware of the FDA announcement, more than half falsely believed there was a recall. Television was significantly associated with both awareness of the FDA announcement and belief in a recall suggesting patients derive most of their perceptions from the television.

Addressing the evidence for FDA nicotine replacement therapy label changes: a policy statement of the Association for the Treatment of Tobacco use and Dependence and the Society for Research on Nicotine and Tobacco.

Cigarette smoking creates a substantial public health burden. Identifying new, effective smoking cessation interventions that optimize existing interventions and promoting effective use of approved medications is a priority. When used as directed, nicotine replacement therapy (NRT) aids smoking cessation, but there is opportunity for improving its effectiveness. Until recently, NRT use guidelines advised smokers to begin using NRT on their quit date, only to use 1 NRT formulation at a time, to refrain from using NRT while smoking, and to stop NRT within 3 months regardless of progress. The Food and Drug Administration (FDA) issued a recent announcement allowing for NRT labeling changes with applications from pharmaceutical companies for such changes, and we applaud this decision. Nevertheless, additional revisions are warranted by current research. There is robust evidence that combining a longer-acting form (e.g., patch) with a shorter-acting form (e.g., lozenge) is more effective than NRT monotherapy and is safe. Moreover, extant evidence suggests that NRT use prior to a quit attempt or for smoking reduction as part of a quit attempt is safe and as effective as starting NRT on quit date. Specifically, prequit nicotine patch increases quit rates and may engage additional recalcitrant smokers. Last, NRT use longer than 3 months is safe and may be beneficial for relapse prevention in some smokers. This report summarizes the FDA announcement, reviews the evidence for further revisions to current FDA NRT guidelines, and makes recommendations for over-the-counter (OTC) NRT labeling to allow for (1) combined use of faster-acting NRT medications with nicotine patch, (2) nicotine patch use prior to quit date or NRT for smoking reduction as part of a quit attempt, and (3) prolonged NRT for up to 6 months without healthcare provider consultation.

PD33-08 PROSPECTIVE EVALUATION OF PATIENTS' KNOWLEDGE AND PERCEPTIONS OF MESH

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Female Urology I1 Apr 2014PD33-08 PROSPECTIVE EVALUATION OF PATIENTS' KNOWLEDGE AND PERCEPTIONS OF MESH Christopher F. Tenggardjaja, Sandip Vasavada, Courtenay Moore, and Howard B. Goldman Christopher F. TenggardjajaChristopher F. Tenggardjaja More articles by this author , Sandip VasavadaSandip Vasavada More articles by this author , Courtenay MooreCourtenay Moore More articles by this author , and Howard B. GoldmanHoward B. Goldman More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.2291AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES In 2011, the U.S. Food and Drug Administration (FDA) released an updated safety communication regarding the use of transvaginal mesh for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Many patients appear to have misconceptions regarding the use of synthetic mesh. The objective of this study was to evaluate patients’ understanding regarding the use of mesh in female reconstructive surgery. METHODS A 25 question based survey was prospectively administered to new female patients presenting to a single academic institution specialty clinic. Patients were invited to participate if they were being seen for either SUI or POP. Established patients were excluded from participation. Demographics and responses were recorded and analyzed using Chi-square and Fisher’s exact. RESULTS Surveys were administered to patients from March 2013 to November 2013. A total of 208 surveys were collected. The typical presenting patient was 60 years old, Caucasian (87%), married (62%), with at least a high school education (97%) and not currently employed (59%). The majority of patients (62%) surveyed were being evaluated for urinary incontinence which had not been previously treated. Patients were not necessarily aware of different types of incontinence. 104 patients (70%) obtained most of their information about mesh from television. The majority of patients said they were unsure if mesh used for SUI was different from that used for POP (65%), were aware of the FDA safety communication (61%), and believed there was a recall of mesh (50%). In patients who were aware of the FDA announcement, 58% believed there was a recall (p=0.03). For patients who were unsure about different types of mesh use in SUI/POP surgery, they were also unsure or more likely to believe there was a recall (p<0.001). Patients exhibited a bimodal distribution when asked about their anxiety and concern about mesh use. CONCLUSIONS The majority of new patients presenting to a specialty female pelvic medicine clinic derive most of their information about mesh from television. Interestingly, those aware of the FDA statement associated this with a recall of transvaginal mesh even though patients were not aware of different mesh types for prolapse or incontinence repair. Furthermore, while 24% of patients had significant concerns about mesh use during surgery, many did not. Based on this study, physicians should educate patients about any misconceptions concerning the use of mesh in female urologic surgery when counseling on treatment for POP or SUI. © 2014FiguresReferencesRelatedDetailsCited byPolland A, Meckel K and Trop C (2015) Incidence of Placement and Removal or Revision of Transvaginal Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence in the Ambulatory Setting before and after the 2011 Food and Drug Administration NotificationUrology Practice, VOL. 2, NO. 4, (160-164), Online publication date: 1-Jul-2015. Volume 191Issue 4SApril 2014Page: e843-e844 Peer Review Report Advertisement Copyright & Permissions© 2014MetricsAuthor Information Christopher F. Tenggardjaja More articles by this author Sandip Vasavada More articles by this author Courtenay Moore More articles by this author Howard B. Goldman More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

FDA Warning Highlights Mefloquine’s Mental Health Risks

FDA Warning Highlights Mefloquine’s Mental Health Risks

Estimating the value of internet marketing in the US pharmaceutical industry

On 2 April 2009 the Food and Drug Administration (FDA) released warning letters to 14 major pharmaceutical companies about search engine advertising, effectively curtailing an aspect of internet marketing by pharmaceutical industry. These warning letters were posted to the public on 3 April 2009. Given that the efficient market hypotheses suggest that stock prices fully reflect all publicly available information and are unbiased indicators of firm value, this article presents an analysis of stock market reactions of pharmaceutical firms around the time of the FDA announcement, using both regular and abnormal returns. We analyze two groups of firms, those that received the warning letters and those that did not receive the letters. We find significantly negative stock market reaction for both groups of firms, suggesting that the letters had negative impact on shareholder’s value to the industry as a whole. The results indicate that internet marketing is important, and thus it is imperative that the industry works in tandem with the FDA to develop better guidelines on the appropriate use of the internet for the marketing of pharmaceuticals. The cost for pharmaceutical firms for not utilizing the internet capabilities to communicate value to the stakeholders can be significant.