Jessica R. Walter

Therapeutic transdermal drug innovation from 2000 to 2014: current status and outlook

The US Food and Drug Administration (FDA) approved the first transdermal drug over 35 years ago. Today, transdermal products represent a growing, multibillion dollar market. From 2000 to 2014, an average of 2.6 new transdermal drug were approved each year. However, only two of these approvals represented new molecular entities (NMEs). Furthermore, none of these approvals were designated for priority review by the FDA. Currently, transdermal drugs are limited in scope to fewer than 20 clinical indications. The past decade has seen significant safety, performance, and cost issues surrounding multiple transdermal drug products. As the field moves towards more complex drug-device combinations to overcome the natural barrier function of the skin, there will likely be more regulatory challenges, but also the potential for broader clinical scope.

A Call for Fertility Preservation Coverage for Breast Cancer Patients: The Cost of Consistency

In 1998, the passage of the Womens Health and Cancer Rights Act required insurance health plans nationwide covering breast cancer treatments to also reimburse for subsequent breast reconstructive surgery and prostheses. In response to low utilization of breast reconstructive services, particularly among racial minorities, plastic surgery interest groups successfully advocated for the passage of the Breast Cancer Patient Education Act, which provides a timely opportunity to reconsider patient accessibility to other equally important quality of life issues for cancer survivors. Currently, the potential threat of infertility as a consequence of cancer therapy does not meet preexisting definitions of infertility, making preemptive fertility preservation elective. Ultimately, cost remains the largest barrier to the pursuit of fertility preservation. In this Commentary, we estimate the potential additive cost of providing fertility preservation coverage for approximately 19 000 eligible women of reproductive age diagnosed with breast cancer based on previously published prevalence and cost data. We determine an upper limit of yearly cost of

Topical Drug Innovation From 2000 Through 2014.

126.6 million US dollars assuming 100% participation. Legislation providing mandatory insurance coverage of breast reconstruction surgeries in all 50 states following cancer treatment represents a powerful policy commitment to address existing health disparities in reproductive health services and ensures comprehensive cancer survivorship care. Extending coverage for fertility preservation in the setting of fertility-threatening treatment offers a consistent stance for insurance coverage of iatrogenic sequelae of cancer therapy at a fraction of the cost of breast reconstruction.

Overview of high-risk medical device recalls in obstetrics and gynecology from 2002 through 2016: implications for device safety

larization was noted on the melasma lesions at baseline compared with perilesional skin using VISIA-CR RBX Red subsurface analysis and laser confocal microscopy. However, no decrease in vascularization was observed on the laser-treated side between the baseline and posttreatment visits. At the final visit, no changes in vascularization were noted between the 2 sides. No scarring or postinflammatory hyperpigmentation was noted.

Reducing FDA Regulations for Medical Devices: Cutting Red Tape or Putting Patients’ Lives at Risk?

&NA; The field of womens health has endured numerous recent controversies involving medical devices such as pelvic meshes, laparoscopic morcellators, and a hysteroscopic sterilization device. With the recent passage of the 21st Century Cures Act, new legislation will change how the Food and Drug Administration regulates medical devices. Given these controversies and new changes, we investigated high‐risk, class I recalls in womens health from 2002 through 2016. Class I recalls for medical devices are defined by the Food and Drug Administration as the most serious recall events and are designated for situations when there is a reasonable probability of serious adverse health consequences or death. We defined a recall event as a group of unique Food and Drug Administration recalls that share a similar reason for recall and occurred within a 1‐month time frame. In total, 7 class I recall events were identified encompassing 83 unique recalls affecting >88,000 medical devices in distribution. Recalls involved a broad range of devices used in womens health including diagnostic assays for chlamydia and gonorrhea, a laparoscopic tissue morcellator, and obstetrical/gynecological surgical kits. Four of 7 (57%) recall events were due to postmarketing problems such as improper packaging and labeling while the remaining 3 (43%) recalls were due to premarketing problems (eg, software issues). Additionally, 3 of 7 (43%) recall events were cleared via the 510(k) pathway, while the remaining were essentially exempt from any form of premarket approval. Two recall events involved sterility concerns of 71 surgical kits used in obstetrics and gynecological surgeries representing the majority of affected devices (78,423) in distribution. Class I medical device recalls are rare but serious events. Most recalled devices in womens health had minimal preapproval regulation and were recalled due to both premarketing and postmarketing reasons. Future regulatory efforts to improve postmarketing surveillance may mitigate the potential impact and frequency of class I recalls, but do not replace the need for a higher burden of proof for both safety and efficacy prior to medical device approval.

Patient-Reported Online Satisfaction for Laser and Light Procedures: Need for Caution.

Department of Ophthalmology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Feinberg School of Medicine, Northwestern University, Chicago, IL, USA; Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Center for Bio-Integrated Electronics, Northwestern University, Chicago, IL, USA

Retrospective Study of the FDA Database for High Risk Medical Device Approvals in Obstetrics & Gynecology [8E]

a local infection. Rare reported side effects are foreign body granuloma and thromboembolism. None of these side effects were noted in our patient. Delayed gel induration, one of the major complications of polyacrylamide filler which generally occurs between 10 and 28months after treatment, was not seen in our patient, even after 9-years of follow-up. Hence, we suggest that polyacrylamide hydrogel dermal filler can be considered as a relatively economical therapeutic option to correct the large subcutaneous defects in selected cases of lipoatrophy secondary to lupuspanniculitis, after adetailed discussion and counseling of the patient.

Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015

INTRODUCTION: The newly proposed 21st Century Cures Act would lead to significant changes to medical device regulation. Recent controversies surrounding pelvic meshes and morcellators highlight the need for better understanding surrounding the regulation and approval of high-risk devices in Obstetrics and Gynecology (OBGYN). METHODS: The FDA database was reviewed for device approvals assigned to the OBGYN advisory committee along the pre-market approval pathway from 2000–2015. The quality of the pivotal studies leading to approval were extracted from the summary of safety and effectiveness data. RESULTS: There were 18 approvals between 2000–2015. The OBGYN advisory committee recommended nine devices for approval and recommended against approval for two devices. Seven devices were not referred for formal review. Three devices have been withdrawn following approval, all of which were either not referred or initially rejected by the committee. Four devices were granted expedited status. The median approval time was 290 days (range 178–1,399). Indications included endometrial ablation (33%), contraception (28%) and fetal monitoring (17%). In total, there were 11 randomized controlled trials, one randomized cross-over study, five non-randomized prospective studies and two human factor studies. 13 of 18 devices required post-market surveillance. CONCLUSION: Compared to other medical specialties, OBGYN ranked 9th out of 17 specialties in high-risk device approvals from 2000–2015. These devices were more likely to be approved based on RCTs compared to prior studies on Cardiology and Gastroenterology devices. The last six years have led to only one device approval suggesting the need to spur device innovation in OBGYN.