FDA Advocacy

Women and the Opioids Epidemic: The Need for a Woman-Centered Response

By NWHN Staff | Jun 18, 2019 | Comments Off on Women and the Opioids Epidemic: The Need for a Woman-Centered Response

Opioid dependency is a bodily adaptation that is likely to disproportionately affect women, because they are more likely to develop opioid dependency in a shorter period of time, compared to men.

An Open Letter to FDA’s New Commissioner

By Cindy Pearson | May 14, 2019 | Comments Off on An Open Letter to FDA’s New Commissioner

The public pays for more than half of the FDA’s budget each year, which entitles us to have a say in the agency’s operations. Late last year, we gave your predecessor, Scott Gottlieb, a report card on his first year as Commissioner—he got mixed grades. Here’s what you could do to get all A’s on your report card.

The NWHN’s Statement on the FDA Ordering Manufacturers of Surgical Mesh to Stop Selling Devices for Uterine Prolapse

By Cindy Pearson | Apr 16, 2019 | Comments Off on The NWHN’s Statement on the FDA Ordering Manufacturers of Surgical Mesh to Stop Selling Devices for Uterine Prolapse

FOR IMMEDIATE RELEASE Contact: Evita Almassi, ealmassi@nwhn.org or (202) 682-6240

FDA General and Plastic Surgery Devices Panel Meeting on Breast Implant Safety

By Tessa Ruff | Apr 15, 2019 | Comments Off on FDA General and Plastic Surgery Devices Panel Meeting on Breast Implant Safety

Earlier in March, the FDA sent warning letters to two breast implant manufacturers, Mentor and Sientra, citing their failure to conduct safety studies after approval. In Australia and France, authorities have been pulling textured implants off the market due to the risk of cancer.

The NWHN’s Statement on the FDA Ordering Sprout Pharmaceuticals to Retain Black Box Label Warning Women Not Mix Addyi and Alcohol

By Cindy Pearson | Apr 12, 2019 | Comments Off on The NWHN’s Statement on the FDA Ordering Sprout Pharmaceuticals to Retain Black Box Label Warning Women Not Mix Addyi and Alcohol

FOR IMMEDIATE RELEASE Contact: Evita Almassi, ealmassi@nwhn.org
or (202) 682-6240

NWHN Statement in Response to the FDA’s Action Against Aid Access

By Cindy Pearson | Mar 12, 2019 | Comments Off on NWHN Statement in Response to the FDA’s Action Against Aid Access

FOR IMMEDIATE RELEASE Contact: Evita Almassi, ealmassi@nwhn.org or (202) 682-6240

The NWHN’s Statement on the Resignation of FDA Commissioner Scott Gottlieb 

By Cindy Pearson | Mar 5, 2019 | Comments Off on The NWHN’s Statement on the Resignation of FDA Commissioner Scott Gottlieb 

FOR IMMEDIATE RELEASE Contact: Evita Almassi, ealmassi@nwhn.org or (202) 682-6240

The NWHN Testifies for the Use of Better Evidence at the FDA

By Tessa Ruff | Feb 27, 2019 | Comments Off on The NWHN Testifies for the Use of Better Evidence at the FDA

In 2016, the FDA reclassified transvaginal mesh used to repair pelvic organ prolapse (POP) as a Class III device—the highest risk category—in response to over 20,000 adverse event reports during a three-year period alone.

Taking on Gender Bias in Clinical Trials

By NWHN Staff | Feb 26, 2019 | Comments Off on Taking on Gender Bias in Clinical Trials

We have made progress as a country, but there is still work to be done. Clinical trials need to broaden their subject base and do a better job of representing all affected parties for the sake of equality and the generation of more rational, insightful data. Patients and healthcare professionals need great transparency and “accurate information about the medical products available to them.”

FDA Meeting – Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse 

By Cindy Pearson | Feb 12, 2019 | Comments Off on FDA Meeting – Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse 

Testimony Delivered at the Meeting of the FDA Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee