Comments on Internet/Social Media Platforms Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

October 29, 2014. We welcome the opportunity to provide feedback on this draft guidance regarding use of internet and social media platforms for communicating about medical products. Patients and consumers increasingly rely on social media and the internet as sources of health and medical information that influence their decisions to seek medical care. Continue reading

Statement of Diana Zuckerman, PhD at FDA Joint Public Advisory Committee Meeting on Chantix

October 16, 2014. We strongly urge you to urge the FDA to keep the black box warning to protect patients and that you strengthen rather than weaken that boxed warning. And, since the meta analyses are fatally flawed, as I and others have pointed out, the FDA should delete the misleading meta-analyses info from the Chantix label. Continue reading

Comments on Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications

October 14, 2014. We oppose the draft guidance as written and strongly urge the FDA to rewrite it. The current draft guidance relies on vague wording and subjective judgments, not science or technological assessments. When it is more specific, it promotes the use of surrogate endpoints and the risk tolerance of a small number of patients whose views come to the FDA’s attention. Continue reading

Testimony of Dr. Christina Silcox Before the FDA Advisory Panel on the Device Classification of More-than-Minimally Manipulated (MMM) Allograft Heart Valves

Oct. 9, 2014. We support the FDA’s recommendation that More-than-Minimally Manipulated (MMM) Allograft Heart Valves be classified as Class 3 devices and therefore subject to the premarket approval process. All other types of heart valves under the oversight of the Center for Devices and Radiological Health at the FDA are classified as class 3. There is no reason that these heart valves should be an exception. Continue reading

Testimony of Dr. Christina Silcox Before the FDA Advisory Panel on the WATCHMAN™ Left Atrial Appendage Closure Device

Oct. 8, 2014. We all know that AF patients are at high risk of ischemic stroke. Warfarin is well-established as an effective treatment, and other new therapies provide safe and effective alternatives. Any new treatment should show clear evidence that the benefits outweigh the risks.

Like many of you, we are skeptical that the Watchman device achieves that goal. The PREVAIL trial shows that the Watchman device is inferior to warfarin for 2 of the 3 primary endpoints. Ischemic strokes and systemic embolisms occurred at higher rates in the Watchman group compared to the control group. Continue reading

Comments on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

We strongly urge the FDA to reassess the Submission Type for certain medical devices and continue to require 510(K) clearance due to the high number of MAUDE reports, including numerous deaths from these devices. Devices that can cause fatal adverse events should not be exempt from FDA regulation. Continue reading

Testimony before the Joint Meeting for Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee

September 17, 2014. From 2010 to 2013, the number of patients receiving testosterone prescriptions increased from 1.3 million to 2.3 million. That means a large and growing number of patients may be at-risk for major adverse events due to TRT. At the same time, it is not clear what percentage of the men taking TRT actually need it for medical reasons. Continue reading