Testimony of Dr. Laurén Doamekpor Before the FDA Advisory Panel on Chantix

The sponsor identified 5 observational studies and 2 meta-analysis studies showing no statistically significant differences in various psychiatric adverse effects between Chantix and other smoking cessation drugs. The sponsor suggests that this evidence supports the removal of the boxed warning for serious psychiatric adverse events. From a scientific and public health standpoint, these studies do not provide an assurance of safety that patients need and deserve. We strongly urge you to recommend that the FDA keep a strongly worded black box warning and delete the misleading conclusions regarding the meta-analyses 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 We oppose the draft guidance as written and strongly urge the FDA to rewrite it. The current draft guidance relies on vague wording and subjective judgments, not science or technological assessments.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

Chantix Citizen Petition

Five leading nonprofit consumer, research and medical organizations identified below petition the Food and Drug Administration (FDA) pursuant to the Food, Drug, and Cosmetic Act 21 USC 352, 505(o)(4), and 21 CFR 10.30 to take action to improve the safety information included in the label for CHANTIX® (varenicline) tablets , a smoking cessation aid approved under NDA 021-928. 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

Letter to Senator Waxman Expressing Concerns About Speeding Up the Development of New Antibiotic Drugs (ADAPT Act)

September 18, 2014. We are writing to express our strong concerns about proposed legislation to speed the development of new antibiotic drugs, H.R. 3742, the Antibiotic Development to Advance Patient Treatment (ADAPT) Act of 2013. Antibiotic resistance is of grave concern, but this legislation will create more problems than it will solve. Continue reading