Decision on rare-disease drug sparked major controversy, seen as marking new direction at FDA

The decision to ignore the FDA Advisory Committee and approve the drug based on inadequate evidence is concerning given the shift in political power and passage of the 21st Century Cures bill, leading to deregulation that could be at the expense of patient safety. Continue reading

To fund projects like the Cancer Moonshot, Congress had to strip away some of the FDA’s most important regulatory powers

The 21st Century Cures Act passed in the House, but comes with a lot of regulatory compromise and threats to patient safety. Most notably, Senator Warren and Senator Sanders oppose the bill along with NCHR President Diana Zuckerman due to patient safety concerns and breaks for Big Pharma. “It really is a David and Goliath issue of where the money is,” said Dr. Zuckerman. Continue reading

Whistleblower case contends surgical device maker misled FDA — and patients paid the price

Jerome Lew is a Hollywood screenwriter, and what happened to him could have come straight out of a horror film.

In 2009, Lew went to UCLA Medical Center for surgery to relieve numbness and pain in his hands. The operation appeared to be a success. But he later began having trouble speaking. His left eye drooped. He developed severe nerve pain and weakness in his neck, arms, and hands. Continue reading

What’s on the Table for the July US-EU Talks Beginning Today?

By Celia Wexler, Who.What.Why. July 11, 2016 EU Trade Commissioner Cecilia Malmström listed several priorities for the European Union when it resumes trade negotiations with the United States on July 11. They include: […] • Greater regulatory cooperation for prescription drugs and medical … Continue reading

National Center for Health Research Joins Other Safety Advocates to Applaud IKEA Recall, Emphasize Need for Consumer Awareness

June 28, 2016 On June 28, 2016 the Consumer Product Safety Commission (CPSC) and IKEA announced the recall of 29 million IKEA Malm dressers responsible for the deaths of three toddlers in tip-over accidents. IKEA has agreed to immediately stop selling … Continue reading

NCHR Testimony at Public Meeting #3 of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria

June 21, 2016 – NCHR is not convinced that strategies to encourage the private sector to solve the problem of new antibiotic development make sense, because there is an inherent conflict between a company’s investment to develop new antibiotics for targeted populations and the public health need to prevent wide-spread use of those drugs. Continue reading

Could this implant be the new weapon against opioid, heroin addiction?

Miami Herald, May 24, 2016. WASHINGTON—The U.S. Food and Drug Administration is expected to decide this week whether to approve a new weapon in the war against heroin and prescription opioid addiction. The Probuphine implant by Braeburn Pharmaceuticals of Princeton, NJ, would be the first FDA-approved implant for opioid dependence and the longest-acting treatment to address the growing problem. Continue reading

NCHR testimony at 2016 FDA workshop on drugs and biological products used during lactation

April 28, 2016 – More clinical studies are desperately needed to determine the safety of drugs in lactating mothers. When these studies are in the planning stages, be cognizant of enrolling mothers that represent a wide diversity of races, ethnicities, and–when appropriate for the drug–ages. Continue reading

Eteplirsen for Duchenne Muscular Dystrophy, Dr. Laura Gottschalk’s Statement at FDA, April 25, 2016

April 25, 2016 – U.S. law requires evidence of safety and effectiveness. The burden of proof lies with Sarepta. If this drug actually works, then Sarepta has failed itself, the patients, and their families, by not conducting a better study that could provide convincing evidence showing that it works. Continue reading

NCHR testimony at 2016 FDA meeting on rociletinib

April 12, 2016 – We realize that there is currently an unmet need for a drug to treat patients whose NSCLC has become resistant to first line TKI therapies via the T790M mutation. However, this does not warrant the approval of yet another drug that will not significantly improve outcomes for these patients. Fortunately, there is hope on the horizon, because the preliminary results for osimertinib for the same patients appears to be much more effective with fewer serious side effects. Continue reading

Comments of members of the Patient, Consumer, and Public Health Coalition on “Drug Interactions with Hormonal Contraceptives: Public Health and Drug Development Implications”

As members of the Patient, Consumer, and Public Health Coalition, we support FDA’s effort to better characterize drug interactions with hormonal contraceptives since reliable and accurate information is necessary to ensure women’s health. In particular, we recommend clinical evaluation of drug interactions for all drugs that are likely to be used in women of reproductive age and that have the potential to cause birth defects, in addition to improving the quality and usefulness of information in FDA-approved labeling. Continue reading

FDA revisits safety of the Essure contraceptive device

NPR, 2015: Many women rely on birth control throughout their lives to prevent unwanted or untimely pregnancies. The Essure contraceptive device is placed in the fallopian tubes essentially sterilizing the woman. This alternative to traditional sterilization methods has caused immense harm to many women and provoked strong responses from patient advocacy organizations and professionals in the health care industry. Continue reading

F.B.I. investigates whether harm from surgical power tool was ignored

The New York Times, May 27, 2015. The Federal Bureau of Investigation has begun looking into whether medical device makers, doctors and hospitals broke the law by failing to report problems linked to a power tool used during gynecologic surgery, according to two people who said they were interviewed by investigators. Continue reading

Testimony on Generic Drug Labeling before FDA by Dr. Anna E. Mazzucco

March 27, 2015 – The current situation creates a terrible double standard, making patient with generic drugs second class citizens. And, when brand name drug manufacturers leave the market after generics become available, nobody is held responsible for updating the label. This is completely unacceptable. Continue reading

Testimony of Dr. Margaret Dayhoff-Brannigan on the Dietary Guidelines Advisory Committee’s report

March 24, 2015 – We strongly agree with the Dietary Guidelines Advisory Committee’s report of a healthy diet as one that is: higher in fruits, vegetables, whole grains, low-fat dairy, seafood, legumes, and nuts; lower in red and processed meats; low in sugar-sweetened foods and drinks; and lower in sodium. Continue reading