Saturday, March 28, 2015

FDA Hearing- March 27, 2015 (with webcast links)

On March 5, the American Association for Justice (AAJ) contacted me and they invited me to testify at an FDA Hearing on March 27. The hearing centered around closing the loophole caused by the Pliva v. Mensing Supreme Court decision, which states that generic drug makers cannot be held responsible for the damage their medications cause.

Generic medications make up 80% of all prescriptions filled in the United States. But generic drug manufacturers are not allowed to independently update their labels to warn of newly discovered side effects. And they can't be held accountable if their drugs injure or kill.

The FDA has proposed a plan to fix the problem, but the generic drug industry is lobbying against it. The plan has already been delayed once, and it could be delayed again. This is why we were asked to testify at the FDA Hearing, so we could speak for everyone who took generic medication and were damaged by it. We went there to publicly call on the FDA to move forward in ensuring all prescription medications, including generic drugs, carry current and accurate safety warnings, because safety is an issue that cannot wait. Both brand name and generic manufacturers should be held accountable for the safety of their products.

Originally, we were supposed to speak at a Congressional Hearing on March 26 but the AAJ needed to prep us for the FDA Hearing and there wasn't time to prep us for both hearings. Representatives from the AAJ attended the Congressional Hearing and we are told that it went very well.

On March 26, I arrived at the Sheraton in Silver Spring, Maryland. At 5PM, we attended the prep meeting with Rose Hernandez, Michelle Kimmel, Sarah Rooney, and Ben Somberg from the American Association for Justice.

I had the pleasure of meeting Lisa Bloomquist, who also traveled to Maryland to testify at the FDA. Lisa and I were there to testify to represent the fluoroquinolone community. QVF Ambassador Jonathan Furman joined us- at his own expense- to help Lisa and I. He was a big help and I appreciate that he sacrificed his time to help us.

At the prep meeting, we met many others who were affected by generic medications. The stories were heartbreaking.

There was Emily, who lost her infant son after she took a generic medication she was told was safe during pregnancy.

Diana, who needed part of her arm amputated.

Anthony, whose life partner of almost 40 years deteriorated so much after taking generic Reglan that he resides in a nursing home and needs round the clock care.

Taylor, who is now 16 years old and lives with life threatening blood clots since she was 13. She almost died and has had over a dozen surgeries. She still lives with blood clots in her lungs.

Keith, whose child has Spina Bifida. He and his wife can barely afford medical care and relies on welfare to get by.

We then practiced our testimony.

Here is Lisa practicing hers. She did a fantastic job.

Here is me practicing mine.

The FDA Hearing was held in Building 31, Room 1503 at the Food and Drug Administration on March 27.

We went through security (where the metal plates and screws I have in my body set off the metal detectors and I had to show my medical devices card), and then checked in to get our FDA Speaker badges.

Here is the meeting agenda:

Because the hearing was running early, I testified at approximately 3PM instead of the scheduled 3:52PM time slot.

This was my testimony. It was accompanied by a Power Point presentation. The clicker to control it was broken so an official with the FDA had to click through the slides for me.

*UPDATE: April 6, 2015 9:30AM: 
Webcast of the FDA Hearing can be found here:
Part 1 Lisa Bloomquist is the first speaker.
Part 2
Part 3
Part 4
I am the third speaker.

"My name is Rachel Brummert. I am Executive Director of Quinolone Vigilance Foundation, a non-profit research and advocacy organization. My travel expenses were paid by the American Association for Justice.

In my work, I hear many stories from people who have been injured and disabled after taking generic fluoroquinolone antibiotics, such as levofloxacin, ciprofloxacin, and moxifloxacin. As someone who suffered injury myself, I am here to talk about my personal experience with levofloxacin.

In 2006, I was prescribed Levaquin to treat a suspected sinus infection.

A few days after I took it, I felt a burning sensation in my hands and feet. By the following week, my left foot went numb, and to this day, it is still numb.

I have ruptured nine tendons. My Achilles tendon once in my right foot, twice in my left foot, and I ruptured tendons in my right wrist, right elbow, left thumb, left ring finger, and both knees.

While surgery fixed the tendons, anything that is operated on on will never be the same and for the last nine years and counting, I have been in pain every day.

Routine tasks are difficult for me. A few years later I have also been diagnosed with a neurodegenerative disease after taking levofloxacin while I was in the hospital. I have lost a large portion of my short term memory and I continue to lose more long term memory every day.

My cognitive and motor function will continue to decline until I am no longer able to take care of myself.

The damage caused by medications I took was more than just financial hardship.

I can no longer afford my home because of increasingly skyrocketing medical expenses and surgeries and I was forced to move. I lost my career that I loved with immeasurable passion and lost good income.

It also has taken an emotional toll on my family who are forced to take on the role of caretakers as I continue to decline.

In addition to being here to tell my own account of how I was injured by a generic medication, I am also here to tell the stories of others who were supposed to be here today, and can't.

Greg Spooner, a husband and father of two, was a healthy, athletic college professor in California.

He took ciprofloxacin in February 2010 for a suspected minor infection. He lost his job of more than 18 years after becoming disabled and he lost his home, forcing him to move.

He has had surgery to repair the damage and he needs more, which he cannot afford right now. He has joint pain, tendon pain, and nerve pain every day and it makes it difficult for him to do routine tasks and play with his young children.

Because he took a generic, no one is accountable for his injuries.

Jeff Stephens is 44 years old and lives in Georgia. He was going to be here today to tell his story, and he can't be because he is so sick and the trip here could kill him.

He took levofloxacin for a suspected sinus infection in January 2013.

He was a world traveler, and had a great job for over 20 years. He is now disabled after taking the generic levofloxacin.

He lost his job after he became disabled and he can no longer afford medical treatments. His parents are hemorrhaging their retirement money to help him pay for treatments and food. He cannot walk unassisted and frequently uses a wheelchair.

He was a healthy man until he took generic Levaquin. Because he took a generic medication, he has been denied justice after suffering severe brain damage, heart palpitations, shortness of breath, musculoskeletal problems, gastric problems, neuropathy, insomnia, and over 20 other adverse reactions.

I am urging the FDA to finalize the rule as it is written. 

This proposed rule will ensure that generic drug companies are responsible for warning the public of the risks involved in taking the medications they sell so that others do not suffer the same way that everyone who testified today has suffered.

Those of us who are here today, despite our suffering, are only a handful of the people who have been irreparably harmed. Those injured by generic drugs have suffered the same injuries and disabilities as those who took brand name medications and justice has been denied because of the current generic drug safety loophole.

The FDA has the power and responsibility to ensure patients are warned and to promote safety by making sure generic drug makers are accountable for their products just as brand name-drug makers are. If this rule is not finalized quickly, it is only adding injury to injury and leaving patients at risk.

Thank you for your time and consideration."

The generic drug industry also had the opportunity to testify. I was not present for that but I was told by people who were that the FDA panel aggressively grilled them and called them out on the misinformation they testified to.

When I was testifying, and I noticed when other victims testified that the FDA panel was paying very close attention to our testimonies.

It was an honor to have been asked to testify and working with the American Association for Justice was an amazing experience.

The AAJ is petitioning the FDA to close the generic drug loophole. To show your support and urge the FDA to finalize the proposed rule as it is written and to do it quickly before more people are hurt or killed, please sign this petition and share it with everyone you know.

Rachel Brummert
President/Executive Director
Quinolone Vigilance Foundation

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