John Fratti: FDA Advocate for Levaquin and Drug Safety

Hershey, PAJohn Fratti has been actively involved with Levaquin and other fluoroquinolone drugs since he was injured by Levaquin. Lawyers and Settlements first spoke with Mr. Fratti in July 2009. He is now a part-time government employee at the Food and Drug Administration as an "FDA Patient Representative for Drug Safety and Risk Management."

Fratti says he got the job by contacting the Office of Special Health Issues. "A doctor at the FDA arranged a meeting with several other FDA doctors this past July," he explains. "Two of those doctors feel that fluoroquinolone toxicity is a very legitimate issue that needs to be addressed. These doctors helped me write recommendations to the agency regarding Levaquin and other fluoroquinolones." (The FDA mandated a black-box warning for Levaquin in July 2008.)

Fratti had training to be a FDA Patient Representative, which explained what it is like to be on an advisory committee meeting. FDA Patient Reps represent the consumer perspective on issues and actions before the advisory committee and they are considered a "Voice for the Voiceless."

"I have an intermittent part-time position on FDA advisory committees when drugs or medical devices are at issue," says Fratti. "I have a vote, along with other medical people such as doctors, nurses, chemists, etc., about whether to keep a drug or medical device on the market, keep on the market with certain restrictions, or have it withdrawn. The FDA mails Patient Reps information to study at home. Supposedly the FDA "Safe Use" initiative is considering the recommendations for fluoroquinolones. I'm not sure how seriously they take me.

"I am scheduled to return to the FDA headquarters in Silver Spring, Maryland, next month for a "Safe Use meeting" and fluoroquinolones are registered as a topic for discussion. I hope to feel well enough to make it to the meeting, which is open to the public. My sister lives close to the FDA in Maryland which is helpful.…"

Fratti also went out on a limb and bought $3,000 dollars worth of Johnson & Johnson stock, which gives him proxy rights. "I went to the J & J annual shareholder meetings in 2009 and 2010 to ask the CEO to add further safety warnings for Levaquin," says Fratti, who wasn't the first fluoroquinolone victim to buy stock with this intent.

"One other injured person bought stock in J & J and attended the shareholder meeting the previous year," adds Fratti. "He received a standing ovation from J & J shareholders after his speech. At the 2010 meeting, I asked the J & J CEO to engage in research to help people who have been injured and disabled from Levaquin—research that is needed to help those injured try and regain some of their lost health. I feel that many of the shareholders are conscientious but the CEO and Board of Directors are not—they simply believe in profits over people.

"The reason I have this position with the FDA is to try and advance my advocacy with Levaquin and fluoroquinolones. My goal is to make sure people have informed consent and better disclosure about the potential irreversible damage from Levaquin and other fluoroquinolones. Other classes of antibiotics should be used before this class of drugs. Fluoroquinolones are meant to be reserved for serious and life-threatening infections rather than a first-choice option."

John Fratti is now reaching out to legislatures, asking them to write letters to the FDA to support this issue.