US Senator Questions FDA for Letting Edwards "Off the Hook" Over Myxo Device

Shelley Wood

May 01, 2009

May 1, 2009 (Washington, DC) — Sen Chuck Grassley (R-IA) has sent a letter to the Food and Drug Administration (FDA) questioning the agency's decision not to hold Edwards Lifesciences "accountable" for marketing what was then known as the Myxo ETlogix annuloplasty ring without FDA clearance [1].

Controversy over the Myxo ring has hitherto centered on whether it was an investigational device when it was used in a patient at Northwestern hospital in April 2006, as reported by heartwire in October 2008; Edwards, who had sold the device for two and a half years, voluntarily pulled the ring off the market within weeks of heartwire 's story, retrieved existing stock of the devices from hospitals, then submitted a 510(k) on October 29, 2008.

It appears to me that the FDA has created a system that makes it easier to ask forgiveness than it is to get permission.

Last month, the FDA told heartwire that the agency had cleared the device April 10, 2009, having determined that the device is as safe and effective as other annuloplasty rings on the market. The agency also concluded that Edwards had made an "honest attempt" to adhere to the FDA's guidance on "Deciding when to submit a 510(k) for a change to an existing device" and would face no sanctions for having sold the ring since March 2006.

Grassley's letter, sent to acting FDA commissioner Dr Joshua Sharfstein earlier this week, takes issue with the agency's view that the company bears no fault for having marketed the device prior to appropriate FDA clearance, suggesting Edwards had been let "off the hook."

"It appears to me that the FDA has created a system that makes it easier to ask forgiveness than it is to get permission," Grassley writes. "How can the agency adequately ensure the safety of patients who use medical devices when it allows manufacturers to determine when a new 510(k) submission is necessary without oversight from the FDA?"

List of Questions Tackle Myxo Case, But Also Broader Policies

In the list of questions posed by Grassley to the FDA, he notes that while companies are encouraged to contact the FDA with queries regarding the need for a 510(k), he points out: "If there are no disincentives for making the wrong determination, why would manufacturers seek advance input from the agency or submit a new 510(k) rather than wait for the FDA to request one?" He challenges the FDA on its policy of allowing companies to keep their "justification to file (or not)" in-house, rather than submitting documents to the FDA, and asks what steps, if any, the FDA is taking to improve its oversight of companies trying to determine whether or not a 510(k) submission is warranted.

With regard to Edwards specifically, Grassley asks what the FDA has asked of the company "to prevent wrong determinations from occurring again in the future." He also requests details on how or when the FDA would have noticed that the company was marketing a noncleared device if it "had not been brought to the FDA's attention."

Several of his questions also focus on the patients who received the Myxo ring before it was cleared, asking whether the FDA has reviewed data on the patients who received the ring during this period or whether they'd even been notified that they'd received a nonapproved device.

"The fact remains that for more than two years patients at Northwestern Memorial Hospital were being implanted with that device before a 510(k) was submitted to the agency," he writes. "Accordingly, I am troubled by what appears to be a 'no harm, no foul' attitude taken by the FDA. The FDA has acknowledged that the dETlogix ring is a 'significant-risk device' that was not cleared or approved and thus should have been studied under an investigational device exemption (IDE). However, it was not studied under an IDE. So, I wonder, where does that leave all of the patients who were not informed that the device being implanted in them was experimental?"

This is not the first letter from Grassley to the FDA about the Myxo. As previously reported by heartwire , Grassley last wrote December 18, 2008 and, according to his latest letter, he received the FDA's response March 4, 2009. He has now given the FDA until May 13, 2009 to respond to his latest questions.

Contacted by heartwire , an FDA spokesperson stated that the agency would be responding directly to Grassley's office and declined to provide any additional comment.

Grassley, who heads up the Senate Committee on Finance, which oversees financials of drug and device companies, Medicare, and Medicaid, has earned a reputation for being tough on both the FDA and the drug and device industry generally, as well as on individuals or academic institutions too cozy with industry. The Wall Street Journal's HealthBlog reported yesterday [2], however, that industry may be getting its "biggest break" in years: Grassley is rumored to be on the verge of leaving the Senate Finance Committee to take the Republican spot on the Judiciary Committee.


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