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FDA Rejects Multidose Syringe Ban

Nov 18, 2008 | Parker Waichman LLP Dr. Andrew von Eschenbach, Commissioner of the U.S. Food and Drug Administration (FDA) has, according to a report by, “rejected an appeal” to ban manufacture of multi-dose vials.  The appeal originated from New York State health commissioner, Dr. Richard Daines, in which he requested a ban of the vials; Eschenbach disagreed, saying the vials are critical in hospital use, reports Newsday.

At the beginning of this year, Daines, in collaboration with New York City's health commissioner, Dr. Thomas Frieden, sent von Eschenbach a letter that urged the FDA to cease manufacture and distribution of the vials, said Newsday.  The two sent the January 18 letter following the much-publicized scandal involving Dix Hills Doctor, Harvey Finkelstein, whose shoddy injection practices put thousands of his patients at risk, infecting at least one patient with hepatitis C.  Although illegal on federal and state levels, Finkelstein reused the vials in such a way that medication in at least one vial was tainted, sickening at least one patient, notes Newsday.

When news broke of the Dix Hills Doctor scandal, the health department came under fire for its legal delays and complex lab practices that allowed the problem to remain unreported for years; it took the health department three years to advise the public of Finkelstein’s shoddy and illegal injection practices, says Newsday.  The health department was also strongly criticized by patient advocates after it was revealed it negotiated with Finkelstein for his office records, a process that helped delay public notification to over 10,000 of Finkelstein’s patients for an incredible three years.   Finkelstein’s malpractice record alone—he has settled an unprecedented 11 malpractice lawsuits inside of a decade—should have prompted an investigation by the Office of Professional Medical Conduct (OPMC), the health department agency that investigates doctors.  It didn’t.  In Finkelstein's case, a hearing was never held and the doctor was placed under state monitoring for three years.  Finkelstein continues to practice.

Newsday reported that in the letter, Daines and Frieden wrote that despite "numerous guidelines and recommendations," there remain doctors whose improper practices do lead to contamination of multi-dose vials.  Daines argues that, according to the Newsday piece, it is better to "engineer out" human error by eliminating multi-dose vials.

von Eschenbach’s written response dated October 20 stated that the vials "are an important dosage option for hospital pharmacies," quoted Newsday, which also said that von Eschenbach added that multi-dose vials are cheaper and “require less storage space.”  The FDA suggests adding a warning statement and instructions on proper usage, instead of banning the vials, said Newsday.  Newsday also reported that Daines said he was frustrated by von Eschenbach’s and the FDA’s response: "I don't think they understood the problem."  Daines explained that the issue is not hospital misuse but misuse by physicians, "I would like safety engineered into the product," he is quoted as saying in  Regardless, Daines said he planned on continuing to work on the issue when the new presidential administrations steps into office this January.  In the meantime, Newsday reports, the state can not “be sued for the Department of Health's slow response to the Finkelstein case” based on a Court of Claims judge ruling that was just made public.

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