Personal Troubles for FDA’s Dr. Maisel

Aug 7th, 2012 | By | Category: FDA

Dr. William Maisel, Fox TV

August 7, 2012 ~ This item  apparently bypassed the desk of MDND. Last month, Deputy Director of the FDA’s Center for Devices and Radiological Health, Dr. William Maisel, was reportedly arrested in a prostitution sting operation in Maryland, according to MassDevice (here).

According to the case report here , Dr. Maisel, 46,  was arrested on Friday, July 13 after allegedly offering a plain-clothes female police officer money for sex. He is facing four charges of prostitution solicitation and one charge of disorderly conduct. His case is set for trial September 20 in Ellicott City, Maryland.

MyFoxDC-TV reported ten men were arrested in Howard County during a reverse prostitution sting. This was the second operation of the year by Howard County and was conducted along the U.S. 1 corridor in Laurel.

FDA co-workers greeted the news with a mixture of shock and sadness, reports Pharmalot (here). There are 30 comments on Pharmalot of a mixed nature.

Dr. Maisel is a prominent cardiologist who joined the FDA in August 2010. Dr. Maisel has been mindful of the delicate balance within the agency between the public and corporate interest. In testimony he has said device makers share some of the blame for a slow review process:

“Industry also shares a responsibility for the success of the review process and safety of medical devices. Data show that some companies submit poor quality applications, ask to meet with us but then ignore our feedback, or conduct poor quality clinical studies. This leads to unnecessary delays, wastes time and money for both industry and FDA, and exposes patients to unnecessary risks.”

April 13, 2011 he spoke about A Delicate Balance: FDA and the Reform of the Medical Device Approval Process (here).

Dr. Maisel is named in a federal lawsuit filed by whistleblowers against the FDA along with chief Margaret Hamburg, Jeffrey Shuren and Kathleen Sebelius, of HHS, accusing them of retaliation and violating the FDA employees’ rights to free speech and protection from search and seizures of personal email.  Background story is here.

The FDA issued a statement to MyFoxDC.com saying this is a personal matter and not related to Dr. Maisel’s work at the FDA.

 

 

 

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One Comment to “Personal Troubles for FDA’s Dr. Maisel”

  1. Dr. William Maisel is the FDA official that informed Dr. Stephen Tower (orthopedic surgeon from AK with a failed metal hip implant) that he had “no standing” unless he was blessed by the medical device industry.

    http://earlsview.com/2013/01/10/dr-tower-writes-to-senator-re-concerns-about-the-regulatory-malfeasance-at-the-fda-metal-on-metal-hip-replacement-debacle/

    http://www.consumerreports.org/cro/magazine/2012/04/cr-investigates-dangerous-medical-devices/index.htm

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.