A member of the group of scientists suing the FDA for surveillance and alleged persecution was under increased scrutiny this week as breast imaging experts accused him of having blocked new breast cancer detection products from reaching the U.S. market.
Dr. Robert Smith spent nearly 4 years at the FDA’s radiological devices arm, during which time none of the 6 digital mammography systems up for approval passed muster with the federal watchdog agency.
A total of 5 such devices were approved prior to Smith’s appointment and 13 have been approved since, according to the Wall Street Journal.
Smith is a member of the so-called "FDA 9," a group of dissident former FDA scientists who sued the agency claiming that leadership spied on their personal email accounts and retaliated against them when they raised questions about certain medical device approvals.
"[Smith] was just upholding the law, being an honest and rigorous regulator," Smith’s attorney, Stephen Kohn, told the Journal. "Industry has a cozy relationship with many at the FDA, but they did not have a cozy relationship with Dr. Smith."
Smith, considered by some to be the unofficial leader of the FDA 9, was criticized by some who said he made strange demands of breast imaging device makers looking for clearance to sell their products in the U.S.
"He began putting in obstacles to approval that were unreasonable," Medical University of South Carolina dean and breast imaging expert Etta Pisano told the paper. "New machines didn’t get on the market."
Pisano and other digital mammography supporters argue that the next-generation devices are an important improvement over
their forebears and that they make it easier for physicians to share files.
Last month Smith came under fire for another trend in his recent past – a series of lawsuits against other former employers as well as against a handful of medical device companies.
In 2006 Smith sued a dozen medical device makers, accusing them of filing false statements in their FDA review applications and thus defrauding Medicare and Medicaid, according to the paper. The U.S. Justice Dept. refused to join that suit and it was dropped last year.
Smith’s 2005 lawsuit against Yale-New Haven Hospital was dismissed and he received at least $250,000 for his claims of retaliation, the Wall Street Journal reported. His case against New York-Presbyterian/Weill Cornell was also dismissed.
