“Whistle-Blower” at Center of FDA Spying Scandal
Before being shown the door amid lawsuits and investigations, Dr. Robert C. Smith accused his bosses at the FDA of “not following the law, not following the science, [and] not following FDA core values” in approving medical devices.
Now, according to a July 30 report in the New York Times, FDA officials have come under fire from Congress after disclosures that they had carried out a surveillance operation that monitored the e-mails of Dr. Smith and four other employees as they wrote to their lawyers, lawmakers, and even President Obama.
Some 80,000 pages of documents intercepted in the spy operation detail Dr. Smith’s campaign to expose what he claimed were harmful practices at the FDA, the Times reported. The documents, accidentally posted online by an FDA contractor, reveal a 4-year process of estrangement between Dr. Smith and his supervisors.
Staff members of three Congressional committees that often criticize the FDA reviewed Dr. Smith’s complaints and decided not to pursue them. The inspector general of the Department of Health and Human Services also examined his claim that the agency was violating the law in reviewing medical devices and concluded that he was wrong.
Dr. Smith’s concerns, however, are now getting a second look. The Office of Special Counsel, which investigates whistle-blower grievances, found this spring that Dr. Smith’s allegations raised a “substantial likelihood” of serious problems and required a full review. That announcement has triggered an investigation by Kathleen Sebelius, Secretary of Health and Human Services.
Three months after the FDA’s surveillance operation began, a supervisor told Dr. Smith that he was being placed on administrative leave for improperly downloading documents and would be let go at the end of his 2-year contract.
For more information, visit the New York Times article.