Nine scientists at the US Food and Drug Administration (FDA) who claimed to Congress that illegal activities were ongoing at the agency have written to President Barack Obama, telling him they believe they are now under criminal investigation.
In early January, the group of scientists wrote to the Obama Administration’s transition team describing their concerns, which specifically relate to the agency’s scientific review process for medical devices. Staff working on the reviews were being forced by their managers to manipulate data, thus endangering patient safety, said the scientists, who claimed the system had been “corrupted and distorted by current FDA managers, thereby placing the American people at risk.”
“There is an atmosphere at the FDA in which the honest employee fears the dishonest employee,” they said, and described the FDA as “fundamentally broken.”
The scientists had initially cvoiced their concerns to then-FDA Commissioner Andrew von Eschenbach back in May, and he promised an internal review. However, last October, frustrated at the agency’s slow progress in dealing with their claims, the nine asked the House Committee on Energy and Commerce for an investigation, which the panel began in November.
This week, the group of nine wrote another letter to Pres Obama, in which they state: “It has been brought to our attention that FDA management may have just recently ordered the FDA Office of Criminal Investigations to investigate us rather than the managers who have engaged in wrongdoing.” They add: “it is an outrage that our own agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress,” and ask the President for his “immediate intervention.”
Pharma urges speedy FDA appointment
Meantime, drugmakers have told Pres Obama that the “vital nature” of the FDA’s oversight of public health means that “identifying a strong, independent Commissioner should be among the first accomplishments of the new Administration.”
Billy Tauzin, chief executive of the Pharmaceutical Research and Manufacturers of America (PhRMA) said Dr Frank Torti was a wise choice as interim Commissioner, who “shares PhRMA’s patient-centric approach and bring a strong commitment to science-based decision-making.” However, he added: “We look forward to President Barack Obama’s expeditious selection of a full-time leader for the FDA.”
The ideal candidate should embrace the need to advocate for an empowered FDA that is adequately resourced and must have the strong managerial skills that are essential for directing science-based activities at an agency that has just expanded its ranks with hundreds of new employees, said Mr Tauzin.__ “These skills are particularly important to an agency that is striving to implement groundbreaking reforms to better position itself to tackle future challenges, including modernizing FDA methods for evaluating safety and efficacy throughout a product’s life cycle,” he added.
