FDA Fights Internal Battle

The circular firing squad mentality into which the FDA has devolved pits agency scientists against FDA managers. The internal struggle features FDA scientists who have written a strongly worded letter to Congress complaining about FDA managers approving unsafe or ineffective medical devices. The matter will be investigated by the House Committee on Energy and Commerce. The letter to Congress comes at a time when the US Supreme Court is deciding a case concerning the FDA and pre-emption.
The Committee chair, John Dingell (D-MI) has vowed to aggressively investigate any FDA wrongdoing that may place consumer’s safety at risk.
While there has always been a certain tension between FDA scientists who push for more definitive trial results before device approval and FDA managers who tend to approve drugs or devices when trial data is not clear, this new breach is remarkable in the level of rancor and publicity. Historically, the FDA has demonstrated a discipline that did not allow internal strife to spill over into the public sphere. Now it appears that the situation is different.
The public accusations contained in the scientists’ letter should give the industry pause regarding the question of pre-emption. Until the Bush Administration, the FDA had always taken the position that state consumer tort lawsuits provided a necessary form of checks and balances and complemented the federal FDA regulations. Perhaps, it’s time to re-visit this notion.