Medical Device Companies Fight FDA Safety Improvements: Report

A recent report by the consumer watchdog group Public Citizen suggests that medical device companies have employed a small army of lobbyists and are spending millions of dollars in an attempt to keep FDA oversight of their industry lax and ineffective. 

The Public Citizen report, “Substantially Unsafe” was submitted along with testimony earlier this month before the U.S. House Committee on Energy and Commerce’s subcommittee on Health. The subcommittee held a hearing on the reauthorization of the Medical Device User Fee Act (MDUFA).

According to the consumer advocacy group, medical device manufacturers have given $19.9 million in campaign contributions to federal candidates since the 2006 election cycle, with lawmakers who introduced legislation to weaken federal medical regulations receiving three times as much as other candidates.

The industry has also put at least 225 lobbyists to work on Capital Hill making efforts to affect legislation, with half of those fielded in the last quarter of 2011. Overall, the industry spent $33.3 million on its lobbying efforts, the report claims.

Public Citizen pointed to defibrillator lead recalls, hip implant recalls and other medical device problems as signs that the FDA’s regulatory oversight of medical devices needs shoring up, not weakening.

Many moderate and high-risk medical devices get through to the market with virtually no required testing by using the FDA’s 510(k) fast-track approval process, which only requires that the device be “substantially equivalent” to an existing device, but the definition of “substantially equivalent” has become overly broad, according to some critics.

Even if a medical device is required to go through the more stringent premarket approval (PMA) process, it faces a weaker test than the one given to drugs, according to the report.

More than 200.000 injuries and malfunctions, and 2,000 deaths linked to medical devices are reported to the FDA each year, according to Public Citizen.