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Watchdog blasts FDA on loose test compliance policy

Group says lax oversight has been applied to critical medical devices including cardiac defibrillators, pacemakers, replacement heart valves and coronary artery stents.

The independent watchdog group Project on Government Oversight revealed Wednesday that top Food and Drug Administration medical-device officials backed off on a requirement that device manufacturers test their products according to federal standards -- the very standards put into place 30 years ago after a prominent lab provided fake data to FDA.

The lax oversight instituted in 2006 applies to some of the most critical devices, including cardiac defibrillators, pacemakers, replacement heart valves and coronary artery stents.

The report calls the nonenforcement policy of so-called good laboratory practices "a high-stakes, unknown-odds gamble with the lives of patients -- particularly those whose survival depends on life-sustaining medical devices."

The report describes a 2006 confrontation between an FDA scientist and a top official in the device division that resulted in an emergency meeting in which a nonenforcement policy regarding good laboratory practices was reiterated.

The decision to abandon enforcement was not made publicly through rulemaking. It was made behind closed doors among top FDA officials who believed enforcement was not feasible, according to the report.

In addition, FDA's budget has been stretched thin in recent years, causing inspection efforts to suffer.

An FDA spokeswoman said the agency has indeed conducted fewer inspections specific to good laboratory practices in recent years, but she pointed to some guidance documents that do speak to the importance of following the standards, which are in place for the earliest stages of animal testing. The spokeswoman said FDA conducted 31 inspections related to good laboratory practices in 2005, 24 in 2006, 8 in 2007 and one in 2008.

Some device firms and some consumer groups are concerned the requirements can delay a lifesaving product's path to the market and jack up the price of devices out of some patients' reach, but the worries do not justify abandoning enforcement, the report said.

The watchdog group wants the Government Accountability Office and the Health and Human Services Department inspector general to audit records related to good laboratory practices to try to determine the extent of noncompliance. It also wants FDA to start conducting enforcement, particularly through random inspections as well as for-cause inspections.

Lastly, the group called for changes in one of FDA's approval methods that allows device-makers to prove their product is "substantially equivalent" to one already on the market rather than conduct rigorous testing.

The House Energy and Commerce Committee is in the thick of an investigation of how FDA handles medical device approval and is looking to make some changes, potentially through introduced legislation that would improve FDA's ability to police food, drugs and devices.