The Food and Drug Administration (FDA) has been criticized for not adequately protecting the public from injuries sustained from food, drugs and medical devices under its control. The FDA itself recently told Congress that it needs more money to do its job. The Bush Administration has agreed to a modest increase in the FDA’s 2009 budget – but will the increase really help consumers?

Analysts say a 50% increase is needed

Analysts have said that the FDA’s 2009 budget needs to be increased by 50% in order for it to adequately protect the public against defective medical devices and unsafe food and drugs. Unfortunately, the proposed increase falls far short of that – 5.7%, bringing the total budget to $2.4 billion. The FDA’s food safety program may receive a higher percentage – 6.8%, bringing the total budget to $662 million. While that amount still needs to be approved by Congress, many have said that a majority of the additional funds may go towards pay increases and general inflationary costs and may not do much to assist the FDA in addressing its shortcomings.

Government study reveals FDA shortcomings

The Government Accountability Office (GAO) released a report that reveals the FDA’s shortcomings in several areas. In a recent congressional hearing, GAO representatives told Congress that the FDA, “[h]as not met statutory requirements to inspect medical device manufacturing facilities.” The report states that the FDA’s “information technology infrastructure is obsolete and unstable; provides an insufficient basis to access, integrate and analyze data and is subject to frequent system failures.”

Court decision may give FDA more responsibility

The GAO report isn’t the only issue that has analysts concerned. The Bush Administration, in conjunction with the FDA, is supporting a controversial pre-emption case currently in front of the U.S. Supreme Court. It could potentially make the FDA wholly responsible for protecting the public from defective medical devices and drugs and prevent injured patients from bringing state lawsuits against manufacturers.

While the administration believes that the FDA can effectively monitor these areas, analysts generally disagree. They point to Medtronic’s defective Sprint Fidelis defibrillator lead wires that were subject to the FDA’s approval process. In that situation, the FDA failed to identify serious issues with the device that ultimately caused five deaths and hundreds, if not thousands, of injuries.

If you’ve been injured by a defective medical device or drug, contact an attorney whose practice focuses in these areas of law. To contact a qualified attorney for a free, no-obligation consultation, please click here.