FDA Approvals and What They Mean to You

FDA Approvals and What They Mean to You
Photo: Mike Licht, NotionsCapital.com, Creative Commons, Flickr
I recently wrote an article on a Supreme Court ruling that limits the ability of patients to sue over defective medical devices if the item has been approved by the Food and Drug Administration (FDA).

A similar decision, pending before the Court, will also limit the liability of pharmaceutical manufacturers, if passed. Experts predict this ruling will fall along the same lines as the one issued for medical devices; that is, any drug approved for use by the FDA, and used in the manner directed, will be exempt from legal challenges.

The secret, at least from a patient’s point of view, will lie in discovering which medical devices (and drugs) have the best track record before allowing a physician to prescribe or install them. Somewhere down the road, physicians and other medical professionals may also be forced to cooperate in this grassroots endeavor to weed out the chronically faulty knee and heart implants, since the FDA is apparently unable to separate the merely useful from the potentially lethal.

A prime example of this laxity would be FDA approvals granted to Minnesota-based Medtronic (NYSE.MDT – $39.77) for its heart devices. Medtronic, which manufactured and subsequently recalled – or has been sued over – a number of these implants, won the final round in a court battle with Charles Riegel ( Riegel v. Medtronic) by default. This blanket escape clause, however, does little to inspire confidence in future FDA approvals.

Nonetheless, the Court’s ruling now makes the FDA the agency of last resort, so it behooves consumers to know which devices are actually approved, as opposed to those that merely claim they are. Concerned consumers can visit the FDA’s approval website to search for this information by product type. The site also provides information and advice on human and animal drug approvals (including AIDS drugs), biological products used in vaccines, blood donor protocols and food additives and packaging (via links to other pages).

The FDA’s stated mission is to protect public health by regulating drugs, biologics, medical devices, food and cosmetics. But, as the FDA points out, not all of these products are required to submit proof to the FDA that their products are safe, effective, and work in the manner described.

Even where products do undergo pre-market approvals, the Phase I, II and III human trials may be based on information obtained from the manufacturer, which allows manufacturers to fudge or even conceal negative results. The FDA rarely does independent testing, but instead rubber-stamps the manufacturer’s findings. This, more than anything, explains why a heavily promoted drug like Celebrex (the only surviving successor to Vioxx), is now being prescribed sparingly by physicians, who recognize it as having cardiovascular risks equal to, or greater than, the banished Vioxx.

The FDA’s failure to identify hazards before they affect a significant portion of the population has become especially true under the Bush administration. An operant phrase from the dirty 30s (caveat emptor; let the buyer beware), when American product manufacture and labeling was virtually unsupervised, is even truer now in the unmanageable oughts. However, FDA approval is better than no approval, so wary consumers would be advised to check out the site before agreeing to a surgical procedure, taking a prescription drug, or purchasing a medical-type product.

The FDA approves medical devices in two categories. Those whose failure would create a high risk for patients are FDA-approved via clinical studies. Non-critical devices like knee replacements, hip replacements, catheters and the like only have to demonstrate that they are substantially the “same as” products currently on the market to earn FDA approval. Low-risk devices like splints, retainers and braces are exempt under the “same-as” clause.

The FDA does not approve cosmetics, except those containing color additives. This includes hair dyes. The FDA also does not approve medical foods, like diabetic supplements, nutrition supplements, or diet supplements, nor does it approve infant formulas. It also does not approve food labels, relying on the manufacturer to accurately state the contents and values of the given food. If your health supplement says it will give you more energy, you can be certain the FDA had no part in establishing that claim.

Now that you know what the FDA does, and does not, approve, it really is up to you to manage your own risk. Read labels carefully, avoid products or websites that claim FDA approval where none exists, consult your physician when in doubt, and report violations of FDA-approved labeling (or adverse reactions to FDA-approved products) by visiting the FDA’s reporting website.

Take health-risk management into your own hands, which is where it properly belongs. No one will ever have as much vested in your health as you do.

Christy Weller, Psy.D., Couples Counseling Boulder. I bring a genuine curiosity, a kind appreciation of where you have been, and a non-judgmental stance so that you feel comfortable exploring your story and making sense of it. I tailor my work to each client and I’m trained in both short-term and long-term therapies.