FDA Criticized by the Government Accountability Office

Normally, it’s  pharmaceutical companies that come under the scrutiny of the FDA.  However, in an interesting twist of fate, the FDA  itself is now under fire for not enforcing its own rules.

Physicians have an innate tendency to trust governing medical entities such as the American Medical Association (AMA), Food and Drug Administration (FDA) and Centers for Disease Control (CDC). Maintaining a reproducible and sustainable standard for reporting clinically relevant pharmaceutical data for new and established drugs has always been a priority for the FDA.

In December 2000, the  FDA issued a call to improve the professional labeling of drug  package inserts and other accredited drug information sources i.e.  the Physician Drug Reference (PDR). In 2006, the standard format for package inserts was modified in an attempt to make it more user-friendly and to serve as an efficient resource tool for patients, physicians, and researchers.

In today’s fast-changing challenging healthcare environment, physicians tend to accept this reported data, and the lack of it, as this is all there is available to them.

However, many would like to know more. For example, how to manipulate a drug dose for a patient with renal failure based on given elimination half life.  Although vital to the management of such patients, all too often, such information is not yet an option for many of FDA approved drugs.

The United States Government Accountability Office (GAO) recently concluded that the FDA lacks a clear and effective process for postmarket drug safety issues. The GAO  also observed that there is a lack of criteria for determining what safety actions to take and when to take them.

This finding is supported by research from  Wesley College, Delaware.   Using the commercially available KnowItAll® informatics platform from Bio-Rad Laboratories, researchers built a Cancer Drug Database containing 85 chemotherapy drugs.  They found that the  reporting of important biological properties such as bioavailability (BIO), plasma protein binding (PPB), elimination half-life (t1/2), volume of distribution (VD), and water solubility were found to be markedly deficient.

According to Malcolm J. D’Souza, Ph.D The evidence is so compelling that the apparent laxity in enforcing reporting regulations for many of these pharmaceuticals is alarming.”

Perhaps the real impact of this research is the red flags it raises.  The FDA guidelines need to be revisited with emphasis on vigilance in reporting all parameters that directly or indirectly affect patient care.

Until the FDA has its house in order, we wonder how much, and for how long either physicians and pharma will continue to trust their own regulatory bodies.  Let us know what you think.

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