FDA Writes Own Rules, Doesn't Follow Them

Washington, DCAccording to a blockbuster investigation, the US Food and Drug Administration (FDA) writes rules, but doesn't follow them. In this way the FDA puts patient health at risk.

It has long been a practice whereby drug companies and major pharmaceuticals enlist the aid of doctors and physicians to educate their colleagues, and the public, with regard to emerging and existing products. They are not paid spokespersons per se, in the typical advertising sense. But they are paid a fair stipend for their time to lecture others, in their own words, about a drug with information most often supplied by the manufacturer.

Whether or not the practice is appropriate has been the subject of much debate among health and consumer advocates, even though the rules allow the practice. And doctors, with rising overhead and insurance costs, depend on such 'consulting' as a way to generate extra income.

However, the question remains whether or not a doctor receiving an honorarium from a pharmaceutical manufacturer can conduct him, or herself without bias when it comes to their participation in the overseeing of a clinical trial.

The US Food and Drug Administration (FDA) has rules in place for that very reason.

And yet it does virtually nothing to police those financial conflicts, and actually considers it a waste of time.

As recently reported in the New York Times, a stunning investigation by the Department of Health and Human Services (DHHS) that was released January 12th found the FDA failed to receive (and, it is assumed, ask for) the various forms and documents that would serve to disclose a doctor's financial conflicts of interest 42 percent of the time. It was also found that in 31 percent of the trials where forms WERE submitted, FDA reviewers failed to document that they had even examined the material.

And perhaps the most damning finding of all—according to the DHHS investigation, of the 20 percent of doctors who duly revealed a significant financial conflict, neither the FDA or even the sponsoring manufacturers took any kind of action, or made any attempt to respond to the conflicts.

It was ten years ago that the disclosure requirements for drug companies and manufacturers conducting clinical trials were implemented by the FDA. Manufacturers, and companies with a vested interest in the trials were required to collect information prior to the commencement of a trail, and report the findings to the FDA.

And yet, the FDA was shown to have made little attempt to enforce the own requirement, and may not even have used the information if, and when it was made available.

It is suggested that there's a lot more information out there than is getting to the required source. As reported in the New York Times, studies have shown that one-fifth, to a full one-third of all doctors carry such conflicts. And yet, less than 1 percent of all doctors involved in the oversight of clinical trials ever bothered to register with the FDA. Those few who did, reported a significant conflict of interest.

A spokesperson for the FDA was on record as saying the agency was not in agreement with reviewing doctors' financial conflicts prior to trials, because they represented a single source of possible bias.

However, the concern remains that such conflicts have the potential to skew studies.

You can see how it could easily happen. A doctor receiving an honorarium from XYZ Corporation for any number of services is involved in a clinical trial with regard to a potential new drug to be manufactured, and marketed by XYZ. One can well imagine the possibility exists that a health risk inherent with the drug could be glossed over, and the negativity mitigated or at least minimized, in deference to the doctor's prior and existing relationship with the sponsoring manufacturer.

Such a potentiality could risk harm to patients, and the inspector general said so.

It should be noted that the rules for conflict reporting allow for a caveat: drug companies and manufacturers can get around the requirement if they certify their due diligence in attempting to secure the required information, but despite all efforts could not do so. Drug companies claimed this exemption in 28 percent of their drug, and medical device applications.

However, it was noted that in a further 23 percent of the applications, companies filed neither exemptions, nor disclosure forms at all.

And here's the most troubling part: after the inspector general recommended that the FDA pull up its socks and improve their policing of their own rules, the agency replied that it basically wasn't worth the trouble.

It's a fair request. You have rules—rules that your agency actually sponsored. Thus, if you have a rule that states a financial disclosure is required, those disclosures should be duly secured, and FDA officials should review the documents before trials actually commence. This should be done, the health inspector recommended, so that patients are protected.

The FDA basically told the health inspector to jump in the lake.

The FDA will be getting new leadership in tandem with the incoming Obama Administration. Some may suggest it can't happen soon enough.