Monday, September 15, 2008

Is The FDA Really So Weak?

We've grown accustomed to hearing complaints that the Food and Drug Administration is powerless. "How can the Agency possibly cause companies to act responsibly?," critics (and plaintiffs' counsel) ask. Historically, the FDA lacked the power to order product recalls, and its authority is limited in other ways. Companies, we're told, run roughshod over the Agency.

We've always known (from personal experience and things we've heard in the industry) that this wasn't true, but it hasn't always been easy to find authority in the legal literature to belie these claims.

Now, there is.

If you're ever in need of helpful authority, take a look at Lars Noah, "The Little Agency That Could (Act With Indifferernce to Constitutional and Statutory Strictures)," 93 Cornell L. Rev. 901 (2008).

We offer these two tasty morsels from Professor Noah's work, just to whet your appetite:

"Congress originally granted the FDA only limited and procedurally cumbersome mechanisms for securing compliance with the statute: product seizures, injunctions, and criminal penalties. The agency has, however, deployed these tools in creative ways: for instance, the FDA may threaten to impose a sanction or withhold a benefit in the hopes of encouraging 'voluntary' compliance with a request that the agency could not impose directly on a regulated entity. . . .

"Such 'arm-twisting' succeeds, and evades judicial or other scrutiny, in part because companies in pervasively regulated industries believe that they cannot afford to resist agency demands."

Id. at 906.

Or how about this?

"The FDA generally lacks the statutory authority to order a recall of potentially dangerous products subject to its regulatory jurisdiction. . . . [T]he FDA generally has resisted proposals to provide it with explicit recall authority. Instead, the agency prefers encouraging voluntary recalls . . . .

"This strategy has succeeded because firms know that a failure to cooperate with an agency request would invite more draconian enforcement measures authorized by statute."

Id. at 908-09.

Needless to say, both of the preceding excerpts omit the usual detailed footnotes that one finds in scholarly work.

The next time your opponent is shedding crocodile tears about the FDA's lack of authority, use Noah's article to wipe away those tears. The FDA has plenty of power to cause industry to obey its "requests."


Anonymous said...

I find this an interesting admission from attorneys who try to tell juries how responsible their clients are because they 'voluntarily' withdrew a product.

Ted Heise said...

anonymous: The two possibilities are not mutually exclusive. The fact that FDA has authority to force a recall does not prevent companies from initiating a recall on their own initiative.

Anonymous said...

The Conversion of our Protector

The Food and Drug Administration (FDA) originated in its original form several decades ago, with thier objective being to ensure the health and safety of the citizens of the United States regarding products that they consume, and the catalyst for its development was due to the concepts originated by a man named Upton Sinclair. However, the objective of the FDA seems to have changed, as they appear to have formed a pathological alliance with the pharmaceutical industry possibly through the money that this industry gives the FDA for various reasons, so it seems. This is such a large amount of funds issued to the FDA by the industry that it has resulted in possibly half of the FDA’s annual income for various reasons. Results of this relationship, one could posit, have been the approval of unsafe drugs on occasion and lack of sufficient regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform. In addition, the FDA lacks sufficient resources to complete thier duties completely, it has been said. In fact, in the FDA's own mission statement, they claim that they will always protect, advance, and improve public health.

An example of this support from the pharmaceutical industry is the Prescription Drug User Fee Act, which requires drug companies to pay around a million dollars for a priority review of a potentially approved drug of theirs. Implemented by the FDA in 1992, it has required increases in the amounts paid by drug companies since then. In fact, of the FDA's estimated 2 billion dollar budget, about 20 percent of this money is from this act. Since 1992 and the implementation of this act, there have been no less than 12 drug recalls, which statistically is significant. To improve public health, it may be best that the FDA receive all funding from the U.S. Treasury.

So this intimacy between the FDA and pharmaceutical industry seems to continue to progress, as illustrated with the new proposal by the FDA to allow the pharmaceutical industry's reps to discuss their products with prescribers off-label, which means that the FDA somehow is accepting and allowing the sales reps of the drug industry to possibly create harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way, many believe.

A prescriber, upon their own discretion, can in fact prescribe a drug off-label. Historically, however, ad for good reasons, representatives from the pharmaceutical industry have been prohibited from suggesting or discussing off-label possibilities with thier promoted products with prescribers, due to the speculative nature of the concept. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and some have been penalized for this behavior in the past in the form of monetary settlements by the Department of Justice, yet appears such penalties are not much of a deterrent for this behavior that may now be authorized and has continued to occur regardless of possible future permission by the FDA.

This FDA protocol that is being considered, called, “Good Reprint Practices”, would require reps to use what in fact may not truly exist, which is truthful and authentic clinical trials related to off-label possibilities of thier promoted products during any dialogues they may have with prescribers. This in itself may lack a necessary degree of validity for such discussions by reps, as it has been suspected that some clinical trials are flawed due to the trials being possibly manipulated by the pharmaceutical companies of the meds involved in such trials through possibly third parties, such as trial deception involving ghostwriting and invalid authors of such trials, which disintegrates the quality of such a study. These facts can be validated and have been discovered by others, so caution instead of autonomy should be utilized regarding clinical trial discussions with health care providers, some may say.

Furthermore, this proposal is additionally flawed due to the fact that most pharmaceutical reps have little of any clinical training. So the ability for pharma reps to analyze data from trials justifying an off-label concept is unlikely. This complicates the idea of this off-label concept- this ignorance of most drug reps in regards to the complexities of these once reliable and dependable methods of proof, and that is the clinical trials. In addition, the proposed relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to manipulate statements to prescribers for their own benefit in regards to their promoted meds while disregarding the health of the consumers of these meds. So, our previous safety administration, the FDA, appears to be evolving into taking somewhat of an apathetic stance regarding the safety of public health by suggesting such practices with what appears to be deliberate intent and reckless disregard for public health, so it seems. This may be due to the FDA now viewing the pharmaceutical industry as thier sponsor or client. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be an actual benefit to public health. Furthermore, this FDA proposal may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing medications correctly, and adding this FDA proposal would just make the situation worse, it seems.

However, there is freedom of speech. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the pharmaceutical sales reps, who, unlike those who may be more academically enriched, have the sole objective of increasing the market share of their promoted meds. Such people, ideally, would not have any association with the makers of such drugs spoken about to prescribers, yet this may be unlikely to occur. Regardless, awareness needs to be achieved by the public about the possible dangers of this FDA proposal, even though it's possible that the public has heard about it through media sources. As citizens, we have the right to insist that the FDA demand and direct the pharmaceutical company to prevent potential harm that may come to patients in need instead of thier apparent desire to please thier bread and butter. More congressional oversight is needed of this Association.

"It is difficult to get a man to understand something when his salary depends upon his not understanding it." --- Upton Sinclair

Dan Abshear
Author's note: what has been written has been based upon information and belief.