The Rest of the Story

Recently, the US FDA has been criticized extensively for failing to adhere to scientific principles.  However, one fact has gone unnoticed:  For all its failings, the FDA is the most scientifically-based part of our government, and the rest of the government could learn a lot from how they do things.  In this essay, I examine the differences between the approval process for new drugs, and the process for crafting new laws.  I demonstrate that the FDA uses the scientific method, to great advantage, whereas Congress uses a cumbersome, unscientific, and unnecessarily dangerous process to develop new legislation.  When I get around to it, I will post a Part II, describing a proposal for a new way to draft laws: evidence-based legislation.

When the FDA receives a new drug application (NDA), they start out with the assumption that they do not know whether the drug is safe or effective.  The burden of proof is on the pharmaceutical company to prove that the drug does work, and that it has an acceptable safety profile.  The FDA will accept only certain kinds of evidence.  Evidence that does not meet quality standards is not accepted and cannot be used.  The FDA receives information about safety and effectiveness, then has a panel of experts review the information.  Only if a majority of experts recommend that the drug be approved, does the drug proceed forward in the approval process.

When the drug is marketed, only some statements can be made to promote the use of the drug.  Statements that can be disproved are prohibited.  Statements that are not in full accordance with FDA guidelines cannot be used.  For example, a pharmaceutical company cannot promote a drug for a purpose other than that for which it has been approved by the FDA.  

Once the drug is approved, the manufacturer is supposed to monitor the outcome of patients treated with the drug.  If there is an indication of a possible problem, the drug is reviewed again.  Continued approval of the drug is contingent upon the outcome of surveillance studies.  It is true that the system does not always work correctly, but at least the basic framework is sound.  For example, the drug Mellaril was taken off the market a few years ago, when new evidence emerged that it had the potential to cause fatal irregularity of heartbeat.  That action was taken about 40 years after the drug was put on the market.  It took a long time, but the system eventually did work.  

To summarize: In the process of drug approval, the starting assumption is an assumption of ignorance: we do not know if the drug is safe or effective.  Evidence is presented to support the hypotheses that it is safe, and effective.  The drug is put on the market, but ongoing surveillance is required.  If the surveillance detects a possible problem, the drug comes under greater scrutiny.  If a problem is found, the drug is withdrawn.

Contrast this to the process of making legislation:  In the making of legislation, the starting assumption is that the legislators know a priori  what is right and what is wrong.  For example, murder is wrong.  It would follow, logically, that legislation that prohibits murder would be the right thing to do.  When legislation is proposed, legislators, lobbyists, and others can make any claims they want about the bill under consideration.  The claims do not have to meet be testable; indeed, they do not have to meet any quality standards at all.  Claims can be made that are outright lies, and there is no penalty.  The assumption is that the deliberative nature of the legislative process will expose any flaws in the legislation.  But the deliberative process follows only a loose outline.  There is no requirement that testable hypotheses be advanced, then subject to rigorous, structured scrutiny.  It is not necessary to define ahead of time what outcomes can be expected from the legislation; nor is there any surveillance after the legislation is passed.  

Clearly, the drug approval process is superior to the legislative process.  We jump all over the FDA if they screw up, yet we let Congress jump all over us with bad legislation, without giving it a second thought.  Most laws have the potential to affect every citizen, whereas even a blockbuster drug has the potential to affect only a small proportion of the citizenry.  Bad legislation can be extremely hazardous to our health.  Why do we let Congress get away with lower standards for themselves, than the standards they set for the FDA?