FDA field regulatory enforcement decisions are not always Science-based

There is universal knowledge that the United States Food & Drug Administration is an agency driven by risk assessment based on scientific data. The agency prides itself in the self- promotion of this principle and it is a principle indoctrinated in the new generations of FDA Investigators and analysis that populate its’ enforcement branch. From report writing to testimony, FDA Officers are trained to be objective, use science to highest degree, and let the report “speak” for itself. Science is the foundation of this great agency’s backbone and the agency strives to make decisions on enforcement based on evidence traceable to scientific facts. The FDA is also a Law Enforcement Agency and has to follow the rules of evidence development when it conducts investigations. There is no question that science is the foundation upon which FDA's actions are supported.

While many FDA regulatory decisions are based on good validate-able data, there are many decisions that some are not decided on pure data analysis or good science. This is especially true when the data is not clear. Regardless of the validity of the data, data centered decisions in many of FDA processes such as drug and device approvals leave a clear path of decision analysis, that is reviewable to intra-agency and outside agency sources from the statistical to the validity issues. These processes are clear and defined with pre-established acceptance or rejection criteria. There is at times some departure from science, even with this great data that is submitted to the FDA, final decisions on approvals/acceptance are at times very much human and political. Which ones are truly political, or impacted by the policy at the time of decision, we may never know. 

The FDA's field enforcement and regulatory processes are at times more difficult to trace than the drug and device approvals and do not leave data pathways that will reveal how a decision was made to take an enforcement action.

FDA is a Regulatory and Law Enforcement Agency and as any Law Enforcement Agency it strives to follow the rules of evidence development for eventual case development. This is designed to withstand out of agency (US Federal Court) review in every field action it takes. Evidence must be collected according to clear instructions and the chain of custody preserved accordingly. Science once again rules and there is little room to be stray from being objective. In fact, investigator's notes are to "stand alone" and can be use as evidence, even if the investigator is no longer available to testify on behalf of the agency.

The agency has massive manuals that guide the investigators like the Investigations Operations Manual, the Regulatory Compliance Manual, the Compliance Program Manuals, and many more guides that instruct the Investigator/Compliance Officer/Analyst in proceeding with case development. Any action that FDA takes must pass the general science and evidence rules of collection as if it will eventually go to court. 

The reader must question: How does the FDA make the final decision to issue an Untitled Letter, a Warning Letter, a Re-inspection and other regulatory actions. Are the decisions driven by a reason to believe, preponderance of evidence or the principle of Beyond Reasonable Doubt? All of these are general levels of evidence used by many law enforcement to execute actions. The general answer from FDA is that they follow the Regulatory Procedures Manual, work plans and other internal guidance documents, but all these manuals only guide to a point in the process and not the final step, which is subjective to a degree. Who and how is the decision made to proceed? How far removed from science and good evidence and due process, are quality measures that are constantly monitored.

FDA like any other institution that enforces rules, regulations and laws, must practice what it preaches. It also has massive internal Quality Assurance Programs to assure all decisions are based on objective processing and not the subjectivity of the decision maker. FDA strives to meet this Quality Control in processing cases, but just like the customers it serves, it frequently fails to meet those Quality goals. Many times, more than what the agency would like to admit, decisions are based on subjective and not objective reasoning or it is not able to trace the science/evidence behind the decision. There are other factors like making a decision while the evidence is “fresh”. Science and evidence demands time accountability. FDA frequently makes mistakes on due process and timely evidence, but it never airs its’ mistakes in public, unless it is forced to do so by congressional mandate or similar process. Yes FDA has gone to court many times and lost.

In the agency’s defense there are many factors that influence why some regulatory actions are taken on some and not on others. Limitation of resources is one of those things that influences objectivity/subjectivity. Poorly trained investigators and managers are also a factor, and at times the final decisions are made at government offices with employees with higher pay scales located in offices a few miles from FDA HQ, just like other government agencies. These are just some of those factors that push the agencies’ decisions farther away from science-based decisions.

At any given time, the many FDA field offices from the investigators to the highest- ranking field officers make regulatory impacting decisions that will cost firms extensive resources. Are they legit, do they follow due process and the science? The practice ranges from simple “wrongful adjudication” to informal decisions that have enforcement binding implications. They might be the decisions that basically places the target firm under the radar for years to come and will escape agency scrutiny to those that will place in on a path to an un-winnable regulatory action. It is true that no law enforcement agency is perfect in enforcement, but those that mess up are frequently the subject of investigations ranging from civil right abuses to laboratory analysis corrections.

The FDA’s mission to protect consumers also frequently earns it a pass on the mistakes it makes in enforcement, due to its’ intention of consumer protection. Yes, it is also subject to external review from the consumers it’s suppose to protect to the highest levels in Congress, but this reviews are usually not science based, why because most of these reviewers are not scientist. When science is the arena, you are playing in FDA's arena. FDA has the advantage many times in this general reviews, all under the umbrella of intent to protect the consumer. The laws under which it operates also frequently places a low burden of proof to take actions.

Yes, there are many non-science based decisions made every day at one of the most scientific based agencies in the US Government. The biggest issue is that when they are made against a firm, usually the firm has to rebuttal them with science based, evidence based proof, that places the firm at a disadvantage. Just try answering one of those famous Warning Letters and wait for the FDA's response. If you are successful at fending off FDA due to a non-science based evidence decision on their part, they don’t even have to apologize, the ultimate and a very non-scientific move. After all, FDA does make mistakes that range from incorrect Notice of Observations to Warning Letters, all of which are internal and not subject to outside court review until much later if it goes to court at all. If FDA issues a Warning Letter incorrectly, no problem, FDA just forgets about it. All this is a one-way street; the firm cannot issue a Notice, Import Alert or Warning Letter to the FDA. Yes I know there are provisions to Sue the FDA but let us be honest, most firms are not prepared to take on the FDA and the US government. In the end, this is not practicing good science at a very scientific agency, but its’ mission is noble.