My Life with the FxA

"So, what the FAA will want to see is..."

I was giving a presentation, transitioning from one slide to another, when I realized that I had just played a wrong note.  Briefly scanning faces in my audience, I saw several confused expressions.  With a mental rewind, my error was obvious.  I was speaking to a group of pharmaceutical scientists, not pilots.  On top of that, the vast majority of them were Europeans because I was speaking in Vienna, Austria.  None of my listeners were likely to be familiar with, or particularly interested in, the FAA (except, perhaps, the other two US citizens in the room who were as keen to get home at the end of the week as I was).

What I had meant to say, and what would have fit the context of my presentation better, was "FDA".

I have been a pharmaceutical scientist for fifteen years.  For the majority of my career, I have specialized in chemical detective work.  To non-scientists, my expertise is most easily likened to the forensic chemistry depicted on CSI, only without the dead bodies (which is fortunate because I do not do well with blood).  It is an engaging and challenging career that, hopefully, has had positive impact on people's lives.  I am sort of like BASF in that I don't actually make anything, but I try to make things better.

April 13, 2003: Where my career got its start in Kalamazoo, MI

Following that slip of the tongue, I was struck by the blurring between my personal and professional lives.  In that moment, standing on the podium, it all made perfect sense.  Superficially, the Federal Aviation Administration (FAA) and the Food and Drug Administration (FDA) are similar in that they are both large, government run bureaucracies.  But as I contemplated beyond the obvious, I was surprised by the depth of similarity between them.

Fundamentally, both Agencies are charged with protecting public health and safety.  They evolved from pre-existing early 20th century organizations, but did not develop into the Agencies we know today until tragedy struck.  In the case of the FAA, the most cited tipping point was the mid-air collision of a TransWorld Airlines Super Constellation with a United Airlines DC-7 over the Grand Canyon in 1956.  Reactive legislation created the FAA and endowed it with the authority to regulate our national airspace with an aim of preventing future mid-air collisions.

July 25, 2004:  Another angle on where I started my career.

Most high school graduates know about Upton Sinclair's "The Jungle" that inspired events culminating in the Pure Food and Drug Act of 1906.  Regulation of pharmaceuticals did not catch up to food regulations until the infamous Elixer Sulfanilamide disaster of 1937 when over 100 people died from ingesting a liquid sulfa drug formulation primarily intended for children.  The formulation contained diethylene glycol as a solvent, which is both sweet tasting and extremely toxic.  Incredibly, the manufacturer broke no laws by using diethylene glycol in their formulation; toxicological testing of new drugs was not a requirement of the time.  Justifiable public outcry from this incident (and others) drove legislation of the Food, Drug, and Cosmetic Act of 1938.  This law gave FDA the authority to closely regulate pharmaceuticals and specified a registration and approval process for new drugs that included safety testing prior to dosing in humans.

Naturally, creation of regulatory agencies sets the stage for conflict with those being regulated.  In my business, being audited by the FDA is met with the same level of enthusiasm as a private pilot subject to an FAA ramp check (that is, if a ramp check lasted for several days).  Even if all "i"s are properly dotted and "t"s crossed, there is always fear of an unscrupulous regulator with an axe to grind.  Whether such fears are warranted or not, there must be a reason that those "FAA: we're not happy until you're not happy" t-shirts are so popular.  Likewise, though it may be fashionable for the media to claim that the FDA is "in the pocket of big pharma", I have seen zero evidence of that in my fifteen years.  I still vividly recall my first visit to the FDA.  I entered that building in Rockville, MD naively expecting an open scientific dialog and left with a rather cynical world view.  At their most casual, these discussions are reminiscent of my doctoral defense.  This is with good reason; it is the role of pharmaceutical scientists to present the data supporting their conclusions and it is up to the FDA to decide if they agree.

October 10, 2002: The Three Rivers - Dr. Haines Municipal Airport (HAI) where I learned to fly.

Despite the inevitable clashes between regulators and those they regulate, most of the individuals with whom I've interacted from the FAA and the FDA have been professional, bright, energetic, and steadfastly passionate about their responsibility to protect public health and safety.  Passion is essential.  These jobs are often not easy and both Agencies are regularly caught in the trap of being considered too stringent by some and too lenient by others; the Kobayashi Maru of the regulator.

One challenge common to both Agencies is that, in the well-intentioned pursuit of safety, they have placed so many hurdles in the aircraft certification and new drug approval processes that innovation is hampered.  In other words, it is easier for the aviation or pharmaceutical industries to go with the tried and true (like magnetos) that the FxA is already familiar with, than to invest in development and regulatory approval for the unconventional.  For aircraft, the experimental (home-built) category provides an outlet for affordable, expedient innovation.  This is one place where the Agencies clearly differ as there is no equivalent for pharmaceuticals.  This strikes me as entirely appropriate.  After all, if a home-built aircraft emblazoned with "EXPERIMENTAL" makes people nervous, just imagine how they would react to such a placard on their prescriptions!

To their credit, both Agencies recognize that excessive regulation does not always add inherent value.  For example, FDA has been promoting  "risk based" and Quality by Design pharmaceutical development strategies intended to focus on what is most important for the particular drug under development.  This is a big change from the previous mode of "check-box" development activities that incur costs without necessarily enhancing quality or safety (and may actually ignore something critical for a given drug).  For its part, the FAA has vowed to take a closer look at its requirements around aircraft certification with an eye toward streamlining the process.  These are good things for everyone.

Airplanes and pharmaceuticals; are there any two industries more regulated than these?  There are days when I wonder why I willingly subjugated both my personal and professional lives under such regulation.  At the heart of the matter is risk/reward.  When I completed my doctorate in chemistry, I had multiple opportunities.  I recall standing in a polymer formulation lab of a very well-known and respected company that was courting me.  My guide showed me the translucent teal case of an iMac (remember those?), explaining that it (the snazzy plastic case) had been developed there.  Though Dustin Hoffman's graduate may have been steered toward plastics, I was more interested in having a meaningful positive impact on people's lives.  This drew me toward the pharmaceutical industry.  As for flying, one need look no further than this blog to see the immense pleasure I derive from aviation.

But I do know this: though both Agencies may be imperfect, their functions are absolutely essential.  During the flurry of recent news about sequestration and air traffic control tower closures, I read some commentary to the effect that ADS-B will render ATC obsolete because pilots will be able to separate themselves.  I do not agree with this.  When airports get busy, I think there is value in having a non-participating third party directing traffic with a goal of doing what is best for everyone.  And for  pharmaceuticals?  Same deal, without question.

Standing on the podium in that Viennese hotel, I corrected my slip of the tongue (without alluding to its cause) and continued on with my presentation with the new found understanding that flying and the practice of pharmaceutical chemistry are more congruent than I previously realized.