Op-Ed: What Do “The Hunger Games” and 510(k) Have in Common? More Than You’d Think.Op-Ed: What Do “The Hunger Games” and 510(k) Have in Common? More Than You’d Think.

Like the tributes thrust into the Hunger Games arena, medical device manufacturers want a fair shot at surviving the ever-changing FDA 510(k) pathway.

By Mark DuVal

The FDA 510(k) program is beautiful and practical in its simplicity, and yet sophisticated in its ability to accommodate complexity and flexibility. It is as maligned as it is revered. But describing the nuanced process in detail is far too complex, as it requires an admixture of macro and micro politics, political philosophy being subtly carried out, and regulatory and administrative law, medicine, and science.

By putting it into a caricature using the pop culture phenomenon The Hunger Games, however, I have tried to provide an amusing analogy to demonstrate what it’s like to take a client through the surprise-filled arena we call the 510(k) program as well as some tips on how to make it out alive.

Casting Call

In The Hunger Games, the cultural elites of a dystopian society occupy the gleaming, glamorous, and intimidating capitol city of Panem. To suppress an uprising from the masses it has subjugated, the Capitol forces two “tributes,” or representatives, aged 12 to 18 from each of the nation’s 12 districts to compete in the annual Hunger Games—a fight to the death of the participants until there is only one survivor. In order to win, the tribute must thwart opponents and survive a high-stakes arena rigged with countless unseen dangers.

A tyrannical governing body, rules that change on a whim, and frustrated masses: Is this scenario beginning to sound familiar?

In the 510(k) games, FDA’s cultural elites have also subjugated the masses (i.e. industry), and are starving them of 510(k)s.

Christy Foreman, director of the Office of Device Evaluation (ODE), as Effie Trinkett.
In The Hunger Games, Effie is the representative from the Capitol who travels to District 12, home of the heroine, 16-year-old Katniss Everdeen. She is responsible for overseeing the ceremony to randomly select the district’s two tributes, ominously dubbed, “the reaping.” Effie goes on to host the tributes—who are essentially being led to their slaughter—in the Capitol as they await their opportunity to defend themselves in the arena.

Startup Medtech Companies as Katniss Everdeen and Peeta Mellark.
The heroes of The Hunger Games have been conscripted to participate in the games on behalf of their struggling and repressed district. These underdogs hail from one of the poorer, disadvantaged, and less-trained districts, and lack the brute strength exhibited by some of their competitors.

Regulatory Affairs Consultant and FDA veteran Phil Phillips, president of Phillips Consulting Group, as Haymitch Abernathy.
As District 12’s only surviving past champion of the Hunger Games, Haymitch is obligated every year to provide guidance to his district’s two tributes. Although he lives the life of a champion, Haymitch has the unenviable duty of helping his district’s tributes to train for combat in the arena in which the odds are heavily stacked against them. Year after year, Haymitch is essentially responsible for preparing his hometown’s youth representatives for their demise—a depressing job, to say the least.

Johnson & Johnson as Cato.
As the tribute representing District 2, Cato hails from a region that essentially breeds “career tributes” to compete in the bloodthirsty games. Career tributes are typically larger and better trained than tributes from other districts and have a long history of winning the Hunger Games. Cato is the biggest and most brutal of the Hunger Games’ contestants.

Dr. David Buckles, CDRH Ombudsman, as Cinna.
Cinna is Katniss’s assigned stylist from the Capitol. As a stylist, Cinna’s job is to help tributes to present themselves well in front of the Capitol’s elite residents in order to gain favor and possibly help from them during the competition.

Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH), as Caesar Flickerman (or Head Gamemaker Seneca Crane).
The Hunger Games are a national spectacle. Interviews with the tributes prior to entering the arena are televised, as is the eventual carnage of the games. And conducting these interviews is the flamboyant television personality Caesar Flickerman. He is warm and friendly when interviewing the tributes in front of the national Panem audience, despite knowing they will soon be heading for their death. In the film version of The Hunger Games, Flickerman also does the play-by-play commentary when the tributes are released into their combat venue. His commentary is meant to elicit sympathy for the players as they battle for survival. He generates gladiator-like excitement and interest in the bloodthirsty pandemonium of the games, from which only one of 24 tributes will emerge victorious.

While the tributes compete, the head gamemaker, who could also be played by Shuren, is constantly manipulating the field of engagement and changing the rules. The competitors must quickly and nimbly adapt to the changing environment in order to survive.

Dr. Margaret Hamburg, FDA Commissioner, as President Snow.
As the authority figure presiding over the nation of Panem, Snow is responsible for calling the shots and devising overarching strategies. President Snow must also decide how to respond to the defiance of the tributes and, later, the masses.

Why We Should be Questioning Authority

This is a funny—yet fitting—analogy to an often-harrowing journey through FDA bureaucracy to obtain a 510(k). But the point is really to highlight that the process has changed and continues to change dramatically. And there is an eventual threshold at which point industry will no longer tolerate injustices, much like the people of Panem.

I frequently appeal FDA decisions on IDEs and 510(k)s, and work on panel meetings with FDA. My goal is to ensure that my clients are on a level playing field and that FDA does not randomly change the rules or apply inappropriate ones on a whim. I just want my “tributes” to have a fair chance at successfully making it out of the 510(k) arena.

FDA is making that difficult, however. During the past four years, FDA has made numerous attempts to legislate through administrative action, even though the agency is not a legislative body. The various branches and divisions frequently make up rules for the program that are not part of a substantial equivalence determination. And through it all, FDA is amazingly risk-averse.

Three years ago, as he was taking over as director of the CDRH and commencing work on redefining the 510(k) program, Shuren told me: “This is not going to be your grandmother’s 510(k).” Well, he has certainly lived up to his word.

Recall that Shuren appointed the Institute of Medicine (IOM) to study and make recommendations to the 510(k) program several years ago. In turn, the IOM essentially suggested aborting the current 510(k) process and reworking it to more-closely resemble the PMA process. This is great (I’m being facetious), considering that this is the same CDRH administration that has dramatically reduced the number of PMA approvals and 510(k) submissions cleared during its tenure and is trying to push 510(k) submissions to de novo review.

CDRH also created 10 internal working groups to consider (re)defining such concepts as same intended use, what constitutes new technological characteristics, when they raise new questions of safety and effectiveness, when are multiple predicates appropriate, and so on. These working groups subsequently produced a new 510(k) modifications guidance that industry promptly forced them to withdraw by working with Congress on the language of the FDASIA statute last July. Think about how monumental that act was: Congress actually told FDA—through legislation—to shelve its proposed modifications guidance because it was so far afield of the current law and a major departure from the current modifications guidance. A coordinated uprising of sorts can be effective.

CDRH also produced a new 510(k) guidance document. To the uninitiated, the guidance makes many small, seemingly inconsequential changes. But to the student of the program, each small change does alter the 510(k) program. And, more importantly, the totality of the changes significantly changes the 510(k) program.

On January 2, 2013, I filed a Citizen Petition on behalf of industry that challenged the new 510(k) guidance—not the modifications guidance—that CDRH put out and asked the branch to withdraw it and start over. The effect remains to be seen. However, this was my act of defiance against FDA akin to Katniss and Peeta’s act of defiance against the Capitol when they planned to eat the poisoned berries.

The Seeds of Revolution

This macro view of today’s regulatory environment is important because it affects what is happening in the micro picture in regards to individual product reviews. First, the Congressional work and public opposition to the way in which FDA is trying to implement the 510(k) program appears to be working. We cannot stop the inevitable march toward requiring more data. But we can slow it down to ensure that it is fairer (i.e. not a science project) and more targeted to unanswered questions of safety and effectiveness.

While the amount of data required varies by individual reviewer, branch chief, and division director, FDA is moderating these requests. I have seen on appeals that management is requesting that the agency accept less data than the reviewer initially requests. The good news is that common sense is eventually applied; the bad news is that it often takes an appeal to upper management to obtain that common sense.

This information has altered how I advise companies to approach their 510(k) submission. Many seasoned regulatory affairs professionals approach their 510(k)s in a very conventional way with an emphasis on science and engineering because that is, after all, what they do for a living. But the 510(k) must be viewed as an advocacy document meant to persuade. And the need for persuasion is built in the framework of the 510(k) program criteria in terms of demonstrating same intended use, same technological characteristics, and that any new technological characteristics do not raise new questions of safety and effectiveness.

Most regulatory affairs professionals do not follow this framework, however. Or, if they do, they do not make strong arguments for each of those elements. They also do not hold FDA’s feet to the fire by making sure that FDA is faithful to the interpretation of the 510(k) program using the statute, regulations, and guidance documents.

By making strong arguments up front, the company demonstrates some degree of sophistication to the reviewer and branch chief in its submission so that FDA is more careful in interpreting the 510(k) program. It is also better to make these arguments up front than rely on challenging the reviewer or branch chief in an appeal after an unfavorable decision. There is an institutional inertia that occurs when a medical device manufacturer lets a reviewer make some bad decisions without contesting them right away. And it is even better to try to preempt those bad interpretations by setting a framework for your argument in your 510(k) submission.

So, with this information, let the 510(k) games begin. And, to quote the Panem elite: “May the odds be ever in your favor.”

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Mark DuVal, J.D., is president of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training, and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, and appeals.

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Photos: Lionsgate/Murray Close