Outsource the FDA New Drug Approval Process

This is the first in an occasional series where we explore What If Scenarios: fanciful looks into the future of R&D. Our intent is not to debate the merits of future scenarios vis-á-vis current practices. We simply paint a picture of an alternate future scenario.

This installment explores the FDA new drug approval (NDA) process. What would it look like if this approval were outsourced to the lowest bidder?

Would you allow a type of medicine on the market that has been shown to cause cancer in mice?

The jury is instructed to ignore that last statement. Just because a class of drugs has been implicated in adverse side effects has no de facto relevance for this member of the class standing before us today. Counselor I warn you against further use of these cheap tactics in my courtroom.

Society uses the judicial system to decide cases of mass murder, billion dollar swindles, and even corrupt judges. And now we use the judicial system to decide whether new drugs are safe enough for release into the market. Our jury in this trial hears both sides of the case, to approve or to reject, and makes a binding decision. We would rather they hear the case up-front, during drug approval, than when it’s too late, as was the case with Vioxx™, Fen-Phen™ and a host of other withdrawn drugs. We make the decision without having to be presented with a parade of maimed and afflicted victims attributed by the trial lawyers to drug company avarice.

We’ve designed our trial procedures to ensure good decisions: avoiding both false-positives (i.e., letting drugs onto the market that it should not) and false-negatives (i.e., rejecting drugs that should be on the market). We have procedures that are self-correcting over time: we learn from our successes and from our mistakes. We have built safeguards into the trial process that protect it from both gaming and political end-runs. We leverage over two centuries of judicial practice to ensure a level playing field for both parties to the case.

We’ve done even better: Our drug approval process is now intricately entangled with the U.S. legal system. Our trial findings have precedent in future litigation involving drugs we’ve approved. We have successfully mimicked the U.S. legal system in our procedures, controls and decision quality.

The Players

  • The Judge … independent judge out of the U.S. court system (or retiree) charged with protecting the integrity of the overall judicial process. His or her main concern is to ensure all participants play fairly.
  • The Prosecutor … comes from a certified law firm. His or her main objective is to get the drug rejected.
  • The Jurors … comes from the general population using a lottery selection system. Their main concern is to fairly evaluate the evidence and to decide whether or not the drug should be approved.
  • The Facilitator … comes from certified consulting firms. His or her main concern is to ensure the jurors effectively process a large collection of complex evidence.
  • The Defense … the drug company seeking approval for their drug.
  • Others … we have a cast of individuals in the roles of court reporter, bailiff, court administrator, etc.

Payments

  • The judicial infrastructure … courtrooms, administrators, filing clerks, secretaries, etc. … are paid for by federal government and industry fees
  • Prosecution fixed fees … preparation for trial, trial execution, and witness reimbursements … are paid for by federal government and industry fees
  • The Prosecution’s bonus for winning … typically the only way the law firms can recoup their customary fees for the hours needed to prosecute the trial … are paid for by losing drug firms

Preparation

  • Drug Firms signal their intention to go to trial by petitioning a slot on the very limited court docket 12-18 months in advance, filing preliminary drug approval materials, and depositing good-faith fees
  • The FDA lines up the players for the trial … law firms are invited to bid (fixed fee) based on the preliminary drug approval documentation … consulting firms are invited to bid based on their facilitation skills … jurors are selected by lottery for the few coveted seats.
  • Law Firms bid for the right to prosecute the trial … bidding both the fixed fees and the bonus payment ... the drug firm may pay to  'equalize' fixed fees across bidders with disparate bonus payouts (i.e., can equalize a bid of $500,000 fixed fee with $10 million bonus to a  bid of $1 fixed fee having a $100 million bonus)
  • The winning Law Firm lines up its subpoenas, depositions, independent laboratory work, prosecution witnesses, etc.

The Play

  • Jury Selection … proceeds in the usual way of a civil trial
  • Witness Selection … proceeds in the usual way of a civil trial
  • Inadmissible Evidence+ … decided at the sole discretion of the Judge
  • Jury Deliberation … guided by a court-assigned expert in faciliation … confidential transcripts are taken to allow later evaluation of trial integrity and player performance
  • Examination and Cross-Examination … very broad latitude for the Judge to intervene with clarifying statements
  • The Verdict … binding, unless the defendant firm wishes to come back in 12-18 months with further evidence for a re-trial of the rejected drug

Game End

  • Announcement of results for public scrutiny
  • Payments are disbursed to all players
  • Independent evaluation+ of player competence and integrity – recommendations for improvement
  • Filing and protection of court transcripts for future reference

What Can Possible Go Wrong?

  • The next Thalidomide … revelations of jury stacking … judicial corruption … grand-standing by members of Congress … and so-on. In the end the only lasting protection comes from public interest groups that have a vested interest in the outcome of the trial.

 

Maybe we should contact Hasbro Company for the rights to the above board game? It's unclear though if the insults to the judicial system listed in the table below should be considered as selections for the Chance or the Opportunity Chest cards.


Below are potential insults to the NDA judicial procedures and possible protections against those insults.

Insults
Protections
Cheating or Conflicts of Interest
  • De-certification of prosecution / facilitation firms
  • Blacklisting of drug firms
  • Vendor selection criteria and procedures
  • Declarations of conflicts of interest
  • Recusal of prosecuting firm, its affiliates and staff from future litigation involving the drugs or companies party to the trial (for predetermined time-frame)
Inappropriate Evidence / Tainting of the Jury
  • Independence of the Presiding Judge
  • Rules on Inadmissibility of Evidence
  • Strict controls on jury selection
Hidden Evidence
  • Site Inspections (using Forensic Techniques)
  • Depositions
  • Rules on date-time stamping of evidence
Shirking (Prosecution not doing their job)
  • Significant premiums for winning
  • Debarment of firms convicted of collusion
Stacking of Jury / Runaway Jury
  • Jury Selection Rules and Controls
Decision Sniping
  • Ongoing tracking and continuous improvement of decision quality
  • Open metrics and reporting of decision quality
Misleading the Jury
  • Influence of the Presiding Judge
  • Independent Facilitation during Jury Deliberations
End Runs
  • Autonomous protections that bind trial decisions
  • Public communication and interest group participation

 

Further Reading