It’s clear the opioid crisis is real. It’s not as clear, though, what kind of obligation this crisis might trigger for anyone to report their own failings to government enforcers. Let’s take a look.
WE’RE DYING, WHO’S REPORTING?
Let’s recall that the catch-phrase “opioid crisis” isn’t a single crisis, but a collection of different and terrible problems. We face challenges as broad as:
– street drugs (legitimate products or drugs laced with a deadly strength of synthetic painkiller).
– diversion of Rx drugs (stolen from Granny’s bedside or hijacked from distributors’ trucks).
– pill mills (whether run by licensed, well-meaning doctors or simple criminals).
– new drugs (ANDAs for delivery systems proven unsafe, NDAs for superstrong new opioids).
That’s just the start. You get the picture: the crisis is more than one politician’s soundbite, more than one Agency’s jurisdiction. One topic politicians haven’t yet pushed into the headlines – industry’s reporting obligations for opioid-related deaths.
WE’RE SUING, WHO’S COUNTING?
As an attorney, I count the size of the crisis by the lawsuit. Lawsuits abound. States are suing drugmakers for over-promotion and pharmacies for flooding the market. Families are reacting to their loved ones’ deaths by suing doctors for prescribing too much and drugmakers for warning too little. It’s hard to keep up.
We could count how many suits, how many deaths, how many souls are lost. What’s not really known involves how many people are lost to which aspects of the crisis. Who by a needle in the arm, who by an Rx drug taken as prescribed? The question informs where to put public resources: FDA’s reporting systems or Medicaid’s addiction counseling. And, we don’t know.
Counting by type of death is important for getting a handle on where the solutions may lie.
DRUGMAKERS ARE QUIET – WHO’S AT FAULT?
Drugmakers are now under indictment for failing to report adverse event reports. Nonreporting of clinically-relevant information is terrible, but it’s not always obvious what’s clinically relevant. Do we place a reporting obligation on the drugmaker for an ER admission from a tainted fake drug? A death from an accidental poisoning? The MedWatch program is supposed to focus on drug side effects – does the opioid crisis count as a side effect? It seems we don’t know how many events occur overall, or what type of prevention might have helped.
This failure to report an adverse event gives us a bad “numerator” to the drug equation – how many events took place. At the same time, though, we face problems from a bad “denominator” – how many of those pills did Americans take last year? When properly-prescribed drugs are diverted, that lowers the number of legitimately-taken pills; when counterfeits flood the market the numbers might move significantly.
We can’t measure how bad the crisis is without data on both the numerator – the number of bad outcomes – and the denominator – the number of pills consumed.
UNDER-REPORTING – CRIME OR OBLIGATION?
Back in 2013, Congress passed some sweeping obligations for drugmakers to report supply chain events, down to package-level barcoding. Yet just as drugmakers have an obligation to follow the statutory reporting requirements, they have a “free speech right” to not report information that’s unrelated. Indeed, they might have an obligation to their shareholders to retain the information as proprietary. Deciding whether reporting is mandated or prohibited is hardly simple here.
Not many folks show a lot of sympathy for Big Pharma when it comes to reporting on opioid matters. Their reporting obligations are sufficiently complex, though, that they might deserve a mix of prosecution and even a little empathy. An area where FDA reporting overlaps with SEC disclosure. It ain’t easy making green.
