I recently posted some thoughts on the dilemma drugmakers face in balancing their reporting obligations to FDA against their general business model of selling their product. I received feedback that reporting obligations are the least of the drugmakers’ woes.
I’ll stand my ground that drugmakers face a huge task in both policing the drug supply chain and in reporting any irregularities on their watch. Since 2015, FDA’s Drug Supply Chain Security Act (https://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/) has put drugmakers in the drivers seat for their products’ safety from the assembly line to the patient. Even so, I never meant to suggest this is the only, or even the biggest, legal risk.
I just came across a list I once scribbled out in an attempt to “issue-spot” the potential liability of drugmakers, wholesalers and others involved in moving pills to patients. As my way of expressing thanks for the feedback, I’ll share the list. Please realize, it’s a mere down payment on the full scope of liability drugmakers might face from courts, shareholders, whistleblowers, FDA, CMS, States and more.
If this list doesn’t scare you, you probably have a future in policy research for major drugmakers.
So, to really understand the range of drugmaker risks under the Opioid Crisis, it’s not enough to look at FDA’s reporting obligations. Consider the legal and regulatory risks related to:
- flaws in the distribution chain (title II of DSCSA, with obligations for safety and for reporting)
- DEA annual production quotas (how did gazillions of pills get manufactured, anyhow?)
- clinical pharmacy laws (state licensure obliges a retail pharmacist to ‘do no harm’)
- shortcomings in monitoring and preventing diversion and adulteration (even from third parties)
- mass tort cases (when suits like the Tobacco Cases or Agent Orange take off, everyone’s in)
- adulteration on another’s watch (what if the pill bottle was adulterated upon first receipt?)
- implied collusion with the pill mills’ reckless demand, or the wholesalers’ stunning over-supply
- implied collusion with diversion to the street (suits move faster when a deep pocket get sued)
- implied collusion with the clinical side of overprescription (how much detailing is too much)
This (incomplete) list applies to the drugmakers. Similar issues face the wholesalers, PBMs, GPOs and others in the chain. In fact, the list of folks facing legal exposure is longer than most people would guess. Ask me: I lived through the Tobacco Settlement, the Agent Orange cases and the Breast Implant litigation. You can sue anyone for anything, you just can’t always make it stick.