Vermont Senator and former Democratic presidential candidate Bernie Sanders introduced a bill into the United States Senate on April 17, 2018, that would impose jail time on pharmaceutical executives whose companies engage in manipulative practices when marketing opioids.
The bill, the Opioid Crisis Accountability Act of 2018, prohibits illegal marketing and distribution of opioids, creates a criminal liability for top company executives, penalizes drug manufacturers who illegally advertise, market, or distribute an opioid product, and requires drug makers to reimburse the United States for “the negative economic impact of their products,” an amount estimated to be north of $78 million by the Centers for Disease Control.
The legislation imposes a ten-year minimum prison sentence and fines equal to the executive’s compensation package if the company is found to have illegally contributed to the opioid crisis. There are a number of ways the Department of Health and Human Services could demonstrate such liability, including by mandating written justifications for prescription orders that seem medically unreasonable.
The proposed bill reduces exclusivity in several ways, including: penalizing manufacturers who illegally advertise, market, or distribute an opioid product by stripping them of any remaining period of market exclusivity and reducing the remaining period of exclusivity by one half for all other opioid products made by the company. It also prevents any new or additional exclusivity from being awarded to the manufacturer with an application for an opioid product before the FDA or for a product advertised as a result of product hopping.
The legislation also prohibits any manufacturers who are found to be in violation of the Act from receiving tax credits and actually requires them to pay an increased amount of taxes, equal to the amount that they would have received in credits.
In a press release issued by his office, Sanders states, “We know that pharmaceutical companies lied about the addictive impacts of opioids they manufactured. They knew how dangerous these products were but refused to tell doctors and patients. Yet, while some of these companies have made billions each year in profits, not one of them has been held fully accountable for its role in an epidemic that is killing tens of thousands of Americans every year. At a time when local, state and federal governments are spending many billions of dollars a year dealing with the impact of the opioid epidemic, we must hold the pharmaceutical companies and executives that created the crisis accountable.”
This is the most recent bill presented to the United States Congress related to the opioid crisis, but takes a more direct aim at pharmaceutical companies than other bills. It is likely that legislation on opioids will be pursued on Capitol Hill prior to the 2018 elections. Whether this bill is part of that answer is yet to be seen, though given the seemingly extreme solutions found in this legislation and the lack of any current co-sponsors, it is fairly safe to say it will not be adopted in its entirety. The House plans to move forward on legislation relating to the opioid crisis by Memorial Day.