[Congressional Record Volume 165, Number 204 (Tuesday, December 17, 2019)]
[Senate]
[Page S7116]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. FEINSTEIN (for herself, Mr. Grassley, Mr. Durbin, and 
        Mrs. Capito):
  S. 3070. A bill to modify reporting requirements under the Controlled 
Substances Act; to the Committee on the Judiciary.
  Mrs. FEINSTEIN. Mr. President, I rise with my colleagues, Senators 
Grassley, Capito, and Durbin to introduce the Preventing Pill Mills 
Through Data Sharing Act.
  Millions of pills flooded small communities throughout the Nation to 
fuel the opioid epidemic we are facing today.
  Despite the fact that opioid manufacturers and distributors were 
required to keep complete and accurate records relating to the sale, 
delivery, or disposal of opioids through the Automated Reports and 
Consolidated Ordering System, often referred to as ARCOS, and to detect 
and disclose suspicious orders of opioids to the Drug Enforcement 
Administration (DEA), these substances still reached our streets.
  That is why my colleagues and I previously introduced the ``Using 
Data to Prevent Opioid Diversion Act,'' which was enacted as part of 
the ``SUPPORT Act'' in 2018. As a result of that law, DEA is now 
required to provide to opioid manufacturers and distributors anonymized 
information related to the number of distributors serving a single 
pharmacy or practitioner, and the quantity and type of opioids being 
delivered to each.
  This information, coupied with the internal controls that these 
companies already use in their efforts to determine the legitimacy of 
opioid orders, is assisting manufacturers and distributors in their 
efforts to better prevent these substances from being diverted to 
someone other than the intended recipient who has a lawful 
prescription.
  That law also strengthened accountability by establishing civil and 
criminal fines for drug manufacturers and distributors who fail to 
consider ARCOS data when determining whether an order for opioids is 
suspicious. Additionally, it increased existing civil fines for drug 
manufacturers and distributors who fail to report suspicious orders and 
keep accurate records ten-fold, and doubled existing criminal fines.
  Finally, our legislation required the United States Attorney General 
to share standardized reports with state officials, including 
regulatory, licensing, attorneys general, and law enforcement agencies, 
related to the distribution patterns collected by the ARCOS database on 
a semi-annual basis.
  This law has ensured that opioid manufacturers and distributors have 
a clear picture of how many pills are going to each pharmacy, thereby 
helping to eradicate pill mills.
  To strengthen this law, my colleagues and I are introducing the 
``Preventing Pill Mills Through Data Sharing Act.'' This new 
legislation is largely based on recommendations included in the October 
2019 U.S. Department of Justice (DOJ) Office of the Inspector General 
(OIG) report related to the DEA's response to the opioid epidemic.
  In that report, the DOJ OIG noted two shortcomings associated with 
the ARCOS system. First, not all registrants input data into the ARCOS 
system at the same intervals.
  While both opioid manufacturers and distributors are required to 
input data on a quarterly basis, manufacturers often input the data 
monthly, while distributors do so quarterly. This means that when the 
DEA provides the quarterly reports that drug manufacturers and 
distributors must use to determine whether orders are suspicious, they 
don't have the most up to date information. Our legislation addresses 
this problem by requiring all registrants to input data on a monthly 
basis.
  Second, the database only captures information for Schedule I and II 
drugs. As a result, addictive drugs in other schedules, which are also 
diverted, are not captured. This includes nine combination opioid 
products.
  For this reason, our legislation expands the reporting requirements 
to include controlled substances in all schedules. Our legislation also 
closes an existing loophole.
  The DEA has informed my staff that, under current law, one pharmacy 
is able to transfer up to five percent of its inventory of controlled 
substances to another pharmacy without having to immediately report to 
the DEA.
  Because these transfers are not automatically reported to the DEA 
through the ARCOS system, it creates a blind spot for the DEA, as well 
as for drug manufacturers and distributors who are required to consider 
data from the anonymized reports generated from the ARCOS database when 
determining whether an order for controlled substances is suspicious.
  Moreover, because pharmacies are not currently required to check the 
ARCOS reports provided by DEA before transferring a controlled 
substance to another pharmacy, they could be inadvertently supplying a 
pharmacy with excess amounts of pills that could easily end up on the 
black market.
  That is why our legislation applies the same reporting requirements 
and penalties to pharmacies transferring controlled substances, except 
in the limited circumstance of a transfer made for a specific patient 
need, as those that are applied to drug manufacturers and distributors.
  In 2018, we lost almost 70,000 individuals to drug overdose deaths in 
our country. Nearly 48,000 of these were opioid-related.
  Drug manufacturers, distributors, and pharmacies all play a critical 
role in preventing future overdose deaths.
  The ``Using Data to Prevent Opioid Diversion Act'' has been 
successful.
  The ``Preventing Pill Mills Through Data Sharing Act'' builds on that 
success and will close existing loopholes in order reduce the diversion 
of controlled substances that are contributing to the massive number of 
overdose deaths in the United States.
  I urge my colleagues to support this legislation and look forward to 
its passage.
  Thank you, Mr. President. I yield the floor.
                                 ______