,,ii #aaeth ,,congress #b;d ,session ,s4 #bhch ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #ae1 #bjah,mrs4 ,feinstein 7for herself1 ,mr4 ,grassley1 ,mrs4 ,capito1 and ,mr4 ,durbin7 introduced the following bill2 which was read twice and referred to the ,committee on the ,judiciary ,a ,,bill ,to amend the ,controlled ,substances ,act to require the ,drug ,enforcement ,administration to report certain information on distribution of opioids1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,using ,data to ,prevent ,opioid ,diversion ,act of #bjah4 #b4 ,findings ,congress finds the following3 7#a7 ,in #bjaf1 there were nearly #fd1jjj drug overdose deaths in the ,united ,states4 ,more than #db1jjj of these deaths were opioid-related4 7#b7 ,the regulations promulgated under the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hja et seq47 require drug manufacturers and distributors to-- 7,a7 provide effective controls against the diversion of controlled substances2 7,b7 detect and disclose suspicious orders to the ,drug ,enforcement ,administration2 and 7,c7 keep complete and accurate records relating to the manufacture or distribution of controlled substances4 7#c7 ,despite the requirements described in paragraph 7#b71 it has been publicly reported that between #bjjf and #bjaf1 nearly #ba1jjj1jjj opioids were distributed to #b pharmacies in ,williamson1 ,west ,virginia1 which has a population of approximately #c1jjj4 ,it has been further reported that between #bjjg and #bjjh1 nearly #i1jjj1jjj pills were distributed to a single pharmacy in ,kermit1 ,west ,virginia1 which has a population of #cib4 7#d7 ,similarly1 it has been publicly reported that #ghj1jjj1jjj oxycodone and hydrocodone pills were distributed to pharmacies throughout ,west ,virginia between #bjjg and #bjab4 ,in the same period1 more than #a1gjj people in the ,state died from overdoses of these #b substances4 7#e7 ,drug manufacturers and distributors are required to report the sale1 delivery or other disposal of narcotics to the ,drug ,enforcement ,administration through the ,automated ,reports and ,consolidated ,ordering ,system4 7#f7 ,notwithstanding the reporting requirement described in paragraph 7#e71 the ,drug ,enforcement ,administration does not disclose the total quantity and type of opioids distributed to a single pharmacy or practitioner with those manufacturers and distributors who are required to input information into the ,automated ,reports and ,consolidated ,ordering ,system4 ,this creates a barrier to identifying and stopping potentially suspicious orders4 7#g7 ,although manufacturers and distributors are already required to provide effective controls against the diversion of controlled substances1 this lack of data sharing may create a barrier to better identifying and stopping potentially suspicious orders4 7#h7 ,on an annual basis1 the ,attorney ,general of the ,united ,states is statutorily required to share the controlled substance or substances in schedule ,,ii that have the highest rates of abuse and to prepare and make available reports on the distribution patterns of such substances1 with ,state regulatory1 licensing1 and law enforcement agencies4 ,the ,attorney ,general of the ,united ,states has entered into data sharing agreements with the attorneys general of the vast majority of ,states1 ,puerto ,rico1 and the ,district of ,colombia to share1 pursuant to ,state law and policy1 data obtained from ,state prescription drug monitoring programs and other sources4 7#i7 ,to further reduce barriers associated with identifying suspicious patterns and stopping the diversion of opioids1 the remaining ,states and territories of the ,united ,states should enter into similar agreements with1 and to the greatest extent practical share data obtained from ,state prescription drug monitoring programs with1 the ,attorney ,general of the ,united ,states4 #c4 ,purpose 7a7 ,in general ,the purpose of this ,act is to provide drug manufacturers and distributors with access to anonymized information through the ,automated ,reports and ,consolidated ,ordering ,system to help drug manufacturers and distributors identify1 report1 and stop suspicious orders of opioids and reduce diversion rates4 7b7 ,rule of construction ,nothing in this ,act should be construed to absolve a drug manufacturer1 drug distributor1 or other ,drug ,enforcement ,administration registrant from the responsibility of the manufacturer1 distributor1 or other registrant to-- 7#a7 identify1 report1 and stop suspicious orders2 or 7#b7 use all available sources of information to determine-- 7,a7 the legitimacy of a customer's order2 and 7,b7 whether or not an order described in subparagraph 7,a7 is suspicious4 #d4 ,amendments 7a7 ,records and reports of registrants ,section #cjg of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hbg7 is amended-- 7#a7 by redesignating subsections 7f71 7g71 and 7h7 as subsections 7g71 7h71 and 7i71 respectively2 7#b7 by inserting after subsection 7e7 the following3 7f7 7#a7 ,the ,attorney ,general shall1 not less frequently than quarterly1 make the following information available to manufacturer and distributor registrants through the ,automated ,reports and ,consolidated ,ordering ,system1 or any subsequent automated system developed by the ,drug ,enforcement ,administration to monitor selected controlled substances3 7,a7 ,the total number of distributor registrants that distribute controlled substances to a pharmacy or practitioner registrant1 aggregated by the name and address of each pharmacy and practitioner registrant4 7,b7 ,the total quantity and type of opioids distributed1 listed by ,administration ,controlled ,substances ,code ,number1 to each pharmacy and practitioner registrant described in subparagraph 7,a74 7#b7 ,the information required to be made available under paragraph 7#a7 shall be made available not later than the #aeth day of the first month following the quarter to which the information relates4 7#c7 7,a7 ,all registered manufacturers and distributors shall be responsible for reviewing the information made available by the ,attorney ,general under this subsection4 7,b7 ,in determining whether to initiate proceedings under this title against a registered manufacturer or distributor based on the failure of the registrant to maintain effective controls against diversion or otherwise comply with the requirements of this title or the regulations issued thereunder1 the ,attorney ,general may take into account that the information made available under this subsection was available to the registrant4 2 and 7#c7 by inserting after subsection 7i71 as so redesignated1 the following3 7j7 ,all of the reports required under this section shall be provided in an electronic format4 4 7b7 ,cooperative arrangements ,section #ejc of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hgc7 is amended-- 7#a7 by striking subsection 7c7 and inserting the following3 7c7 7#a7 ,the ,attorney ,general shall1 once every #f months1 prepare and make available to regulatory1 licensing1 attorneys general1 and law enforcement agencies of ,states a standardized report containing descriptive and analytic information on the actual distribution patterns1 as gathered through the ,automated ,reports and ,consolidated ,ordering ,system1 or any subsequent automated system1 pursuant to section #cjg and which include detailed amounts1 outliers1 and trends of distributor and pharmacy registrants1 in such ,states for the controlled substances contained in schedule ,,ii1 which1 in the discretion of the ,attorney ,general1 are determined to have the highest abuse4 7#b7 ,if the ,attorney ,general publishes the report described in paragraph 7#a7 once every #f months as required under paragraph 7#a71 nothing in this subsection shall be construed to bring an action in any court to challenge the sufficiency of the information or to compel the ,attorney ,general to produce any documents or reports referred to in this subsection4 4 7c7 ,civil and criminal penalties ,section #djb of the ,controlled ,substances ,act 7#ba ,u4,s4,c4 #hdb7 is amended-- 7#a7 in subsection 7a7-- 7,a7 in paragraph 7#ae71 by striking or at the end2 7,b7 in paragraph 7#af71 by striking the period at the end and inserting 2 or2 and 7,c7 by inserting after paragraph 7#af7 the following3 7#ag7 in the case of a registered manufacturer or distributor of opioids1 to fail to review the most recent information made available by the ,attorney ,general in accordance with section #cjg7;f7 before each distribution of a controlled substance referred to in such information4 2 and 7#b7 in subsection 7c7-- 7,a7 in paragraph 7#a71 by striking subparagraph 7,b7 and inserting the following3 7,b7 7i7 ,except as provided in clause 7ii71 in the case of a violation of paragraph 7#e71 7#aj71 or 7#ag7 of subsection 7a71 the penalty shall not exceed #aj1jjj4 7ii7 ,in the case of a violation described in clause 7i7 committed by a registered manufacturer or distributor of opioids and related to the reporting of suspicious orders for opioids1 failing to maintain effective controls against diversion of opioids1 or failing to review the most recent information made available by the ,attorney ,general in accordance with section #cjg7;f71 the penalty shall not exceed #ajj1jjj4 2 and 7,b7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by inserting or 7,d7 after subparagraph 7,b72 and 7ii7 by adding at the end the following3 7,d7 ,in the case of a violation described in subparagraph 7,a7 that was a violation of paragraph 7#e71 7#aj71 or 7#ag7 of subsection 7a7 committed by a registered manufacturer or distributor of opioids that relates to the reporting of suspicious orders for opioids1 failing to maintain effective controls against diversion of opioids1 or failing to review the most recent information made available by the ,attorney ,general in accordance with section #cjg7;f71 the criminal fine under title #ah1 ,united ,states ,code1 shall not exceed #ejj1jjj4 4 #e4 ,report ,not later than #a year after the date of enactment of this ,act1 the ,attorney ,general shall submit to ,congress a report that provides information about how the ,attorney ,general is using data in the ,automation of ,reports and ,consolidated ,orders ,system to identify and stop suspicious activity1 including whether the ,attorney ,general is looking at aggregate orders from individual pharmacies to multiple distributors that in total are suspicious1 even if no individual order rises to the level of a suspicious order to a given distributor4