,,ii #aadth ,,congress #ast ,session ,s4 #bbad ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,october #bh1 #bjae ,mrs4 ,gillibrand 7for herself1 ,ms4 ,warren1 ,ms4 ,stabenow1 ,mr4 ,brown1 and ,mr4 ,blumenthal7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act to require patient medication information to be provided with certain prescription drugs4 #a4 ,short title ,this ,act may be cited as the ,cody ,miller ,patient ,medication ,information ,act4 #b4 ,patient medication information for prescription drugs ,chapter ,v of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cea et seq47 is amended by inserting after section #eje;,e the following3 #eje;,f4 ,patient medication information for prescription drugs 7a7 ,in general ,not later than #b years after the date of enactment of this section1 the ,secretary shall issue final regulations regarding the authorship1 content1 format1 and dissemination requirements for patient medication information for drugs subject to section #ejc7;b77#a74 7b7 ,content ,the regulations promulgated under subsection 7a7 shall require that the patient medication information with respect to a drug-- 7#a7 be scientifically accurate1 include relevant patient safety information1 and be based on the professional labeling approved by the ,secretary2 and 7#b7 include standard1 nontechnical1 understandable1 plain language that is not promotional in tone or content1 and contain at least-- 7,a7 the established name of the drug or the proper name of the biological product1 as applicable2 7,b7 drug uses2 7,c7 general directions for proper use2 7,d7 contraindications1 the most frequently occurring adverse reactions1 and adverse reactions that are important for other reasons 7such as because they are serious71 especially with respect to certain groups such as children1 pregnant women1 and the elderly2 7,e7 measures patients may be able to take1 if any1 to reduce the side effects and risks of the drug2 7,f7 when a patient should contact his or her health care professional2 7,g7 instructions not to share medications1 and1 if any exist1 key storage requirements1 and recommendations relating to proper disposal of any unused portion of the drug2 7,h7 known clinically important interactions with other drugs and substances2 and 7,i7 a statement of whether sufficient data are available concerning the use of the drug in specified subpopulations1 such as women1 pregnant women1 lactating women1 women and men of reproductive age1 pediatric1 geriatric1 racial and ethnic minority groups1 and other subpopulations4 7c7 ,timeliness1 consistency1 and accuracy ,the regulations promulgated under subsection 7a7 shall include standards relating to how the ,secretary-- 7#a7 shall perform timely reviews and updates of patient medication information as new drugs and new information become available2 7#b7 may perform1 when appropriate1 updates to help communicate information that is shared by similar drug products or drugs within classes of medications in order to avoid patient confusion and harm2 and 7#c7 shall develop a process1 including consumer testing1 to assess the quality and effectiveness of patient medication information in ensuring that patient medication information developed in accordance with this section promotes patient understanding and safe and effective medication use4 7d7 ,electronic repository ,the regulations promulgated under subsection 7a7 shall provide for the development of a publicly accessible electronic repository for all patient medication information documents and content to facilitate the availability of patient medication information4 4 #c4 ,enforcement and dissemination 7a7 ,enforcement ,section #ejb of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #ceb7 is amended by adding at the end the following3 7dd7 ,if it is a drug subject to section #ejc7;b77#a7 and patient medical information described in section #eje;,f is not provided1 as required under section #ejc7;b77#a74 4 7b7 ,dissemination ,section #ejc7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7 is amended by inserting ,under the circumstances determined by the ,secretary through regulation or guidance1 a drug dispensed in accordance with this paragraph shall be accompanied by the patient medication information for such drug developed in accordance with section #eje;,f after by the pharmacist44