,i #aaeth ,,congress #ast ,session ,h4 ,r4 #agjc ,,in ,,the ,,house ,,of ,,representatives ,march #bc1 #bjag,mr4 ,griffith introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to amend the ,federal ,food1 ,drug1 and ,cosmetic ,act with respect to determining the intended use of drugs and devices4 #a4 ,short title ,this ,act may be cited as the ,medical ,product ,communications ,act of #bjag4 #b4 ,communications regarding intended uses of drugs and devices2 scientific exchange ,the ,federal ,food1 ,drug1 and ,cosmetic ,act is amended by inserting after section #bja of such ,act 7#ba ,u4,s4,c4 #cba7 the following3 #bja;,a4 ,intended uses of drugs and devices 7a7 ,intended use ,for purposes of this ,act1 including sections #cja7;d71 #ejb7;f77#a71 #eje1 #eaj1 and #eae and for purposes of section #cea of the ,public ,health ,service ,act1 the intended use of a drug1 biological product1 or device-- 7#a7 shall be determined by reference to the objective intent of the manufacturer and sponsor of such drug1 biological product1 or device1 or persons acting on the manufacturer's or sponsor's behalf1 as demonstrated by statements contained in labeling1 advertising1 or analogous oral statements2 and 7#b7 shall not be determined by reference to-- 7,a7 actual or constructive knowledge of the manufacturer or sponsor that such drug1 biological product1 or device will be used in a manner that varies from the use approved for marketing under section #eje1 #eaj1 or #eae of this ,act or section #cea of the ,public ,health ,service ,act2 or 7,b7 scientific exchange as described in subsection 7b74 7b7 ,scientific exchange 7#a7 ,in general ,for purposes of this ,act1 including sections #cja7;d71 #ejb7;f77#a71 #eje1 #eaj7k71 and #eae and for purposes of section #cea of the ,public ,health ,service ,act1 the scientific exchange of information about a drug1 biological product1 or device1 as described in paragraph 7#b71 shall not constitute labeling1 advertising1 or evidence of a new intended use4 7#b7 ,requirements for scientific exchange ,a communication by a manufacturer or sponsor1 or a person acting on behalf of a manufacturer or sponsor1 about the manufacturer's or sponsor's drug1 biological product1 or device1 or use of such drug1 biological product1 or device1 that has not been approved for marketing under section #eje1 #eaj1 or #eae of this ,act or section #cea of the ,public ,health ,service ,act1 about a device or use of such device that has not been approved or cleared for marketing under section #eaj or #eae of this ,act1 or about information that is not included in the drug1 biological product1 or device labeling1 constitutes scientific exchange when-- 7,a7 the communication is supported by scientifically appropriate and statistically sound data1 studies1 or analyses2 7,b7 the communication includes a conspicuous and prominent statement that the drug1 biological product1 or device1 or use of such drug1 biological product1 or device1 that is the subject of the communication1 has not been approved for marketing under section #eje1 #eaj1 or #eae of this ,act or section #cea of the ,public ,health ,service ,act1 or that such communication includes information that is not contained in the drug1 biological product1 or device labeling1 as applicable2 and 7,c7 for communications relating to a drug1 biological product1 or device that has not been approved for marketing under section #eje1 #eaj1 or #eae of this ,act or section #cea of the ,public ,health ,service ,act1 or relating to a use of a drug1 biological product1 or device that has not been so approved1 the manufacturer and sponsor make no claims that such product or use has been demonstrated to be safe or effective4 7#c7 ,scientific exchange described ,the scientific exchange of information under paragraph 7#b7 may include-- 7,a7 dissemination of scientific findings in scientific or lay media2 7,b7 publication of results of scientific studies2 7,c7 letters to the editor in defense of public challenges2 7,d7 communications at scientific or medical conferences or meetings2 7,e7 dissemination of medical or scientific publications1 reference texts1 or clinical practice guidelines2 7,f7 communication1 both proactive and reactive1 of information regarding a manufacturer's research and development efforts2 7,g7 communication1 both proactive and reactive1 of scientific1 medical1 or technical information or findings1 including communication of such information by personnel in scientific1 medical1 or clinical development departments of manufacturers2 and 7,h7 communication1 both proactive and reactive1 of health care economic and health outcomes information1 including communication of such information delivered by or on behalf of the health care economic or health outcomes departments of manufacturers to an individual1 group of individuals1 or entity responsible for contributing toward1 advising1 or facilitating decisionmaking related to health care resource or utilization management1 including decisions about the selection of drugs1 biological products1 or devices for a population of patients4 7#d7 ,rule of construction ,nothing in this subsection shall be construed-- 7,a7 to authorize the ,secretary to require that a manufacturer or sponsor submit an application1 certification1 or other such submission1 or to seek the ,secretary's review or approval1 before1 during1 or subsequent to engaging in scientific exchange2 or 7,b7 to limit the ability of manufacturers or sponsors to engage in communications or activities that properly constitute scientific exchange as that term is described in paragraph 7#b7 but that are not specified in paragraph 7#c74 4