,i #aafth ,,congress #ast ,session ,h4 ,r4 #dcii ,,in ,,the ,,house ,,of ,,representatives ,september #ai1 #bjai,mr4 ,latta 7for himself1 ,mrs4 ,wagner1 ,mr4 ,norman1 ,mr4 ,olson1 ,mr4 ,lamborn1 ,mr4 ,meadows1 ,mr4 ,allen1 ,mr4 ,williams1 ,mr4 ,smith of ,new ,jersey1 ,mr4 ,weber of ,texas1 ,mr4 ,watkins1 ,mr4 ,gianforte1 ,mr4 ,chabot1 ,mr4 ,babin1 ,mr4 ,ratcliffe1 ,mr4 ,loudermilk1 ,mr4 ,rutherford1 ,mr4 ,la,malfa1 ,mr4 ,flores1 ,mr4 ,kevin ,hern of ,oklahoma1 ,mr4 ,abraham1 ,mr4 ,harris1 ,mrs4 ,hartzler1 ,mr4 ,estes1 ,mr4 ,gibbs1 ,mr4 ,grothman1 ,mr4 ,wittman1 ,ms4 ,foxx of ,north ,carolina1 ,mr4 ,walberg1 and ,mr4 ,higgins of ,louisiana7 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 to prohibit the approval of new abortion drugs1 to prohibit investigational use exemptions for abortion drugs1 and to impose additional regulatory requirements with respect to previously approved abortion drugs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,support ,and ,value ,expectant ,moms and ,babies ,act of #bjai or the ,,save ,moms and ,babies ,act of #bjai4 #b4 ,abortion drugs prohibited 7a7 ,in general ,section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 is amended by adding at the end the following3 7z7 ,abortion drugs 7#a7 ,prohibitions ,the ,secretary shall not approve-- 7,a7 any application submitted under subsection 7b7 or 7j7 for marketing an abortion drug2 or 7,b7 grant an investigational use exemption under subsection 7i7 for-- 7i7 an abortion drug2 or 7ii7 any investigation in which the human embryo or human fetus of a woman known to be pregnant is knowingly destroyed4 7#b7 ,previously approved abortion drugs ,if an approval described in paragraph 7#a7 is in effect for an abortion drug as of the date of enactment of the ,support ,and ,value ,expectant ,moms and ,babies ,act of #bjai1 the ,secretary shall-- 7,a7 not approve any labeling change-- 7i7 to approve the use of such abortion drug after #gj days gestation2 or 7ii7 to approve the dispensing of such abortion drug by any means other than in-person administration by the prescribing health care practitioner2 7,b7 treat such abortion drug as subject to section #ejc7;b77#a72 and 7,c7 require such abortion drug to be subject to a risk evaluation and mitigation strategy under section #eje-a that at a minimum-- 7i7 requires health care practitioners who prescribe such abortion drug-- 7,i7 to be certified in accordance with the strategy2 and 7,,ii7 to not be acting in their capacity as a pharmacist2 7ii7 as part of the certification process referred to in clause 7i71 requires such practitioners-- 7,i7 to have the ability to assess the duration of pregnancy accurately2 7,,ii7 to have the ability to diagnose ectopic pregnancies2 7,,iii7 to have the ability to provide surgical intervention in cases of incomplete abortion or severe bleeding2 7,,iv7 to have the ability to ensure patient access to medical facilities equipped to provide blood transfusions and resuscitation1 if necessary2 and 7,v7 to report any deaths or other adverse events associated with the use of such abortion drug to the ,food and ,drug ,administration and to the manufacturer of such abortion drug1 identifying the patient by a non-identifiable reference and the serial number from each package of such abortion drug2 7iii7 limits the dispensing of such abortion drug to patients-- 7,i7 in a clinic1 medical office1 or hospital by means of in-person administration by the prescribing health care practitioner2 and 7,,ii7 not in pharmacies or any setting other than the health care settings described in subclause 7,i72 7iv7 requires the prescribing health care practitioner to give to the patient documentation on any risk of serious complications associated with use of such abortion drug and receive acknowledgment of such receipt from the patient2 7v7 requires all known adverse events associated with such abortion drug to be reported1 excluding any individually identifiable patient information1 to the ,food and ,drug ,administration by the-- 7,i7 manufacturers of such abortion drug2 and 7,,ii7 prescribers of such abortion drug2 and 7vi7 requires reporting of administration of the abortion drug as required by ,state law1 or in the absence of a ,state law regarding such reporting1 in the same manner as a surgical abortion4 7#c7 ,reporting on adverse events by other health care practitioners ,the ,secretary shall require all other health care practitioners to report to the ,food and ,drug ,administration any adverse events experienced by their patients that are connected to use of an abortion drug1 excluding any individually identifiable patient information4 7#d7 ,rule of construction ,nothing in this section shall be construed to restrict the authority of the ,secretary1 or of a ,state1 to establish1 implement1 and enforce requirements and restrictions with respect to abortion drugs under provisions of law other than this section that are in addition to the requirements and restrictions under this section4 7#e7 ,definitions ,in this section3 7,a7 ,the term abortion drug means any drug1 substance1 or combination of drugs or substances that is intended for use or that is in fact used 7irrespective of how the product is labeled7-- 7i7 to intentionally kill the unborn child of a woman known to be pregnant2 or 7ii7 to intentionally terminate the pregnancy of a woman known to be pregnant1 with an intention other than-- 7,i7 to produce a live birth2 or 7,,ii7 to remove a dead unborn child4 7,b7 ,the term adverse event includes each of the following3 7i7 ,a fatality4 7ii7 ,an ectopic pregnancy4 7iii7 ,a hospitalization4 7iv7 ,a blood loss requiring a transfusion4 7v7 ,an infection1 including endometritis1 pelvic inflammatory disease1 and pelvic infections with sepsis4 7vi7 ,a severe infection4 7,c7 ,the term gestation means the period of days beginning on the first day of the last menstrual period4 7,d7 ,the term health care practitioner means any individual who is licensed1 registered1 or otherwise permitted1 by the ,united ,states or the jurisdiction in which the individual practices1 to prescribe drugs subject to section #ejc7;b77#a74 7,e7 ,the term unborn child means an individual organism of the species homo sapiens1 beginning at fertilization1 until the point of being born alive as defined in section #h7;b7 of title #a1 ,united ,states ,code4 4 7b7 ,ongoing investigational use ,in the case of any investigational use of a drug pursuant to an investigational use exemption under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;i77 that was granted before the date of enactment of this ,act1 such exemption is deemed to be rescinded as of the day that is #c years after the date of enactment of this ,act if the ,secretary would be prohibited by section #eje7z77#a77;,b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a71 from granting such exemption as of such day4