,,ii #aaith ,,congress #ast ,session ,s4 #bebi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #cj1 #bjbe,mr4 ,husted 7for himself and ,ms4 ,hassan7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to increase the clarity and predictability of the process for developing applications for ,rx-to-nonprescription switches4 #a4 ,increasing the clarity and predictability of the process for developing applications for ,rx-to-nonprescription switches 7a7 ,in general ,section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7;b77 is amended by adding at the end the following3 7#g7 ,rx-to-nonprescription switches 7,a7 ,meetings ,any person planning to submit an application for an ,rx-to-nonprescription switch may submit to the ,secretary a written request for a meeting1 for purposes of developing a plan for such application that addresses the potential risks to public health of such switch and the evidence necessary to support such application1 including the design of any necessary studies1 and the format and content of the planned application4 ,the ,secretary may grant such a meeting1 as appropriate1 consistent with established procedures for granting meetings with1 and providing to1 applications under this section4 ,each such meeting shall be documented in meeting minutes4 7,b7 ,guidance 7i7 ,in general ,not later than #ah months after the date of enactment of this paragraph1 the ,secretary shall issue guidance to increase the clarity and predictability of the process and standards for approval of applications for nonprescription drugs under this section1 including in the case of applications for an ,rx-to-nonprescription switch1 especially with respect to prescription drugs with well-established safety profiles for which an applicant may seek approval for nonprescription use4 7ii7 ,contents ,the guidance under clause 7i7 shall-- 7,i7 describe how published reports in medical literature1 any previous finding of safety or effectiveness for the drug under this section1 the results of significant human experience with the drug1 unpublished studies and other data1 and other sources of information may be used to support an application for a nonprescription drug1 including in the context of an application for an ,rx-to-nonprescription switch2 7,,ii7 set forth procedures for sponsors to request meetings described in subparagraph 7,a7 and document the recommendations made in such meetings2 7,,iii7 describe evidentiary expectations to support approval of an application for a nonprescription drug1 including in the context of an application for an ,rx-to-nonprescription switch1 including how sponsors can demonstrate that consumers can appropriately self-select and use the drug and comprehend the nonprescription drug label2 and 7,,iv7 provide recommendations for how mechanisms1 in addition to the required ,drug ,facts ,label1 such as mobile applications and decisions aids1 can be incorporated into the information submitted in support of an application for an ,rx-to-nonprescription switch4 7,c7 ,plan to engage with stakeholders ,not later than #a year after the date of enactment of this paragraph1 the ,secretary shall develop and make publicly available on the website of the ,food and ,drug ,administration a plan to engage stakeholders on steps and factors for application holders and other stakeholders to consider in identifying approved prescription drugs that may be promising candidates for applications for an ,rx-to-nonprescription switch4 7,d7 ,definition ,the term ,rx-to-nonprescription switch means the approval of an application1 or supplemental application1 as applicable1 submitted under this section by the holder of an approved application for a prescription drug seeking approval to market such drug as a nonprescription drug1 including for-- 7i7 a full ,rx-to-nonprescription switch1 under which a drug previously approved for prescription use only is-- 7,i7 approved for nonprescription use under the same conditions of use as applied to the drug when approved for prescription use2 or 7,,ii7 approved for nonprescription use subject to one or more additional conditions for nonprescription use2 and 7ii7 a partial ,rx-to-nonprescription switch1 under which the drug is approved for nonprescription use only under certain conditions of use described in the approved labeling1 while the drug otherwise remains approved for prescription use only4 7,e7 ,rule of construction ,nothing in this paragraph shall be construed to-- 7i7 supersede or modify the authority of the ,secretary under section #eje;,g with respect to the regulation of ,,otc monograph drugs2 or 7ii7 authorize the disclosure by the ,secretary of confidential commercial information or trade secrets4 4 7b7 ,,gao ,report 7#a7 ,in general ,not later than #a year after the date of enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate and the ,committee on ,energy and ,commerce of the ,house of ,representatives a report that evaluates-- 7,a7 the number applications for an ,rx-to-nonprescription switch approved during the period beginning on ,october #a1 #bjbb1 and ending on the date of the report2 7,b7 the number of drugs for which an application for an ,rx-to-nonprescription switch was approved during such period subject to an additional condition for nonprescription use2 7,c7 among the drugs for which an application for a full or partial ,rx-to-nonprescription switch was approved during such period1 the average length of time from receipt by the ,food and ,drug ,administration of the application to the approval of such application2 7,d7 the number of partial ,rx-to-nonprescription switch applications approved during such period1 and the number of applications for such a partial switch not approved2 7,e7 any barriers to timely and predictable review of applications for an ,rx-to-nonprescription switch2 7,f7 engagement by the ,food and ,drug ,administration with public stakeholders1 including public meetings or additional activities to support review of applications for an ,rx-to-nonprescription switch2 and 7,g7 opportunities for collaboration between the ,center for ,drug ,evaluation and ,research and the ,centers for ,medicare ,medicaid ,services for the purpose of analyzing health insurance claims data for commonly prescribed drugs that appear to be suitable for an ,rx-to-nonprescription switch4 7#b7 ,definition ,in this subsection1 the term ,rx-to-nonprescription switch has the meaning given such term in paragraph 7#g7 of section #eje7;b7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #bdd7;b771 as added by subsection 7a74