,i #aafth ,,congress #b;d ,session ,h4 ,r4 #fjhj ,,in ,,the ,,house ,,of ,,representatives ,march #d1 #bjbj,mr4 ,peters 7for himself1 ,mr4 ,engel1 ,ms4 ,eshoo1 ,mr4 ,guthrie1 ,mr4 ,schrader1 ,mr4 ,mc,caul1 ,mr4 ,hudson1 and ,mr4 ,bilirakis7 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 reduce drug shortages1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,preventing ,drug ,shortages ,act4 #b4 ,additional manufacturer reporting requirements in response to supply disruptions 7a7 ,expansion ,to include active pharmaceutical ingredients ,subsection 7a7 of section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is amended-- 7#a7 in the matter preceding paragraph 7#a71 by inserting or its active pharmaceutical ingredients after a drug2 and 7#b7 in the matter following paragraph 7#b7-- 7,a7 by inserting or its active pharmaceutical ingredients before that is likely2 7,b7 or its active pharmaceutical ingredient or ingredients after that drug2 and 7,c7 by adding at the end the following3 ,notification under this subsection shall include full disclosure of the problems resulting in the supply disruption1 the source of the active pharmaceutical ingredient1 any alternative sources for the active pharmaceutical ingredient that are known or contacted by manufacturer1 information concerning the extent of the supply disruption1 the expected duration of the supply disruption1 the expected impact to distribution and availability in pharmacies1 and such other information as the ,secretary may require44 7b7 ,manufacturing reporting ,section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7 is amended by adding at the end the following3 7j7 ,manufacturer reporting ,each manufacturer of a drug described in subsection 7a7 or of any active pharmaceutical ingredient of such a drug shall report in such manufacturer's annual establishment registration and product listing under subsections 7b7 and 7j7 of section #eaj the specific facilities in which such drug or ingredient is manufactured 7including the volume manufactured at each such facility7 to help ensure uninterrupted supply of the drug or ingredient4 ,information obtained through reporting under this section shall be maintained by the ,secretary in a confidential and internal manner and shall be trade secret and_/or confidential commercial or financial information pursuant to section #eeb7;b77#d7 of title #e1 ,united ,states ,code4 4 7c7 ,consumer notification ,not later than one year after the date of enactment of this ,act1 the ,secretary shall develop and submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate legislative and regulatory recommendations for consumer notification in the case of a drug shortage1 discontinuance1 or interruption of the manufacture of a drug described in section #ejf;,c7a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c7a771 including recommendations for notification to patients and physicians1 pharmacists1 and other practitioners authorized under applicable ,state law to prescribe or dispense drugs4 7d7 ,effective date ,the amendments made by this section shall take effect on the date that is #ahj days after the date of enactment of this ,act4 #c4 ,,gao report on intra-agency coordination 7a7 ,in general ,not later than #ah months after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to the ,committee on ,energy and ,commerce of the ,house of ,representatives and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate a report examining the ,food and ,drug ,administration's intra-agency coordination1 communication1 and decision making in assessing drug shortage risks1 and taking corrective action4 7b7 ,content ,the report shall include-- 7#a7 consideration of-- 7,a7 risks associated with violations of current good manufacturing practices2 7,b7 corrective and preventative actions with respect to such violations requested by the ,food and ,drug ,administration2 7,c7 the effects of potential manufacturing slow-downs or shut-downs on potential drug shortages1 including the discontinuance of drug manufacturing and marketing2 7,d7 efforts to prioritize review of applications for drugs that the ,secretary has determined under section #ejf;,e of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;e7 to be in shortage2 and 7,e7 efforts to prioritize inspections of facilities necessary for approval of applications for drugs described in subparagraph 7,d72 7#b7 a description of how the ,food and ,drug ,administration proactively coordinates strategies to mitigate the consequences of the violations1 slow-downs1 and shut-downs described in paragraph 7#a7 across agencies2 and 7#c7 an evaluation of changes in relevant ,food and ,drug ,administration practices that such agency has proposed but not yet implemented4 #d4 ,improving critical infrastructure by requiring risk management plans 7a7 ,risk management plans ,section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cef;c71 as amended by section #b7;b71 is further amended by adding at the end the following3 7k7 ,risk management plans ,the ,secretary may require a manufacturer of a drug described in subsection 7a7 to conduct periodic risk assessments-- 7#a7 to identify vulnerabilities in the manufacturing supply chain of such manufacturer2 and 7#b7 to develop plans to mitigate the risks associated with any vulnerabilities so identified4 4 7b7 ,guidance ,not later than #ah months after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services1 acting through the ,commissioner of ,food and ,drugs1 shall finalize guidance implementing subsection 7l7 of section #ejf;,c of the ,federal ,food1 ,drug1 and ,cosmetic ,act1 as added by subsection 7a74 ,such guidance shall include guidance on-- 7#a7 examples of what may be considered a vulnerability in the manufacturing supply chain in conducting a risk assessment pursuant to such subsection2 7#b7 the timeframe within which a manufacturer must conduct such an assessment and provide a response to the ,food and ,drug ,administration2 7#c7 expectations of the ,secretary of ,health and ,human ,services for a manufacturer to mitigate in a reasonable manner any risks associated with vulnerabilities in the manufacturing supply chain identified in such an assessment2 and 7#d7 how the ,secretary will coordinate with other ,federal agencies to communicate and resolve any such vulnerabilities4