Sec. 1008. STUDY ON DRUG SHORTAGES

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## SEC. 1008 STUDY ON DRUG SHORTAGES ###

(a)Study The Comptroller General of the United States shall conduct a study to examine the cause of drug shortages and formulate recommendations on how to prevent or alleviate such shortages. ###

(b)Consideration In conducting the study under this section, the Comptroller General shall consider the following questions: ####

(1)What are the dominant characteristics of drugs that have gone into a drug shortage over the preceding 3 years? ####

(2)Are there systemic high-risk factors (such as drug pricing structure, including Federal reimbursements, or the number of manufacturers producing a drug product) that have led to the concentration of drug shortages in certain drug products that have made such products vulnerable to drug shortages? ####

(3)Is there a reason why drug shortages have occurred primarily in the sterile injectable market and in certain therapeutic areas? ####

(4)#####

(A)How have regulations, guidance documents, regulatory practices, policies, and other actions of Federal departments and agencies (including the effectiveness of interagency and intra-agency coordination, communication, strategic planning, and decisionmaking), including those used to enforce statutory requirements, affected drug shortages? #####

(B)Do any such regulations, guidances, policies, or practices cause, exacerbate, prevent, or mitigate drug shortages? #####

(C)How can regulations, guidances, policies, or practices be modified, streamlined, expanded, or discontinued in order to reduce or prevent such drug shortages? #####

(D)What effect would the changes described in subparagraph

(C)have on the public health? ####

(5)How does hoarding affect drug shortages? ####

(6)How would incentives alleviate or prevent drug shortages? ####

(7)To what extent are health care providers, including hospitals and physicians responding to drug shortages, able to adjust care effectively to compensate for such shortages, and what impediments exist that hinder provider ability to adjust to such shortages? ####

(8)#####

(A)Have drug shortages led market participants to stockpile affected drugs or sell such drugs at inflated prices? #####

(B)What has been the impact of any such activities described in subparagraph

(A)on Federal revenue, and are there any economic factors that have exacerbated or created a market for such activities? #####

(C)Is there a need for any additional reporting or enforcement actions to address such activities? ####

(9)#####

(A)How have the activities under section 506D of the Federal Food, Drug, and Cosmetic Act (as added by section 1003 of this Act) improved the efforts of the Food and Drug Administration to mitigate and prevent drug shortages? #####

(B)Is there a need to continue the task force and strategic plan under such section 506D, or are there any other recommendations to increase communication and coordination inside the Food and Drug Administration, between the Food and Drug Administration and other agencies, and between the Food and Drug Administration and stakeholders? ###

(c)Consultation With Stakeholders In conducting the study under this section, the Comptroller General shall consult with relevant stakeholders, including physicians, pharmacists, hospitals, patients, drug manufacturers, and other health providers. ###

(d)Report Not later than 18 months after the date of the enactment of this Act, the Comptroller General shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the results of the study under this section. # TITLE XI OTHER PROVISIONS ## Subtitle A Reauthorizations