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H.R. 5651, Food and Drug Administration Reform Act of 2012 1 (May 24, 2012)

handle is hein.congrec/cbo10766 and id is 1 raw text is: CONGRESSIONAL BUDGET OFFICE COST ESTIMATE May 24, 2012 H.R. 5651 Food and Drug Administration Reform Act of 2012 As ordered reported by the House Committee on Energy and Commerce on May 10, 2012 SUMMARY H.R. 5651 would authorize the collection and spending of fees by the Food and Drug Administration (FDA) for certain activities to expedite the marketing approval of prescription drugs and medical devices and to regulate drugs after they enter the market. The bill would provide the FDA with additional regulatory authority to improve the safety of the drug supply chain and establish an early warning notification system to mitigate or prevent critical drug shortages. It also would create a new approval procedure for breakthrough drug therapies and offer financial incentives to drug sponsors to produce certain antimicrobial drugs. The legislation would require FDA to publish the scientific or regulatory rationale for significant decisions issued by the agency regarding a device and establish an expedited process to appeal such decisions. In addition, the bill would permanently reauthorize FDA's programs that evaluate the use of drugs by children. CBO expects that enacting the bill would affect the average price of prescription drugs available in the market. Some provisions in the bill would result in higher average prices for certain drugs; other provisions would accelerate the entry of generic versions of some drugs, which would lead to lower average prices. CBO estimates that the net effect of enacting H.R. 5651 would be to reduce the average price of prescription drugs slightly through 2017 and to increase prices in subsequent years. CBO estimates that enacting H.R. 5651 would: * Reduce direct spending, on net, by $72 million over the 2013-2017 period but increase direct spending by $244 million over the 2013-2022 period. * Increase federal revenues by less than $500,000 over the 2013-2017 period but lower revenues, on net, by about $3 million over the 2013-2022 period.

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