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1 H.R. 2374, Stop STALLING Act 1 (May 13, 2019)

handle is hein.congrec/stpsll0001 and id is 1 raw text is: Congressional Budget Office Cost Estimate May 13, 2019 By Fiscal Year, Milions of Dollars 2019 2019=2024 2019o2029 Direct Spending (Outlays) 0 -42 -98 Revenues Deficit Effect 0 0 8 -50 18 -117 H.R. 2374 would authorize the Federal Trade Commission (FTC) to initiate a civil action against any persons involved with submitting certain petitions to the Food and Drug Administration (FDA) that are objectively without merit and who use the agency's administrative review process for the purpose of interfering with the business of a competitor. Such persons would be liable for violating the FTC Act. (Under the bill, the term persons includes individuals or entities.) Under current law, section 505(q) of the Federal Food, Drug, and Cosmetic Act governs how certain petitions submitted to FDA are treated. Such petitions request FDA to take or refrain from taking an action by the agency that could delay approval of pending marketing applications, including applications for lower priced generic and biosimilar drugs. FDA's draft guidance details how FDA assesses whether a petition is submitted with the primary purpose of delaying the approval of an application. If such a determination is made, FDA may summarily deny the petition if it also does not on its face raise valid scientific or regulatory issues. FDA may refer such cases to the FTC, although a recent appellate court ruling limits FTC's litigation authority in this area. In addition to establishing a statutory framework for FTC's litigation authority, the bill also would allow FTC to impose civil penalties and seek other appropriate relief in district court from parties that violate antitrust law in this area. If FDA determines that a petition was submitted primarily to delay approval of a marketing application and refers it to the FTC, the See also CBO's Cost Estimates Explained, www.cbo.gov/publication /54437; How CBO Prepares Cost Estimates, www.cbo.gov/publication/53519; and Glossary, www.cbo.gov/publication/42904.

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