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1 H.R. 1520, Purple Book Continuity Act of 2019 1 (May 3, 2019)

handle is hein.congrec/pplbkc0001 and id is 1 raw text is: j Congressional Budget Office Cost Estimate May 3, 2019 Millions of Dollars 2019 2019-2024 2019-2029 Direct Spending (Outlays) 0 0 0 Revenues Deficit Effect 0 0 0 0 0 0 Under current law, the Food and Drug Administration (FDA) publishes a reference guide for biological products, Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations, commonly known as the Purple Book. H.R. 1520 would codify publication of the Purple Book by FDA, require that the agency include more detailed information in the compendium, make the data available in a searchable electronic format, and update it every 30 days. The Purple Book currently specifies whether a biological product licensed and marketed under section 351 (k) of the Public Health Service Act (PHS) has been determined by FDA to be biosimilar to (or interchangeable with) the reference biological product. The Purple Book also includes the date a biological product was licensed for marketing under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity. Information contained in the Purple Book is useful to health care practitioners and developers of biosimilar or interchangeable products and is updated periodically by FDA. H.R. 1520 would require that the FDA proactively determine the reference product exclusivity for each licensed biological product listed in the Purple Book. The determination of reference product exclusivity is a complex, resource intensive assessment for the agency to make; thus, under current law it is generally made either for reasons of regulatory necessity or because the license holder that submitted the application requested the determination. The bill also would direct FDA to solicit public comments regarding the type See also CBO's Cost Estimates Explained, www cbo.gov/publicationi54437; How CBO Prepares Cost Estimates, www.cbo.gov/publicationi53519; and Glossary, www.cbo~govipublication/42904.

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