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1 [1] (May 17, 2019)

handle is hein.crs/govztl0001 and id is 1 raw text is: Congressional Research Service 0 May 17, 2019 Drug Pricing and the Law: Regulatory Exclusivities The Food and Drug Administration (FDA) generally must approve pharmaceutical products, such as drugs and biologics, before they can be marketed in the United States. To obtain approval of a new drug or biologic (i.e., the brand-name or reference product), the sponsor must submit to FDA data from clinical investigations demonstrating that the underlying product is safe and effective for its intended use. Conversely, a follow-on product, such as a generic drug or biosimilar, via an abbreviated process by relying upon the data generated to support approval of the reference product. In order to balance interests in competition with the countervailing interest in encouraging innovation, federal law establishes periods of regulatory exclusivity that limit FDA's ability to approve applications to market pharmaceutical products under certain circumstances. There are two general categories of regulatory exclusivity: (1) data exclusivity, which precludes applicants from relying on the reference product's clinical data to demonstrate the safety and effectiveness of the follow-on product; and (2) marketing exclusivity, which precludes FDA from approving any other application for an identical or biosimilar product for the same use, even if the applicant has generated its own data. During a period of data exclusivity, a company could theoretically submit a full application with its own data for the same pharmaceutical product and use. As a practical matter, however, data exclusivity and marketing exclusivity may generate the same result due to the significant investments required to generate the necessary safety and effectiveness data. This table describes the types of exclusivities available, their duration, criteria to obtain them, and the impact on FDA's ability to approve other applications. For more information, see CRS Report R45666, Drug Pricing and Intellectual Property Law: A Legal Overview for the 116th Congress, coordinated by Kevin J. Hickey. Table I.Regulatory Exclusivities for Pharmaceutical Products for Human Use Type of Exclusivity Length Criteria Effect Drugs New Chemical Entity 21 U.S.C. §§ 355(c)(3)(E)(ii), 355(j)(5)(F)(ii), 355(u) Other New Product 21 U.S.C. §§ 355(c)(3)(E)(iii) & (iv), 355(j)(5)(F)(iii) & (iv) First to File Paragraph IV 21 U.S.C. § 355(j)(5)(B)(iv) 5 years; may be reduced to 4 years if abbreviated new drug application (ANDA) contains paragraph IV certification that a patent listed for the reference drug is invalid or not infringed by the generic product 3 years 180 days Application for drug containing an active ingredient that has not been approved before; or application for a drug that contains as an active ingredient a single enantiomer (each of a pair of molecules that are mirror images of one another) that: (I) is contained in a previously approved racemic drug (a mixture of two enantiomers in equal amounts) but has not otherwise been approved as an active ingredient; (2) treats a therapeutic category that is different from that of the racemic drug or other approved enantiomer of the drug; and (3) does not rely on data contained in application for previously approved racemic drug and must include full reports of new clinical investigations Application for a change to an approved drug that contains at least one new clinical investigation that is essential to the approval of the application and is conducted or sponsored by the applicant First to file an ANDA with a paragraph IV certification that a patent listed for the reference drug is invalid or not infringed by the generic product FDA cannot accept an abbreviated application for the same active ingredient that relies on the data in the reference drug application FDA cannot approve an application that relies on the data in the reference drug application for 3 years FDA cannot approve another ANDA for the same drug until 180 days after first commercial marketing of first filer https:icrs reports.cong ress go

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