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1 1 (July 1, 2024)

handle is hein.crs/govepih0001 and id is 1 raw text is: Congressional Research Service Informing the legislative debate since 1914 July 1, 2024 Skinny Labels for Generic Drugs Under Hatch-Waxman New brand-name drugs are often protected from generic competition by patents. In general, a drug manufacturer intending to market a generic version of a brand-name drug must either wait for those patents to expire or challenge the validity or applicability of the patents in court. While some drug patents cover the active ingredient itself, other patents cover different things related to the drug, such as a method of using the drug. When some methods of using a drug are still patented but other uses are not, the Hatch-Waxman Act of 1984 (P.L. 98-417) provides a special process to allow limited generic entry before patent expiration. This process-sometimes called Hatch- Waxman's skinny-label provisions-allows a generic manufacturer to seek approval from the U.S. Food & Drug Administration (FDA) only for approved uses of the drug no longer protected by patents. This In Focus provides background on the skinny-label provisions. New and ener Drug Approval All new drugs must be approved by FDA before they can be marketed or sold in the United States. New drugs are generally approved by FDA through a new drug application (NDA). To obtain FDA approval, NDA sponsors typically conduct clinical trials to demonstrate a drug's safety and effectiveness-a costly and time-consuming process. NDA sponsors must also submit proposed labeling for the drug for FDA's approval, including the approved indications for use of the drug (e.g., the diseases or conditions that the drug is approved to treat). Although FDA approves new drugs for specific indications, physicians may still prescribe an approved drug off label to treat other indications that FDA has not reviewed for safety and effectiveness. To encourage generic drug entry, Hatch-Waxman created a separate pathway for FDA approval through abbreviated new drug applications (ANDAs). ANDA filers need only show that their product is pharmaceutically equivalent and bioequivalent to an FDA-approved drug with the same active ingredient (such that the new drug can be expected to have the same therapeutic effect). As a result, generic drug manufacturers need not conduct their own clinical trials on safety and efficacy, and often sell the drug at lower prices. ANDA filers must also propose labeling for the generic drug, which generally must be identical to the referenced brand-name drug's labeling. Pharmaceutca Patents Patents, which are granted by the U.S. Patent and Trademark Office, protect new and useful inventions. Patent rights last for about 20 years. If the patent is valid, no one else may make, use, sell, or import the patented invention in the United States during that period without permission from the patent holder. Pharmaceutical manufacturers may patent a drug's active ingredient, drug formulations, methods of using a drug, devices to administer a drug, and methods of making a drug (among other things). A single brand-name drug may be protected by multiple patents that expire at different times. Orange Book Patents and Use Codes An NDA sponsor must submit to FDA information on any patent that either (1) claims the drug (i.e., an active ingredient, formulation, or composition patent) or (2) claims a method of using the drug for which FDA approval is sought. For method-of-use patents, FDA regulations require the NDA sponsor to include a description of the patent and information on whether the patent claims one or more FDA-approved methods of using the drug. This description must be adequate to assist future ANDA filers in determining whether the patent covers a given approved use (i.e., a drug's indication). The description provided by the NDA sponsor on method-of-use patents is known as a use code. The NDA sponsor must also identify the sections of the proposed drug label that describe the method(s) of use claimed by the patent. If the drug is approved, FDA publishes the patent information and use codes (along with any updates) in a resource known as the Orange Book. The Orange Book lists all FDA-approved nonbiologic drugs, along with therapeutic equivalence evaluations and information on drug patents and other exclusivities. For more information, see CRS In Focus IF12644, Patent Listing in FDA 's Orange Book. FDA views its authority over patent information in the Orange Book as ministerial. That is, FDA does not independently verify the accuracy of use codes and other patent information; FDA merely publishes it in the Orange Book. NDA sponsors must declare, however, that the patent information they submit is accurate and complete. ANDAs and Patent Cert fncation Paragraph - V Certifications Under Hatch-Waxman, ANDA filers must usually make a certification for each patent listed in the Orange Book for the drug at issue. For example, ANDA filers may certify that there are no patents listed for the drug or that all the listed patents are expired. In that case, FDA may approve the ANDA whenever its review is complete. ANDA filers may also may make what is called a paragraph IV certification: a claim that the patent is either invalid, or would not be infringed (i.e., violated) by the ANDA filer making and selling the generic drug. Paragraph IV certifications often lead to patent litigation in federal 0