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Regulatory Focus™ > News Articles > 2020 > 5 > FDA looks to overhaul Orange Book, seeks input on patent listings

FDA looks to overhaul Orange Book, seeks input on patent listings

Posted 29 May 2020 | By Michael Mezher 

FDA looks to overhaul Orange Book, seeks input on patent listings

Nearly 40 years after its creation, the US Food and Drug Administration (FDA) is looking to modernize its Orange Book, which lists patent, exclusivity and therapeutic equivalence information for approved drugs, as part of its effort to increase drug competition.
 
Specifically, FDA is seeking input on how the Orange Book is used and by whom, and on the types of patents that should  be submitted for listing in the book, such as those covering the device constituent of a drug-device combination product or a patent for a risk evaluation and mitigation strategy (REMS) for an approved drug.
 
The agency also released a draft guidance featuring 19 questions and answers covering general questions related to the Orange Book; petitioned abbreviated new drug applications (ANDAs); the movement of products between the active and discontinued section of the Orange Book; and patent listings.
 
“Although the Orange Book already provides extensive information about approved drug products, we want to ensure that it provides as much value as possible to those that rely on it, including consumers, health care professionals and drug developers,” said Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research (CDER).
 
Public consultations
 
To gather the input, FDA opened two public consultations, one asking a series of questions regarding the stakeholders who use the Orange Book, and the other posing more than a dozen questions about the types of patent information that should be included in the book.
 
“FDA would like to know how stakeholders and the public use the Orange Book and how it can be improved to make sure the published information is clear and helpful,” FDA writes in the Federal Register notice announcing the first consultation.
 
That consultation asks who or what entities use the Orange Book and why, as well as what information and features they would like to see added to make it more useful. The agency also asks specific questions about the information currently included on therapeutic equivalence, such as how that information is used and whether it promotes drug competition.
 
In its consultation on what types of patents should be included in the Orange Book, FDA says there is confusion about what types of patents should be submitted for listing, and noted that there are “both benefits and challenges” to listing or omission of certain patent information.
 
“Stakeholders have requested clarification on whether certain types of patents fall within the scope of required patent information that must be submitted for listing in the Orange Book…and FDA is aware that some [new drug application] NDA holders have submitted patents for listing in the Orange Book, including certain types of device-related patents and REMS-related patents, for which there may be uncertainty regarding whether these are in fact the type of patents that must be submitted,” FDA writes.
 
While patent listing can help 505(b)(2), a type of NDA that allows an applicant to reference a study they do not have right of reference to, and ANDA applicants identify patents that could block the entry of a follow-on product and give those applicants a change to challenge those patents while their application is being reviewed by FDA.
 
“However, this also creates the possibility of a stay of approval of the 505(b)(2) application or ANDA and implicates other statutory procedures and requirements under the Hatch-Waxman framework,” FDA says.
 
In total, FDA asks 14 questions surveying NDA holders and 505(b)2 and ANDA applicants on challenges posed by listing certain patents, whether the agency should clarify the types of patents that must be listed and specific questions on patents for drug products, method-of-use, REMS and digital applications associated with an approved drug.

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