{"id":346070,"date":"2025-12-15T23:27:40","date_gmt":"2025-12-15T23:27:40","guid":{"rendered":"https:\/\/peraltafinancing.com\/uncategorized\/when-is-an-approval-not-an-approval-before-1962\/"},"modified":"2025-12-15T23:27:40","modified_gmt":"2025-12-15T23:27:40","slug":"when-is-an-approval-not-an-approval-before-1962","status":"publish","type":"post","link":"https:\/\/fivemor.com\/?p=346070","title":{"rendered":"When is an Approval Not an Approval? Before 1962."},"content":{"rendered":"


\n<\/p>\n

\n

Priority Review Vouchers (PRV) are incredibly valuable\u2014several have sold for hundreds of millions of dollars.\u00a0 Which is why it makes sense that Sun Pharma Advanced Research Co. Ltd. and Sun Pharmaceutical Industries, Inc. went to the mat fighting FDA for a PRV for phenobarbital.\u00a0 And last week, that fight was rewarded by the District Court for the District of Columbia, which found<\/a> that FDA\u2019s refusal to award a PRV was unlawful under the Administrative Procedure Act based on the definition of the word \u201capproved.\u201d<\/p>\n

For the uninitiated, a PRV is a voucher that can be redeemed for Priority Review on a subsequent application.\u00a0 Use of the voucher therefore reduces the PDUFA goal for a non-Priority Review eligible application from 10 months to 6 months.\u00a0 A PRV can be awarded for a statutorily-enumerated tropical disease or, relevant here, a rare pediatric disease approved before September 2026 (there used to a Medical Countermeasure PRV, but that has lapsed).\u00a0 In order to be eligible for a rare pediatric disease PRV, the application must be for the prevention or treatment of a rare pediatric disease, submitted under section 505(b)(1) of the FDC Act, approved between September 30, 2016 and September 30, 2026, based on clinical data from a study evaluating pediatric populations and dosages without an adult indication, and eligible for priority review.\u00a0\u00a0 Integral to the issue at hand here, the application also must seek approval for \u201ca drug . . . that contains no active moiety . . . that has been previously approved in any other application under subsection (b)(1), (b)(2), or (j) of section 355 of this title.\u201d<\/p>\n

Back to the action: The fight starts in November 2022, when Sun received approval for SEZABY (phenobarbital) to treat neonatal seizures. \u00a0But in approving SEZABY, FDA informed Sun that it denied Sun\u2019s request for a rare disease PRV.\u00a0 FDA denied the PRV on the basis that SEZABY \u201cis not an application for a drug \u2018that contains no active moiety . . . that has been previously approved in any other application under subsection (b)(1), (b)(2), or (j) of section 505\u2019 of the FD&C Act.\u201d \u00a0\u00a0FDA pointed to NDA 000597 for phenobarbital and atropine as the basis of denial, noting that the Agency had \u201cidentified at least one NDA for a drug product containing phenobarbital as an active moiety that came into effect before 1962 and was deemed <\/em>approved by the 1962 Amendments.\u201d<\/p>\n

Importantly, the phenobarbital NDA referenced by FDA, NDA 000597, was submitted in 1939, when section 505 of the FDC Act provided that an NDA would automatically <\/em><\/strong>become effective unless a contrary order were issued; as the Court explained, the NDA \u201cbecame effective not by any positive agency action but by its inaction<\/em>.\u201d\u00a0 In 1962, Congress amended the FDC Act to require affirmative agency approval based on evidence that showed the drug is effective; applications that previously became effective under the Act were \u201cdeemed\u201d approved by FDA, allowing them to continue to be marketed unless FDA ordered its removal after two years for lack of efficacy.\u00a0 In 1972, FDA determined that there was a lack of substantial evidence to support effectiveness of the phenobarbital drug, proposed to withdraw NDA 000597 in 1977, and formally withdrew approval in 1982.<\/p>\n

Based on these facts, Sun argued that NDA 000597 was not an application under section 505(b)(1), (b)(2), or (j) of the FDC Act because those provisions did not exist in 1939.\u00a0 But even if it were an application, Sun argued, the application was not \u201capproved\u201d as Congress contemplated under the plain language of the statute.\u00a0 \u00a0The word \u201capproved\u201d requires affirmative review, which did not apply to phenobarbital, as it was automatically approved by FDA inaction and later only \u201cdeemed\u201d approved.<\/p>\n

FDA, on the other hand, argued that NDA 000597 was an \u201capplication under subsection (b)(1)\u201d precisely because<\/em><\/strong> it was deemed approved under the 1962 amendments.\u00a0 And, because it was \u201cdeemed\u201d approved, the application is<\/em><\/strong> approved, according to FDA.\u00a0 Thus, since phenobarbital was one of the active moieties in approved NDA 000597, FDA contended that the active moiety had been previously approved by FDA and not entitled to a PRV.<\/p>\n

The Court sided with Sun.\u00a0 Because FDA did not \u201c\u201csanction officially\u201d phenobarbital, or \u201cconfirm [it] authoritatively,\u201d or \u201caccept [it] as satisfactory,\u201d and because it was only \u201cdeemed\u201d approved and later withdrawn for lack of efficacy, the Court said, \u201c[i]n no ordinary sense then was NDA 000597 ever \u2018approved.\u2019\u201d\u00a0 By cross-referencing the 1984 Hatch-Waxman Amendments that introduced the modern-day 505(b) and (j) approval pathway, the Court explained that \u201cCongress clearly signaled that any \u2018previous approval\u2019 had to have successfully navigated\u201d the modern-day application process.\u00a0 Finally, the Court found that FDA\u2019s interpretation conflicted with the purpose of the rare pediatric PRV: Congress could not have intended a drug that \u201cwas never able to show efficacy and was ultimately pulled from the market to erect an obstacle to future developments in the treatment of rare pediatric diseases.\u201d<\/p>\n

This decision is meaningful\u2014both in the context of rare pediatric diseases and beyond.\u00a0 It opens up grandfathered drugs to be eligible for a very valuable PRV if they are repurposed for a pediatric or tropical disease.\u00a0 While that is interesting, it is relevant to a very small number of drugs.\u00a0 Nevertheless, the decision has serious implications beyond the world of PRVs:\u00a0 effectively, the decision will force FDA to reexamine the definition of a \u201cnew\u201d drug in any <\/em><\/strong>context in which the active moiety cannot have been previously \u201capproved.\u201d\u00a0 \u00a0Specifically, this is important from an NCE context, as FDA previously has interpreted NCE to apply only to drugs that have never been approved, searching its records all the way back to 1938.\u00a0 \u00a0Presumably, this leaves FDA\u2019s interpretation vulnerable to challenge, as drugs \u201capproved\u201d between 1938 and 1962 were not necessarily \u201capproved.\u201d\u00a0 \u00a0We\u2019re watching to see whether someone\u2014maybe even Sun\u2014takes this to court to obtain an NCE period for a pre-1962 drug.<\/p>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"

Priority Review Vouchers (PRV) are incredibly valuable\u2014several have sold for hundreds of millions of dollars.\u00a0 Which is why it makes sense that Sun Pharma Advanced Research Co. Ltd. and Sun Pharmaceutical Industries, Inc. went to the mat fighting FDA for a PRV for phenobarbital.\u00a0 And last week, that fight was rewarded by the District Court […]<\/p>\n","protected":false},"author":1,"featured_media":331285,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[168550,168551],"tags":[11708],"dealstore":[],"offerexpiration":[],"class_list":["post-346070","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-hatch-waxman","category-prescription-drugs-and-biologics","tag-approval"],"yoast_head":"\nWhen is an Approval Not an Approval? 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