{"id":3211,"date":"2017-03-05T03:43:50","date_gmt":"2017-03-05T08:43:50","guid":{"rendered":"http:\/\/allphasepharma.com\/dir\/?p=3211"},"modified":"2025-09-20T19:11:48","modified_gmt":"2025-09-21T01:11:48","slug":"qidp-liberal-hand-out-fda","status":"publish","type":"post","link":"https:\/\/allphasepharma.com\/dir\/2017\/03\/05\/3211\/qidp-liberal-hand-out-fda\/","title":{"rendered":"QIDP, a Liberal Hand-Out from FDA"},"content":{"rendered":"

\"\"<\/a><\/p>\n

On our blog site, \u2018QIDP\u2019 stands for \u201cQualified Infectious Diseases Product\u201d but when you look up \u2018QIDP\u2019 on the internet, you will find that it also stands for \u201cQualified Intellectual Disabilities Professional\u201d. Looking at the more recent crop of ID products that garnered QIDP status, you wonder whether there is a connection between the two.<\/p>\n

Why is FDA giving a QIDP designation to reformulated old products, now used in an expensive inhaler, when there is no innovation regarding the antibiotic, only in inhaler technology, with little risk for the developers, little benefit to the customer patient, and with nothing but a thinly veiled \u2018qualified product\u2019 justification?<\/p>\n

Should orange juice have QIDP labeling and command premium pricing protection \u2013 because the added Vitamin C is good for influenza prevention?<\/span><\/p>\n<\/div>\n

Why did RedHill RHB-104 receive QIDP status earlier this year? RHB-104 is a combination of clarithromycin (old drug), rifabutin (older drug) and clofazimine (really old drug) in a combination that have been used\u00a0 for the treatment of NTM (esp. MAC) for many years. The \u2018innovation\u2019, as best we can fathom, is that RedHill is on a mission to find a mycobacterial etiology for Crohn\u2019s disease. The theory is an old hat, but coming from Australia, the country that discovered H. pylori causes PUD, we refrain from judgement and give them the benefit of doubt.\u00a0 All the power to those who fight orthodoxy. Still, this is not drug development but Phase 4 line extension work; it does not fill an empty pipeline.<\/p>\n

Much has been talked about the fact that QIDP status is handed out too liberally. We agree with those who find it hard to understand why secnidazole, a topical BV drug, should get patent extension for the \u201cprevention of HIV\u201d.<\/p>\n

Why are biologicals excluded from consideration for QIDP status? \u00a0There are several promising anti-toxin mAb in development but as biologicals they are excluded from QIDP by law. Strangely, on the one hand, the original criteria for QIDP designation are being stretched beyond recognition, on the other hand there are projects that appear deserving but cannot even apply. Must we leave it at that?<\/p>\n

Critics of the way FDA hands out QIDP labels opined that there are already enough anti-staphylococcal (incl. MRSA) drugs, and efforts should be directed against Gram-negatives[1]<\/a>. This smacks a bit of hypocrisy: the same folks \u2013 10 years ago \u2013 wanted nothing more than a novel MRSA drug. Now that we have a flurry of them, Monday-morning quarterbacks complain about industry neglecting those bad gram-negative bugs. While it is difficult to make any predictions, we remain optimistic that the newer BL\/BLI combinations, plazomicin and colistin-like drugs will somehow eventually catch up in the Gram-negative arena as well.<\/p>\n

From our perspective, we are glad for any new antibiotic, even if it comes with a small change in spectrum or with only few improvements. We do not believe that only break-through drugs should be considered for QIDP status. Incremental improvements have served us well; the benefits seen with each new generation of cephalosporins, the ever-improved spectrum of quinolones has demonstrated that evolution, not revolution, is feasible and desirable. This makes for a sustainable approach for R&D in industry.<\/p>\n

But we don\u2019t like it when companies and FDA abuse the QIDP system for purely commercial and political gains; the GAIN Act was meant to be a deal benefitting society as much as industry. We feel the regulatory gatekeepers are becoming too lax and companies too greedy, abusing the system more and more in recent applications.<\/p>\n

It should not take a QIDP professional to understand QIDP labeling\u2026<\/p>\n

Abbreviations:
\n<\/strong>PUD \u00a0 \u00a0 \u00a0peptic ulcer disease
\nBV \u00a0 \u00a0 \u00a0 \u00a0bacterial vaginosis
\nNTM \u00a0 \u00a0 non-tuberculous mycobacteria
\nBL\/BLI \u00a0beta-lactam\/beta-lactamase inhibitor
\nMAC \u00a0 \u00a0 Mycobacterium avium-intracellulare complex
\nGAIN \u00a0 \u00a0Generating Antibiotics Incentives Now Act<\/p>\n

Reference:
\n<\/strong>[1]<\/a> http:\/\/www.in-phrmatechnologist.com\/Regulatory-Safety\/FDA-veteran-questions-science-behind-antibiotics-fast-track<\/p>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

On our blog site, \u2018QIDP\u2019 stands for \u201cQualified Infectious Diseases Product\u201d but when you look up \u2018QIDP\u2019 on the internet, you will find that it also stands for \u201cQualified Intellectual Disabilities Professional\u201d. Looking at the more recent crop of ID products that garnered QIDP status, you wonder whether there is Continue reading QIDP, a Liberal Hand-Out from FDA<\/span>→<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":3215,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":true,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[19,18],"tags":[1271,403,1360,1476,2011,1863,2005,2007,5,2006,1583,1865,83,2008,1775,1472,2009,170,2010,1371,1229,2002,2004,1239],"class_list":["post-3211","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-qidp_antibiotic","category-the_viewpoint","tag-allphase-pharma-consulting","tag-antibiotic-blog","tag-bacterial-vaginosis","tag-blbli-combination","tag-bv","tag-clarithromycin","tag-clofazimine","tag-crohns-disease","tag-fda","tag-gain-act","tag-harald-reinhart","tag-mac","tag-mrsa","tag-mycobacterium-avium-intracellulare-complex","tag-non-tuberculous-mycobacteria","tag-ntm","tag-peptic-ulcer-disease","tag-plazomicin","tag-pud","tag-qidp","tag-redhill-biopharma","tag-rhb-104","tag-rifabutin","tag-secnidazole"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2017\/03\/Great-Heist-slider.jpg?fit=640%2C180&ssl=1","jetpack_shortlink":"https:\/\/wp.me\/p4KWFr-PN","jetpack_sharing_enabled":true,"jetpack-related-posts":[{"id":157,"url":"https:\/\/allphasepharma.com\/dir\/2014\/04\/22\/157\/antibiotics-with-qidp-designation\/","url_meta":{"origin":3211,"position":0},"title":"Antibiotics with QIDP Designation – – – Updated 9-30-14","author":"Harald","date":"April 22, 2014","format":false,"excerpt":"For the latest QIDP listing, please click HERE \u00a0 Since\u00a0FDA issued the QIDP designation in 2012, many companies have requested this important 'label'. \u00a0Which should not come as a surprise: QIDP status confers significant benefits - and there is no downside. While an official FDA list of drugs that have\u2026","rel":"","context":"In "QIDP Antibiotics"","block_context":{"text":"QIDP Antibiotics","link":"https:\/\/allphasepharma.com\/dir\/category\/qidp_antibiotic\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/04\/FDA-GAIN-LPAD-banner-copy.jpg?fit=640%2C200&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/04\/FDA-GAIN-LPAD-banner-copy.jpg?fit=640%2C200&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/allphasepharma.com\/dir\/wp-content\/uploads\/2014\/04\/FDA-GAIN-LPAD-banner-copy.jpg?fit=640%2C200&ssl=1&resize=525%2C300 1.5x"},"classes":[]},{"id":2911,"url":"https:\/\/allphasepharma.com\/dir\/2016\/11\/25\/2911\/prospecting-antibiotics\/","url_meta":{"origin":3211,"position":1},"title":"Prospecting for New Antibiotics","author":"Harald","date":"November 25, 2016","format":false,"excerpt":"The QIDP designation was introduced in 2012 to incentivize drug development in antiinfectives. 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