QIDP, a Liberal Hand-Out from FDA

On our blog site, ‘QIDP’ stands for “Qualified Infectious Diseases Product” but when you look up ‘QIDP’ on the internet, you will find that it also stands for “Qualified Intellectual Disabilities Professional”. Looking at the more recent crop of ID products that garnered QIDP status, you wonder whether there is a connection between the two.

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 ‘qualified product’ justification?

Should orange juice have QIDP labeling and command premium pricing protection – because the added Vitamin C is good for influenza prevention?

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  for the treatment of NTM (esp. MAC) for many years. The ‘innovation’, as best we can fathom, is that RedHill is on a mission to find a mycobacterial etiology for Crohn’s 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.  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.

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 “prevention of HIV”.

Why are biologicals excluded from consideration for QIDP status?  There 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?

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]. This smacks a bit of hypocrisy: the same folks – 10 years ago – 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.

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.

But we don’t 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.

It should not take a QIDP professional to understand QIDP labeling…

PUD      peptic ulcer disease
BV        bacterial vaginosis
NTM     non-tuberculous mycobacteria
BL/BLI  beta-lactam/beta-lactamase inhibitor
MAC     Mycobacterium avium-intracellulare complex
GAIN    Generating Antibiotics Incentives Now Act

[1] http://www.in-phrmatechnologist.com/Regulatory-Safety/FDA-veteran-questions-science-behind-antibiotics-fast-track


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