In Search of Meaningful GAIN in Renewal of Prescription Drug Act
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in half the time to approval compared to the 12-month Standard Review goal most antibiotics are currently afforded.
3. Fast track review. Sponsors of QIDPs would be provided with early and frequent communications with the FDA, in addition to the typical review and communication opportunities, to expedite the review and potential approval process.
4. Updated guidance. The GAIN Act provides for a specific timetable for the FDA to develop and issue draft and final guidance, and provides sponsors with the opportunity to request written recommendations from the Secretary of Health and Human Services on the guidance for antibiotic trials if such guidance is lacking from the FDA.
5. Pathogen-focused drug development. Requires the FDA to issue guidance on pathogen-focused antibacterial drug development.
While all of these provisions are welcome improvements that will facilitate the development of drugs currently in the development pipeline, they are not sufficiently game-changing to encourage large pharmaceutical companies to re-enter antibiotic development—nor will they likely incentivize private or public institutional investors to create new companies or to double down on their current investments in biotech companies developing antibiotics.
First, the market for hospital-based antibiotics does not scale appropriately to the growth needs of large pharmaceutical companies. The perverse reason for this is that antibiotics cure acute diseases, which limits their sales compared to drugs needed to treat chronic ailment.
For example, growing the nearly $67 billion in revenue that Pfizer reported last year by 5 percent would require an additional $3 billion in new revenues. Peak sales for a hospital antibiotic would likely top out at about $1 billion before patent expiry. Pfizer’s linezolid (Zyvox), approved to … Next Page »