FDA nudged to treat antibiotics like rare disease drugs
A research group wants the FDA to give applications for new antibiotics some of the same treatment now lavished on rare disease drugs, aiming to address a well-known lack of antibiotics development across the biopharma industry, Reuters reported.
Researchers worry that investments in creating new anti-bacterial drugs are relatively tiny in the face of the big problem of antibiotic-resistant superbugs. The Infectious Diseases Society of America (IDSA) yesterday asked Congress to consider a proposal that would let the FDA allow developers of antibiotics to enroll fewer patients in clinical trials and get speedy responses from the agency--two of the benefits that rare disease drugmakers have enjoyed for decades.
This special treatment has helped turn rare diseases from a backwater of drug development into a hot area of R&D for many biopharma outfits. Whether the same perks that helped rare disease drugs will benefit antibiotics is an open question. Many rare disease treatments such as Genzyme's enzyme therapies are chronic use drugs, making them more lucrative than antibiotics that are given to patients only until their infections are eradicated.
Yet there's no denying that the antibiotics field has only a few Big Pharma players. Reuters reports that the only major drugmakers with antibiotics units are GlaxoSmithKline ($GSK) and AstraZeneca ($AZN). Others have opted to invest in antibiotics development via deals with outside companies or have abandoned the field completely. And the IDSA thinks that the regulatory changes would spur a turnaround for antibiotics development.
"This proposal creates a new mechanism, similar to the orphan drug act (for rare diseases)," Robert Guidos, IDSA's vice president of public policy and government relations, told Reuters. "It's a game-changer."
- read the Reuters article
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