The Congress and FDA are contemplating to new pathway for drug approval of antibiotics which are lifesaving and needed critically. The proposed new pathway has been suggested by IDSA. FDA is also in favor as the new approval option would make more drug accessible and control prescription drug abuse.
Purpose of this is to have another feasible approval option for antibiotics which treat serious infections. The need is being felt by FDA to treat infections for which no effective treatment is available in market. Current approval process is lengthy, expensive and time consuming which discourages pharma companies to develop drug which is required by few thousands patients. The new pathway will be based on Special Population Limited Medical Use (SPLMU) mechanism.
IDSA proposed this amendment during a hearing session held for reauthorization of USA FDA's Prescription Drug User Fee Act. PDUFA bill was enacted in 1992 and it requires reauthorization every 5 years from House of Senate. PDUFA has helped a lot in fast approval of drug, which made access to the drug for which no alternative is available in market. The senators are due to discuss the integration of the proposed amendment within another pending bill named as Generating Antibiotic Incentives Now (GAIN). The proposed provision of GAIN bill is to offer incentives to encourage development of new antibiotics for the treatment of diseases which are resistant to current antibiotics.
Antibiotics resistant infections are epidemic for countries across the world. Antimicrobial resistance is a condition where bacteria develop resistance to respond a drug. This means the drugs which were effective to treat infection are now not effective because of bacteria's resistance capability. The proposed mechanism would help to resolve the issue before the current condition worsens and pose serious threat to public health.
SPLMU mechanism would help improve feasibility of approval for the drug which are targeted to be used in few hundred patients.
Purpose of this is to have another feasible approval option for antibiotics which treat serious infections. The need is being felt by FDA to treat infections for which no effective treatment is available in market. Current approval process is lengthy, expensive and time consuming which discourages pharma companies to develop drug which is required by few thousands patients. The new pathway will be based on Special Population Limited Medical Use (SPLMU) mechanism.
IDSA proposed this amendment during a hearing session held for reauthorization of USA FDA's Prescription Drug User Fee Act. PDUFA bill was enacted in 1992 and it requires reauthorization every 5 years from House of Senate. PDUFA has helped a lot in fast approval of drug, which made access to the drug for which no alternative is available in market. The senators are due to discuss the integration of the proposed amendment within another pending bill named as Generating Antibiotic Incentives Now (GAIN). The proposed provision of GAIN bill is to offer incentives to encourage development of new antibiotics for the treatment of diseases which are resistant to current antibiotics.
Antibiotics resistant infections are epidemic for countries across the world. Antimicrobial resistance is a condition where bacteria develop resistance to respond a drug. This means the drugs which were effective to treat infection are now not effective because of bacteria's resistance capability. The proposed mechanism would help to resolve the issue before the current condition worsens and pose serious threat to public health.
SPLMU mechanism would help improve feasibility of approval for the drug which are targeted to be used in few hundred patients.
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