Industry experts from U.S see possibility that pharmaceutical companies may halt investing for medicines indicated for the treatment of diseases such as diabetes drugs or weight loss pills.
The reason for that is believed to be lack of precise approval guidelines for medicines. Any product with therapeutic effects has to earn FDA approval before getting in market. Drug manufacturers are confused about how FDA inspects risk factors associated with medicine.
Focus of drug companies is likely to shift to other drugs, such as cancer drugs, where life-saving management is assured in case of severe side effects. The Food and Drug Administration is looking forward to address the concern.
Mr. Christopher Viehbacher, chairman of Pharmaceutical Research and Manufacturers of America (PhRMA), believes that there should be clear methods or guidelines which are being used by FDA so that manufacturer can predict the outcome before investing in production.
Pharma drug companies are preparing strategy for coming Congressional hearing on FDA user fee act. User fee is the fee manufacturer companies pay for faster review of their product by FDA.
Renewal is required from Congress for Prescription Drug User Fee Act (PDUFA) every 5 years. Current fee structure is due to expire on September 2012.
Recently several weight loss pills have been denied approval by Food and Drug Administration. There are many weight loss pills, such as Acomplia. Review panel sensed that obesity drugs by Arena Pharmaceuticals, Orexigen Therapeutics and vivus have approval barrier for diet pills because of safety reasons.
In United States around 70% of the population is over weight and medicines will help weight control along with regime and workouts.
Patient’s well-being and safety are the concern of Food and Drug Department which Mr Viehbacher agrees on.
The reason for that is believed to be lack of precise approval guidelines for medicines. Any product with therapeutic effects has to earn FDA approval before getting in market. Drug manufacturers are confused about how FDA inspects risk factors associated with medicine.
Focus of drug companies is likely to shift to other drugs, such as cancer drugs, where life-saving management is assured in case of severe side effects. The Food and Drug Administration is looking forward to address the concern.
Mr. Christopher Viehbacher, chairman of Pharmaceutical Research and Manufacturers of America (PhRMA), believes that there should be clear methods or guidelines which are being used by FDA so that manufacturer can predict the outcome before investing in production.
Pharma drug companies are preparing strategy for coming Congressional hearing on FDA user fee act. User fee is the fee manufacturer companies pay for faster review of their product by FDA.
Renewal is required from Congress for Prescription Drug User Fee Act (PDUFA) every 5 years. Current fee structure is due to expire on September 2012.
Recently several weight loss pills have been denied approval by Food and Drug Administration. There are many weight loss pills, such as Acomplia. Review panel sensed that obesity drugs by Arena Pharmaceuticals, Orexigen Therapeutics and vivus have approval barrier for diet pills because of safety reasons.
In United States around 70% of the population is over weight and medicines will help weight control along with regime and workouts.
Patient’s well-being and safety are the concern of Food and Drug Department which Mr Viehbacher agrees on.
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