Newsletter - September 10, 2015
Should FDA Be More Flexible For Approval of Drugs For Severe Diseases?
FDA approval is primarily based on avoiding “false positive” or the Type I error, which means approval of a drug that is ineffective or harmful. FDA review is focused on making sure that all products it approves meet the minimum threshold of being safe and effective. According to a policy paper published by an MIT Professor this week, the FDA criteria for approval is unfair as it does not take into consideration the need for a drug intended to treat more severe diseases. The paper provides an interesting but flawed justification for its rationale. The acceptable level of “false positive” by FDA is 2.5%, basically FDA would approve a drug if there is a 2.5% chance of it being ineffective. Read More...
Drug Industry Lobby Group Defends High Drug Prices
This is the year of drug pricing debate. There are numerous voices to challenge high price charged by manufacturers for life-saving drugs, including introduction of a bill this week in the US Congress to add measures for price control. While political and public opinion appears to be shifting towards reducing the spiraling cost of new drugs, the drug industry is fighting back. While the price-control group is getting better at its message, unfortunately, the drug industry is still using old arguments of the high cost of developing new drugs and the challenges to approval. A recent article by Phrma, the largest lobby group for the US drug industry, argues that drug approval process is getting more challenging and expensive, trying to justify the high price for drugs once approved. Read More...
Should FDA Be More Flexible For Approval of Drugs For Severe Diseases?
FDA approval is primarily based on avoiding “false positive” or the Type I error, which means approval of a drug that is ineffective or harmful. FDA review is focused on making sure that all products it approves meet the minimum threshold of being safe and effective. According to a policy paper published by an MIT Professor this week, the FDA criteria for approval is unfair as it does not take into consideration the need for a drug intended to treat more severe diseases. The paper provides an interesting but flawed justification for its rationale. The acceptable level of “false positive” by FDA is 2.5%, basically FDA would approve a drug if there is a 2.5% chance of it being ineffective. Read More...
Drug Industry Lobby Group Defends High Drug Prices
This is the year of drug pricing debate. There are numerous voices to challenge high price charged by manufacturers for life-saving drugs, including introduction of a bill this week in the US Congress to add measures for price control. While political and public opinion appears to be shifting towards reducing the spiraling cost of new drugs, the drug industry is fighting back. While the price-control group is getting better at its message, unfortunately, the drug industry is still using old arguments of the high cost of developing new drugs and the challenges to approval. A recent article by Phrma, the largest lobby group for the US drug industry, argues that drug approval process is getting more challenging and expensive, trying to justify the high price for drugs once approved. Read More...