Newsletter - February 2, 2017
No New FDA Regulations Means Keeping the Status Quo
FDA will not be able to make any new rules due to President Trump’s executive order (EO) signed this Monday. The EO requires that before creating a new rule, the Agency must identify two existing rules that can be scrapped, hence the name “Two-For-One Order (ToFOO)”. Additionally, the cost for implementing the new rule must be equal or less than the cost of implementing the rules being scrapped thereby assuring a net cost change of $0. Read More
Bringing Manufacturing to the US Will Not Reduce Drug Prices
What is the main reason for high prices of drugs; is it the extensive regulations, is it long time to develop new drugs, is the cost of manufacturing in the US, or a combination of all, or just that the industry has products whose demand is fixed? The industry has products that we can’t live without, literally, and hence can charge us whatever it can make us pay. Read More
No New FDA Regulations Means Keeping the Status Quo
FDA will not be able to make any new rules due to President Trump’s executive order (EO) signed this Monday. The EO requires that before creating a new rule, the Agency must identify two existing rules that can be scrapped, hence the name “Two-For-One Order (ToFOO)”. Additionally, the cost for implementing the new rule must be equal or less than the cost of implementing the rules being scrapped thereby assuring a net cost change of $0. Read More
Bringing Manufacturing to the US Will Not Reduce Drug Prices
What is the main reason for high prices of drugs; is it the extensive regulations, is it long time to develop new drugs, is the cost of manufacturing in the US, or a combination of all, or just that the industry has products whose demand is fixed? The industry has products that we can’t live without, literally, and hence can charge us whatever it can make us pay. Read More
