GENERIC DRUG PRICING AND THE END GAME

Generic drugs have been hailed for the impact they have had on the United States healthcare industry. These group of medicines has ensured that Americans have access to affordable yet qualitative prescription medicine, thereby ensuring improved healthcare delivery.

At its most basic, a generic drug is a copy or replica of a brand-name drug, dispensed with the same dosage, intended use, effects and side effects, route of administration, risks, safety, and strength as the original (patented) drug. Unlike the original medication, a generic drug enters the market at much less a cost compared to that for a brand name due to lower production costs and less stringent regulatory approval routes/paths.

http://www.postpoems.org/authors/artic1904/prose/1060242

The Business Dynamics of Generic and Brand name medication
While the usage statistics for generic drugs means that Americans can access cheaper yet effective medicine, the returns on investment for generic drug production may prove to be its death knell.  Consider that supply chain dynamics for generic drugs give a return on investment of 64 percent, while brand name manufacturers posts as much as /retain over 76 percent of revenue.
While these numbers do not differ to large extents, the impact is telling. This is because of the nature of the two markets involved- generic and brand name.  It is important to note that the brand drug industry is generally controlled by one manufacturer with exclusivity (patent rights for a period of time), while the generic industry follows a multi-competitor model with drug prices decreasing as more competitors enter the marketplace, given the less expensive/arduous path to market entry.
http://www.medicalmingle.com/doctor1970/blog/2018/02/24/generic_drug_supply_chain_and_other_matters

 

Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices

In the United States of America, the figures are more compelling. The FDA continues to propose and enforce regulatory policies that give great traction to the development and deployment of generic medicine. Some of these policies include the following:
1. Improving the efficiency of the generic drug approval process.
2. Providing advisory services to developers of generic medicine in capacity and knowledge building.
3. Creating policies that favor the development of a new class/category of generic drugs referred to as complex drugs.
As a result of these efforts, the US has achieved impressive figures with the use of generic medicine.

https://www.bloglovin.com/@teddyredwings/generic-drugs-savings

This new MAPP does not alter the important Generic Drug User Fee Amendments II review goals or program enhancements, nor does it alter the regulatory requirements for ANDA approval. Rather, the goal of the MAPP is to guide FDA staff to help ensure we work more efficiently with the goal of improving review times.