FDA Commissioner Speaks About Increasing Efficiency in Drug Development
By Philip Garbarini '20
Dr. Scott Gottlieb, the commissioner of the FDA, spoke to a House Appropriations subcommittee on Tuesday April 17th addressing issues in the process of making drugs available after they have won approval from the FDA.
He first revealed that the FDA will be releasing guidance documents to help increase efficiency in drug development. He said the documents mainly focused on under researched disorders and aimed to decrease the need of excessive testing. For example, the guidance provided about blood disorders will decrease the need for animal testing, and outline ways to develop drugs more efficiently and get earlier approval dates.
Next, Gottlieb addressed that drug manufacturers and pharmacy benefit managers (PBMs) are working together to “hamstring biosimilar competition.” This can be attributed to the fact that the FDA has approved 9 biosimilars and only 3 are available to purchase in the US. Biosimilars are a biologic medical product which is almost an identical copy of an original product that is manufactured by a different company.
Currently, major drug manufacturers are pairing with pharma benefit managers to create restrictive contracts and rebating their drugs. While this does decrease the price of drugs for consumers in the short-term, this drastically decreases competition between drug developers. This means that prices will likely over time as middlemen such as PBMs increase their share in the profits.
Gottlieb says this is the main reason for the rising drug prices, as PBMs pocket rebates instead of giving them to the insurance members. This system is not commonly spoken about and the entire process is complicated and out of public speculation.
However, there has been recent signs of progress, as the insurers Aetna and UnitedHealth Group have pledged to pass manufacturer rebates directly on to their fully insured members.
In conclusion, Gottlieb wants to make drugs as accessible as possible to consumers. He plans on doing this by providing guidance to increase drug develop efficiency, and to decrease the role of middlemen such as PBMs who increase the price of drugs. This is the easiest way to stop rising drug prices and add clarity to the healthcare industry.
SOURCES