Therefore encourage one another and build each other up
Dr. Ajay Babu Pazhayattil
Vice President | Pharmaceutical Management Consultant | Validation, Quality, Technical Operations Leader | Author | 24K+
The pharmaceutical industry has been extensively blamed for inflated prices and lobbying (see a recent presidential proclamation). The administrations strategies to reduce drug prices are primarily focused on the innovators: brand, generic or biosimilars. A new bill with proposed price control measure is expected to impact the industry.
FDA's efforts can be categorized into 3 broad strokes:
- Modernizing FDA’s programs and increasing review efficiencies for brand name and generic products.
- Providing product and technology-specific guidance to increase regulatory and scientific clarity ensuring efficient product development.
- Reducing anti-competitive behavior of firms attempting to game FDA regulations or to delay competition.
Examples of actions already taken (2017-2019):
The regulators intentions are very clear, i.e. increase competition in the pharma innovation and manufacturing sector. These measures are sure to minimize potential for monopolies.
Beyond focusing on pharmaceutical innovators, there needs a similar approach on affiliated segments who are equally responsible for driving up the price. Reliable healthcare market data is key in defining innovation priorities and manufacturing decisions. If lowering price and continued innovation is the target, cost of healthcare data need to be addressed as well:
Healthcare data is collected by removing patient name and assigning another ID (to meet HIPAA requirements) while keeping most of the other information intact. Data mining and analytics can quickly de-anonymize the patient data-set for commercial use. Soon a single organization is expected to receive over $2.8 billion annually for sharing this refined public data. (Just to put thing into perspective, industry only pays $2 billion to US FDA as annual fees).
There have been no plans to provide easy access to healthcare data, ex. prescription pattern. If data is available in its entirety, pharmaceutical organizations can readily determine business/product development opportunities enabled by latest powerful data science tools without depending on expensive data sources and time consuming consultations.
Do you think policies to lower drug prices should also consider disrupting healthcare data monopolies?
Should regulators start collating and providing pharmaceutical organizations with public healthcare market data?
Feel free to share, comment & voice your thoughts
President at Brian G. Nadel GMP Consulting LLC. We Help you write replies to 483s and Warning Letters from US FDA
5 年Ajay - This is a well written article. It is not realistic to expect NDA Pharma companies to cooperate with each other and share their data. Moreover, unless the American society changes from being capitalistic to socialistic, big corporations will continue to try and protect their monopolies. How many new drugs are coming from Europe and ROW today?