I recently was a guest on the Willis Report on the Fox Business News channel to discuss some pharmaceutical companies’ efforts to protect their patents against generic competition. The landscape in pharmaceutical research and development has changed greatly over the past 15 years. The focus has narrowed to specific disease states, such as cancer, as opposed to addressing broader disease states like hypertension. The medications that are emerging are part of a growing class called biologics. They are very complex molecules and they work on the cellular level. They are usually rapidly infused or injected in a physician’s office or hospital setting. These medications are also extremely expensive to develop.
Congress embedded into the Affordable Care Act (ACA) the “Biologics Price Competition and Innovation Act (BPCIA”). The BPCIA was designed to accelerate the introduction of biosimilars, which are drugs that have similar, but not identical, properties to the biologic original. As with most elements of the ACA, this is another grand idea that lacks any detail on how to accomplish its intended task. It is this lack of detail regarding the “interchangeability” of biosimilars, therapeutic naming issues, and patient and physician consent concerns that has forced Big Pharma into pre-emptive strike mode. Drug companies are seeking patent protection over what they perceive as potentially unnecessary restrictions that could lower utilization of their branded biologic. If they’re successful, then consumers may not have a lower cost alternative for disease states like breast cancer, psoriasis or rheumatoid arthritis.
During the intense debate surrounding the ACA, Former House Speaker Nancy Pelosi said that “we have to pass the bill so that you can find out what’s in it”. This latest battle, pitting Big Pharma versus consumers (i.e.: senior citizens who are among the highest utilizers of medicine,) is a direct result of big idea politicians giving scant attention to the consequences of their legislative actions. While they congratulate themselves for forcing their grandiose ideas through the legislatures, they foist yet another ugly battle on Americans that potentially victimizes one of the most vulnerable segments of our society –the elderly.
Watch Video Here: