As background, I've worked for years helping companies deal with FDA approvals. My Dad was an MD and I know some of the high insurance premiums that MDs pay make it burdensome for them to operate in various fields. I know first hand that the additional tax on medical device companies in the ACA will be a drag on the industry. In multiple instances, I have talked to companies that will never bring the product the US because the regulatory hurdles make it too expensive for them to bother. So, frankly, we are not always given access to the best products or, if we are, it is long after they could be used in Europe or other parts of the world.
On the flipside, we don't want every product that is approved in Europe to be sold here. The FDA employs a lot of hard working, honest, and diligent people. There is great value in knowing the products that get approved have some proven level efficacy and safety. Theirs is a hard job, but the fact that getting product approval is time consuming and sometimes unpredictable stymies investment - which stymies innovation and access to better treatments (completely) in some cases. One of the reasons for this is that the FDA is relatively risk averse, because employees and the agency pay a high price for approving a product that is later found to have problems. However, risk is inherent in the approval of all products, because the number of patients that will receive use a product is always much greater than the number of people that can be studied in testing.
Is there anything we can will simultaneously help MDs, help industry, and protect the public?
The answer is yes, but it requires a big government solution. It fits with elements of the ACA.
Establish an additional tax on the healthcare system which would be paid for by removing costs associated with legal fees and improved profits by streamlined approval processes:
(More fully) track the safety and efficacy of all medical care and products (this is part of the ACA anyway). Use this to create a second approval phase for drugs, biologics, and devices; creating the potential for the FDA to speed initial approvals.
Funds payment of short and long term disability and damages associated with all medical care and products. This would acknowledge that all products and providers may do some harm at some point, and ensures everyone would receive help without having to prove intent or negligence. Individual payments will be established by the government.
Provide tort reform so that only the government can levy fines and penalties against companies, hospitals, and care providers. This could include punitive fines if companies are negligent, but would typically be framed within the actual impact of the healthcare products and services against the performance of all products and care givers of a similar type. Obviously care providers such as MDs need a separate review process than products.
Provide clear and quantified criteria for the safety and efficacy performance for initial approval and continued usage of medical products. Allow for a two teired approval process that acknowledges the risk of products and utilizes the expanded tracking system to revisit the approval.
I can already hear the complaints and I know this is a pipe dream, but this addresses a number of things I have seen personally: device/pharma/biologics companies are largely trying to do good things (for a profit) but are threatened by our current business/legal environment, MDs are under a lot of pressure but most are trying to do the right thing, and real people suffer death, real, and sometimes permanent damage in our medical care system.
We need to do better and the solution requires rethinking where we are.