The Medical Innovation Manifesto is an 18-point prescription for changes at the Food & Drug Administration (FDA), Securities & Exchange Commission (SEC), Financial Industry Regulatory Authority (FINRA), (Health & Human Services (HHS) and the U.S. legal system that are needed to address the many roadblocks that prevent medical advances from reaching patients. The Manifesto is Chapter 10, the last chapter of Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances. The list was devised by the author, Joseph Gulfo, based on his 25+ years as a senior executive in the biopharma and medical device sectors.
The Medical Innovation Manifesto is a list of very specific and viable actions that could be implemented in the future. For example:
1. Expand and Enforce the FDA Binding Protocol Agreement Process. This should extend to all products requiring Phase III studies. The goal posts should be set in concrete, immutable and not subject to trend or the whim of new reviewers and new management.
2. Eliminate Programs and Policies That Demand Evidence-Based-Medicine and Comparative Effectiveness Analyses Prior to Payment / Reimbursement of New Medical Innovations and Products. These are seen in Obamacare, Accountable Care Organizations, and capitated systems. Breakthrough medical innovations require many years—up to 10 or more—to be fully and properly inculcated into practice. The manner in which they are used in years 1 to 5 can be quite different than in year 10…
3. Remove Excessive and Burdensome Regulatory Requirements For Growth Companies at Securities Exchange Commission and FINRA. For companies with revenues < $100 million, market capitalization < $750 million, or with stock trading under $5.00 per share:
a. Eliminate dark pool trading (this one should be for all companies)
b. Eliminate shorting
c. Eliminate options and derivatives trading that has the effect of “shorting”
d. Require financial message board participants and financial newsletter providers and bloggers to disclose financial relationships with entities that own securities in companies about which they are commenting
e. As well as others…
Order a copy of the book to read the full Medical Innovation Manifesto, as well as the rationale behind each of the points.