Regulatory creep can be defeated by leadership

The FDA is broken. Many have advocated for significant changes at the FDA, if not its complete elimination.  I am not in the latter group; I still believe in a strong Food and Drug Administration.

The need for rules, policies, and a level playing field for all drug, biologics, and device innovators is critical – norms and standards are required, as are audits and inspections, particularly of foreign manufacturers. Without the FDA, there would be no Good Clinical Practices, no rigorous clinical trials, no standardization, and no statistical validity in conclusions, all of which are very helpful for patients and for the industry.

{mosads}And, I have seen many instances early in my career when the FDA has worked well, so I know it is possible.

When I first came into the industry, the FDA was appropriately skeptical of new products. However, I was able to reach reviewers readily on the phone as well as for important in-person meetings. Most importantly, when there were disagreements, good data won the day. While I believe this is no longer the case, I think that we can get back to a time when easier and more effective communication is possible, and when reasonable data requirements and solid data rule the day.

In those days, the FDA accepted its mandate to promote health through the timely and efficient review of clinical trial data of new products. At the time, the FDA understood that medicine is an art, not a science, and that the more drugs, biologics, and devices that were safe and effective that were made available to doctors, the better. In those days, the FDA understood that “evidence-based medicine” flowed from good clinical studies and years of experience with a product on the market. Yes, back then, the FDA believed in market forces weeding out the products of greatest utility from those of marginal benefit. FDA accepted its role in advancing health, not simply protecting the medical status quo out of fear.

An insidious disease has settled-in over the years, and it has caused regulatory creep – the FDA has become increasingly more powerful and with that power, it has come to believe that it can impose medical utopia. It believes that it can change the laws of human learning and behavior with respect to new medical products, as well as the laws of product adoption and use. The belief that the “all-powerful” US government can create an idealized medical world that solves all problems has taken root. Of course, it cannot.

This change parallels other changes in our society regarding the role and scope of government in our lives. The rise of libertarianism is a reaction against this “nanny-state” mentality. The mindset can be defeated with data, and we have plenty of data with respect to the value of new medical products. Most importantly, the mentality and regulatory creep can be defeated with leadership.

Yes, as with virtually every problem that I have ever faced in my life and business career, solid leadership is needed. A leader who espouses the FDA mandate to promote health can roll back all of the regulations and guidance that have been imposed over the last 15+ years and return us to an FDA that measures itself on the health of America, not on simply reducing medical risk.

We need to empower FDA leaders, and the leaders, in turn, need to empower their staffs, to do the right thing – to look at data and make decisions on new products based on the safety and effectiveness, not on what-ifs and potential implications. The leaders need to be unafraid and inspire confidence in their staffs. Leadership can do this.

Step one is for America to demand more from the FDA. America needs to demand that the scientific breakthroughs about which they hear every day make it into their medicine cabinets quickly. Americans need to let the FDA know that in America, errors of omission are more egregious than errors of commission, when the rules are followed and intentions are noble.

Americans are beginning to do just that – look at the right to try initiatives.

And this behavior would allow the leadership to give Americans what they need – safe and effective new products for them to live better, longer, and happier lives.

Gulfo is the author of INNOVATION BREAKDOWN: How the FDA and Wall Street Cripple Medical Advances (Post Hill Press) and CEO of Breakthrough Medical Innovations. He has more than 25 years of experience in the biopharmaceutical and medical device industries and is former CEO of MELA Sciences.