Dr. Scott Gottlieb's Departure from FDA
At this point in 2019 it is impossible not to give some well-deserved attention to the departure of Dr. Scott Gottlieb from the U.S. Food and Drug Administration (FDA). Anyone associated with pharmaceuticals or packaging was surprised at the announcement. Depending on your company’s situation you might be pleased or disheartened. The HCPC falls into the latter category, although we are quite hopeful for the future.
We agree with the quote from U.S. Health and Human Services Secretary Alex Azar II summing up Gottlieb’s service:
“Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more. The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”*
To those of us in the packaging industry I think the sentiment is right on target. Not only were the policies promoted by Gottlieb targeting key problems affecting our pharmaceutical supply chain, but more importantly, the patients themselves.
Over the years, FDA often seemed like this unapproachable old uncle who was more likely to scold you than cooperate toward any common goal. Under Gottlieb’s reign this facade seemed to melt away. This was the most approachable period for FDA that I can recall: open dialogue, shared ideas and common goals.
Starting with the ongoing work surrounding DSCSA, which is still grinding through seven years toward full implementation, FDA has engaged industry at all levels to pursue solutions. I firmly believe if all industry segments were interested in reaching the goal of a safe supply chain we would be there already. Sadly, FDA had to fight through segments of industry gauntlet determined to protect the status quo and the bottom line instead of patients. FDA has none the less stayed the course of pursuing end-to-end implementation that is its charter per the legislation.
The above reference to the opioid epidemic and the youth tobacco issues are today at the forefront of national problems that only can be attacked through strong leadership in the face of industry lobbyists once again determined to protect the status quo. By engaging the players in dialogue, inviting them to D.C. for open meetings and aligning stakeholders from all segments of the supply chain, Gottlieb’s team brought the right minds into the room to get the discussion off dead center. Under Gottlieb, the FDA team was able to stop the conversation and begin action. Case in point is the passing of the Support for Patients and Communities Act which, with the FDA and Gottlieb’s input, includes the formal recognition of unit dose blister packaging, as a tool to prevent opioid addiction.
We applaud his action and leadership and can only hope that his successor looks to the recent past for inspiration in how to solve current problems by engaging industry. We believe Gottlieb’s energy and vision penetrated all levels of FDA, and we are hopeful that his torch will be taken up by those remaining and those to follow. Thanks for your two years, Dr. Gottlieb.