FDA Commissioner’s Tweetorials: The New Age of FDA Advice Via Tweets 
[Posted on: Thursday, August 2, 2018]

Recently the FDA Commissioner, who is a prolific Tweeter, started Sunday-special tweets called the “Sundaytweetorials” to discuss broad issues. Last Sunday’s “tweetorial” included a series of 22 tweets discussing issues related to clinical trial design. The tweets discussed common strategic considerations for clinical trial design and related issues. Although there were no new announcements or proposals in the tweetorial, they summarized widely available information for better clinical trial design. There are several ways to improve the efficiency of clinical trials such as conducting seamless trials that transition from one phase to the other without the intervening stops, adaptive trials that learn from within to improve chances of success, master protocols that allow testing of multiple therapies in one global trial to speed identification of the most promising products amongst several contenders, and using relevant surrogate endpoints to improve outcome estimates. So, in effect the Commissioner was reconfirming current FDA advice in a series of tweets trying to connect the dots for the readers. All these strategies are important to consider and can apply to practically all kind of products and clinical trials. For all stakeholders these are important topics to review and incorporate in development strategies. And indications are that the industry is doing just that. Adaptive clinical trials have become increasing common and seamless trial and Master protocols could be considered as extensions of the adaptive trials. However, the relationship between the cost of clinical trials and the prices of drugs is weak at best. The prices of all newly FDA-approved drugs and increases in the prices of existing products are based on the demand in the market rather than what did it cost to develop a given product. True that the cost of clinical trials is used as a common excuse by the industry for high drug prices, but the biggest influencer on drug prices is competition. And FDA knows that. And hence FDA has made a policy decision to encourage competition by easing the path to approval of new products. But the rules for review and approval have not evolved leading to high amount of subjectivity of FDA decisions. There is a disconnect between the announced policies and realities of the review process. For example, FDA announced an expedited pathway for approval of generic drugs for drugs that have none or few generic competitions. But there has been no new timelines or incentives proposed for developing such generic drugs. There are limits to what the management can wish for and FDA is no different. But management can certainly take the driving seat to conveying its intent directly to the stakeholders that it regulates. FDA Commissioner’s tweets are a great way to emphasize his desire to see these strategies taken advantage of by developers. It’s a great way to communicate with the industry and consumers. And this trend will continue.