On May 21, the 21st Century Cures Act was passed by the House Energy & Commerce Committee unanimously (fifty-one to zero). Since then, a great deal of PR has been devoted to securing its full passage in the House and Senate.
I do not believe that the bill should be passed for five reasons:
1. It rewards bad behavior — In July of 2014, the Sunscreen Innovation Act was passed – it gave the FDA nine months to move forward in its review of eight sunscreens that have been languishing at the FDA for up to 13 years despite being approved in Europe and other countries, with decades of worldwide experience. Within seven months, the FDA rejected all eight applications. The agency completely rejected Congress’ directive to move forward with a very simple proposition – approve topical compounds used by consumers throughout the world. Twenty-first Century Cures includes many items that are not as simple to comprehend, or as easy to implement.
2. It will do to device regulation what BTD has done to drugs and biologics — One of the provisions of 21st Century Cures is the creation of an expedited approval pathway for medical devices that address significant unmet medical needs, akin to the Breakthrough Therapy Designation (BTD) program for drugs and biologics. Just like BTD, the pathway is completely superfluous – there are already provisions for expedited review that include these medical scenarios. BTD has completely corrupted biopharma development efforts preferentially toward narrow niche claims. Do we really want this to happen with medical devices, for medical innovation to be directed by incentive, and not by science and medicine?
3. It adds even more regulations — The reason that 21st Century Cures was undertaken in the first place is because the FDA has not been performing in a manner consistent with its lawfully mandated parameters with respect to review and approval times. This has occurred despite mounting regulations – many passed as part of the Prescription User Fee Act and its multiple reauthorizations – designed to increase the transparency and speed of reviews. The number of regulatory requirements imposed by the FDA have increased 15% between 2000 and 2012. Moreover, FDA rules issued under the Obama administration are twice the length of the Gutenberg Bible. All of this has not worked, yet, this is exactly what 21st Century Cures is – more laws, rules, and guidance documents. And with all of these provisions, some have actually said that the $550 million is not enoughfor the FDA to implement 21st Century Cures!
4. The FDA doesn’t need 21st Century Cures — It has already been empowered to the fullest extent possible by the Federal Food, Drug & Cosmetic Act (FD&C) – “to promote health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely fashion.” This includes “ensuring that… (B) human and veterinary drugs are safe and effective; (C) there is reasonable assurance of the safety and effectiveness of devices intended for human use.” 1 Notice the words promptly, efficiently, and timely. The FDA doesn’t need to be empowered to remove outdated policies, for example, first of all because the FDA itself implemented them, and second, it has broad authority to do whatever is needed to promote health. The real problem is that the FDA not fulfilling its clear mandate.
5. It wastes political capital that could be spent on effective solutions — Instead of incentivizing niche uses of devices and biopharma products, what if the development of novel multi-drug/device approaches to our most vexing health crises (like diabetes, obesity, and Alzheimer’s disease) were encouraged? Instead of directing the FDA to generally consider patients’ perspectives (with no specifics), what if Right to Try Laws were implemented on a national basis, including means by which biopharma and device companies can provide experimental products to terminally ill patients without risk that doing so will undermine their development efforts with the FDA? Instead of giving the FDA $550 million, why not institute penalties for poor review performance?
Bringing the FDA in line with twenty-first century technology, medicine, consumerism, and psychology is a great idea, but 21st Century Cures does not achieve this.
I do recommend increasing the NIH budget, as provided for in the 21st Century Cures proposal, but not moving forward with its FDA provisions. Rather, let’s use the political energy to seriously address what is wrong with the FDA.
Joseph Gulfo is the Executive Director of The Rothman Institute of Innovation and Entrepreneurship at Fairleigh Dickinson University and author INNOVATION BREAKDOWN: How the FDA and Wall Street Cripple Medical Advances (Post Hill Press). He has more than 25 years of experience in the biopharmaceutical and medical device industries and is former CEO of MELA Sciences.