Sometimes a year will go by and the regulatory process will seem to move in geologic time (versus real time) and nothing new has happened, that was NOT the case in 2017 which has shaped up to be a very a busy year for the FDA and drug developers. This article will explore all the major changes this year including guidance documents drafted and finalized, new legislation, other areas of interest and some tools to help you explore additional areas not covered herein but might be of interest to you; the impact of these changes is provided for some of the information. First stop, a new CEO for the FDA, or in FDA speak, a new commissioner.
The head of the FDA is like a Captain of a ship, the CEO; this person sets the tone for interpretation of regulations, application of regulations and what regulations will be focused on. Dr. Scott Gottlieb was sworn in as the 23rd Commissioner of Food and Drugs on May 11, 2017 and has been busy every since doing what he can to streamline drug development (from both the Sponsor and FDA perspective), speed up breakthrough therapy reviews, issue more guidance documents and crack down on the opioid addiction epidemic. Based on his brief output for 2017, 2018 will be another whirlwind year as well.
The beginning of 2017 was a busy time for the FDA, there was a flood of guidance documents published in the Federal Register as either draft or final guidance document as it seemed like the FDA wanted to get through as many guidance documents as possible prior to the regime change since a new president usually means a change in the head of the FDA.
Following is a list of all guidance documents published in 2017 so far, their status followed with all manufacturing guidance documents highlighted. Want to know where you can check for new guidance documents? FDA posts them here.
Search for the guidance document you want here.
What were the major legislation that was passed this year and will find their way to implementation through the passage of regulations or by other means enacted?
On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), with provisions that went into effect October 1, 2017 and remain in effect through September 30, 2022. FDARA included reauthorization of:
- Prescription Drug User Fee Act (PDUFA) (Fifth time reauthorized)
- Generic Drug User Fee Amendments (GDUFA) (first time reauthorized) (ANDA, Drug Master Files,
- Biosimilar User Fee Act (BsUFA) (first time reauthorized)
21st Century Cures Act
Some could argue that this was signed into law on 2016, not 2017 so it shouldn’t be included here, but just like a tsunami that gets started out at sea (i.e. 2016), the effects of the law hit land in 2017. Some of the major legislation and acts introduced in this law (and supported by FDARA) include:
- The Regenerative Medicine Advanced Therapy, or RMAT, that offers a new expedited option for certain eligible biologics products.
- The Breakthrough Devices program, designed to speed the review of certain innovative medical devices.
- Reauthorization of the Priority Review Vouchers for pediatric orphan drugs
- Real World Data
- Novel Clinical Trial Design
- Issue patient focused drug development guidance
- Issue compliance activity reports (whether or not companies have posted on clinicaltrials.gov or not)
Want to see the FDA’s progress with the act? Progress reports can be found here.
OTC Monograph User Fee Program?
A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations, and would support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph. This user fee act is currently being negotiated. For more and current information.
Agreements and Other Items of Interest
Mutual Recognition promises new framework for pharmaceutical inspections for United States and European Union. The United States and the European Union (EU) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and EU regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities. Ultimately, this will enable the FDA and EU to avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk.
On October 31 2017 it was announced that the FDA will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements including: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom..
The agency is expected to announce additional countries that meet FDA requirements in the first quarter of 2018, and believes that the progress made so far puts them on track to meet their goals of completing all 28 national capability assessments in the European Union (EU) by July 2019.
Tools that Can Help Predict Upcoming Regulations or Stay Updated
Guidance document agenda for 2017
Still using an old guidance document? See the list of withdrawn guidances.
Novel drug approvals in 2017
First time Generic approvals.
Meredith Brown-Tuttle, RAC, FRAPS, is the principal consultant for Regulatorium a company specializing in regulatory intelligence, writing and strategy. She is the author of IND Submissions: A Primer, published by Barnett, Regulatory Intelligence 101, published by RAPS, numerous articles and a member of the RAPS Board of editors. She can be reached at email@example.com.