Highlights from the PricewaterhouseCoopers 2017 FDA report

The FDA has hit a 20 year low in the issuance of new federal regulations according to the findings in a new report published by PricewaterhouseCoopers (PwC).  In 2017, we saw only 6 new regulations whereas in the past we would see on average 33 new regulations per year.   


However, the Food and Drug Administration (FDA) is about more than just imposing new regulations, there are other methods of enforcement such as facility inspections to crack down on drug quality issues and issuance of warning letters and guidance documents.  These key ways in which the FDA shapes policy has seen little change in 2017.

Will these trends extend into 2018?

We’ll need to wait and see how the trend continues into 2018 but if history is any guide, we mostly likely will see an uptick in regulations.  According to the report, Presidents Bush and Obama saw an increase in FDA rulemaking in their second year in office.  Also, in the fall 2017 regulatory agenda, it was noted that there are 18 new pharmaceutical regulations under various stages of development.  It remains to be seen if these will be completed and released in 2018 though.  

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Remarkably, there are 98 guidance documents, spanning 18 categories, that are planned for release later this year.  These guidance’s encompass mostly procedural changes and have a strong emphasis on pharmaceutical quality, the generic drug industry and clinical trials.  It will be interesting to see how these changes will impact the approval process and ultimately the number of drugs that make it to the market. Issuance of warning letters are expected to increase since data integrity remains a key concern in the industry

Some other highlights from the report

The PwC report highlights the effect of FDA Commissioner Gottlieb’s regulatory philosophy on promoting the exchange of information and transparency that ultimately leads to competitive policies and eliminates restrictive ones.  This alternative movement within the FDA is quite popular with pharmaceutical industry leaders who feel this will streamline regulatory procedures that will help get their product to market faster.

Due to the increase attention to drastic drug pricing crisis, US states are taking some steps to help tackle the problem since the federal government seems to be dragging their feet to get a handle on it.  State reporting methods have been popping up and will help ensure companies maintain transparency with operational, accounting and commercial costs for the public to see.

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