Since our  March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred at the Executive Branch management level.  In addition, of great interest to us is the fact that the Food and Drug Administration (FDA) took its first major public step toward implementing the goals laid out in the President’s directive. On September 8th, the FDA issued seven Requests for Information that solicit “broad public comment on ways [FDA] can change [its] regulations to achieve meaningful burden reduction while continuing to achieve [its] public health mission and fulfill statutory obligations.” As detailed below, FDA issued one notice for each major product-focused Center, and one specific to cross-cutting agency regulations.

This post outlines the backdrop for–followed by the details of–FDA’s public request for input about which regulations should be cut or modified. Continue Reading FDA Takes First Steps to Cut Regulations, Solicits Public Feedback

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion.  Not surprisingly, FDA has taken a hard-line approach in its guidance on off-label communications, similar to the Agency’s forceful January 2017 memo. This aggressive stance has not, however, translated into increased enforcement. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 4

Our colleague Bethany Hills recently discussed the Food and Drug Administration’s Digital Health Innovation Plan, which sets forth the agency’s new approach to regulating digital health. Her discussion appears in a FierceHealthcare article published earlier this week entitled “9 Companies Will Play a Huge Role in Shaping the FDA’s Novel Approach to Digital Health.” The full article can be found here. Stay tuned for additional coverage related to the agency’s evolving digital health strategy.

It has been some time since we provided a detailed update on the status of FDA’s user fee legislation making its way through Congress, so that’s what is on tap for today. The House passed the lengthy FDA Reauthorization Act (FDARA) on July 13, 2017 as H.R. 2430, and House members have now left Washington, D.C. for the traditional August recess.

Although the previous self-imposed congressional deadline of completing work on FDARA by the end of July has passed, FDA Commissioner Scott Gottlieb informed agency employees via email on July 24th that he would not be sending out any lay-off notices to user fee-funded staff “unless and until September 30 passes without reauthorization.” The publicizing of this policy decision by the Commissioner may have been intended to signal to the Senate that the sky is not falling (yet), but that they need to get to work.  Continue Reading August 2017 Is Here – Will FDARA Get Done Soon?

Unbeknownst to many, Congress established the Health Care Industry Cybersecurity Task Force in 2015 to address the health care industry’s cybersecurity challenges. That Task Force–a combination of public and private participants–released a report last week describing U.S. healthcare cybersecurity as being in “critical condition.” This conclusion, while disheartening, shouldn’t be surprising to readers of this blog. We’ve blogged about a range of cybersecurity issues affecting health care, from the potential hacking of medical devices with deadly consequences, to ransomware attacks that threaten to shut down hospitals.  Continue Reading HHS Task Force Says Healthcare Cybersecurity is in “Critical Condition”

On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934.  The committee voted almost unanimously to move the bipartisan bill forward, with only Senator Bernie Sanders (I-Vt.) and Senator Rand Paul (R-Ky.) voting against it.  And in an interesting overlap of FDA-related news, the Agency’s brand-new Commissioner, Dr. Scott Gottlieb, was also sworn in on May 11th following a speedy (albeit politically controversial and party-line) confirmation process and Senate vote.  With less than a week on the job, Dr. Gottlieb is already receiving pressure from varied stakeholders to ensure the user fee legislation is enacted in a timely manner in order to avoid disrupting the Agency’s work. Continue Reading FDA User Fee Legislation Moves Forward in Senate with Multiple Policy Riders On-Board

In my last post, I introduced a series of posts that will explore FDA’s historical approach to off-label drug and device communications, how that position has evolved (or not) to the modern day, and predict where that policy might end up a few years from now. This post focuses on the history of FDA’s off-label communication and promotion policy, and while it is by no means a comprehensive history, I attempt to reveal some of the origins and early development of the Agency’s approach to off-label uses and promotion.  In fact, FDA’s early position on off-label communications closely resembles the Agency’s stance on the subject today. Continue Reading The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 2

Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging.  As we previously reported, a discussion draft of the FDA Reauthorization Act was released jointly by leaders of the Senate HELP Committee and the House Energy & Commerce Committee two weeks prior to that comment deadline.  It now seems that the late start to the 2017 user fee legislative process – along with the rapid approach of summer and the risk of Agency layoffs if this five-year reauthorization cycle is not completed before August – has gotten everyone pushing on the accelerator a bit. Continue Reading More Bipartisan Bills Hope to Catch a Ride on the UFA Reauthorization Legislation

On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting (see here and here for our past coverage), these two committees have held numerous public hearings since the beginning of March to learn more about FDA’s “big 4” user fee programs – for prescription drugs, medical devices, generic drugs, and biosimilars.  Continue Reading Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

As we noted previously in our introductory blog post on the 2017 User Fee Act (UFA) reauthorization process, the first UFA hearing on Capitol Hill was convened on March 2, 2017 by the House Energy & Commerce Committee’s (E&C) Subcommittee on Health.  That hearing focused on the UFAs specific to generic drugs and biosimilar biological products.  Since then, Congress has held several more UFA hearings, and multiple FDA-related bipartisan bills that could become important to this process have been introduced.  So it’s time for an update on how things are going with the UFA reauthorizations. Continue Reading FDA User Fee Hearings Picking Up Steam on Capitol Hill