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?

Congress returns from its Memorial Day recess to four full weeks of legislative activity. The drama of the American Health Care Act (AHCA) now hangs over the Senate. The House will return to its regular work once they advance the FDA User Fee Reauthorization, with the Senate also having to schedule floor time for the package. Also on our radar this month will be the date June 21st– the date in which insurers decide if they will participate in the Obamacare Marketplace for 2018. This could play a role in the Administration’s ongoing discussions regarding cost-sharing reductions, as well as how the Senate approaches its version of the AHCA. Continue Reading Congress Returns for June Session to Face AHCA, User Fees and More

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

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

Associate Editors

Mintz Levin’s Health Law Practice

As the health care and life sciences industries continue to undergo sweeping regulatory change, your company might be facing unprecedented structural and operational challenges. Heightened government scrutiny of industry practices certainly adds to the complexity of operating in the market for all providers, payors, manufacturers, distributors, and suppliers.Read More