A draft bill recently introduced in the U.S. Senate serves as a good reminder that compliance with data breach reporting requirements is critical. This bill follows significant, high-profile data breaches by Uber and Equifax, both of which involved millions of individuals (87 million and 145 million, respectively) and both of which went unreported for a significant period of time following discovery by the companies. Equifax took more than a month to notify the public, while Uber took more than a year. Continue Reading Proposed Law Would Criminalize Failures to Report Data Breaches
Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of October 23, 2017. The preview discusses the Alexander-Murray stabilization package introduced by Senators Lamar Alexander (R-TN) and Patty Murray (D-WA), and, in particular, where the stabilization package falls among Congress’ other priorities such as DACA and border security and what we are likely to see next.
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?
The Massachusetts legislature has targeted July 1, 2017 as the date by which it will have legislation on Governor Charlie Baker’s desk regarding the commercial cultivation, processing, and sale of non-medicinal cannabis products for adult use. On June 23rd, the House and Senate each appointed members to a 6-member conference committee that is tasked with resolving the differences between the (renumbered) House and Senate bills, H.3776 and S.2097. There are a number of differences to be addressed, including taxation, enforcement, and the ability of communities to limit or prohibit the establishment of cannabis businesses, even when a community has allowed a registered medical marijuana dispensary. ML Strategies has issued a Client Alert summarizing the progress of this issue from passage of the November 16, 2016 ballot question establishing “recreational” production and sale of cannabis products, through this most recent legislative activity. Stay tuned for further coverage.
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
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
In the alphabet soup that is health and FDA law and policy (if you don’t know what we mean, are you sure you should be reading this blog?), one acronym that doesn’t get a lot of respect is “UFA.” This is the first is a series of blog posts that aim to educate and inform our readers about why the UFA acronym matters and how the UFA legislative process may be particularly significant in 2017.
UFA stands for “User Fee Act,” of which there are many flavors in this modern era – from the old-timer Prescription Drug User Fee Act (PDUFA), born in 1992, to the more toddler-ish Biosimilar User Fee Act (BsUFA) that joined us in 2012. Other important UFAs for the U.S. health care system and stakeholders are the Medical Device User Fee Amendments (MDUFA), which were enacted first in 2002, and the Generic Drug User Fee Amendments (GDUFA) that launched at the same time as their biosimilar companion. Continue Reading Let the 2017 “UFA” Games Begin!
The Connecticut State Senate recently passed a bill that would impose additional disclosure and consent requirements on retailers offering pharmacy rewards programs to consumers. If the bill passes the Connecticut House and becomes law in its current form, violations would expose retail providers of such programs to suit under the state’s consumer protection laws as soon as July 1, 2014.
The bill would require a retailer, prior to enrolling a consumer in a pharmacy rewards program, to provide the consumer with a plain language summary of the terms or conditions of the program. If a HIPAA authorization is required to participate in the program, the summary must include a “conspicuous notice, in bold font” of what constitutes a HIPAA authorization. HIPAA requires an authorization for uses and disclosures of PHI for all marketing communications, except for face-to-face encounters and communications involving a promotional gift of nominal value (such as pens and notepads).