Skip to content

Advocacy at a Glance

November 8, 2020

Top-Line: This week’s Analysis and Commentary tries to sort through some of the knowns and unknowns about the election’s impact on FDA resources. HHS has issued a regulatory sunset rule, for which comments are due quickly with the intent to promulgate the rule by January 20. The impact of who is the majority party in the Senate, the Presidential transition, and progress in food safety are addressed.

Alliance Webinar with CDRH Director Dr. Jeffrey Shuren Announced. The Alliance is pleased that Dr. Shuren, Director of the Center for Devices and Radiological Health has accepted our invitation to a webinar on Thursday, December 3, from 2:00 to 3:00 p.m. ET. He will be addressing CDRH’s priorities and resource needs and we have asked him to specifically address the Center’s digital health initiatives. To sign-up to participate, please contact Reed Diskey. The event is limited to Alliance members and media. If you are not a member and would like to participate, please contact Steven Grossman.

HHS Releases Regulatory Sunset Rule. As reported by Biocentury (here), Fierce Healthcare (here), and Politico (here; under “Inside the Humphrey Building”), HHS released a proposed rule (here) that would sunset regulations that are more than 10 years old unless they have gone through a formal review. Public comments on the proposed rule are due by December 4, except for certain provisions that will be open for comment through January 4. The intended timeframe is for final promulgation by January 20 (i.e. before the end of President Trump’s first term). Politico reports that the proposed rule has

raised alarms among staff at FDA and other government agencies that issue large numbers of regulations ….

Federal Government in Transition. We don’t yet know who will be inaugurated President in January, but the process of transition for a new president or a re-elected president has already been set in motion. In last week’s Analysis and Commentary, we explained what will happen regardless of the winner.

Food Agency Leaders Describe Their Efforts During the Pandemic. Understandably, public attention has focused in 2020 on FDA’s work on pandemic-related vaccines, therapeutics, and diagnostics. What that misses is the extraordinary pressures upon food leaders and the progress they are making in protecting the public from foodborne illnesses and assuring the continuity in our nation’s food supply. A recent Food Safety News article (here) features the remarks of Frank Yiannas, FDA’s Deputy Commissioner for Food Policy and Response on this topic.

FDA and the States Have Worked Together to Implement the FSMA Produce Safety Rule. Food Safety News editor Dan Flynn has provided an interesting commentary (here) on how FDA, the National Association of State Departments of Agriculture (an Alliance member), and others have worked together over the past decade to successfully implement the Produce Safety Rule (PSR). This was the biggest on-the-farm assignment FDA had ever been given. The key, as expressed by a NASDA representative was: “educate before you regulate.”

Invoices for Alliance 2021 Dues to Be Mailed the Week of November 9. We send the 2021 membership dues invoices out at this time of the year so that members can choose to pay out of their 2020 or 2021 budgets. If you are a member and have not received an invoice by November 16, please let us know. While we believe that most of our members have sustained no or little loss in revenue due to the pandemic, we are aware that a few have been severely affected. If this is your case, please contact Steven Grossman to discuss how to continue your membership.

Comments are closed.