This Week at FDA: What we learned at MedCon, looking to RAPS Euro Convergence and more

This Week at FDAThis Week at FDA | 06 May 2022 |  By 

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week we’ve been covering the annual MedCon 2022 conference, presented by the AFDO/RAPS Healthcare Collaborative. At the meeting, Jeff Shuren, FDA’s device center chief, said the agency is planning to ease back into holding pre-submission meetings for all products after hitting the pause button last year. He also noted again the agency faces “critical regulatory burdens” in regulating digital health if Congress doesn’t extend the agency’s authority.
On the topic of digital health, a number of industry MedCon panelists praised the FDA’s digital health precertification (Pre-Cert) pilot program that has been in the works since 2017. While the agency is winding down the pilot, panelists noted that to fully implement this program too would require additional authority from Congress .
During MedCon, the FDA also discussed plans to prioritize medical device inspections that were relaxed during the pandemic. Agency officials announced a new “careful and cautious” approach to conducting foreign inspections.
Last weekend, Bakul Patel, FDA’s digital health chief and the man who is credited with creating the Pre-Cert program, announced on LinkedIn he would be leaving the agency this week. He has, however, not detailed what the future holds for him.
While our focus this week was on MedCon, next week we’ll be focusing on RAPS Euro Convergence, taking place in person in Amsterdam, where European regulators and regulatory professionals will be speaking about a number of topics such as EU IVDR, implementation of new clinical trial regulations, medical device cybersecurity and more.
This week the House Energy & Commerce committee presented the markup of the 2022 user fee reauthorization bill. Besides renewing the various product user fee programs, it includes a number of riders that address topics such as diversifying clinical trials and giving FDA more inspection tools. It also would give the agency the authority to require manufacturers to protect their products from cybersecurity threats and provide a software bill of materials in their labeling -- a major industry ask.
One thing noticeably absent from the bill is new authority for the FDA to regulate laboratory developed tests (LDT).
Late this week,  FDA put strict limitations on the use of Johnson & Johnson’s COVID-19 vaccine. The vaccine now is authorized only for people aged 18 years and older and only when other authorized or approved COVID-19 vaccines are either not accessible or clinically appropriate. An additional group who still may receive the Janssen vaccine are those who “would otherwise not receive a COVID-19 vaccine,” according to the agency’s announcement. The changes in authorization come after a lengthy analysis, evaluation and investigation of reported cases of thrombosis with thrombocytopenia syndrome (TTS) after receiving the Janssen vaccine
A slew of Republican lawmakers this week wrote to the FDA, and the Centers for Disease Control and Prevention (CDC) telling them to use a higher regulatory threshold to approve COVID-19 vaccines for children 6 months and older.
STAT News this week also reported that the White House could run out of Covid-19 vaccines if it moves forward with plans to encourage all adults to get a second COVID-19 vaccine booster dose by Sept. 1. The reporting is based on budget documents sent to Congress that have not previously been made public.

Drugs and Biologics
After a draft majority opinion of the US Supreme Court of the United States in which justices agreed to overturn the landmark case Roe v. Wade that ensures access to abortion was leaked to Politico, the New York Times reported abortion pills are likely to become the next battleground for anti-abortion activists. A follow-up article in Politico noted that the draft opinion has rekindled interest in a potential Rx-to-OTC switch for oral contraceptives.
The International Council for Harmonization (ICH) published a guidance this week on a roadmap for developing Model Informed Drug Development (MIDD). The objective is to create a unified approach to model informed assessments for efficacy and safety for new drugs across regulatory regimes.
Pharmaceutical companies Vizient and RISCS, this week also announced a joint pilot program to enhance assurance of pharmaceutical supply. On the heels of supply chain concerns due to the COVID-19 pandemic, their program would use a rating system to evaluate critical aspects of a resilient supply chain and provide increased transparency according to the drug-makers.
Medical Devices
The International Medical Device Regulators Forum (IMDRF) this week announced a new draft guidance addressing legacy medical device cybersecurity. The guidance is the by-product of a medical device cybersecurity guidance issued by the group in 2020 where stakeholders asked for more granularity for legacy devices which have been especially difficult to manage since many were developed without cybersecurity in mind.
The FDA this week announced the first in vitro diagnostic test to help diagnose Alzheimer’s disease (AD) earlier that would also reduce radiation risk for patients by minimizing the need for positron emission tomography (PET) scans. Fujirebio Diagnostics’ Lumipulse G β-Amyloid Ratio (1-42/1-40) test works by detecting β-amyloid proteins in the cerebral spinal fluid (CSF), an indication a patient may have AD.


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