This Week at FDA: Senate committee to vote on Califf’s nomination; FDA ordered to speed release of Pfizer vaccine documents

Regulatory NewsRegulatory News | 07 January 2022 |  By 

Welcome back to This Week at FDA! There’s lots of big news to cover in this week’s installment, including some items from before the holidays, updates on COVID-19 vaccines and Robert Califf’s nomination to lead the FDA. Plus, we get word that FDA’s move to harmonize its quality system regulation with ISO 13485:2016 may finally be on the horizon.
Last month, Califf breezed through his nomination hearing in front of the Senate Committee on Health, Education, Labor and Pensions. On Tuesday, 12 January, the committee will vote to advance his nomination to the Senate. While Califf’s nomination faces some opposition, he is widely expected to be confirmed for a second stint as FDA commissioner.
Just after the New Year, FDA detailed changes to the organizational structure of its product centers for drugs, biologics, medical devices and tobacco, as well as the Office of the Chief Scientist, in two Federal Register notices.
FDA also took several actions related to COVID-19 vaccines this week including authorizing booster doses of the Pfizer-BioNTech vaccine to children ages 12-15, shortening the interval between the second dose and a booster dose to five months and allowing for a third dose in a primary series of the vaccine for immunocompromised children ages 5-11. Today, FDA moved to shorten the interval between the second dose of the Moderna vaccine and a booster to five months.
Drugs and biologics
After a defeat in court on Thursday, FDA will likely be forced to release a trove of documents related to its review of Pfizer’s COVID-19 vaccine Comirnaty. FDA had sought to release the documents at a pace of about 500 pages per month, which US District Judge Mark Pittman rejected as too slow. Instead, Pittman ordered the agency to release 55,000 pages per month. Pittman acknowledged the “unduly burdensome” challenges the agency will face in reviewing the documents for release but said that the FOIA request “is of paramount public importance.”
FDA recently revised its Manual of Policies and Procedures (MAPP) discussing the allowable excess volume/content in injectable drugs and biologics packaged into vials, to ensure there amount of excess product “is sufficient to alloy for withdrawal and administration of the net container content of the drug product.” The revised MAPP takes effect on 28 January.
The agency also proposed to withdraw three the approval of new drug applications (NDAs) from two drugmakers after the companies “repeatedly failed to submit the required annual reports and have not responded to the Agency’s request for submission of the reports.”
FDA shared the latest data on regenerative medicine advanced therapy (RMAT) designation requests. The agency saw a decline in requests in FY2021, which continues a downward trend in new requests since FY2018. The number of requests granted similarly dropped for the year. In the first quarter of FY2022, the agency has received 7 requests, which puts it on pace to fall between FY2020 and FY2021, if the current pace of requests holds.
Shortly before the holidays, FDA said it is aware of issues with the modified iPLEDGE risk evaluation and mitigation strategy (REMS) for the acne drug isotretinoin and called on the Isotretinoin Products Manufacturers Group (IPMG) to come up with a “workable solution” as soon as possible. Isotretinoin is subject to a REMS as it carries a high risk of fetal injury, severe birth defects and pregnancy loss.
Medical devices
After years of delays, FDA has submitted its proposed rule for harmonizing and modernizing its medical device quality system regulation with the international standard, ISO 13485:2016 to the White House Office of Management and Budget for review. The shift has been teased since 2018, and the proposed rule was initially slated for release by April 2019. Now, three years later, the proposed rule may finally see the light of day.
Just before the holidays, FDA finalized guidance on non-clinical and clinical investigations of devices used to treat benign prostatic hyperplasia (BPH). The guidance supersedes an earlier guidance on the topic issued in 2010. The agency also finalized guidance on premarket notifications for arthroscopy pump tubing sets intended for multiple patient use.
Enforcement and recalls
In early December, medical device maker Medtronic received a warning letter detailing violations related to the company’s MiniMed 600 series insulin infusion pumps. While news of the warning letter was widely covered after the company disclosed that it had received the letter, the letter provides extensive detail about the observations raised during a month-long inspection last summer.
Another device maker, DSAART, LLC., was warned for good manufacturing practice (GMP) violations at its Carson City, Nevada facility. The firm, which makes silicone facial and body contouring implants, was cited for issues with its process validation, complaint handling, corrective and preventive action (CAPA), product controls, and design validation procedures.
The agency sent warning letters to two companies, Varigard, LLC and Amcyte Pharma, Inc., for marketing unapproved products with claims to treat or prevent COVID-19.
A warning letter was also sent to a clinical investigator in Ukraine for failing to retain records for the required period while a biologics license application (BLA) for the product being investigated was pending. FDA said the sponsor of the study’s contract research organization discovered the records were missing while preparing for the inspection.
What we’re reading
This report from ProPublica looking into the federal government’s continued coverage of HeartWare heart pumps following an FDA warning letter in 2014, in which the agency “threatened to notify other federal health agencies about the inspection’s findings.” That notification never occurred, and ProPublica reports that the Centers for Medicare and Medicaid Services (CMS) and the Department of Veterans Affairs continued to pay for the device, despite issues identified by FDA.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you