Biologics

Previously Demoted FDA Official Forshee Returns to CBER

Richard Forshee, an FDA vaccine safety official demoted during former CBER director Vinay Prasad's tenure, has returned to a senior leadership position at the Center. Forshee announced in a 10/19 LinkedIn post that he had become director of CBER's Office of Biostatistics and Pharmacovigilance (OBPV), which plays a central role in evaluating the safety of vaccines and other biological products.

His appointment follows a period of controversy over personnel decisions and alleged political interference in vaccine safety research under Prasad's leadership.

In a May letter, Sen. Richard Blumenthal (D-CT) cited Forshee's demotion as part of what he described as a broader pattern of political interference with FDA scientists. Blumenthal identified Forshee as an author of two COVID-19 vaccine safety studies that FDA leadership allegedly prevented from being published. The studies, involving Medicare beneficiaries and commercially insured patients, reportedly found no previously unrecognized safety concerns associated with COVID-19 vaccination during 2023 and 2024.

The senator accused FDA leadership of suppressing scientific findings and requested records concerning decisions to block publication of the studies and personnel actions involving career scientists.

HHS disputed the studies' conclusions, maintaining that they were not adequately supported by the underlying data.

Forshee subsequently served in CDER's Office of Surveillance and Epidemiology before returning to CBER.

FDA Warns Baxter Over GMP Issues at Injectable Drug Plant

FDA has issued a warning letter to Baxter International citing significant GMP deficiencies at its Round Lake, IL, manufacturing facility, including recurring cross-contamination involving cephalosporin antibiotics, inadequate sterile manufacturing controls, particulate contamination and failures to properly investigate sterility test results. The just-posted 9/29 Warning Letter, which followed

Senators Urge FDA to Crack Down on ‘Research Use Only’ Drugs

Sen. Jim Banks (R-IN) is leading a group of senators urging FDA to ramp up enforcement against online vendors using “for research use only” labeling to market unapproved drugs and active pharmaceutical ingredients (APIs) to consumers, citing growing concerns about counterfeit versions of Eli Lilly’s investigational weight-loss

FDA Guidance on Drug-Related Software, Labeling Requirements

FDA has finalized a guidance entitled Regulatory Considerations for Prescription Drug Use-Related Software that outlines how prescription drug manufacturers should address software applications used with their products, including when claims about the clinical benefits of such software can be included in FDA-approved drug labeling. The guidance addresses mobile

Device QMSR Fears Easing: Panel

Industry executives and FDA officials who participated in a 10/19 panel at The MedTech Conference say initial industry concerns about the new Quality Management System Regulation (QMSR) and its implementation by FDA are easing as companies get more experience with inspections under the new protocol. A Regulatory Affairs Professionals

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FDA Warns Baxter Over GMP Issues at Injectable Drug Plant

Senators Urge FDA to Crack Down on ‘Research Use Only’ Drugs

FDA Guidance on Drug-Related Software, Labeling Requirements

Device QMSR Fears Easing: Panel