FDA Policy/General

PhRMA Taps Former House Leader Cantor as Next President

The Pharmaceutical Research and Manufacturers of America (PhRMA) board of directors have selected former House majority leader Eric Cantor as the group’s next president and chief executive officer. Cantor represented Virginia’s 7th Congressional District as a Republican from 2000 to 2014, serving as House Majority Leader from 2011 to 2014.

Cantor will replace Stephen Ubl, who has led PhRMA since 2015, effective 11/9. Ubl will continue to serve as a strategic advisor to PhRMA until 1/15/2027.

In Congress, Cantor was instrumental in building support for legislation that established Medicare Part D, expanding access to drug coverage for seniors and people with disabilities. “He also laid the groundwork for the passage of the 21st Century Cures Act, a landmark bill with bipartisan support that provided a significant increase in funding for the NIH and included Food and Drug Administration (FDA) reforms designed to speed medicine approvals to get them to patients faster,” PhRMA said in a release.

After leaving Congress, Cantor served as vice chairman and managing director at Moelis & Company where he advised organizations and executives on business strategy, mergers and acquisitions, public policy, and the global economic landscape.

Grossman Backs Overton for FDA Head Following Hearing

FDA policy analyst and former HHS official Steven Grossman said FDA commissioner nominee Heidi Overton demonstrated at her confirmation hearing that she understands the agency must remain grounded in law, science and established regulatory processes, arguing that she could be a productive commissioner despite the difficult political environment she would

Significant API Deviations at Curia New York

A 1/28-2/5 FDA inspection at the Curia New York drug manufacturing facility in Rensselaer, NY, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A just-released 9/18 Warning Letter says the specific deviations were: * failure to have laboratory control

2 Firms Warned on Veterinary Product Linked to Horse Deaths

FDA has issued Warning Letters to Neogen Corp. and Sciarra Aeromed Inc. after an investigation linked fungal contamination in a veterinary wound-care product to serious infections in nearly 100 horses and at least 20 deaths. An agency notice says Neogen Vet HYCOAT, a hyaluronate sodium solution labeled as sterile,

Daiichi Sankyo and Merck Withdraw BLA for Lung Cancer

Daiichi Sankyo and Merck have withdrawn a BLA seeking accelerated approval for ifinatamab deruxtecan (I-DXd) for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The action was based on input from FDA indicating that “data supporting

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Grossman Backs Overton for FDA Head Following Hearing

Significant API Deviations at Curia New York

2 Firms Warned on Veterinary Product Linked to Horse Deaths

Daiichi Sankyo and Merck Withdraw BLA for Lung Cancer