International

Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.

NAD and NARB track their decisions on support for ad claims with Federal Trade Commission policies, including the requirement of RCTs to support health claims for supplements, a standard the industry argues is required for drug claims and shouldn’t be applied for dietary ingredients.

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

After the product’s initial launch in May 2024, California’s government has now expanded the availability of its CalRx-branded generic OTC Narcan to all of its citizens.

CHPA Health In Hand Foundation accepting nominations for 2025 US Self-Care Marketing Awards; Celsius hires former PepsiCo as president/COO and closes $1.8bn acquisition of energy drink competitor Alani; and AdvoCare adds John Peirano as integrated marketing VP after hiring Kathy Blosser supply chain VP.

Dyes and colors which FDA says industries agree should no longer be used aren’t unsafe and are currently used only with the agency’s approval, industry stakeholders say. Center for Science in the Public Interest says the dyes are used “in tens of thousands of foods and beverages that are commonly consumed here in the United States.”

Lowell Zeta, a senior counselor at the FDA from 2020 to 2021, returns as deputy commissioner for strategic initiatives. The agency also names a new acting CIO and acting CVM director, but OGD's Ted Sherwood and OPDP's Catherine Gray retired.

HHS Secretary Kennedy commends food companies for cooperating, but also says, “We have them on the run now and we are going to win this battle. And four years from now, we're going to have most of these products off the market.”

Concern is unavoidable for most marketers of OTC drugs and dietary supplements in the US. As Canaccord Genuity analysts said in a 15 April research note, “uncertainty remains about how the tariff situation will play out.”

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.