Speakers from the EMA and European Commission, as well as Pfizer and HRA Pharma, debated at the AESGP's Regulatory Conference the ongoing digital transformation of the European consumer healthcare market, the latest developments in the implementation of the new medical devices regulations, and the best ways to encourage Rx-to-OTC switching across the EU.

Trade groups PCPC and CHPA say they likely will request that FDA defer further rulemaking on sunscreen ingredients that require additional data to retain their GRASE designations under the agency’s proposed rule for a final OTC sunscreen drug monograph, issued in February. For now, the associations are asking for an extension of the allotted comment period beyond May 28, 2019.

Poland's ministry of health is calling for codeine, dextromethorphan and pseudoephedrine to be reverse-switched from OTC to prescription status in response to abuse of the drugs by adolescents. At the same time, an academic paper argues Ireland should restrict codeine to prescription-only sale to combat an addiction epidemic "verging on eruption."

White House budget request published March 11 proposes a $643m increase in FDA's total FY 2020 funding, with $281m of the increase from FY 2019 in user fees and $362m from the agency's budget authority. Request includes OTC monograph user fees again, increased by $6m.

Scott Gottlieb claimed higher profile than most previous FDA commissioners with frequent Twitter posts and by including his remarks in many agency communications to industries and consumers. In his nearly two years in post, he also had more central role in FDA initiatives in areas such as keeping unsafe products labeled as supplements off the market and explaining why hemp and CBD are available and supplements even though FDA considers the products noncompliant as dietary ingredients.

Consolidated Appropriations Act gives FDA $5.58bn overall, 8.7% more than allocated in FY 2018. FDA received $268.8m in additional budget authority and $178.3m in additional user fee funds. FY 2019 funding would have lapsed Feb. 16 and another government shutdown would have started if President Trump didn't sign the bill on Feb. 15.