Lobbying

Multi-cancer diagnostics can help get oncology patients the treatment they need more quickly, but lack of reimbursement has kept such tests out of reach for many patients. Bills providing coverage have passed or are under consideration in more than half of the states and have been introduced in both houses of US Congress.

A draft declaration to be presented to the UN General Assembly in September suggests that a “lack of regulation of over-the-counter use of antimicrobials” is one of the “drivers of antimicrobial resistance.” Industry, however, insists that misuse and over-prescription of antibiotics are the primary drivers of AMR, and is advocating for the text to be amended accordingly. 

Just under a third of UK parents who smoke or have smoked in the past believe there isn’t enough support to quit, and nearly a quarter don’t know where to go for support, Kenvue reports, based on recent surveys. In response, the firm launches the “Smokefree Families” initiative to help the 1.8m households in England with children and at least one smoker to become smoke free. 

The UK's consumer healthcare industry association, PAGB, sets out six priorities for the new UK government, following the landslide victory of the Labour Party in the recent general election. One of these priorities is driving Rx-to-OTC switch - something that the UK public also wants, according to the association's latest Self-Care Census, published to mark International Self-Care Day 2024.

“Science is pretty evident that there's no connection between supplement use and eating disorders,” says NPA’s Kyle Turk. “CRN continues to raise fundamental concerns about what benefit the bill offers,” says CRN’s Steve Mister.

Almost half of Europeans are now dissatisfied with their national health systems, a recent survey by Stada finds. Company CEO Peter Goldschmidt urges for dialogue with governments and health ministries to see how self-care can help “build resilient health systems for the years to come.”

Emergent BioSolutions, Harm Reduction Therapetuics, Hikma, Teva and other drug manufacturers commit to increased supply of naloxone and nalmefene in meeting with ]White House Office of National Drug Control.

Should the consumer health industry be exempt from the EU Packaging and Packaging Waste Directive? This question is hotly debated by representatives from major flexible packaging supplier Amcor and OTC manufacturer Perrigo at the 60th AESGP Annual Meeting in Brussels, Belgium. 

BIO CEO John Crowley sat down with Pink Sheet at the industry’s annual convention to discuss his vision for a newly restructured BIO, his thoughts on the upcoming US elections and whether he’d ever lead another biotech. 

The Association of the European Self-Care Industry's 60th Annual Meeting in Brussels, Belgium, opens with a rousing call to action from president Jonathan Workman. Looking to the upcoming EU elections, Workman urges industry to push for widening access to OTC medicines through switch, digital and sustainable investment, improved health literacy and regulatory flexibility.

Ag committee members in 23 May markup likely to broach topic of delta-9 THC limit for hemp. Since hemp was de-scheduled in 2018, cannabinoids other than delta-9 but with psychoactive effects have become leading sales drivers. “Most states now have legal marijuana programs, they just don't know it,” says cannabis industry attorney.

A survey of 1,000 EU health consumers commissioned by AESGP finds that OTC users see numerous benefits of digital patient information leaflets, but are agreed that information should also continue to be available in paper form.

Association CEO John Crowley tells the Pink Sheet that a survey which found decoupling from China could be disruptive underscores the need to do so because having the supply chain ‘tied up with a global adversary is profoundly worrying to all of us.’

The Association of the European Self-Care Industry gives EU regulators a to-do list of targeted reforms to save the Medical Devices Regulation from the scrapheap.

Sanofi consumer health scientific affairs lead moves to CHPA; change in Bayer’s US consumer health marketing helm; Viatris CCO moves from same post at Moderna; Qnovia expands scientific advisory board; and Powerade powers Girls Inc. scholarships, programs.

US Cannabis Council says farm bill reauthorization is “key opportunity to tackle the national crisis caused by unregulated intoxicating hemp products” by limiting the variety of hemp derivatives which qualify as de-scheduled.

The EU Parliament's Environment, Public Health and Food Safety committee proposes a “compromise amendment” to the new pharmaceutical directive that would include only antimicrobials for which there is an “identified risk of antimicrobial resistance” to the prescription requirement. 

The EU Parliament's Environment, Public Health and Food Safety committee takes a compromise position with regards to the Packaging and Packaging Waste Directive. Medicines and medical devices should be exempt, but only until 2035, at which point the European Commission should check whether the development of materials and the recycling process have progressed, and may adjust this exemption accordingly.

During a recent hearing of the US House Energy and Commerce Health Subcommittee, lawmakers discussed the best approach to regulating laboratory developed tests (LDTs) with a panel of experts representing clinical labs. At issue was the FDA’s proposed rule that places LDTs under the same regulatory purview as other in vitro diagnostics, which would require medical facilities to receive agency approval for the LDTs they develop in their own labs.

Guest speaker and lawyer Kevin Duan joins Brian Yang and Dexter Yan to discuss the planned US BIOSECURE Act, the US approval of BeiGene's anti-PD-1 drug and the latest antibody-drug conjugates in development at Chinese pharma firms.