Lobbying

“I think the Republican Congress is going to slow down all of what's called progress, for lack of a better word, toward having hemp be accessible to folks in all kinds of forms,” says Doug Gansler, former Maryland state AG and chair of Cadwalader, Wickersham & Taft LLP’s state AG practice.

In the wake of a US presidential election that saw Donald Trump returned to power, the US Association for Accessible Medicines has called for the next administration to take action to help support the generics and biosimilars market.

UK consumer healthcare industry association PAGB is calling on the UK government to explore the Rx-to-OTC switch of at least 25 OTC products over five years, and work with the country's medicines agency to re-evaluate the restrictive criteria for reclassification. 

The US Food and Drug Administration is undergoing seismic leadership changes, from the expected post-election departure of two-term Commissioner Robert Califf to the retirement of longtime Center for Devices and Radiological Health Director Jeff Shuren. What might the new management mean for the medtech industry? Silverman Group President and former FDAer Steve Silverman has some insight.

This Thursday (26 October) the United Nations will discuss whether OTC antimicrobial products should be restricted to prescription-only status by UN member states. In advance of this, we catch up with UK association CEO Michelle Riddalls, to learn about the PAGB’s role in crafting the global consumer healthcare industry’s response.

What’s next for public-private partnership MDIC? According to president and CEO Andy Fish, the group’s work on patient engagement, cybersecurity and more is just getting started. 

The European Commission has registered a European citizens' initiative that explains how the EU can foster equitable, timely, affordable, safe and legal access to innovative psychedelic-assisted treatments. Work towards securing the one million signatures needed for the next step is starting soon.

The revised EU Urban Wastewater Treatment Directive, which obliges pharmaceutical and cosmetic industries to contribute at least 80% towards the costs of removing micropollutants from wastewater through quaternary treatments, will place an additional burden of around €2bn per year on German manufacturers, says Pharma Deutschland. 

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.