House Committee Clears Bills To Prevent Pay-For-Delay Deals, Assure Generic Access To Samples

Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

If US tariffs on pharmaceutical supply chain products come into force they could be disruptive for companies. Ewan Townsend, of the international law firm Arnold & Porter, explains how companies can mitigate issues through negotiating with suppliers and reallocating tariff responsibilities.

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.