Regulatory attorneys suggest different issues that might form the basis of manufacturer-sponsored litigation against the Centers for Medicare and Medicaid Services.
The Inflation Reduction Act specifically bars legal action against many aspects of the Medicare price negotiation program it establishes. But regulatory attorneys agree industry-sponsored legal action against the implementation of the Medicare price negotiation program is inevitable.
The law mandates there can be no “administrative or judicial review” of the Centers for Medicare and Medicaid Services’ selection...
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.
European health systems already pay far too much for new medicines and payers will not accept higher prices to compensate for lower US prices, according to Anja Schiel, from NOMA, the Norwegian health technology assessment body.
The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.
The UK drug regulator, the MHRA, is set to launch its decentralized manufacturing framework in July, and has issued a series of guidance documents that it believes will help companies and also be of value to other countries that are considering how best to regulate the fledging sector.
Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
