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US FDA’s Most Unusual Advisory Committee

 
• By Laura Helbling and Michael McCaughan

Agency's opioid response efforts have pushed advisory committee into unusual territory in recent years. But a two-day meeting to discuss potential labeling changes to recommend co-prescribing of the overdose reversal agent naloxone moved way beyond any of the conventional boundaries of committee meetings.

FDA Advisory Committee Feature image

The Dec. 17-18 joint meeting of the US FDA’s Anesthetic & Analgesic Drugs Products and Drug Safety & Risk Management Advisory Committees was probably the single most unusual and creative use of the advisory committee format by the agency’s new drug review center.

The formal discussion topic was itself unusual, but well within the boundaries of advisory committee fare: whether FDA should consider...

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More from Pricing Debate

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

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.

‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe

 
• By Francesca Bruce

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.

Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says

 
• By Cathy Kelly

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.

New Pricing Agreements And Greater Transparency: What A US MFN Policy Could Mean For France

 
• By Francesca Bruce

A potential MFN drug pricing policy in the US could also lead to a greater push for collaborative action in the EU, such as joint procurement among the member states, says one European industry expert.

More from Market Access

Argentina Speeds Up Market Access Process

 
• By Francesca Bruce

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

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.

‘Brainless’ US MFN Policy Could Drive Pharma Investment To Europe

 
• By Francesca Bruce

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.