Antibiotic is first approval in FDA national priority scheme

 The FDA has lost no time in approving the first drug under its recently launched Commissioner's National Priority Voucher (CNPV) programme, clearing an antibiotic manufactured in the US.

The fast track – which allows medicines to be reviewed in as little as one to two months rather than the usual 10-12 months – was introduced earlier this year with the aim of bringing important new therapies to patients more quickly and plugging gaps in the domestic supply of essential medicines.

The first CNPV approval falls into the latter category, and is for a US-manufactured version of the widely used antibiotic Augmentin XR (amoxicillin-clavulanate potassium) that was among the first candidates that entered into the programme.

An initial batch of nine medicines was announced in October, and six more were added last month, including GLP-1 agonist-based weight loss medicines from Eli Lilly and Novo Nordisk.

"Over the last few decades, America lost control of supply chains for key medicines we depend on. That chapter is over – we're entering a new era of manufacturing here at home," said FDA Commissioner Marty Makary.

According to the FDA, there have been seven shortage reports for amoxicillin and two for Augmentin XR in recent years, which have resulted from global supply chain vulnerabilities for active pharmaceutical ingredients (APIs), many of which – particularly for generic medicines – are not manufactured domestically in the US.

"These shortages have resulted in significant clinical consequences, including treatment delays and increased reliance on broader-spectrum antibiotics when preferred first-line therapies become unavailable," said the agency.

The CNPV system has already proved controversial since it was announced, with concerns raised (PDF) that political appointees rather than career regulators are carrying out the reviews and have been selected for political reasons – for example, as a quid pro quo for pricing deals or investments in domestic manufacturing.

The former head of the FDA's Center for Drug Evaluation and Research (CDER), 25-year FDA veteran Richard Pazdur, reportedly clashed with Makary over the legality of the CNPV system before announcing his retirement just weeks into the job. Meanwhile, George Tidmarsh – Pazdur's equally short-tenured predecessor – has also claimed he was ousted after questioning the scheme.

Makary has previously said the CNPV programme will bring "the agility of frontline medical decision-making to our regulatory processes" and insisted that the FDA's "rigorous standards for safety, efficacy, and quality" will be maintained.

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