FDA and generic drug sector agree ‘epoch making’ plant inspection fee plan

The deal, reported in the New York Times​, is designed to help the US Food and Drug Administration (FDA) monitor the quality of active pharmaceutical ingredients (API) used in non-branded pharmaceuticals sold in the US, 80 per cent of which come from facilities outside the country.

While details of the planhave not been disclosed the newspaper reported that the deal will only cover generic APIs and drugs, rather than branded pharmaceuticals and over-the-counter (OTC) medications whose supply chains are “usually have more secure​.”

It also reported that, in return for the user fees, the generic manufacturers involved in the scheme would have their facilities inspected once every two years, which is comparable with the FDA’s inspection programme for US production plants.

According to news website Medpage Today​ the FDA agreed the proposals with a number of key industry bodies including the Generic Pharmaceutical Association (GPhA), the Bulk Pharmaceuticals Task Force (BPTF) and the European Fine Chemicals Group (EFCG).

EFCG board member Guy Villax, CEO of generic drugmaker Hovione, told the New York Times​ that the potential deal is “epoch making” and reiterated his contention that the complexity of generic supply chains makes them “highly susceptible to being infiltrated by falsified​.”

This echoes comments Villax made during an interview with in-Pharmatechnologist.com at CPhI last year​.

FDA commissioner Margaret ​Hamburg ​also stressed the importance of the new agreement, which is due to go before the US Congress in the next few weeks.

“If a program along the lines of what the parties are working on is enacted by Congress, it would represent a real breakthrough​,” she said, adding that “the FDA.’s entire generic drug program would be placed on a much more stable footing​.”

in-Pharmatechnologist.com will update this story as and when more information becomes available.