Quality regulations lag behind modern understanding; FDA

By Nick Taylor

- Last updated on GMT

Quality regulations lag behind modern understanding; FDA
Regulations have failed to keep pace with modern understanding about manufacturing and quality, a FDA director said.

In recent weeks the US Food and Drug Administration (FDA) has discussed its strategy to oversee the global pharmaceutical supply chain. Much of the focus is on increased resources but the FDA would also welcome more power in certain areas.

The regulations around drug safety and quality have not been really modified for a long time and are probably not totally congruent with modern understanding​”, Janet Woodcock, director of the Center for Drug Evaluation and Research at FDA, told a Congress subcommittee hearing.

Woodcock was responding to questions about whether the generic drug user fee act (GDUFA) will give the FDA everything it needs to ensure pharmaceutical quality. GDUFA will give the FDA funds to better cope with globalisation, Woodcock said, but in its current form has little impact on its powers.

More power

In some areas the FDA wants new powers to go with the funds. “We have to prove that there’s something wrong with [an import]. In most other countries that’s not the case. Other countries can hold drugs at the border if they even feel they might not meet the standard​”, Woodcock said.

Republican Congressman Tim Murphy said this would “come as a shock to most Americans​” and questioned whether the system meant different standards for domestic and overseas manufacturers. Until legislators grant the FDA more power it will have to make do with its new funds though.

The funds will help the FDA clear its backlog of generics applications and boost oversight of overseas facilities. It is unlikely to get more funding from Congress though. Democratic Congressman Frank Pallone said: “[Increased FDA funding] has simply become too difficult a battle to overcome​.”

Related topics: Processing, Globalisation, QA/QC

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