Track and trace details need to be worked out in FDA reauthorization

With the House passing its version of the FDA reauthorization law, the agency is poised to have greater powers to do such things as inspect foreign manufacturing facilities and manage drug shortages. But there are differences yet to be reconciled with what the Senate envisions, like the level of supply-chain tracking that will be required of the industry to protect against counterfeit medications.

Both the Senate and House bills grant the FDA the authority to require drugmakers to give a heads up about supply interruptions that could lead to shortages. Then the agency can work with other manufacturers to try and fill the gaps and avoid the shortages that have plagued the industry more often in recent years, reports Reuters. That is done voluntarily now.

Both bills provide for higher fees from drug manufacturers--including, for the first time, generic drugmakers, to speed reviews. The fees will make up nearly half the agency's $4.5 billion budget next year, Reuters says. But as far as track and trace, the FDA wants a system to track small quantities from manufacturing to pharmacies, something the industry says is too expensive. The industry supports a program that would track lots and that could be refined over time, more to its liking.

There are other differences, Reuters says, over medical device oversight and incentives for making antibiotics for conditions where there are few current treatments. But the final version is expected to give the agency more authority to inspect manufacturing plants around the world where 80% of the ingredients used in drugs now originate. It gives the FDA leverage to inspect the manufacturing plants of foreign companies, or to block their products if they refuse. It also is expected to put the responsibility on drug manufacturers to audit their suppliers to insure that their APIs meet U.S. standards. 

- read the Reuters story
- here's Bloomberg's take

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