Safeguarding the US Pharmaceutical Supply: Woodcock Discusses Challenges, Shift Overseas

Regulatory NewsRegulatory News | 30 October 2019 |  By 

As drug and active pharmaceutical ingredient (API) manufacturing moves overseas to cut costs, quality and reliability concerns have been raised and the House Energy & Commerce Committee’s Subcommittee on Health met Wednesday to discuss the supply chain with one of the US Food and Drug Administration’s top officials and other experts.

Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, explained how part of the problem is that FDA does not know the volume of APIs coming from China or other countries to the US, and only knows the number of manufacturing facilities approved. According to Woodcock’s written testimony, China has 230 (13%) of the API manufacturing facilities serving the US, while the US has 510 (28%) and the rest of the world has 1048 (59%).

But as Anna Eshoo (D-CA) noted, it’s the API volume, which may change over time, that matters. FDA’s data show that the number of registered facilities making APIs in China more than doubled between 2010 and 2019.

Eshoo highlighted the recent shortage of the pediatric cancer drug vincristine, which occurred after Teva withdrew from the market for business reasons and Pfizer struggled to meet demand. But Woodcock said, “My understanding is that Pfizer has supplies and people can call and get vincristine right now.” (Here’s the shortage listing for vincristine on FDA’s website).

Teva, which controlled about 3% of the vincristine market, “notified us properly that they were leaving the market,” but Pfizer “didn’t notify us of their manufacturing issues,” Woodcock added, explaining that FDA first heard of the shortage from MD Anderson Cancer Center.

But overseas quality issues may also drive up the number of drug shortages in the US, and a recent FDA analysis showed that of 163 drugs that went into shortage from 2013 to 2017, quality problems were responsible for the shortages 62% of the time.

So, what tools does FDA need to better respond to potential overseas manufacturing issues and expected shortages?

Woodcock pointed to the need for new authority to ask manufacturers for real-time data, which is authority the agency currently does not have. She also said the agency needs to find ways to hire new inspectors as there has been a decline in recent years in surveillance inspections. But she stressed that funding is not the issue for hiring.

Eshoo pressed Woodcock on conducting surprise manufacturing inspections overseas, but Woodcock explained that although for-cause inspections are unannounced, most of the surveillance inspections, including the ones overseas, are announced. She said that using announced inspections overseas is a trade-off because, “If we send a lot of people to a site that isn’t producing product or open, we waste time.”

And it will be difficult to bring some of this manufacturing back to the US because both China and India enjoy a labor cost advantage, as API manufacturing in these countries can reduce costs for US and European companies by an estimated 30% to 40%, Woodcock said in her written testimony.

Michael Wessel, commissioner of the US-China Economic Security Review Commission, also explained how the increasing reliance on Chinese manufacturing poses security risks. He questioned what would happen if China threatened supplies of certain critical drugs that are no longer made in the US.

Meanwhile, the Government Accountability Office (GAO) is putting together a report on FDA’s ability to oversee drug and API manufacturing that occurs outside the US. A previous GAO report on the same topic found, “While FDA officials shared examples of the foreign offices’ accomplishments, they do not systematically track such information, nor have they fully assessed the extent to which the offices are helping to ensure drug safety.”

Subcommittee Hearing


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