Pharmaceutical regulators questioned by Senate about foreign inspections

Erin McCallister Senior Manager, Health Research Institute, PwC US June 11, 2020

At a June 2 hearing of the Senate Finance Committee, FDA officials testified about the agency’s inspection processes at foreign manufacturers of pharmaceuticals and outlined the tools it has been using since inspections have been on hold.

According to the FDA, as of May, 26% of manufacturing facilities for active pharmaceutical ingredients (API) were located in the US. Another 26% were in the European Union. Nineteen percent were located in India and 13% in China. For all FDA-regulated drugs, 46% of fill-finish facilities are in the US; 19% are in the EU, 10% in India and 7% in China.

The FDA told the committee that all products are held to the same regulatory standard. “Whether a drug is produced in the US or overseas, it must undergo the same process,” said Judith McMeekin, associate commissioner for regulatory affairs.

However, the Government Accountability Office (GAO) provided results from a December report in which it found that the FDA often provided up to 12 weeks of advance notice to foreign manufacturers, while domestic inspections are unannounced. Additionally, in some cases, the foreign manufacturers provided an English-speaking interpreter of regulatory documents or the investigators were sent without a translator, particularly in Japan and China, which the GAO highlighted as an area of concern.

The investigation also found that the FDA has 190 investigators in the US who conduct foreign inspections but that 58 positions were vacant.

The GAO has “had long-standing concerns about FDA’s ability to oversee the global supply chain,” said Mary Denigan-Macauley, director of health care at the GAO. “The pandemic has further complicated the playing field,” since inspections have been halted, she added.

The FDA outlined the steps it’s taking in lieu of on-site inspections, such as direct product inspections and testing at the border. However, “the lack of foreign inspections removes a critical source of information about the quality of the drugs manufactured for the US market,” Denigan-Macauley said.

Given the critical challenges highlighted by the GAO, senators pressed the FDA officials for other methods that could be deployed, including incentives for companies to manufacture more APIs and finished drug products in the US.

One potential solution offered by Dr. Douglas Throckmorton, FDA deputy director for regulatory programs, was greater adoption of advanced manufacturing systems.

“[One division of the FDA]’s vision is to spur the industry to modernize so the quality can be consistently and reliably be built into each tablet or vial they produce,” Throckmorton told the committee. “This includes initiatives to encourage advanced manufacturing technologies and quality management maturity.”

The new technologies could improve quality and consistency and “reduce the length of the supply chain, and we believe there would be a good business case for drug firms to on-shore those factories and bring them back to the US,” he added.

HRI impact analysis

While the FDA also has shelved most of its domestic inspections because of the pandemic, lawmakers and policymakers have increasingly called for measures to push industry to move larger portions of the medical supply chain to the US. The agency is continuing to take steps to increase the adoption of advanced manufacturing processes amid the pandemic.

In May, the Biomedical Advanced Research and Development Authority (BARDA) awarded a $354 million contract to a new US company to manufacture “essential medicines at risk of shortage.” The company has been tasked with using advanced manufacturing to build a long-term national stockpile of APIs.

An HRI analysis of new drug shortages reported to the FDA since February found 547 drugs added to that list, though some of the drugs are different dosage sizes and formulations for the same API. For 138 of those drugs, an increase in demand is cited as the reason for the shortage, with nearly all of them used to treat COVID-19 symptoms or to sedate patients during the intubation process.

Advanced manufacturing includes new medical product manufacturing processes that can improve drug quality, address shortages of medicines and speed the time to market, such as continuous manufacturing and 3D printing, according to the FDA.

Last year, the FDA issued draft guidance related to quality considerations for continuous manufacturing. Since the COVID-19 pandemic began, it has worked with multiple entities to advance 3D manufacturing of needed medical supplies, including swabs, face shields and other personal protective equipment.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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