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Jill Wechsler is BioPharm International's Washington Editor, firstname.lastname@example.org.
US and European regulatory officials continue to anticipate supply shortages in multiple areas.
The continued novel coronavirus (COVID-19) outbreak has fueled fears of drug shortages, primarily for APIs produced in China, including key ingredients in antibiotics, painkillers, and diabetes drugs. Although several Chinese manufacturers recently reported they were back in business after the holiday closures, US and European regulatory officials continue to anticipate supply shortages in multiple areas, as are generic-drug producers in India, which also obtain APIs from China.
Biopharma companies also face disruptions from delays in conducting clinical trials in China. Many US and global drug companies have launched studies in China as part of multi-regional development programs, as well as local trials to support the marketing of a drug in China that is already approved in other regions, as documented in clinicaltrials.gov data analyzed by www.biocentury.com. Sponsors looking to test potential antivirals and vaccines for effectiveness against COVID-19, moreover, are experiencing difficulties in identifying and enrolling suitable study participants who have been exposed to the virus but have not had previous treatment.
FDA is paying attention to these issues, as seen in a statement by FDA Commissioner Stephen Hahn last week acknowledging that the continued spread of the coronavirus could lead to disruptions and shortages of critical medical products in the United States. So far, the main supply problems have involved respirators, surgical masks, and other protective gear, which FDA is monitoring to identify excessive orders to distributors. The agency also wants drug manufacturers to report on emerging supply issues and is beefing up resources to review and coordinate such data.
At the same time, FDA has postponed planned inspections of medical product manufacturers in China due to a State Department travel warning. The agency usually conducts some 500 inspections a year in China, but now has put on hold routine surveillance site visits scheduled for February and March. In the meantime, Hahn said the agency will increase import sampling and seek to review records of uninspected facilities to determine the need for any import alerts. And as with all APIs, FDA will continue to hold manufacturers of finished dosage forms “responsible for ensuring the quality of their products.”
The delay in inspections is sure to raise concerns on Capitol Hill, where leading legislators have been voicing concerns about the nation’s growing reliance on drugs and APIs from China and limited FDA inspections and oversight of these products. The chair of the House Energy & Commerce health subcommittee, Rep. Anna Eshoo (D-Ca), has listed US reliance on foreign manufacturing of generic drugs as a “top-line issue” for 2020, a move fueled by ongoing recalls and warnings about several widely used drugs contaminated with nitrosamines. Military and national security experts also have warned about a possible trade war with China aggravating the nation’s overreliance on imports of such critical products. Various commissions and think tanks have proposed stronger federal efforts to ensure the safety of medical product imports, expand drug production in US facilities, and more FDA oversight of foreign producers.
Similar fears about drug shortages have raised alarms in Europe, where manufacturers also are dependent on APIs from Asia, as reported at a meeting of European Union health ministers last week. Although the European Medicines Agency (EMA) has not received reports of supply disruptions, a sustained virus outbreak and production shutdowns could undermine the pharmaceutical supply chain, particularly for generic drugs, the officials agreed. The EU may launch a joint procurement plan to purchase protective medical equipment.
FDA also is concerned about manufacturers making false claims or marketing fraudulent products related to preventing or treating the virus. An FDA task force is closely monitoring for such activities related to COVID-19 and is working with retailers to help monitor online promotions making illegal claims.
The potential for increased import and sales of illicit medical products continues to be a main regulatory challenge, as seen in the recent FDA announcement of a broad enforcement action to halt massive imports of dangerous, unapproved drugs and medical devices from India. A joint operation in January 2020 involving FDA and India’s customs and border protection agency stopped some 500 shipments of unapproved or illegal products, including opioids. Many of the illicit products were transshipped through other countries and ordered through illegal online pharmacies.