FDA mon­i­tor­ing 20 drugs at risk of short­age due to coro­n­avirus

As part of its ef­forts to en­sure the sup­ply of med­ical prod­ucts from Chi­na dur­ing the on­go­ing coro­n­avirus (Covid-19) out­break, the FDA has iden­ti­fied 20 drugs that are made in or pro­duced sole­ly from ac­tive phar­ma­ceu­ti­cal in­gre­di­ents (APIs) sourced from Chi­na.

In a state­ment to Fo­cus, FDA spokesper­son Stephanie Cac­co­mo said the agency has been in con­tact with the com­pa­nies that make the 20 prod­ucts and that “none of these firms has re­port­ed any short­age to date.”

Cac­co­mo al­so said that the FDA has been in con­tact with more than 180 man­u­fac­tur­ers to re­mind them of their re­spon­si­bil­i­ty to no­ti­fy the agency of an­tic­i­pat­ed sup­ply dis­rup­tions and ask that they re­view their sup­ply chains for API and oth­er com­po­nents sourced from Chi­na.

“At this time, no firm has re­port­ed a short­age is an­tic­i­pat­ed for any drug due to COVID-19,” Cac­co­mo said.

The state­ment came af­ter a re­port from Ax­ios on Sun­day al­leged that FDA had com­piled a list of about 150 drugs that are at risk of short­age, which prompt­ed Sen. Josh Haw­ley (R-MO) to send a let­ter to the FDA.

While the num­ber of prod­ucts FDA is mon­i­tor­ing seems to be low, con­cerns are still be­ing raised about the US’ re­liance on Chi­na for phar­ma­ceu­ti­cals and oth­er med­ical prod­ucts.

In a let­ter sent to FDA on Tues­day, Rep. Bill Pascrell (D-NJ) and Sen. Robert Menen­dez (D-NJ) said the out­break pos­es a “po­ten­tial­ly calami­tous” risk to the US med­ical prod­uct sup­ply chain. The law­mak­ers asked the FDA for more de­tails on how it plans to en­sure the safe­ty and se­cu­ri­ty of drugs and per­son­al pro­tec­tive equip­ment sourced from Chi­na.

Nan­cy Mes­son­nier CDC

Mean­while, on Tues­day, the World Health Or­ga­ni­za­tion brought its tal­ly of con­firmed cas­es of the virus to more than 80,000 glob­al­ly, in­clud­ing 2,700 deaths. While the num­ber of new cas­es re­port­ed in Chi­na seems to have plateaued, the sit­u­a­tion re­mains volatile as more coun­tries re­port cas­es.

The US Cen­ters for Dis­ease Con­trol and Pre­ven­tion (CDC) al­so warned that it ex­pects the coro­n­avirus to even­tu­al­ly be­come more wide­spread in the US. So far, the CDC has con­firmed 57 cas­es of Covid-19 in the US, 40 of which were evac­u­at­ed from the Di­a­mond Princess cruise ship that was quar­an­tined in Japan.

Dur­ing a tele­brief­ing on Tues­day, Nan­cy Mes­son­nier, di­rec­tor of the CDC’s Na­tion­al Cen­ter for Im­mu­niza­tion and Res­pi­ra­to­ry Dis­eases, said, “Ul­ti­mate­ly, we ex­pect to see com­mu­ni­ty spread in this coun­try. It’s not so much a ques­tion of if this will hap­pen any­more but rather a ques­tion of when this will hap­pen and how many peo­ple in this coun­try will have se­vere ill­ness.”


RAPS: First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

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George Yancopoulos (Regeneron)

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