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Japan’s Abe Follows Trump in Fast Drug Approvals After Criticism

Isabel Reynolds

(Bloomberg) --

Prime Minister Shinzo Abe’s government is following the U.S. in speeding up the approval of still unproven virus drugs, as he faces new criticism over his plan for exiting a state of emergency and reviving Japan’s economy.

Japanese regulators -- which usually take a year for drug approvals -- authorized the use of Gilead Sciences Inc.’s remdesivir just three days after receiving the application. Abe has also said that Fujifilm Holdings Corp.’s rival anti-viral drug Avigan, a treatment he has long cited in public remarks, was in line for clearance by the end of the month.

The accelerated process comes as Abe faces growing dissatisfaction with his efforts to contain the coronavirus, despite a recent decline in new infections. Japan is only the second country to approve the use of remdesivir after the U.S., which said the drug originally intended to treat Ebola could be administered on an emergency basis to hospitalized Covid-19 patients with low blood-oxygen levels or on breathing support.

“He’s been criticized for not being fast enough, so he tried to blunt that argument a little bit,” said Steven Reed, an emeritus professor of political science at Chuo University. “I don’t think it’ll have a serious effect on public opinion, at least until results come in.”

While Japan has so far avoided an outbreak on the scale of those in the U.S. and some European countries, the economic impact of the virus has left many businesses reeling. The downturn may hurt the chances for Abe’s ruling Liberal Democratic Party in a general election that must be held by autumn 2021.

News reports in Japan have drawn contrasts with neighbors such as South Korea and Taiwan, highlighting their nimble use of technology and public health measures to bring down new infection numbers to manageable levels. Meanwhile, Abe’s efforts have been hindered in some cases by the reliance on fax machines and antiquated name seals to process official documents. He was criticized for reluctance to restrict entry to the country from China and for a delay in declaring a national emergency.

An opinion survey published by the Nikkei newspaper Monday found that 55% disapproved of the Abe government’s handling of the crisis, compared with 44% a month earlier. His decision to send two cloth masks to every household in the country was ridiculed by voters more interested in promised cash handouts that have yet to materialize.

The probability of a Japanese recession in the next 12 months has risen to 100%, according to economists surveyed by Bloomberg earlier this month. Abe last week extended a national state of emergency to the end of the month, effectively keeping some businesses closed, although lightly affected regions are likely to be removed from it earlier. Eighteen of Japan’s 47 prefectures have recorded no new cases for a week.

Many around the world seeking some relief have focused their hopes on remdesivir. Gilead shares surged 23% since between when China first confirmed human-to-human transmission of the virus in January and May 8, compared with a 2.9% decline in the Nasdaq over the same period.

The drug’s efficacy is far from certain, with multiple trials still under way. One early analysis of a U.S.-led trial released last month showed that about two-thirds of severe Covid-19 cases improved when treated with remdesivir, a finding top U.S. infectious disease expert Anthony Fauci called “quite good news.”

However, an analysis of a separate Chinese trial prematurely published -- and then retracted -- by the World Health Organization in April indicated that the drug didn’t show benefits in preventing death and reducing virus load. The study was halted early after the country’s caseload fell and researchers struggled to enroll enough test subjects.

Nonetheless, the U.S. Food and Drug Administration quickly approved the drug for emergency treatments. Japanese regulators then authorized the use of the drug based on the FDA’s approval.

The remdesivir authorization marked only the second time Japan has used its emergency approval system, the health ministry said. The three-day turnaround compares with an average of almost a year for regular drug approvals in Japan, according to the Pharmaceuticals and Medical Devices Agency.

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The Japanese premier’s best hope of restoring an economy he long boasted of reviving under his “Abenomics” policy program, may be to assuage fear by introducing treatments or vaccines. Abe is set to lay out plans for a gradual re-opening after his expert panel meets Thursday.

The slow pace of most virus policy measures indicates Japan’s bureaucracy has failed to swing into crisis mode, said Hiroyuki Kishi, a former trade ministry official who’s now a professor at Keio University. The same organizational faults were to blame for the relatively low level of virus testing and the long wait for cash handouts, Kishi said.

“They knew by early March that the situation was serious,” he said. “It was all very leisurely.”

(Updates with details in sixth paragraph)

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