The Health 202: The White House is prepping an executive order to shift drug production to U.S.

The Health 202: The White House is prepping an executive order to shift drug production to U.S.

with Paulina Firozi

The coronavirus pandemic has laid bare just how much the United States relies on Chinese manufacturers for medical supplies. 

But President Trump’s plan for an executive order to shift drug and medical production to this country – by suddenly cutting off federal agencies from those offshore supply chains – could make it even harder to obtain supplies critical to combating the pandemic, such as personal protective equipment, testing supplies and even medications to treat coronavirus patients. 

The order, which the administration has been working on since March, is expected to apply to government programs and agencies that directly purchase drugs and medical supplies, according to lobbyists and industry watchers. They may include the Department of Veterans Affairs, the Strategic National Stockpile and the Federal Bureau of Prisons. 

The goal is to ease crippling supply chain problems that left the United States without enough tests and protective equipment.

The order, led by White House trade adviser Peter Navarro, would broaden existing federal requirements for government agencies to prioritize buying supplies for medicines deemed “essential” from U.S. manufacturers, rather than companies in China or elsewhere around the world. 

As we’ve written in The Health 202, labs struggled to ramp up coronavirus testing, and hospitals and nursing homes ran short of personal protective equipment over the spring. These failures hampered the national and state responses to the pandemic, leaving the United States with far more infections and deaths than any other country. Even now, shortages of protective medical gear are looming as outbreaks grow in the South. One big reason why is because these supplies often come from other countries, which were also dealing with outbreaks. 

Neither the White House nor the Department of Health and Human Services gave us details about when the order might be released or what it might contain. But HHS Secretary Alex Azar told Bloomberg Radio that the pandemic showed medical supplies are crucial for national security and suggested Trump will use executive authority to “fund and incentivize domestic manufacturing” for prescription drugs and personal protective equipment. 

“The coronavirus pandemic brought home that core elements of our medical supply chain are just as strategic to our national security as, say, nuclear submarines and aircraft carriers are, and have to be treated with that same kind of approach,” Azar said. White House Chief of Staff Mark Meadows told Fox News that the executive order is among several Trump will sign this week.  

But U.S. dependence on China is exactly why drugmakers and business groups aren’t enthused about cutting ties during a pandemic. 

The nation’s pharmaceutical industry has pushed back against the potential order, arguing that the United States shouldn’t shut itself off from a global supply chain. 

“Turning our backs on trading partners during a crisis could damage our relationships long after this pandemic ends,” the Pharmaceutical Research and Manufacturers of America and dozens of other business and trade groups wrote in a March letter to the administration.

Other critics say that revising the government’s purchasing rules won’t provide a quick solution to the supply shortages of the current pandemic. “Making Buy American provisions tighter during the current crisis would likely do more harm than good,” write William Reinsch and Jack Caporal of the Center for Strategic and International Studies.

The U.S. relies heavily on Chinese companies for generic drugs and raw materials to make them. 

Eighty percent of the nation’s active pharmaceutical ingredients come from overseas — and China is its No. 2 supplier, behind only Canada.

When it comes to generic drugs, a “substantial portion” of U.S. imports come either directly from China or third countries such as India, which use active ingredients sourced from China, according to a report by the U.S.-China Economic and Security Review Commission.

Moreover, U.S. dependence on China for drugs and drug products is growing. Its imports of Chinese medical equipment increased 78 percent between 2010 and 2018.

The order probably would revise how a 1933 law encouraging American-made products is applied to pharmaceuticals.

The Buy American Act requires federal agencies to prioritize buying products made in the United States. It works by slapping a cost penalty on bids from companies that don’t meet Buy America requirements.

But several exemptions allow agencies to duck the requirements when it comes to buying medical supplies internationally. Under the executive order the administration is mulling, the exemptions and waivers would be pulled back for essential medicines and penalties would be broadly applied to products produced offshore.

The administration is still considering how to determine which medicines are essential drugs, lobbyists say. The order could direct the Department of Health and Human Services and the Defense Department to come up with a list. Or it could rely on a list of more than 400 essential medicines compiled by the World Health Organization.

Ahh, oof and ouch

AHH: The Trump administration has officially told the United Nations it plans to withdraw from the World Health Organization.

The move could have a major impact on public health diplomacy. “It is not clear whether the president can pull the United States out of the organization and withdraw funding without Congress. When Trump first threatened to withdraw, Democratic lawmakers argued that doing so would be illegal and vowed to push back,” Emily Rauhala, Karoun Demirjian and Toluse Olorunnipa report. “… The decision to withdraw comes after months of criticism and threats from the U.S. president.”

The letter sent to U.N. Secretary General António Guterres has not yet been made public, and the United States must give a year’s notice and pay any debts to the U.N. agency before an exit. 

Sen. Lamar Alexander (R-Tenn.) criticized the decision, per C-SPAN producer Craig Caplan:

House Speaker Nancy Pelosi (D-Calif.) called the president’s move “an act of true senselessness”: 

From Sen. Robert Menendez (D-N.J.): 

Trump began to target the agency as coronavirus took hold in the U.S., after initially praising the WHO’s handling of the crisis. He announced in April he would freeze funding to the agency amid a review of its coronavirus response. 

OOF: A nursing home in Pennsylvania gave residents hydroxychloroquine, including to patients who hadn’t been tested for the coronavirus. 

The drug regimen worried some nurses at the Southeastern Veterans’ Center in the suburbs of Philadelphia, who called the widespread and off-label use of one of the antimalarial drugs Trump touted the “covid cocktail,” Debbie Cenziper and Shawn Mulcahy report. 

The regimen also appeared to go against guidance from the Food and Drug Administration, which said in March that the drugs should only be used during clinical trials or in hospital settings where “careful heart monitoring” is provided. 

“For more than two weeks in April, a drug regimen that included hydroxychloroquine was routinely dispensed at the struggling center, often for patients who had not been tested for covid-19 and for those who suffered from medical conditions known to raise the risk of dangerous side effects, interviews, emails and medical notes and records obtained by The Washington Post show,” they write.

Several nursing home staff members said more than 30 residents may have received the drug. The center and the two state agencies responsible for oversight have released little information about what transpired. 

“The Department of Military and Veterans Affairs has confirmed the use of the drug but has not offered details about what led the doctors on site to decide to use it,” my colleagues add. “The state Department of Health, which inspected the home on May 1 and did not cite a single deficiency in infection control or patient care, declined to say whether hydroxychloroquine was administered. The center has released no information about how patients were selected or monitored.” 

OUCH: Florida Gov. Ron DeSantis (R) wouldn’t explain why the state has not started reporting daily hospitalization data.

The governor, who has pledged to report the data, did not respond to repeated questions about why that hasn’t yet happened, the Miami Herald’s Samantha Gross reports. The state is an exception among others that have regularly reported the number of currently hospitalized coronavirus patients. 

“Miami-Dade County Mayor Carlos Gimenez, who sat next to DeSantis at the Tuesday event, ordered hospitals in the county to report patient admissions, ICU capacity, ventilator inventory and other data every day starting on April 4,” Samantha reports. “The number of people entering hospitals each day for COVID-19 is key data that public health experts monitor to measure the potential strain on hospital systems and the seriousness of the disease’s resurgence.” 

The news conference was held indoors at the Miami Medical Center, which was turned into a coronavirus nursing facility, Samantha reports.

Notably, reporters were not informed before the news conference that there were 18 patients that tested positive for coronavirus at the same facility: 

Another notable moment, shared via Vox’s Aaron Rupar: 

Florida has emerged as the new coronavirus epicenter. 

“Nearly 1 out of every 100 residents is infected with the virus, hospital intensive care units are full or filling up, and big-name visitors who chose Florida for their first post-isolation events are now mired in questions and controversies about safety,” Cleve R. Wootson Jr., Isaac Stanley-Becker and Lori Rozsa report. “Amid escalating infections, Florida, once held up by President Trump as a model for how to manage the novel coronavirus, is faring poorly.”

The governor has downplayed the outbreak’s growth, citing expanded testing as a reason for more positive results. 

“Hospital leaders, lawmakers, physicians, epidemiologists, advocates and others familiar with the state’s response said a false sense of security set in when grim predictions about the virus’s spread in Florida did not come to pass in March and April. DeSantis declared victory, attending a laudatory news conference at the White House with President Trump,” Cleve, Isaac and Lori write. 

“… But observers maintain the state then failed to prepare for a surge of the virus, which struck as residents were seeking refuge in air-conditioned indoor spaces, where the virus is believed to be most easily transmitted.” 

Coronavirus latest

And here are a few more good stories to catch up on this morning: 

Around the world: 
  • Sweden has allowed life to carry on mostly unrestricted during the pandemic, which led to thousands more deaths than in nearby countries and has not much spared its economy. It’s a cautionary tale for other nations moving to lift their restrictions, the New York Times’s Peter S. Goodman reports.
  • Brazilian President Jair Bolsonaro tested positive for coronavirus after months of dismissing the severity of the pandemic and shunning masks and social distancing practices, the New York Times’s Ernesto Londoño, Manuela Andreoni and Letícia Casado report. In Brazil, more than 65,000 people have died of the virus.
The Trump administration’s efforts: 
  • Anthony S. Fauci called the focus on the country’s decreasing mortality rate a “false narrative.” “There’s so many other things that are very dangerous and bad about this virus. Don’t get yourself into false complacency,” he said during a news conference with Sen. Doug Jones (D-Ala.).
  • The president is ramping up the pressure on state and local officials to reopen schools in the fall, disparaging the efforts to keep them shuttered as politically motivated, Laura Meckler reports. “The president did not mention that his own reelection prospects may depend on whether voters see the country as having recovered from the economic and social devastation of the novel coronavirus pandemic,” she adds.
Good to know: 
  • What is the journey of a single burger during a pandemic? Jessica Contrera has a must-read story that provides a glimpse into the impact the pandemic has had on the beef supply chain, and the many people — from the virus-stricken meatpacker to the chef who took a pay cut — who have continued to work amid the many hurdles.

Sugar rush

Source link