By Jeff Overley

Law360 (June 2, 2020, 11:22 PM EDT) -- Senate Finance Committee members Tuesday grilled U.S. Food and Drug Administration leaders for easing access to an unproven medication sold by a banned drugmaker for COVID-19 treatment and explored ways to reduce American reliance on overseas drug production.

The committee's hearing included lawmakers and witnesses who appeared in person and via videoconference because of the contagion risks of the novel coronavirus. It was titled, "COVID-19 and Beyond: Oversight of the FDA's Foreign Drug Manufacturing Inspection Process," but branched out widely to include discussion of politics potentially affecting the FDA's decisions and nationwide unrest over allegations of police brutality against black Americans.

Here are four highlights from a contentious hearing.

Democrats Rip Absence of FDA Chief

Three high-ranking FDA officials delivered testimony, but Democratic lawmakers decried the absence of FDA Commissioner Stephen Hahn.

"Commissioner Hahn is not with us today for one reason, and that is because the Trump administration blocked his testimony," Sen. Ron Wyden, D-Ore., said at the start of Tuesday's hearing. "The Trump administration did this to prevent the committee from holding the point person for the FDA accountable."

The absence appeared to have an impact, as lawmakers at times complained that FDA witnesses were unable to answer their questions.

One example came when Sen. Maggie Hassan, D-N.H., denounced the agency's emergency use authorization for malaria drug hydroxychloroquine in COVID-19 patients and accused the FDA of allowing "highly inaccurate COVID-19 tests to enter the market."

"These decisions have negatively impacted our day-to-day response to this pandemic and potentially put lives at risk," Hassan said. "Yet, we do not have an FDA official here today who can speak to those decisions."

Lawmakers Question Leeway for Trump-Touted Drug

Democrats aggressively probed the FDA's authorization of hydroxychloroquine and its partial lifting of an import ban on Indian drugmaker Ipca Laboratories Ltd. to increase the product's availability for U.S. patients.

President Donald Trump has touted the drug for months despite it not being proven safe or effective in COVID-19 patients, and he even claimed recently to have taken the drug as a prophylactic. Trump's constant hyping of hydroxychloroquine has fueled speculation that the FDA acted to appease the president.

"Can you confirm that the FDA did not change its protocol for [granting emergency use authorizations] during the pandemic?" Sen. Robert Menendez, D-N.J., asked at one point.

Douglas Throckmorton, a deputy director in the FDA's Center for Drug Evaluation and Research, replied, "The approach, as far as I am aware, was the same as the approach we have taken in past emergency use authorizations."

About a month after issuing the EUA, the FDA in late April warned that hydroxychloroquine carries potentially serious side effects in COVID-19 patients.

Mary Denigan-Macauley, health care director at the U.S. Government Accountability Office, also testified at Tuesday's hearing and said that her office is investigating the FDA's actions.

"We do have work that we're beginning that is going to ... look at the decision-making and look to see if any criteria had changed," Denigan-Macauley said.

She also alluded to the FDA's relaxation of Ipca's import ban, which stemmed from a 2016 warning letter that described "systemic data manipulation" at the company's manufacturing sites.

"You need to maintain good criteria when you take a drastic step like that — allowing an importer who's banned to be able to have a drug like hydroxychloroquine come into the United States," Denigan-Macauley said.

Sens. Fret About Supply Chain Reliability

Extensive discussion Tuesday focused on how the coronavirus pandemic has cast doubt on the reliability of a global supply chain that's heavily dependent on manufacturing abroad, especially in India and China. As of last year, the two countries were home to about 40% of all foreign sites that ship pharmaceuticals to the U.S., according to the GAO.

"It seems to me there's one thing that COVID-19 has taught us — it's we can't rely on supply chains coming from outside of our country," Sen. John Cornyn, R-Texas, said Tuesday.

Throckmorton noted that moving more production to the U.S. — a key goal of the Trump administration — is challenging because it's much less expensive to make drugs in countries with lower labor costs and weaker environmental regulations. One possible solution, he said, would be to help drug purchasers identify drugs of superior quality.

"We believe there is fundamentally a disconnect in terms of the incentives to create high quality and the reimbursement for the products that are of high quality," Throckmorton said. "And we think we can change that if we could provide additional transparency, potentially grading products that are made to a very high quality."

The goal, Throckmorton added, would be to let drug buyers "know that they could potentially choose those products over products that barely meet the mark."

Timing, Focus of Hearing are Criticized
 
Multiple Democrats on Tuesday questioned the decision of Sen. Chuck Grassley, R-Iowa, the committee's chairman, to hold the hearing in the first place. For example, Sen. Sherrod Brown, D-Ohio, argued that the hearing's scheduled topic fell outside the committee's jurisdiction and that "simply putting 'COVID-19' into the name of the hearing doesn't make it about the pandemic."

That's a debatable point — drug quality hasn't been the biggest concern during COVID-19, but the FDA in March did largely halt overseas inspections because of the pandemic. And Tuesday's discussion of the security of drug supply chains is something that multiple attorneys have told Law360 in recent interviews that they're watching closely as a direct result of the coronavirus crisis.

Brown, Hassan and Sen. Bob Casey, D-Penn., also cited widespread protests involving supporters of the Black Lives Matter movement and related clashes with law enforcement.

"I'm astounded by the topic of this hearing," Brown said. "Our country is in crisis. People are dying of a disease that continues to spread. … Black Americans continue to die at the hands of the very people who are supposed to protect them."

--Editing by Michael Watanabe,

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