FiercePharmaPolitics—COVID-19 brings divisions on hydroxychloroquine, reopening

Rick Bright
In testimony last week, ousted Biomedical Advanced Research and Development Authority Director Rick Bright said researchers have to move swiftly to learn more about hydroxychloroquine and other potential COVID-19 meds. (PHE.gov)

Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate.

As the pandemic plays out, political divisions have unfolded around hydroxychloroquine and reopening economies, for starters.

At center stage last week was a House hearing over ousted Biomedical Advanced Research and Development Authority (BARDA) Director Rick Bright’s whistleblower complaint. While the hearing spanned numerous subjects relating to the U.S.' COVID-19 response, lawmakers and Bright spent considerable time discussing hydroxychloroquine. President Donald Trump backed the drug as a "game changer," but so far, hydroxychloroquine hasn't succeeded in any any large controlled studies. 

Sponsored by Lubrizol Life Science

[Webinar] Cannabinoid Formulation - from Farm to Pharma

Wednesday, June 24, 2020 | 12pm ET / 9am PT

A handful of cannabinoid-based pharmaceutical products are on the market today, and an ever-growing number are in the global development pipeline. This webinar will explore key considerations in developing cannabinoid-based pharmaceutical products, including an overview of global pharmaceutical cannabinoid usage today, common challenges formulating with CBD and other cannabinoids, and more.

At the hearing, Republicans said they’ve heard stories about the drug working for some patients. Rep. Michael Burgess, a doctor from Texas, said he’s “hearing from a lot of doctors in my state, around the country, who have experience” using the med and have seen “significant benefit.”

Bright responded that he’s heard those “anecdotal stories” as well. But, he said, they were “not conducted in the context of a randomized, controlled clinical study,” so that info is very tough to interpret.

Another lawmaker, Rep. Morgan Griffith, questioned why Bright and others have been so cautious about the drug when COVID-19 patients are dying with no other options.  

“Can’t we be so careful that we accidentally kill people?” Griffith questioned.

Officials need to “move swiftly” on trials to be able to understand risks and “make sure those drugs are used in a very safe and controlled manner," Bright responded.

Even as the med has failed some recent studies, officials aren’t giving up. The National Institutes of Health just unveiled a large controlled study through which patients will be able to take it at home.  

The nearly four-hour meeting touched on many other subjects than just one medicine. Testimony included Bright’s early efforts to raise alarm about the outbreak and prepare stockpiles of personal protective equipment. But his warnings weren’t taken seriously by Department of Health and Human Services (HHS) officials, he said, and on April 20 he was “involuntarily” transferred to a new post. 

RELATED: Hydroxychloroquine takes another hit in failed small-scale COVID-19 study 

Meanwhile, HHS Secretary Alex Azar appeared on CNN following Trump’s Friday comments that with a “vaccine or no vaccine, we’re back.” The president was speaking at the unveiling of “Operation Warp Speed,” an aggressive program aiming to deliver a COVID-19 vaccine by the end of the year. 

Echoing the president’s message, Azar told CNN’s Jake Tapper that "everything does not depend on a vaccine.” The health secretary also appeared on Fox and said that in states that are reopening, officials haven’t observed a spike in cases. Despite his optimism, Vox points out most Americans are worried states will roll back social distancing measures too swiftly.

Lastly, on the drug pricing front, Democratic lawmakers opted not to include pricing measures in their latest relief bill, sparking concerns that Congress is allocating billions of dollars for COVID-19 R&D but not seeking pricing guarantees. 

Suggested Articles

WuXi AppTec has appointed Celgene CAR-T program veteran David Chang to lead its cell and gene therapy CDMO, WuXi Advanced Therapies.

Maryland-based Emergent BioSolutions has won a $628 million contract with BARDA to manufacture targeted COVID-19 vaccine hopefuls.

About 76% remdesivir patients had at least one point of clinical improvement on a 7-point scale at day 11, versus 66% of patients on standard care.