The risk in 'cutting red tape' for coronavirus treatments Presented by the Partnership for America's Health Care Future

With help from David Lim and Arthur Allen

On Tap

— "Bad advice" from the president to tout unproven coronavirus drugs.

— The third spending package could boost drug and device oversight, but lab groups discontent.

— "Detroit won't save us from a ventilator shortage" as car makers turn to medical supplies.

A message from the Partnership for America's Health Care Future: Let’s build on what’s working in health care where private coverage, Medicare, and Medicaid work together to ensure every American has access to the care they need, not start over with a one-size-fits-all public option system. Learn more.

Happy Friday and welcome back to Prescription Pulse! Given the unprecedented public health challenge confronting regulatory affairs teams, the AgencyIQ leadership team has decided to pull its research and analysis content on the virus and its regulatory implications in front of the paywall. Continue sending pharma/device news and tips Sarah Owermohle ([email protected] or @owermohle), David Lim ([email protected] or @davidalim) and Arthur Allen ([email protected] or @ArthurAllen202)

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Coronavirus

THE RISK IN ‘CUTTING RED TAPE’ FOR CORONAVIRUS TREATMENTS — The president on Thursday promised that “out-of-date” FDA rules would be tossed in a bid to get potential coronavirus drugs to people faster — but was light on details about how that would happen.

In a far-ranging press briefing, Trump name-checked Gilead’s remdesivir — currently in five clinical trials, including three in the U.S. — and a pair of decades-old malaria drugs that he said “could be a game changer.” If either chloroquine or hydroxychloroquine works against coronavirus, "your numbers are going to come down very rapidly,” he said.

The problem: While each of those meds has shown some promise, it’s not clear yet how effective they are. And a pandemic is not the time to be uncertain, say bioethicists and researchers. In particular, the 2018 Right to Try law that President Donald Trump touted as a “tremendous success” does not have as many data reporting requirements as typical pathways. And it’s only been used a handful of times.

"Wow, that is bad advice from President Trump," said Diana Zuckerman, a drug safety expert at the National Center for Health Research. "Lives can be saved if red tape is cut in terms of making tests, respirators, and hospital beds more available. Making untested antivirals available is not a good strategy."

“Right now, to push the Right to Try pathway seems really irresponsible and dangerous,” said Holly Fernandez Lynch, a bioethicist at University of Pennsylvania. “This is the type of thing that's critically important to preserve clinical trials for or we’re not going to be able to figure out whether this stuff works.”

The balancing act: FDA Commissioner Stephen Hahn seemed to pull back from the president’s optimism at the same briefing, emphasizing that clinical trials are ongoing and data collection is still the key. “What's important is not to provide falsehood but provide hope,” he said as he emphasized the agency’s years-old expanded use pathway — dubbed compassionate use — as a way to dose people but collect data.

“We need to make sure the sea of new treatments will get the right drug to the right patients, at the right dosage, at the right time,” he said. “That's why it is important we have our professionals looking at these therapeutic development.”

Gilead has already used the compassionate use pathway to dose critically ill patients, a spokesperson said. “Remdesivir is an investigational antiviral with limited data at this time — it is not approved anywhere globally and has not been demonstrated to be safe or effective for any use,” said Gilead’s Ryan McKeel. “We are in discussions with regulatory agencies, including FDA, to determine the most appropriate pathway for approval of remdesivir in the event that the data are positive.”

Drug lobby PhRMA also seemed wary of moving too fast to dose panicked patients. "A lot of these [drug] products are already being deployed through clinical trials as well as compassionate use or emergency use authorities," Steve Ubl, PhRMA CEO, said a day earlier when asked about the Right to Try push. "I'll leave it at that."

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DRUG AND DEVICE WINS (AND DISAPPOINTMENTS) IN THE GOP BILL — The sprawling health care system’s many stakeholders have all made big-dollar asks to Congress as the Senate works fast on the nation’s third stimulus package to address the pandemic.

But the Senate GOP’s draft goes light on funding — a sign that the lobbying battle will only intensify as negotiations ramp up.

The American Clinical Laboratory Association has already panned the bill’s approach to pricing for coronavirus testing, which primarily focuses on payers and providers. Commercial lab lobbyists were pressing for a $5 billion “emergency laboratory surge capacity fund” to support costs including supplies and child care for lab workers.

“What we saw today was really inadequate and it leaves labs to pay the costs for free tests. It means labs are performing Covid-19 at a loss. Labs certainly are supportive of free testing, but right now there is not a mechanism for them to be paid,” an ACLA spokesperson told POLITICO.

The group also slammed lawmakers for not including a plan to address patients who show up to drive-through testing without an insurance card, saying there is no fix for uncompensated care.

DETROIT WON'T SAVE US FROM VENTILATOR SHORTAGES ANYTIME SOON — Automakers are offering up their factories to help solve the shortage of ventilators needed to treat an expected crush of coronavirus patients, but production likely won't begin for months — too late to help ease the immediate need, write Tanya Snyder, Adam Behsudi, Megan Cassella and Anthony Adragna.

Hours after Detroit’s big three automakers — General Motors, Ford Motor Company and Fiat Chrysler — announced Wednesday that they were shuttering their North American factories, at least two of them, Ford and GM, signaled that they might open them back up to make ventilators and protective medical equipment.

The reason those factories shut down was partly due to pressure by the United Auto Workers, and local and state governments, to comply with social distancing guidelines to keep employees safe, and partly a product of plummeting demand for automobiles.

The push for automobile companies to begin helping the medical manufacturing industry comes as the country — facing a shortage of goods like ventilators, masks and other personal protective equipment for medical workers — shifts to a wartime footing to combat the coronavirus pandemic.

But a spokesperson for General Motors underscored Thursday that there is no concrete plan yet to do anything.

“This is very early,” said GM's Jeannine Ginivan. “Right now it’s just an internal feasibility study on whether it‘s possible for us to help out in the production of medical equipment.”

TESTING SUPPLY SHORTAGES? FDA TURNS TO TWITTER — The FDA is seeking information about swabs, test kits, instruments and supplies for transporting and preparing samples for analysis — and it’s turning to Twitter.

Wading into the Wild West of social media for help during a global pandemic may seem unsophisticated for an agency charged with regulating the nation’s drugs and medical devices, writes David Lim. But thanks to a decades-old law, the FDA cannot require device manufacturers to report shortages in the same way it can for drugmakers.

“@US_FDA suggests companies make public their inventory, production schedule and a hotline number to address questions regarding availability of reagents and other supplies needed for #COVID19 testing,” Anand Shah, the agency’s deputy commissioner for medical and scientific affairs, tweeted on March 17. “If you have an allocation plan to maximize efficient testing, please post.”

Meanwhile: The president’s 2020 budget request proposed requiring device makers to tell the FDA if a significant interruption of essential products was likely, and to file regular reports on their manufacturing capacity.

Similar plans have been gaining steam in Congress. Sen. Josh Hawley (R-Mo.) introduced a bill in February to bolster FDA’s authority to monitor device shortages, and Sens. Kelly Loeffler (R-Ga.) and Bob Casey (D-Penn.) unveiled similar legislation in March.

But with those proposals in legislative limbo, the agency may have to get creative to track potential shortages at a time when countries around the world are competing for the same basic testing supplies.

MILKEN INSTITUTE LAUNCHES COVID-19 TRACKER — The think tank on Wednesday launched the resource to track therapies and vaccines for the disease. The tracker includes information on the organization developing the medical product, funding sources, anticipated timing and related media coverage.

Eye on FDA

FDA POSTPONES U.S. INSPECTIONS OVER VIRUS — FDA is cutting back on domestic inspections of all regulated products including drugs, devices, tobacco and food to protect inspectors from the coronavirus, David reports.

For-cause inspections deemed to be mission critical will continue, including response to natural disasters, outbreaks and other emergencies that impact regulated products, the agency said Wednesday. The domestic violation rate stood at approximately 5 percent of regulated firms last fiscal year, according to FDA. The decision echoes the agency's move last week to suspend suspend foreign inspections.

The decision echoes the agency's move a week earlier to suspend foreign inspections. The FDA plans to review records instead of visiting firms in person to help maintain oversight and is looking at other ways to continue its work. But in the meantime: “Safety and quality need to be owned by the industry, and firms have the primary responsibility to reliably produce quality products,” Commissioner Stephen Hahn said.

FDA GREENLIGHTS FLEXIBLE TRIAL MOVES AMID VIRUS — The agency on Wednesday said companies and researchers could alter trials to keep subjects safe during the coronavirus pandemic, Arthur Allen reports.

… Right now, near-lockdown conditions in states like Washington and California have severely challenged scientists who are trying to recruit patients or have them in for visits during clinical trials. So FDA said scientists can make necessary changes without prior approval of FDA or institutional review boards as long as they report them afterward.

That includes collecting specimens and assessing patients remotely through phone and video calls, FDA said in the guidance.

The move shows a “a remarkable degree of flexibility” in how drug trials could go for the foreseeable future, writes Cowen analyst Rick Weissenstein. “FDA acknowledges the reality that clinical trials conducted during the COVID-19 epidemic could be tainted by missing data, patient drop-outs and deviations from protocol — and ultimately sets different review expectations for product applications that will be in place long after the outbreak is contained.”

Quick Hits

THERANOS IS BACK: IN A CORONAVIRUS PATENT DISPUTE — A shell company called Labrador Diagnostics LLC, which says it holds the rights to two Theranos patents, has sued a company making Covid-19 tests for patent infringement, The Verge’s Nicole Wetsman reports. The lawsuit using patents from the now-infamous Theranos could force testmaker BioFire to stop producing — prompting one legal expert to call it “the most tone-deaf IP suit in history.” Soon after reports of the lawsuit swirled, Labrador said it would allow third parties to use its technology — but it’s unclear what conditions could be attached, or whether the claims are valid.

A message from the Partnership for America's Health Care Future: As the unaffordable costs and negative consequences of new government-controlled health insurance systems like the public option become clearer, Americans are urging our leaders to build on what’s working and fix what isn’t – not start over. Learn more.

Document Drawer

Senate health committee ranking member Patty Murray (D-Wash.) in a letter Thursday requested HHS OIG launch an investigation into HHS’ development and deployment of CDC’s diagnostic test for coronavirus.

Follow us on Twitter Sarah Owermohle @owermohle