The first coronavirus-linked drug shortage Presented by the Partnership for America's Health Care Future

With help from Sarah Karlin-Smith, Arthur Allen, Susannah Luthi and Brianna Ehley

On Tap

— FDA identifies the first coronavirus-linked drug shortage plus new details on device risks.

— Coronavirus testing barriers continue and threaten the U.S. response.

— Questions raised about making affordable vaccines for the virus — and what the government could do.

A message from the Partnership for America's Health Care Future: A new poll found lowering costs is voters’ top priority when it comes to health care, but the public option could force the average worker to pay $2,300 a year in new taxes even if they like their current coverage and care. Get the facts.

Happy Friday and welcome back to Prescription Pulse! Have we missed something? Send news and tips to Sarah Owermohle ([email protected] or @owermohle), Sarah Karlin-Smith ([email protected] or @sarahkarlin), Arthur Allen ([email protected] or @ArthurAllen202) and David Lim ([email protected] or @davidalim).

Public Health

THE FIRST CORONAVIRUS DRUG SHORTAGE — The FDA said late Thursday that it has identified the first known drug shortage caused by the coronavirus outbreak in China.

The manufacturer had recently notified the agency of its shortage but it just became clear that it was related to disruptions in the production of its active ingredient in China, Commissioner Stephen Hahn said. He added the agency is working with companies to mitigate the shortage.

FDA did not identify the medicine, but it updates its drug shortage list daily. New additions over the past few days included antibacterial infusion Avycaz and Mylan-made beta-blocker Pindolol, for which stock is low because of shortage of an active ingredient.

FDA also shed light on possible challenges for device supplies. It announced that is knows of 63 manufacturers that utilize 72 factories in China to make "essential" medical devices — including many with worker shortages due to the coronavirus. No such devices are reported to be in short supply, but device makers aren't legally required to disclose if circumstances exist that could lead to shortages.

Widespread shortages of personal protective equipment like masks, gloves or surgical gowns are not being reported, but FDA said it is aware of reports that health care providers are increasing orders of the protective devices to prepare for a potential severe U.S. outbreak. Some related supply challenges for certain devices have been reported to the agency.

LIMITED CORONAVIRUS TESTING CAPACITY THREATENS U.S. RESPONSE — Federal officials are also scrambling to avert a public health crisis and reduce the odds of a full-fledged coronavirus outbreak.

CDC announced the first potential case of community spread in Northern California on Wednesday night, shortly after President Donald Trump addressed the nation on the outbreak. A hospital memo revealed that stringent federal rules prevented testing of the patient for a full week, despite multiple requests by doctors.

Public health laboratories have faced widespread challenges verifying CDC’s emergency diagnostic, and only a handful are actively testing for the virus. The agency’s Atlanta headquarters is only able to test 350 to 500 samples a day, according to agency Director Robert Redfield.

The CDC chief said that other countries have been able to expand screening faster than the United States, blaming the delay on federal regulations that govern tests developed in-house by hospitals and laboratories. Redfield also said that FDA has been supportive of efforts to boost testing, POLITICO’s Brianna Ehley reports.

The Association of Public Health Laboratories told POLITICO that even if all public health labs were able to test for the virus using the CDC diagnostic, they would only be able to analyze about 100 tests per day. That raises questions about whether the United States would be able to screen enough suspected cases in a large outbreak.

“We haven’t looked widely enough to believe that it is not here outside the known cases,” said Marc Lipsitch, an epidemiology professor at the Harvard T.H. Chan School of Public Health. “China tested 320,000 people in Guangdong over a three-week period. This is the scale we need to be thinking on,” he added.

CDC EXPANDS TESTING CRITERIA — Redfield told lawmakers Thursday that doctors nationwide will now be allowed to screen anyone they suspect is infected with coronavirus.

Earlier CDC criteria limited testing to people experiencing symptoms who had traveled from affected countries or had been in contact with someone known to have the virus.

MORE CAPACITY ON THE WAY? — HHS Secretary Alex Azar told lawmakers Thursday at least 40 labs should now be able to test for coronavirus after FDA authorized a modified version of CDC’s diagnostic.

But APHL senior director of public policy Peter Kyriacopoulos said it will likely take days for those labs to get testing up and running.

“They are now working through the process of making certain that the science works in each of their operations, which is exactly what you want to do,” Kyriacopoulos said.

FDA appears open to allowing labs to use a shared laboratory developed test under a standard protocol, according to a letter Commissioner Stephen Hahn sent to APHL.

The public health labs still must submit the test to FDA for review, according to the agency — which says the law requires it to evaluate such tests in emergency situations.

“FDA has developed a template to streamline the process to facilitate the protocol that you propose while ensuring FDA’s appropriate oversight,” Hahn wrote in the letter.

Diagnostic maker Qiagen confirmed to POLITICO that it plans to ask FDA to grant an emergency use authorization for its coronavirus diagnostic by Monday at the latest.

AZAR: WE CAN’T CONTROL A CORONAVIRUS VAX’S COST, BUT WE’ll TRY — HHS Secretary Alex Azar said in a congressional hearing this week that the government can’t promise an affordable coronavirus vaccine when one eventually launches (which NIAID’s Anthony Fauci says is still at least a year away).

“We would want to ensure that we work to make it affordable, but we can’t control that price because we need the private sector to invest,” Azar told the House Energy and Commerce committee Wednesday. The secretary softened his approach in a Ways and Means hearing the next day, telling lawmakers that the administration would “work to ensure that there are appropriate protections” to make federally funded vaccines — like the Moderna product with NIH, or the BARDA-funded Johnson & Johnson candidate — affordable.

Drug pricing advocates and Democrats remain unimpressed. Any potential coronavirus vaccine "should be available to everyone, not dependent on 'Big Pharma,’” Speaker Nancy Pelosi said in a press conference Thursday.

The U.S. government is driving coronavirus vaccine research, Public Citizen president Robert Weissman pointed out in a statement that called for the government to commit to nonexclusive licensing of whatever vaccine is developed.

It’s “not just a matter of justice and avoiding profiteering, it’s a matter of public health urgency,” said Weissman. “If the vaccine is not made affordable around the world, then it won’t work to stop what could turn into a global pandemic.”

INDUSTRY: WE’RE DONATING COMPOUNDS, SUPPLIES IN CORONAVIRUS FIGHT — Drugmakers have donated compounds with the potential to treat coronavirus for emergency use and research, along with much-needed medical supplies, drug industry lobby PhRMA said this week. Several companies are also at work on vaccines or treatments, including Moderna, J&J and Gilead.

PhRMA also said that its members are working hard to prevent or mitigate potential drug shortages, and have partnered with both U.S. and Chinese health agencies to focus on research that could speed up development of coronavirus therapies.

In Congress

SENATORS WARN OPTUM TO COMPLY WITH INSULIN PROBE — Pharmacy benefit manager Optum is trying to wave off the Senate Finance Committee’s investigation into high insulin prices by providing only information that’s already public, Chairman Chuck Grassley and ranking member Ron Wyden wrote to the company this week.

“Optum’s unwillingness to provide the documents we requested fits an industry-wide pattern of fighting efforts to shed light on PBMs’ practices,” the senators said.

"We have provided thousands of pages of documents in response to the Committee’s request, and will continue to work with them on this important issue," a spokesperson said.

Eye on FDA

FDA GETS AN EARFUL ON AI REGULATION — How should FDA regulate AI in radiology? Very carefully, if you believe experts and industry representatives who spoke at a workshop on Tuesday. The performance of AI can depend tremendously on context — say, whether a polyp is flat or raised, said Ronald Summers, a senior radiology scientist at NIH. The results may be unexplainable, and AI systems can be brittle — lacking consistency across datasets or different types of imaging hardware.

One big conundrum stems from how health systems deploy AI to read images. They can set error thresholds lower — and run the risk of false negatives — or high, producing more false positives that human radiologists will have to carefully examine, which sort of undercuts the whole purpose.

There will be pressure to set them high, said Keith Dreyer, chief data scientist at Partners Health. “It’s not unreasonable to expect superhuman performance from AI,” he added, because “each false negative could represent a loss of life.”

Despite the poor job that some radiologists do at reading mammograms, for example, “we may be more comfortable with human error than we would be with computer error,” said Constance Lehman, chief of breast imaging at Massachusetts General Hospital.

There were optimists in the crowd as well. Software will produce bad results sometimes, but clinicians can catch them, said Bibb Allen, chief medical officer of the American College of Radiology’s Data Science Institute. Judgement, after all, is the humans’ job. “AI is kind of like my dog,” he added. “It’s pretty non-judgmental.”

In the Courts

STATES PUSH BACK ON POSSIBLE LAWYER FEES IN OPIOID SUIT — Thirty-seven state attorneys general warned this week that a push for more money by lawyers leading mass litigation against drug firms for their alleged roles in the opioid epidemic may be thwarting hope of a global settlement. The Monday letter is the latest sign of tensions as a broad swath of states press for a global settlement with the nation’s three main drug distributors and Johnson & Johnson.

The letter rejected a proposal from municipalities’ lead attorneys, who last month asked the presiding judge to impose a 7 percent fee for their work. The AGs argue states might have to pay into this fund, spending money on attorney fees they could otherwise use to fight the epidemic.

Judge Dan Polster is overseeing thousands of lawsuits that have been consolidated in his Ohio district court.

The lead attorneys say AGs’ concerns are based on a misunderstanding of how the fund would work and hope to talk with the states about their concerns.

Elsewhere: the nation’s largest generics opioids maker, Mallinckrodt Pharmaceuticals, announced a $1.6 billion settlement deal, agreed upon by all the disparate parties.

Drug Pricing

ICER REVISES MIGRAINE REPORT, BUT ADVOCACY GROUPS STILL NOT SATISFIED — The Institute for Clinical and Economic Review revised its previous assessment of two new migraine drugs, determining that they meet its long-term cost-effectiveness thresholds — after previously ruling the cost of the medicines was too high. The final evidence report concluded that Allergan’s Ubrelvy, which costs $4,896 a year, and Biohaven’s rimegepant meet the cost-effectiveness threshold.

Biohaven’s drug is still under review by FDA and doesn’t have a list price. Because rimegepant is the same type of treatment as Ubreelvy, ICER assumed its price will be comparable. The report also found that Eli Lilly’s Lasmiditan, which costs $4,610 a year, is not cost-effective.

The revised analysis of Allergan and Biohaven’s drugs came after ICER “work[ed] closely with Allergan to identify high-quality evidence demonstrating additional clinical benefits for ubrogepant beyond the two-hour time point required by the FDA for the clinical trials.” The trials submitted for approval compared the drugs to placebo two hours after patients took the medicine.

Use older meds first: Despite the revised cost-effectiveness assessments ICER says it would be “reasonable” for insurers to require prior authorization for these drugs, since they did not demonstrate superiority to older, less-expensive medicines. ICER encouraged the companies to conduct long-term trials that directly compare the migraine treatments as the clinical trials of the new drugs compared the medicines to placebo.

ICER has experienced a lot of pushback from the drug industry and patient groups who argue the assessments don’t fully consider the various benefits of a drug. The new ICER assessment drew mixed reviews from two migraine focused groups — the Coalition for Headache and Migraine Patients and Headache & Migraine Policy Forum. “We continue to have concerns that the ICER approach under-counts the real economic costs of migraine disease and under-values the benefits of these new medicines,” they said. They are pushing ICER to analyze the drugs again using a framework the group is switching to that will place greater weight on societal benefits of a drug.

MEDICAL DEVICES

FDA WANTS WARNING FOR GYNECOLOGIC SURGERY TOOL — Labeling materials for laparoscopic power morcellators should contain a boxed warning that the devices can spread cancer during fibroid surgery and decrease patients’ long-term survival, FDA said in a draft guidance Wednesday.

The agency also updated its 2014 safety communication this week, adding a recommendation to only use the devices with a tissue containment system.

NEW ELECTRONIC 510(k) TEMPLATE — CDRH Director Jeff Shuren announced Wednesday that device manufacturers will soon be able to apply to a participate in a pilot of an electronic submission template for the most common type of medical device application. Nine companies will be selected for the pilot.

“This highly-interactive submission template is intended to allow manufacturers to provide information to the FDA that’s complementary to CDRH internal review templates currently used to review 510(k)s, allowing us to receive information and evaluate the submission more efficiently and consistently,” Shuren said in a statement.

Quick Hits

GOODRX SHARED CUSTOMER DATA WITH SOCIAL MEDIA GIANTS — There is a potentially big trade-off to using the GoodRx app to shop drug prices — the company is sharing customer data with Facebook, Google and others, writes Consumer Reports’ Thomas Germain. The price comparator has sent personal details about consumers’ prescription searches to more than 20 internet-based companies, Germain reports. GoodRx said after the article was published that it planned to stop sharing personal medical details with companies and had appointed a new head of data privacy.

Pharma Moves

Pfizer’s Upjohn Division CFO Sanjeev Narula will be CFO of its new joint venture with Mylan, Viatris. Pfizer and Mylan also announced Viatris’ board of directors.

Christine Shreeve is retiring as Director of Communications for FDA’s Center for Drug Evaluation and Research. Shreeve joined CDER five years ago.

A message from the Partnership for America's Health Care Future: According to a recent study, the public option could add $700 billion to the federal deficit in the first ten years alone and become the third largest government program behind Medicare and Social Security. With voters most concerned about costs when it comes to health care, we can’t afford a new government-controlled health insurance system. Let’s build on what’s working where private coverage, Medicare, and Medicaid work together, not start over. Get the facts.

Document Drawer

Sens. Bill Cassidy, Dick Durbin, Joni Ernst, Sheldon Whitehouse, Jeanne Shaheen and Todd Young introduced a bipartisan bill to extend Medicare Part B coverage of immunosuppressant drugs for kidney transplant patients past the current 36-month statutory limit.

Sen. Josh Hawley (R-Mo.) introduced legislation aimed at securing the medical product supply chain after reports of potential shortages due to the coronavirus outbreak in China.

The U.S. Chamber of Commerce wrote a letter endorsing S. 3129 (116), the “Lower Costs, More Cures Act of 2019,” saying it would reduce prices without imposing inflation fines like S. 2543 (116).

Follow us on Twitter Sarah Owermohle @owermohle