Postal service pressure turns to prescriptions

With help from Zachary Brennan and Lauraine Genota

On Tap

— Postal service pressure turns to prescriptions as concerns mount over mail-order drugs.

— McKesson takes private vax distro lead amid questions about the rollout plan.

— Does pharma fear Kamala? Wall Street says they might.

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Budget

POSTAL SERVICE PRESSURE TURNS TO PRESCRIPTIONS — Doctors and policy experts are increasingly concerned that the turmoil over the U.S. Postal Service’s fate could delay prescription drug deliveries.

How much? About 4.9 percent of prescriptions dispensed in 2019 came through the mail, according to Drug Channel Institute CEO Adam Fein. But that doesn’t factor in the pandemic.

“We know that mail order use has gone up dramatically with COVID-19, too, as people are hoping to avoid going into pharmacies to fill medications,” said Stacie Dusetzina, a Vanderbilt University health policy professor. Mail-order prescriptions shot up 21 percent this March compared to the same period last year, according to one study.

Veterans also massively rely on mail-order prescriptions. Roughly 80 percent of medicines doled out through Veterans Affairs are fulfilled by mail, according to a letter that House lawmakers sent to the VA and postmaster general demanding answers on USPS delays. They said that in fiscal year 2019 alone, VA’s mail-order pharmacy system processed 125.2 million outpatient prescriptions.

Which meds? Roughly 45 percent of mailed prescriptions in 2019 were specialty pharmaceuticals — costly or complex medicines like injectables — where pharmacies didn’t use USPS, wrote Fein.

Mail-order is typically used for chronic care medications, like regular prescriptions for heart disease and diabetes, Dusetzina said.

“Mail-order prescriptions can be particularly important in rural areas where the local pharmacy may be a long distance away,” the American College of Physicians wrote in a statement warning that millions depend on the deliveries.

What’s not clear: How much the major pharmacies rely on USPS for mail-order prescriptions versus other carriers. They don’t want to say, either.

“We use all national delivery carriers to ensure we’re getting packages to patients in the most efficient manner, and we are not currently experiencing any unusual delays in deliveries,” said an Express Scripts spokesperson.

Amazon’s PillPack said they use several services, including USPS, and “adjust the carriers we use to ship medications based on available information.”

From CVS: “We’re closely monitoring the current situation. As a member of The Package Coalition, we’ve joined businesses of all sizes in advocating for emergency relief funding for the Postal Service.”

What’s next: The House will vote Saturday on a $25 billion proposal to rescue the Postal Service, but it’s unclear whether the GOP-controlled Senate will take up the measure.

In the meantime, both House and Senate lawmakers overseeing veterans’ affairs have written to USPS and Veterans Affairs Secretary Robert Wilkie questioning postal delays that impact vets’ prescriptions.

Democratic leaders of the House Energy and Commerce Committee announced Monday that they would investigate the postal service changes’ pressure on prescription drug deliveries.

President Donald Trump has criticized the post office, accusing it of inefficiency, but on Monday tweeted “SAVE THE POST OFFICE.”

Coming Up in Pharma

TODAY to THURSDAY: The National Academies of Sciences, Engineering, and Medicine holds a three-day virtual workshop on tackling vaccine access and hesitancy issues.

TODAY: Healthline hosts a virtual town hall with NIAID Director Anthony Fauci.

Coronavirus

MCKESSON TO LEAD VAX DISTRIBUTION — HHS announced Friday that the major distributor would partner with CDC to dole out Covid-19 vaccines nationwide, a massive undertaking that also includes Pentagon support.

McKesson is “a natural choice” for the job because of prior experiences and partnerships, wrote Morgan Stanley analyst Ricky Goldwasser in a note. McKesson was the sole distributor for swine flu vaccines in 2009 and 2010, plus it works with cold-chain logistic provider Cryoport (cold storage being essential for many vaccines).

McKesson’s clients also include Walmart and CVS, which could be major administration sites if commercial pharmacies are part of distribution, which they expect to be. Some states have already introduced bills to let commercial pharmacists administer the shots, while the National Association of Chain Drug Stores has urged governors to put those plans in place.

All eyes are still on the rollout plan. Questions remain about how involved the military will be in logistics and distribution. Former FDA Commissioner Scott Gottlieb expressed doubts about total government control of eventual vaccines. “What they should be doing is directing the existing supply chain,” he said on CBS’s “Face the Nation” program Sunday. “I wouldn’t try to recreate the wheel here.”

Eye on FDA

EMILY MILLER STARTS AS TOP FDA COMMS OFFICIAL — Miller is now Assistant Commissioner for Media Affairs, where she’ll be “leading the Office of Media Affairs cadre in communicating the FDA’s important public health developments and actions,” HHS Assistant Secretary Michael Caputo wrote in a memo first shared with PULSE.

— It’s the latest strategy and comms hire at FDA, where John “Wolf” Wagner started in June as FDA’s top external affairs official. The agency has been peppered by press questions and under scrutiny from watchdogs and Democrats during the pandemic.

Miller also is joining FDA as a political appointee, a departure for a role that’s often been filled by career appointees.

FDA AUTHORIZES SALIVA-BASED COVID TEST — A saliva-based coronavirus test developed by researchers at Yale is now authorized for emergency use, the FDA announced on Saturday. The non-invasive test may prove cheaper and more efficient than current tests that require swabs and other testing components that have been prone to shortages, federal officials have said.

The Yale team developed and validated the test in partnership with the NBA and National Basketball Players Association. The league has used it on NBA players and staff over the last couple months.

THE FIRST-EVER FDA DEVICE SHORTAGE LIST — Surgical gowns, gloves, masks, certain ventilators and various testing supplies needed to respond to the coronavirus pandemic are on the FDA’s first-everlist of medical devices in shortage, David Lim reported.

The agency is not disclosing who makes any of the devices on the list, which it released late Friday, because that “will adversely affect the public health by increasing the potential for hoarding or other disruptions.” Instead, the agency has released the product codes of devices in shortage.

… The shortage list was released hours after Trump touted the progress his administration has made in securing critical protective gear and other supplies.

In Congress

HOUSE DEMS LAUNCH VAX OUTREACH BILL — Efforts to boost public confidence in vaccines have to begin soon if people are expected to take a coronavirus shot when one is available or get up to speed on pediatric vaccine rates that have dipped during the pandemic, Democratic Reps. Lauren Underwood of Illinois and Kim Schrier of Washington state said Monday.

The pair introduced a bill that would provide $560 million to state and local health departments for efforts such as flu shot campaigns and outreach to promote no-cost programs for children to get basic shots. They hope to attach the measure to the next coronavirus relief package.

“The anti-vaxxer movement is growing. … They are already sowing doubt about Covid vaccines worldwide,” said Schrier, a pediatrician.

The lawmakers cited concerns about low uptake of a prospective coronavirus vaccine in communities of color and other vulnerable populations. And they said funding toward broad vaccine efforts could also reduce the risk of other outbreaks or a worse flu season.

“Frankly the last thing we need right ow are outbreaks of measles, chicken pox or pertussis,” Schrier told reporters.

Research Corner

CHANGES TO PILL SHAPE CAN LEAD TO NONADHERENCE, STUDY FINDS — Most patients say they’re not notified when their pills change in appearance between refills, and pharmacists report that these changes happen frequently, according to a study conducted by Harvard Medical School researchers and the FDA.

Of 1,000 patients who reported a pill change, 12 percent said they either stopped taking their medication or used it less frequently because of the switch. “Our findings reveal opportunities to improve patients’ experiences with pill appearance changes through better notification practices and patient education,” the researchers said.

MORE QUESTIONS AROUND HCQ — To smoke out a predatory journal, two Swiss grad students made up a study purporting to show that hydroxychloroquine was deadlier than scooters, Zachary Brennan writes.

The Asian Journal of Medicine and Health took the bait, publishing the research — attributed to fake authors at imaginary institutions such as “The Institute for Quick and Dirty Science” — before retracting it Saturday, Retraction Watch reports. The journal in question had previously published a controversial study co-authored by a member of France’s parliament that found hydroxychloroquine benefited Covid-19 patients.

Industry Intel

PHARMA MAY FEAR KAMALA, ANALYSTS SAY — Biopharma companies are quietly worrying that Democratic president nominee Joe Biden and his VP pick Kamala Harris might be willing to work with Republicans to lower drug prices, writes Zachary.

The risk for biopharma is a dealmaker who will compromise with Republicans on an effective bill, Bernstein biotech analyst Ronny Gal said in an investor note Monday. “Biden is a compromiser (not sure he is ‘effective’) and Harris seems to be in the same vein,” he wrote.

RBC Capital Markets analyst Brian Abrahams also said in an investor note that although Harris didn’t make drug pricing a key issue in her presidential campaign, “she took a strong stance in support of Medicare For All and for arguably aggressive drug pricing initiatives.” That could pull Biden to the left, Abrahams wrote.

Around the Agencies

THINK TANK LAUNCHES COVID MONEY TRACKER — The bipartisan nonprofit Committee for a Responsible Federal Budget on Monday unveiled a money-tracking tool to trace allocations from the White House, Congress and Federal Reserve towards Covid-19 efforts from paycheck programs and economic relief to vaccine funding.

So far: Policymakers have committed trillions of dollars, much of it toward paycheck protection, unemployment benefits and other economic relief. There has been roughly $114 billion in health-related spending, the committee said. Lawmakers have authorized $89.6 million in supplemental FDA spending.

Pharma Worldwide

MODERNA SETS UP SHOP IN EUROPE — The U.S.-based biotech has enlisted Swiss chemical company Lonza to make Moderna’s experimental Covid-19 vaccine, while Spanish manufacturer Rovi will package the doses in vials and labels.

While a U.S. contract priced the shot at roughly $25 per dose, the price has not yet been determined in Europe. Ray Jordan, the company’s chief corporate affairs officer, told POLITICO Europe’s Jillian Deutsch that countries with bigger orders will get lower prices.

By the end of 2021, Moderna expects to produce 500 million doses of the vaccine in Europe, and up to 1 billion doses in total, Nicolas Chornet, the company’s new senior vice president of international manufacturing in Europe, told Jillian.

Quick Hits

Trump is eyeing an oleander plant extract as a dietary supplement or as a drug to cure Covid-19, despite lack of proof that it works, Axios’ Jonathan Swan reports.

The U.S. is tying payments for Covid-19 vaccines to timing milestones for production and approval, putting pressure on drugmakers to meet targets, Reuters’ Carl O’Donnell reports.

Sanofi has agreed to buy multiple sclerosis treatment developer Principia Biopharma Inc. for $3.68 billion, The Wall Street Journal’s Peter Stiff and Joseph Walker report.

Document Drawer

The CDC announced the Advisory Committee on Immunization Practices will meet on Sept. 22 starting at 10 a.m.

The National Foundation for Infectious Diseases is joining more than 85 public health organizations and national experts to launch the Keep Up The Rates campaign, which encourages people of all ages to keep up with their routine vaccinations.

The FDA alerted clinical laboratory staff and health care providers about the risk of false results from Thermo Fisher Scientific TaqPath COVID-19 Combo Kit.

The FDA published a notice of a stay of action regarding the final regulation banning electrical stimulation devices for self-injurious or aggressive behavior.