NIH enlisted to help FDA assess at-home Covid tests in effort to boost supply

From: POLITICO's Prescription Pulse - Tuesday Oct 26,2021 04:02 pm

Oct 26, 2021

Presented by the Biosimilars Forum Foundation

With help from Alice Miranda Ollstein.

On Tap

— The Biden admin is funding an NIH program to help assess at-home Covid-19 tests in an effort to get more of the rapid tests on the market and push down their cost.

— FDA advisers will take initial steps this week to make pediatric Covid vaccines a reality.

— Progressive Democrats say their efforts to include government negotiation of drug prices in the party’s social spending bill are getting squeezed.

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A message from the Biosimilars Forum Foundation:

Americans agree that healthcare costs are out of control, and biosimilars are a commonsense, bipartisan solution to the rising costs of prescription drugs. Biosimilars are just as safe and effective as brand name biologics, and they increase competition, lower prices and provide patients with greater access to effective treatment options. Congress and the Biden administration should lower healthcare costs now by increasing the use of biosimilars, which can save Americans $133 billion by 2025.

Coronavirus

FDA TEAMS WITH NIH TO ASSESS AT-HOME TESTS — The National Institutes of Health is working with FDA to evaluate new at-home Covid-19 tests as part of a broader effort to get more rapid diagnostics onto the market.

The $70 million Independent Test Assessment Program, housed within NIH’s Rapid Acceleration of Diagnostics initiative, will be tasked with helping FDA assess Covid-19 tests that can be manufactured in large numbers, HHS said Monday.

“RADx was really designed to make those decisions for investment purposes — and we’ve shared those analyses with FDA — but not for regulatory, just to give color and flavor and help them understand our decisions,” Bruce Tromberg, the NIH scientist leading the RADx initiative, told POLITICO. The new effort is already conducting deep dives on “at least one company” this week, he added.

FDA also announced it is easing some regulatory requirements. Manufacturers with at-home tests on the market currently authorized as serial tests — where a patient takes two tests over a period of time to test for Covid-19 — can now ask FDA to market the product as a single-use test for symptomatic people without submitting extra data.

FDA also suggested that test-makers seeking authorization for a home test similar to one already on the market can more easily qualify for permission to market their tests. For example, the agency appears open to approving some tests without requiring proof they work well in children as well as adults.

A new at-home test hits the market. FDA granted emergency authorization to an at-home test made by Celltrion Thursday. The over-the-counter test, called DiaTrust, can be used serially by asymptomatic adults and a single time by adults with symptoms.

FDA ADVISERS DELIBERATE PFIZER’S PEDIATRIC COVID VACCINE — The day parents have been waiting for has arrived: FDA’s vaccine advisory committee kicks off its meeting today on whether to recommend the Pfizer-BioNTech Covid vaccine for kids ages 5 to 11. Should the panel give the thumbs-up, expect FDA to act later this week. The CDC’s own vaccine advisers are scheduled to meet Nov. 2 and 3 to finalize clinical recommendations for Director Rochelle Walensky’s approval. That means the 28 million children in that age group could be getting their initial shots by the first full week of November.

But it doesn’t mean today’s meeting will be smooth sailing for Pfizer and BioNTech. Committee members are likely to put the companies through their paces on the vaccine’s safety in the youngest people being considered to date for immunization. While no one in the clinical trials developed myocarditis, an inflammatory heart condition linked to the messenger RNA vaccines, Pfizer acknowledged the trial size — doubled at FDA’s behest — was not large enough to detect the rare side effect.

FDA added to the intrigue around pediatric vaccines by posting its staff analysis of Pfizer’s data late Friday night. That didn’t deter your co-host from flipping through the pages and finding the agency suggested the benefits of inoculation outweigh the risks to kids. But FDA also indicated if case numbers dropped to levels seen in June, the argument for vaccination could be harder to make if myocarditis becomes a safety concern in that age group.

States are champing at the bit: We’re sure to hear more in the coming days about states’ plans to immunize kids 5 to 11, but here’s one to highlight. Illinois announced Monday it already has more than 2,200 locations and vaccine providers across the state registered to vaccinate children. Its initial allocation is expected to include about 500,000 doses.

BIDEN ADMIN TO EASE INTERNATIONAL TRAVEL RESTRICTIONS — The White House announced Monday the U.S. will ease air travel restrictions on fully vaccinated foreign nationals starting Nov. 8, POLITICO’s Tanya Snyder reports. Most people will be required to show both proof of full vaccination and a negative Covid-19 test taken in the three days before the flight. Read more details on the new policy here.

STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.

In Congress

LAWMAKERS, ADVOCATES SOUND ALARM ON DRUG PRICING COMPROMISES — Democrats racing to reach an agreement on their broader social spending bill say they’ve had to dramatically water down the drug price negotiation piece that was originally the lynchpin of the package, POLITICO’s Alice Miranda Ollstein reports.

Talks between the House, Senate and White House remain fluid, and nothing has yet been finalized. But progressives, in particular, are alarmed at the direction they’ve taken in recent days and now say the final product will likely allow government negotiation over a very limited set of drugs, if any at all.

State of play: Lawmakers are now weighing only negotiating the drug costs after their period of exclusivity has expired, which would exclude many of the costliest drugs and incentivize pharmaceutical companies to extend their patents as long as possible. The costs would be pegged to those paid by VA instead of the international reference pricing scheme of H.R. 3 (117).

“There isn't negotiation where it matters. It will leave us at the mercy of monopoly pricing power,” Rep. Peter Welch (D-Vt.) lamented on a call with reporters Monday. “It just breaks the back of the whole concept.”

Other pieces of the drug pricing plan, including penalties for companies that raise prices faster than inflation and a redesign of categories under Medicare Part D, remain intact, Alice reports. But robust negotiation was the piece of the bill Democrats were counting on to both lower drug costs for tens of millions of consumers and generate hundreds of billions in federal savings the party had planned to funnel into expansions of Medicare and Medicaid — pieces that are now, themselves, on the chopping block.

While acknowledging he has had to amend his original proposal because of the concerns of his more conservative colleagues, Senate Finance Chair Ron Wyden (D-Ore.) disputed Monday night that the final bill would go easy on the drug industry: “I’m going to insist on a real negotiation provision. It’s got to be a real one. It can’t be so limited that the government is not really addressing the problem. I’m not going to accept a fig leaf on negotiation.”

PEW DROPS LDT WHITE PAPER AMID VALID ACT DISCUSSIONS — A new research paper published by The Pew Charitable Trusts’ Liz Richardson argues the laboratory developed test market is not well understood, even among lab professionals. It is also unclear how the performance of the tests compare to FDA-reviewed diagnostics, Richardson adds.

“Because labs are not required to publicly report adverse events associated with LDTs to a central authority, there is no comprehensive data quantifying the number and nature of incidents tied to inaccurate LDTs,” the Pew paper states.

A message from the Biosimilars Forum Foundation:

Eye on FDA

BIDEN CHATS WITH CALIFF ABOUT TOP FDA JOB — Former FDA Commissioner Robert Califf talked with President Joe Biden Friday, two people with knowledge of the discussion told POLITICO. The meeting comes after Califf emerged in recent weeks as the top candidate to permanently run Biden’s FDA.

Biden has not yet finalized his pick. But the two people with knowledge of the matter and a third person familiar with the search process said Biden’s meeting with Califf represents a final step ahead of a formal decision. The White House spent the past several weeks vetting Califf, who led the FDA for a year under President Barack Obama.

Industry Intel

FTC ISSUES PROPOSAL TO LIMIT FUTURE DAVITA MERGERS — The Federal Trade Commission proposed Monday to impose “strict limits on future mergers” by dialysis company DaVita. The proposed order would also require the company to divest three Utah dialysis clinics to Sanderling Renal Services.

“DaVita has a history of attempting to buy up competing dialysis clinics in an industry that is already highly concentrated, in large part due to the acquisition activity of DaVita and other large dialysis clinic chains,” FTC Bureau of Competition Director Holly Vedova said in a statement. “This is a big concern, and it is compounded by the fact that the limited number of nephrologists available to work at the clinics creates an opportunity for anticompetitive restrictions on labor.”

Pharma Moves

Waxman Strategies has hired Gina Drioane as senior director of health policy communications with a focus on health-equity issues. She was previously associate director of federal policy and advocacy communications at Planned Parenthood Federation of America.

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Pharma Worldwide

MODERNA GETS EU BACKING ON BOOSTER DOSE — A 50-microgram booster dose of Moderna’s Covid vaccine “may be considered” for adults six months past their second shot, a European Medicines Agency committee said Monday. National governments can formally recommend boosters on their own, POLITICO Europe’s Carlo Martuscelli notes.

EU REGULATORS BEGIN COVID TREATMENT REVIEW — The EMA has begun a rolling review of Merck and Ridgeback’s oral antiviral Covid drug, the companies announced Monday. They’ve already applied for emergency use authorization in the U.S., with FDA advisers slated to meet on the treatment next month.

Inside AgencyIQ

FDA issues guidance on submission of real-world data — Legislators and pharmaceutical companies pushing for the FDA to permit the broader use of real-world data (RWD) and evidence (RWE) in regulatory submissions received new guidance this week , which may assist in those efforts. RWD refers to data that is collected outside of a clinical trial, such as data from electronic health records, while RWE refers to the analysis of that data. While the FDA has already accepted the use of RWE in dozens of instances, the agency has now issued a guidance on a far more practical topic: The use of data submission standards to ensure regulators can efficiently review the data.

Since 2012, FDA has required the submission of new drug applications electronically using agreed-upon standards, which is meant to make it easier for the FDA to receive, review, store and analyze data. Sponsors using RWE will need to convert their data into one of the recognized FDA data standards – a process called “transformation” or “mapping.” However, FDA noted that its recommendations remain a work in progress due to the complexity of the data being submitted. “FDA plans to issue further guidance and/or to update the [Data Standards] Catalog with standards for study data that are derived from RWD sources,” it wrote in the guidance. Comments on the draft guidance are due Jan. 21.

A message from the Biosimilars Forum Foundation:

Americans agree that healthcare costs are out of control, and biosimilars are a commonsense, bipartisan solution to the rising costs of prescription drugs. Biosimilars are safe, effective, lower-cost medicines that can provide patients relief from a variety of diseases, such as cancer, diabetes and rheumatoid arthritis. Just as generic drugs provide lower-cost options for patients with small-molecule drug prescriptions, biosimilars provide lower-cost options for patients with more expensive biologic drug prescriptions. And, biosimilars have widespread support. This year, the Biden administration signed The Advancing Education on Biosimilars Act and issued an executive order directing HHS to increase support for biosimilars. Congress is also considering the Star Rating for Biosimilars Act, the Increasing Access to Biosimilars Act, and the BIOSIM Act. Congress and the Biden administration should lower healthcare costs now by increasing the use of lower-cost biosimilars, which can save Americans $133 billion by 2025.

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