CDC approves mix-and-match Covid-19 boosters

By Lauren Gardner and David Lim

Presented by the Pharmaceutical Care Management Association (PCMA)

With help from Megan R. Wilson, Katherine Ellen Foley and Ben Leonard.

— The CDC green-lighted Covid-19 booster shots for certain groups, allowing those eligible their choice of brand.

— Democrats’ drug pricing blueprint spurred a K Street spending bonanza in the third quarter.

— FDA expands its partnership with Aetion to develop and assess Covid-19 treatments.

It’s Friday. Welcome back to Prescription Pulse. Here’s hoping today is a bones day.

Send tips to David Lim (dlim@politico.com or @davidalim), Lauren Gardner (lgardner@politico.com or @Gardner_LM) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).

A message from the Pharmaceutical Care Management Association (PCMA):

Congress is considering repealing the Medicare prescription drug rebate rule. If not repealed, the rule will increase Medicare Part D premiums 25% and cost taxpayers $170 billion. The federal government should repeal this rule and instead focus on policies that would reduce prescription drug costs.

BOOSTER SEASON ARRIVES — Fall has arrived in Washington and so has booster season. The CDC endorsed Covid-19 boosters on Thursday, opening the door to millions of Americans to get additional doses as soon as today.

Under the recommendations of CDC's independent advisers — endorsed late Thursday by Director Rochelle Walensky — those who originally received the Moderna vaccine could get boosters if they fall into the same age or risk profiles as Pfizer recipients currently eligible. But all Johnson & Johnson recipients would be permitted to seek out boosters once they’re at least two months out from their initial immunization.

The advisory committee worded its recommendation votes to ensure they weren’t endorsing one boosting approach over another — as in, boosting with the same manufacturer’s product versus mixing brands. Some members were concerned with the prospect of people, particularly women in their 30s, getting two doses of the J&J shot given the link between that vaccine and an elevated risk of a blood-clotting condition in that age group.

NOVAVAX’S WOES DRAG ON GLOBAL VAX CAMPAIGN — The U.S. vaccine maker is grappling with manufacturing issues that threaten its plans to share more than 1 billion doses worldwide, POLITICO’s Sarah Owermohle, Adam Cancryn and Erin Banco scooped this week. Novavax has yet to prove to regulators that it can consistently produce vaccines that meet FDA’s purity standards. The company insisted that its vaccine will be ready for use this year in some countries, and that it plans to file for emergency use authorization in the U.S. by the end of 2021.

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LOBBYING BOOM OVER DRUG PRICING — Democrats’ drug pricing proposal has been a boon for K Street's pharma lobbyists as health care sector interests look to head off potentially billions in lost profits.

The top 10 lobbying spenders in the pharmaceutical sector shelled out $29.25 million on advocacy during the third quarter of this year, which runs from July through September — 22 percent more than the same period in 2020.

Roughly 40 percent of health care entities that spent at least $500,000 this past quarter were pharmaceutical companies or industry groups, according to an analysis of lobbying disclosures from POLITICO's Megan Wilson.

Forms detailing lobbying activities for the third quarter were due at midnight Thursday.

Here are the top 10 pharmaceutical industry lobbying spenders during the third quarter of 2021:

— Pharmaceutical Research and Manufacturers of America spent $7.44 million (vs. $5.96 million in Q3 2020).

— Horizon Therapeutics spent $3.49 million (vs. $1.56 million in Q3 2020).

— Biotechnology Innovation Organization spent $3.36 million (vs. $3.17 million in Q3 2020).

— Genentech spent $2.67 million (vs. $2.75 million in Q3 2020).

— Amgen spent $2.62 million (vs. $2.92 million in Q3 2020).

Other notable pharmaceutical company lobbying increases of the quarter include:

— Merck & Co., which spent $1.7 million (vs. $980,000 in Q3 2020).

— Boehringer Ingelheim, which spent $1.06 million (vs. $610,000 in Q3 2020).

— AstraZeneca, which spent $1.02 million (vs. $450,000 in Q3 2020).

DURBIN PRESSES HHS, FDA TO BOOST ACCESS TO AT-HOME RAPID TESTS — Senate Majority Whip Dick Durbin (D-Ill.) is the latest member of Congress to urge the Biden administration to increase the nation’s supply of rapid at-home Covid-19 tests. The senior lawmaker described the country’s testing infrastructure as “an important and under-developed aspect” of the pandemic response.

“In order to maximize the public health benefit and utility of this rapid testing capacity, FDA and HHS should explore appropriate flexibilities in its regulatory standards to better enable additional accurate, at-home rapid tests to come to market and be accessible in an over-the-counter (OTC) manner for the general public,” Durbin wrote in a Thursday letter to HHS Secretary Xavier Becerra and acting FDA Commissioner Janet Woodcock.

LEE, POCAN URGE U.S. TO BACK OFF KRATOM — Two strange congressional bedfellows are asking the Biden administration to oppose any attempt to ban the sale of kratom, a possible opioid alternative, internationally.

In a letter obtained by POLITICO, Sen. Mike Lee (R-Utah) and Rep. Mark Pocan (D-Wis.) said U.S. support for such a decision, which could come as soon as December, “ties the United States to the whims of the majority of international actors, and diminishes the need for public health experts to thoroughly evaluate substances that lead to domestic decisions based on evidence and data.”

A message from the Pharmaceutical Care Management Association (PCMA):

BIOGEN’S BLOCKBUSTER ALZHEIMER’S DRUG GENERATES A PALTRY $300K — Aduhelm, the contentious Alzheimer’s drug that earned FDA approval in June, brought in $300,000 in revenue in the third quarter, Biogen company executives reported in an earnings call on Wednesday.

The drug is the first of its kind to clear the deformed amyloid proteins thought to cause Alzheimer’s disease. But despite now being available at 120 health care settings across the U.S., “the lack of clarity on reimbursement has delayed patient access to the first treatment to address an underlying pathology of Alzheimer's disease,” Michel Vounatsos, Biogen’s CEO, said. The Centers for Medicare and Medicaid Services will make a decision on whether it will cover the pricey treatment in July 2022. Some private insurers and hospitals have said they won’t cover Aduhelm at all, while others have said they will follow CMS’s lead with coverage.

Building trust in the data: Biogen stated that it would be publishing the results of its late-stage clinical trials in a peer-reviewed journal imminently. It also said it had submitted early plans for its required Phase IV randomized, controlled study to FDA, which it aims to complete earlier than anticipated, and is awaiting feedback.

PHLOW INDUCTED INTO BARDA MANUFACTURING NETWORK — Phlow, a Richmond, Virginia-based drug manufacturing company, has been included in the Biomedical Advanced Research and Development Authority contract development and manufacturing organization network, the company announced Wednesday. Phlow specializes in continuous manufacturing, and in 2020 received its first partnership with BARDA to help develop the national supply of essential medicines.

FDA GRANTS MARKETING ORDERS TO TOBACCO PRODUCTS THAT NO LONGER EXIST — The Food and Drug Administration gave marketing orders for four smokeless tobacco gums and chews on Tuesday after determining that they are appropriate for the protection of public health, Katherine reports.

But there's a catch: The company that made the products hasn't sold them since early 2019.

FDA’s decision is the second marking order it’s issued; the first went to an e-cigarette and tobacco-flavored vapes from Vuse, which is owned by R.J. Reynolds. The marketing orders approved this week cover four kinds of mint-flavored gums and chews made by Verve, a brand name owned by Altria — which is also the parent company of Philip Morris USA and owns 35 percent of the e-cigarette company Juul.

FDA requires Altria to regularly report its marketing plans, sales data and information on Verve's customer base as part of its marketing orders. Because the company discontinued these gums and chews, these requirements will be a light lift.

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FDA EXPANDS PARTNERSHIP ON COVID TREATMENTS — The agency is strengthening its partnership with Aetion, a health tech company that employs real-world evidence analysis, to look into potential inpatient Covid-19 interventions, the company said Thursday.

The move builds on a relationship dating back to May 2020, when the agency agreed to work with Aetion to tackle pressing Covid-19 issues using data, POLITICO’s Ben Leonard reports.

“In terms of what we’ve learned so far, it’s mostly about how to do smart research in a very unusual circumstance,” Aetion CEO Carolyn Magill said in an interview. “We had to be looking at data from the previous two weeks.”

The new expanded partnership will lay the groundwork for “rapid development and evaluation of Covid-19 therapies,” the company said, and aid in future pandemic preparedness. Former FDA head Scott Gottlieb is a board director with Aetion.

The real word: Real-world data — which can be pulled from EHRs and other sources — can supplement clinical trial data, as research shows that clinical trials can leave some groups underrepresented. The 21st Century Cures Act mandated that the agency look into ways to use more real-world evidence in evaluating therapies.

An Aetion analysis found that 78 percent of FDA-approved new drug and biologics license applications in 2020 used real-world evidence, up from 53 percent in 2019.

New guidance: The FDA also issued new draft guidance for industry for drug and biological product submissions with real-world data Thursday. The guidance calls for “adequate processes” to ensure confidence in data during curation and transformation, among other things.

FDA PROPOSES FRAMEWORK FOR OVER-THE-COUNTER HEARING AIDS — The FDA on Tuesday proposed establishing an over-the-counter hearing aid market in the U.S. for adults, an action that may eventually give millions of people with hearing loss an opportunity to obtain a lower-cost device without requiring that they see an audiologist.

FDA medical device chief Jeff Shuren told reporters the regulation took so long to issue — more than four years — because the agency wanted to get feedback on what the “appropriate performance criteria” for OTC hearing aids should be.

Draft guidance bonus: FDA also updated its draft guidance laying out recommendations for developers of personal sound amplification products — products the agency says “are not considered OTC alternatives for hearing aids.”

Julie Morita, executive vice president of the Robert Wood Johnson Foundation, is joining CDC’s Advisory Committee to the Director. See the rest of the new committee members here.

Andrew Burnett is joining the American Clinical Laboratory Association as director of government affairs. He previously worked for Sen. Richard Shelby (R-Ala.) as a health policy adviser.

FDA manufacturing bill passes House — A bipartisan bill, HR 4369, passed Tuesday in the House of Representatives would support efforts by the FDA to invest in advanced manufacturing methods, including “continuous manufacturing” — a technique where a finished drug product is produced as part of a contained, continuous, end-to-end process, as opposed to “batch” manufacturing where the process is stopped between steps. Continuous manufacturing is designed to be more efficient and higher-quality, and could help avoid drug shortages.

The bill would allow the FDA to designate up to five academic institutions as National Centers of Excellence in Advanced and Continuous Manufacturing, and authorizes $100 million for the program for the next five years. The legislation now heads to the Senate.

FDA approves interchangeable Humira, but access delayed until 2023 — This week the FDA approved the first interchangeable biosimilar monoclonal antibody, Cyltezo, a biosimilar to AbbVie’s Humira (adalimumab) to treat certain inflammatory diseases. In theory, the approval is a significant benefit to patients, but it has some notable short-term caveats. Because of a patent settlement agreement, Cyltezo won’t be marketed until July 1, 2023. Because of existing marketing exclusivity, not all of the drug’s indications will be included on Cyltezo’s label, reducing access for some patients. And the drug’s sponsor, Boehringer Ingelheim, is still awaiting a response from the FDA about how the regulator defines the “strength” of a biosimilar product, which could have major implications for the availability of other biosimilar and interchangeable products in the future. AgencyIQ has a full analysis of the approval and related regulatory issues here.

An increasing number of states are taking steps to bolster privacy laws around at-home DNA tests, Emily Mullin writes for Wired.

STAT’s Erin Brodwin digs into Amazon Pharmacy a year after it formally launched.

FDA announced Wednesday it is extending the deadline to register to publicly comment at its Nov. 2 virtual meeting on the BsUFA reauthorization process. The new deadline is Oct. 26 for a verbal request to speak at the meeting. The deadline for written comments is Dec. 2.

A message from the Pharmaceutical Care Management Association (PCMA):

Congress has shown bipartisan support to delay the Medicare prescription drug rebate rule and avoid increasing Medicare premiums by 25%. Now Congress should permanently repeal this rule to avoid disrupting Medicare beneficiaries’ affordable Part D prescription drug coverage and to save taxpayers $170 billion.

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