Vaccine makers push for boosters

With Sarah Owermohle

PROGRAMMING NOTE: Prescription Pulse will not publish from Monday, Aug. 30, through Monday, Sept. 6. We’ll be back on Tuesday, Sept. 7.

— Vaccine makers trot out push for booster shots of their Covid-19 vaccines, ahead of an ACIP meeting Monday.

— The Congressional Budget Office takes another look at the House’s drug pricing bill.

— USTR says it will weigh tariff exclusions for Chinese-made Covid-19 products on a case-by-case basis.

It’s Tuesday. Welcome back to Prescription Pulse. We might not be in your inbox with a newsletter next week, but we’ll still be reporting the news.

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PFIZER AND BIONTECH ASK FDA TO APPROVE THIRD DOSE OF THEIR COVID VACCINE — Just days after the FDA granted full approval to the companies’ two-dose vaccine regimen, they began submitting data for full approval for a third shot. Currently, booster shots for the vaccine are only authorized for people who have had solid organ transplants, or similarly weakened immune systems. The companies plan to finish their application by the end of the week.

Booster bonanza: Johnson & Johnson said Wednesday that clinical trials found a booster shot of its one-dose vaccine increased Covid-19 antibodies ninefold one month after vaccination, compared to the levels seen one month after the first shot, Lauren Morello reports. The company plans to submit those data to the FDA.

And a second vaccine approval on the horizon: Also on Wednesday, Moderna announced it had finished submitting rolling data to its biologics license application for its Covid-19 vaccine. It would be the second Covid vaccine to receive full approval,

The stars align: The timing of all three of these developments falls in line with the Biden administration’s plans to roll out boosters to everyone who has received both doses of Pfizer-BioNTech’s or Moderna’s vaccines by late September, pending FDA authorization and a review by the CDC’s vaccine advisory panel.

The CDC’s vaccine advisory committee is convening on Monday. The agenda includes discussion of the Pfizer-BioNTech vaccine post-approval and safety updates on all three Covid shots now available. But the most interesting item on the docket is talk of a framework for Covid-19 booster doses.

CBO REPORT LAYS OUT DRUG PRICE NEGOTIATION STAKES — Fewer early-stage drugs are expected to come to market if Speaker Nancy Pelosi’s price negotiation bill, H.R. 3, goes into effect — but it’s not as bad as people might think, the Congressional Budget Office found in a Thursday report.

CBO had already estimated that H.R. 3, which would allow negotiation on a category of drugs, would lead to roughly eight fewer new medicines in the following decade and 30 fewer drugs over the subsequent 10 years. In an updated assessment, the budget analysts say early-stage drugs are most affected but “CBO… now expects more new drugs to be introduced over the next decade under current law.”

Why it matters: Critics of the negotiation approach are likely to highlight this analysis as the latest evidence that new, potentially life-saving medicines won’t reach Americans because drug companies can’t reap the revenues from costly development.

While nine out of 10 Americans said in a recent Kaiser Family Foundation poll that they support drug price negotiation, opposition to the approach soared to 65 percent when respondents were told negotiation could limit access to new drugs.

What CBO says: It isn’t clear what kind of medicines could be affected — after all, if a product is assured a big market because of patients’ needs, pharmaceutical companies are unlikely to abandon its development. Plus “the policy may lead to lower prices and increased usage for drugs already on the market.”

INFLUENTIAL DRUG PRICING PANEL TO DISCUSS VALUE OF COVID-19 TREATMENTS — The Institute for Clinical and Economic Review will conduct a comparative review of five antiviral or antibody treatments for mild to moderate Covid-19 infections, it announced on Thursday. Currently, the group is taking comments on its draft overview report; the assessment will be finalized and presented at a Midwest Comparative Effectiveness Public Advisory Council meeting in April 2022, where the independent evidence review panel will vote on the findings.

USTR TO WEIGH TARIFF EXCLUSIONS FOR CHINESE-MADE COVID-19 GOODS CASE-BY-CASE — The Office of the U.S. Trade Representative said it will consider on a “case-by-case” basis whether to continue to exclude Chinese-made medical products needed in the fight against Covid-19 from the tariffs that former President Donald Trump imposed on more than $350 billion worth of goods, POLITICO’s Doug Palmer reports.

“USTR is requesting public comments on whether to extend particular exclusions for COVID-19 products for up to six months,” the trade agency said in a Federal Register notice set to be published this morning.

The tariff exclusions on 99 product categories, including such items as masks and gloves, are set to expire on Sept. 30. The Biden administration already issued one short-term extension for all the items earlier this year.

OFF-LABEL USE OF ANTI-PARASITIC DRUG TO TREAT COVID-19 SKYROCKETS — The number of outpatient prescriptions for Ivermectin, a medication used to treat infections caused by parasites like lice or river blindness, has drastically increased in the final weeks of summer, as patients mistakenly try to use it to treat Covid-19, the CDC reports. The week ending Aug. 13, pharmacies dispensed roughly 88,000 doses of the drug — a 24-fold increase from pre-pandemic levels.

The NIH has found insufficient evidence that ivermectin can treat or prevent Covid-19, and in some cases it can be toxic.

DOUBTS OVER ADUHELM SHIFT PAYERS AND PROVIDERS INTO REGULATORY ROLE — Few of the 2 millions of eligible patients have received Biogen’s newly-approved Alzhiemer’s drug as insurers and providers weigh whether to even offer the pricey treatment, which has not yet been proven clinically beneficial, Katherine reports.

The uncertainty about Aduhelm’s efficacy has forced payers and providers into a pseudo-regulatory role, controlling patients’ ability to get the drug to an unprecedented degree. Experts who study drug regulation worry that the situation will erode public confidence in the FDA’s decision-making.

Mind the gap: In July, CMS launched a national coverage determination plan to see if Aduhelm meets its criteria of being “reasonable and necessary” for patients — but that won’t wrap up until April 2022. In the meantime, private insurance companies and even some hospital systems have said they are going to either wait for CMS’s decision, or are outright denying coverage of the drug, which was once viewed as a blockbuster.

FDA DENIES MARKETING OF ROUGHLY 55,000 E-CIGARETTES — The FDA issued its first marketing denial orders to three companies responsible for tens of thousands of flavored e-cigarettes on Thursday. These companies — JD Nova Group, Great American Vapes and Vapor Salon — failed to show that the benefit of their flavored e-cigarettes to adult smokers was greater than the risk of their appeal to teenagers. The agency still has millions of products to review by its Sept. 9 deadline.

BD GETS EUA FOR AT-HOME COVID TEST — Diagnostics manufacturer BD announced Wednesday that FDA granted emergency use authorization to its at-home Covid-19 test — but the company says it will be a couple months before the at-home tests will be sold to the public.

“We don’t provide specifics on pricing, but it will be competitive with other at-home tests, given the additional value our test provides,” BD spokesperson Troy Kirkpatrick told POLITICO. “Our production capacity for rapid tests is about 12 million per month. That is an ‘all-in’ number of tests produced for both the professional BD Veritor Plus System and the BD Veritor At-Home test.”

PEW: VALID ACT NEEDS CHANGES TO PROTECT PUBLIC HEALTH — The Pew Charitable Trusts is calling on Congress to make changes to the VALID Act, legislation that would overhaul how the U.S. regulates diagnostics and laboratory-developed tests.

Specifically, the group wants exemptions from premarket review to be more narrowly defined, a pilot program for the bill’s proposed technology certification review pathway prior to a large rollout, FDA authority to claw back tests on the market that could pose a threat to public health, and additional resources for the agency.

“If there’s not agreement on the policy, then this won’t be in a position to hitch a ride to packages moving, like the user fee agreements,” Pew’s Liz Richardson told POLITICO. “So the changes need to happen, ideally sooner rather than later if this has a chance of hitching a ride.”

HOMECARE INDUSTRY PANS CMS NOTICE ON PHILIPS RECALL — The American Association for Homecare on Thursday blasted a Wednesday CMS notice that stated suppliers are responsible for replacing or repairing impacted Philips ventilators and sleep apnea devices at no cost to Medicare beneficiaries if the equipment is less than five years old. If it is older, Medicare will help pay for a replacement, according to the notice.

“We’re disappointed that CMS has chosen to raise the expectations of Medicare beneficiaries that a quick solution is at hand without providing any context on the constraints on product availability or approved repair protocols,” AAHomecare CEO Tom Ryan said in a statement.

CALIFORNIA LAWMAKERS FLOAT SWEEPING STATEWIDE VACCINE MANDATE — A group of California lawmakers is considering whether to introduce a proposal to require all residents to show proof of Covid-19 vaccination to patronize hotels, indoor restaurants, gyms, theaters and other establishments, Susannah Luthi reports. It would also compel in-state employers to require their workers to get vaccinated, but lawmakers don’t yet have a sense of timing for the measure.

CALIFORNIA’S KIDNEY DIALYSIS BATTLE RESUMES — Labor unions trying to restrict kidney dialysis centers’ profits filed on Wednesday for a proposed third California ballot initiative that seeks to rein in the industry, Victoria Colliver reports.

SEIU-United Healthcare Workers West has been leading the charge against the predominantly for-profit industry. It is seeking to put a new measure on the November 2022 ballot that would call for a doctor, nurse practitioner or physician assistant to be present at all times during treatments, more stringent requirements for reporting infections, and for the clinic ownership interests of physicians to be disclosed to patients.

Aamir Malik has joined Pfizer as an executive vice president and chief business innovation officer, coming from McKinsey & Company.

Former Obama HHS Secretary Kathleen Sebelius is the new chair of the board of directors of biotechnology company Humacyte.

The mental health companies Ginger and Headspace announced Wednesday that they will merge to form Headspace Health.

Here are some highlights from our colleagues over at AgencyIQ, the regulatory insight platform for FDA.

FDA pulls recognition of review organization, citing fraud — According to an alert last week from the FDA, the agency has withdrawn its recognition of one of the review organizations working as part of its 510(k) Third Party Review program (3P510(k)). The program allows low-risk or well-understood device types to be preliminary reviewed by an accredited third-party review. The FDA will then conduct a shorter secondary review. However, the FDA alleged that one of the review organizations faked employee information and communicated false information to its client. Because the 3P510(k) program only cleared 74 devices in 2019, it’s possible that the FDA – or Congress – may not believe that it’s worth the trouble to maintain given the fraud allegation.

FDA to host workshop on transparency for AI/ML devices — The FDA plans to host a workshop in October on artificial intelligence (AI) and machine learning (ML) enabled medical devices, focusing on how to define “transparency” for these products and the best way to communicate this information to users. Unlike traditional medical devices, AI/ML-based devices typically have outputs (such as recommendations) that are derived from complex algorithms and processes that may not be discernible to an end user. FDA’s upcoming workshop wants to dig into how the FDA might promote transparency, such as “information that would be helpful for a manufacturer to include in the labeling of and public facing information of AI/ML-enabled medical devices, as well as other mechanisms for information sharing.”

CVS is limiting the number of rapid at-home Covid-19 tests customers can purchase due to demand for the products, Bloomberg’s Emma Court reports.

A dangerously decentralized inspection system led to over 1,400 Covid-19 deaths among residents and staff in state VA nursing homes, Joanne Kenen, Allan James Vestal and Darius Tahir found in a POLITICO investigation.

FDA issued draft guidance on Wednesday for cancer drug makers on the use of pharmacokinetic-based criteria to support the approval of alternative dosing regimens for PD-1 or PD-L1 blocking antibodies.