New at-home test could double U.S. supply, FDA says

By David Lim and Lauren Gardner

With help from Katherine Ellen Foley

— A new at-home Covid-19 test that received emergency authorization from FDA on Monday is poised to double the supply of at-home tests in the U.S. in the next several weeks.

— October is set to be a pivotal month for Covid-19 vaccines. FDA advisers are scheduled to meet on recommending Moderna and Johnson & Johnson boosters for adults as well as Pfizer vaccines for kids 5 to 11.

— FDA has finalized rules for tobacco product applications.

It’s Tuesday. Welcome back to Prescription Pulse. Who else is excited to see Cheryl Burke and Peloton’s Cody Rigsby perform for Britney Week on “Dancing With the Stars” in Covid quarantine in what might be the best PR yet for the vaccines’ protection against severe infection?

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).

NEW AT-HOME TEST COULD DOUBLE U.S. SUPPLY, FDA SAYS — An announcement by FDA late Monday is poised to reshape the U.S. at-home testing landscape in the coming weeks if all goes as planned.

The FDA’s emergency authorization of Flowflex, made by San Diego-based ACON Laboratories, comes as a surge in new infections driven by the Delta variant has forced retail pharmacies to limit the number of rapid tests customers can buy.

“Today’s authorization for the ACON Laboratories Flowflex COVID-19 Home Test should significantly increase the availability of rapid, at-home tests and is expected to double rapid at-home testing capacity in the U.S. over the next several weeks,” FDA medical device director Jeffrey Shuren said in a statement.

The company plans to scale manufacturing of the home test — which can be used by individuals who have no symptoms without repeat testing — to 100 million units a month by the end of the year, according to FDA. By February, manufacturing capacity of 200 million of the tests a month is anticipated.

BOOSTER SEASON IS THE NEW SPOOKY SZN — In case you forgot to mark your calendars Friday afternoon, here’s your reminder: FDA’s vaccine advisory committee will meet three times this month to weigh recommendations for Covid-19 booster shots and the initial Pfizer vaccination series for some children.

The dates: The independent experts will consider Moderna boosters on Oct. 14. J&J’s vaccine will get the booster treatment on Oct. 15, when advisers will also discuss National Institutes of Health data on heterologous boosting, colloquially known as “mix-and-match,” where a patient received one primary vaccine series and then gets an additional dose of another manufacturer’s shot.

Then on Oct. 26, the FDA panel will examine Pfizer’s bid to obtain emergency use authorization for a smaller dose of its vaccine in kids ages 5 to 11.

The context: Moderna is the only manufacturer to have publicly made a move that would trigger an advisory committee meeting, so the scheduling announcement was FDA’s way of showing its cards on what’s coming down the pike and when. The New York Times reported Monday that J&J is expected to seek authorization for its booster this week, and Pfizer’s application for young kids is also expected imminently.

Mixing and matching brands for boosters got a lot of attention last month before FDA and CDC endorsed the Pfizer booster for certain people who got the manufacturer’s initial series. Positive safety and efficacy data would ease the way for regulators to remove a logistical barrier to booster-shot administration.

Myocarditis in focus: A study of about 2.4 million Kaiser Permanente members in Southern California found that myocarditis post-mRNA vaccination was rare in adults, with 5.8 cases per million people after the second dose. The study, published in JAMA Internal Medicine determined all the affected individuals were men under 40 with no prior history of cardiac issues. Though cases are rare and typically mild, “it would be worthwhile to identify the mechanism of cardiac injury from vaccines,” two doctors unaffiliated with the research said in an accompanying editorial.

SHOT: PFIZER MAINTAINS HIGH EFFICACY AGAINST HOSPITALIZATION — The Pfizer-BioNTech vaccine remains about 90 percent effective against hospitalization for all Covid variants for at least six months, according to a study published in The Lancet Monday. But the shot’s ability to prevent any infection dropped from 88 percent in the first month after full vaccination to 47 percent after five months.

CHASER: EU DRUG REGULATOR ENDORSES PFIZER BOOSTER FOR ADULTS — The European Medicines Agency on Monday recommended booster doses for healthy adults six months after receiving the second Pfizer dose. The regulator also advised that people with severely weakened immune systems may get a booster dose of either the Pfizer-BioNTech or Moderna shot 28 days after their second dose, POLITICO Europe’s Helen Collis reports.

MERCK’S EXPERIMENTAL COVID-19 DRUG RAISES HOPES FOR A PILL TO FIGHT VIRUS — Merck reported its oral antiviral molnupiravir appeared to halve the risk of hospitalization or death from Covid-19 in a late-stage clinical trial Friday, raising hopes for a simple treatment for the virus, POLITICO’s Lauren Morello and Katherine report. It performed so well that the independent review board overseeing the study recommended the trial be ended early. Merck and its partner Ridgeback Biotherapeutics said they will seek FDA authorization for the drug “as soon as possible.”

“Having an effective treatment for Covid-19 in a pill form would have a significant positive impact on this pandemic,” said Molly Howell, the immunization program manager for the North Dakota Department of Health. Currently, few treatments are available for Covid-19, and those that exist must be given in a health care setting. An at-home treatment that could reduce the severity and length of symptoms could significantly reduce the patient burden at hospitals and increase the overall survival rate of the drug.

COLLINS TO STEP DOWN FROM NIH — National Institutes of Health Director Francis Collins plans to announce his resignation today after 12 years leading the agency, POLITICO’s Megan Wilson, Sarah Owermohle and Erin Banco scooped. The departure of the physician-geneticist, a pandemic-era media surrogate for the administration who’s the longest-serving NIH director, has been in the works for a while, per one person familiar with the situation.

Registration is OPEN for Breakthrough Summit 2021, the most important rare disease conference of the year! On Oct. 18 and 19, the National Organization for Rare Disorders will host the virtual Rare Disease and Orphan Products Breakthrough Summit. The Summit brings together the rare disease community from across the globe, including experts from patient advocacy, government, industry, media and academia, to discuss the current and critical topics in rare diseases. For access to two days of networking and dynamic programming on topics including drug pricing, genetic testing, Covid-19, equity and inclusivity, REGISTER NOW.

GENERIC DRUGMAKERS PAY $447M ON PRICE-FIXING ALLEGATIONS — Taro Pharmaceuticals, Sandoz and Apotex Corp.agreed to pay a combined $447.5 million to the federal government and participate in a five-year corporate integrity program to resolve allegations they conspired to fix various drug prices, POLITICO’s Sarah Owermohle reports. The government alleged that between 2013 and 2015 the three companies made backdoor agreements on drug prices, supply and allocations to different customers to control the market.

The Justice Department has ongoing lawsuits against other generic drug manufacturers, including Teva Pharmaceuticals alleging price fixing, and the attorneys general of nearly every state have also sued more than 20 generic drugmakers on similar charges.

FDA PUBLISHES FINAL RULES ON TOBACCO PRODUCT APPLICATIONS — The Food and Drug Administration has finalized its rules for tobacco companies wishing to submit premarket tobacco applications (PMTAs) and substantial equivalence reports as of Monday. The agency finalized the rules nearly a month after its court-ordered deadline for reviewing all applications for new tobacco products and 13 months after companies had to submit their applications to FDA for review. The rules will go into effect Nov. 4. Companies that previously submitted PMTA’s or substantial equivalence reports won’t be held to the finalized rules’ standards. However, if they received marketing denial orders, they may reapply based on the criteria outlined in the final rule.

CDRH LAYS OUT HOW TO TELL PATIENTS ABOUT CYBERSECURITY VULNERABILITIES — FDA Friday published a white paper laying out how medical device companies and other federal partners can best communicate about cybersecurity issues with medical devices.

The agency wants such warnings to be easy to read and understand, be timely and usable, include what is not known, and be easy to find online.

“As the use of connected medical devices increases and cybersecurity threats to the healthcare sector have become more frequent, more severe, and more clinically impactful (U.S. Food & Drug Administration, 2018), it is increasingly important for the FDA, industry, and other messengers to consider ways to improve on cybersecurity safety communications,” the paper states.

FDA PUBLISHES DE NOVO FINAL RULE — FDA on Monday published a final rule formally establishing classification procedures and criteria for medical device manufacturers seeking to use the agency’s De Novo pathway.

“While several comments object to sections or subsections of the proposed rule, almost all comments voice support for the objective of the proposed rule: to establish regulations implementing the De Novo classification process,” the rule states.

TELL US WHAT YOU THINK: Do you listen to POLITICO podcasts? We want to hear from you! Tell us what you like, what you could do without, and what you want to see in the future from the POLITICO Audio team! Your responses will help us improve our offerings and tailor our podcast content to better fit your needs. Find the survey here.

Emergent BioSolutions has promoted Assal Hellmer to senior director for business communications and Matt Hartwig to senior director for media relations. The firm also announced Katherine Getty has been promoted to director for federal government affairs (h/t POLITICO Influence).

For more than a decade, the consulting firm McKinsey & Company advised both the FDA’s drug regulatory branch and the pharmaceutical companies who wished to skirt certain policies, Ian MacDougall reports for ProPublica. The firm never disclosed to the agency that it was working with pharmaceutical manufacturers.

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

FDA drug approvals remain near record highs — The FDA’s Center for Drug Evaluation and Research approved 53 novel drugs during fiscal 2021, the third highest total across the last decade, according to an analysis by AgencyIQ. The approval total trails only fiscal years 2020 (61) and 2018 (54). Rare disease and oncology products made up a large portion of novel drug approvals. Almost 50 percent of approved novel drugs, known as new molecular entities, were granted Orphan Drug Designation prior to approval, meaning the drug is intended to treat a disease or condition affecting fewer than 200,000 people domestically.

Cancer drugs also made up a large portion of fiscal 2021 novel drug approvals, with 32 percent of products being reviewed by CDER’s Office of Oncologic Diseases. About one quarter of all approvals were made using the accelerated approval pathway, meaning the product was approved based on a surrogate or intermediate endpoint. In addition, 68 percent of fiscal 2021 approvals were granted priority review, granting them six-month target review dates instead of the standard 10.

The White House Office of Management and Budget completed its review of an FDA proposed rule expected to lay out regulations establishing an over-the-counter hearing aid market.

Follow us on Twitter

David Lim @davidalim Lauren Gardner @Gardner_LM

Follow us

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings

This email was sent to by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA

Please click here and follow the steps to .