| | | | |  | | By David Lim, Lauren Gardner and Katherine Ellen Foley | With help from Alice Miranda Ollstein and Megan Wilson
| | | — Democrats sent drug pricing provisions of their reconciliation package to the Senate parliamentarian this week. — Juul products remain on the market after the FDA stays the market denial orders it issued the company. — The FDA expands prescribing authority for Paxlovid to pharmacists, with some limits. It's Friday. Welcome to Prescription Pulse. Are you House Energy and Commerce Committee ranking member Cathy McMorris Rodgers' senior legislative assistant KRISTIN FLUKEY? We want to hear from you. Send tips and feedback 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).
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Democrats sent the drug pricing piece of their reconciliation package to the Senate parliamentarian this week. | Anna Moneymaker/Getty Images | 'BYRD BATH' REDUX — Democrats sent the drug pricing piece of their still-under-negotiation reconciliation package to the Senate parliamentarian this week to ensure the provisions can pass with fewer than 60 votes. They also want to get this particular procedural step — in which the parliamentarian reviews the proposed text to determine if it complies with the Byrd rule — out of the way while talks continue on the thornier tax, climate and Obamacare subsidy pieces, Hill sources told Alice and Megan. Both sides expect to meet with the parliamentarian to make their case on which pieces should be in or out when she returns from vacation next week, but the talks could drag on for more than a week after that, aides said. Democrats are confident for two reasons: 1. The language is more-or-less the same as what they've been running by the parliamentarian's office for months. 2. They've already carved out one provision most likely to be nixed — a $35 a month cap on co-pays for insulin in commercial insurance plans — which lawmakers hope to pass in a separate, bipartisan bill. Both Senate aides and industry sources are skeptical, however, that the separate insulin package can get 10 Republican votes — noting that conservatives have openly criticized the insulin out-of-pocket cap proposal as government price-setting. Others, they added, may be loath to give Biden and Democrats any kind of win so close to the midterms, although some Republicans may sign onto the politically popular measure. Lawmakers and advocates on the right and left are also grumbling that the out-of-pocket cap lets the pharmaceutical industry off the hook for the high prices and merely shifts the cost to insurers and the government instead of lowering it. Should that bill fall apart, pieces of it may end up in the reconciliation effort, they said. Several Senate Finance Committee Republicans want Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) to hold hearings on any drug pricing measures — such as insulin draft legislation — before they are brought to the floor. "We request that the Senate Finance Committee hold a mark-up on this or any drug pricing legislation within the Committee's jurisdiction before it is brought to the full Senate for consideration," Sens. Pat Toomey (R-Pa.), John Barrasso (R-Wyo.), Steve Daines (R-Mont.), Rob Portman (R-Ohio) and Ben Sasse (R-Neb.) wrote in a letter to Wyden and Crapo on Wednesday. WYDEN RELEASES INTERIM REPORT ON PHARMA TAX AVOIDANCE — On Thursday, Wyden released an interim report outlining the way some pharmaceutical companies avoid paying federal taxes with offshore subsidiaries. The report focused on AbbVie, maker of the top-selling drug Humira, which the report asserts paid corporate income taxes on only 1 percent of its taxable income in 2020. Per the report, the other 99 percent of the company's income came from offshore subsidies, which were likely subject to the lower tax rates created by a 2017 Republican-backed tax law.
| | | | DON'T MISS DIGITAL FUTURE DAILY - OUR TECHNOLOGY NEWSLETTER, RE-IMAGINED: Technology is always evolving, and our new tech-obsessed newsletter is too! Digital Future Daily unlocks the most important stories determining the future of technology, from Washington to Silicon Valley and innovation power centers around the world. Readers get an in-depth look at how the next wave of tech will reshape civic and political life, including activism, fundraising, lobbying and legislating. Go inside the minds of the biggest tech players, policymakers and regulators to learn how their decisions affect our lives. Don't miss out, subscribe today. | | | | | | | | CALIFF, VIDAL WANT TO CURB PATENTING OF 'INCREMENTAL' GENERIC CHANGES — The FDA and the U.S. Patent and Trademark Office are working to prevent generic drug manufacturers from abusing the patent system to delay competition. "The USPTO will protect against the patenting of incremental, obvious changes to existing drugs that do not qualify for patents," USPTO Director Kathi Vidal and FDA Commissioner Robert Califf wrote in a Wednesday blog post. "This effort can lead to lower drug prices because drug companies will not be able to unjustifiably delay generic competition based on trivial changes to a drug product."
| | | FDA LETS PHARMACISTS DOLE OUT PAXLOVID, WITH LIMITS — On Wednesday, the FDA expanded its emergency use authorization for Paxlovid, allowing pharmacists limited prescribing authority for the Covid-19 drug. The move represents a win for pharmacy groups, which have lobbied since December for a greater role in ensuring patients can access the antiviral pills, which must be started within five days of symptom onset to be effective. "This move by the FDA will improve Americans' ability to access timely Covid-19 treatments and keep patients out of the hospital," said Rep. Buddy Carter (R-Ga.), a pharmacist by trade. The caveats: The FDA noted in its announcement a hope that the decision would expand access to the treatment. But the EUA amendment puts the burden on patients to furnish enough lab work to their pharmacist to help them determine eligibility for the drug, raising questions of how much wider access to Paxlovid will increase. Pharmacists must screen for kidney or liver problems that Paxlovid could exacerbate, and patients must provide a list of all medications they take so the pharmacist can identify any potential drug-drug interactions — of which there are dozens. Pharmacists also want the Biden administration to do more to ensure they're compensated for advising patients and doctors on Covid antivirals. Some have claimed to see reimbursement rates as low as $1. QUEST GETS ICATT COVID TESTING CONTRACT — Quest Diagnostics announced Thursday it is joining the Center for Disease Control and Prevention's Increasing Community Access to Testing program, an initiative to expand access to Covid-19 testing in underserved communities. No-cost out-of-pocket testing will be offered at approximately 1,200 of the company's patient service centers in communities disproportionately impacted by the pandemic. Certain uninsured individuals who have symptoms, had a recent exposure to someone infected by Covid-19 or have other health risks could be eligible for the tests.
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Labcorp is the first national laboratory to offer a monkeypox test. | Business Wire | LABCORP STARTS SCREENINGS FOR MONKEYPOX — The first major commercial laboratory started testing samples for monkeypox on Wednesday, a step that effectively doubled the U.S.' testing capacity for the virus, according to the Centers for Disease Control and Prevention. Other commercial laboratories — Aegis Sciences, Mayo Clinic Laboratories, Quest Diagnostics and Sonic Healthcare — are working to operationalize the CDC orthopoxvirus test being used to detect monkeypox in the coming days, according to the American Clinical Laboratory Association. "We expect that eventually over the next coming weeks, [the commercial labs will] each be able to ramp up to a capacity of at least 10,000 tests per week," FDA diagnostics director Timothy Stenzel told test developers at a virtual town hall last week. "So that does take us to about 60,000 tests per week in the U.S."
| | | FDA SUSPENDS JUUL'S MARKETING DENIAL ORDER — The FDA announced this week that, for the first time ever, it had stayed its market denial orders for Juul vape products while it conducts an additional review of the company's marketing application, Katherine reports. In a joint legal motion filed Wednesday, the regulatory agency stated that it does not intend to take enforcement action on Juul products while its stay is in place — meaning that for now, Juul vapes and pods are available to consumers. Whiplash: In late June, the agency ordered all of Juul's products off the market, citing concerns around toxicity data. The next day, Juul filed for an emergency stay on enforcement while it appeals the decision in the U.S. Court of Appeals for the D.C. Circuit. Now, both parties have asked the court to refrain from taking any action on the case until the FDA finishes its additional review. What happened? "My read on this now is that the FDA is going back to reanalyze Juul's application based on the lawsuit," Desmon Jenson, a lawyer at the Public Health Law Center at the Mitchell Hamline School of Law who focuses on commercial tobacco policy, said. It's unlikely the FDA will rescind its marketing denial order, but the agency will want to ensure it is in a position to win, given Juul's strong position in the e-cigarette arena, he added. At least one senator isn't happy: Senate Majority Whip Dick Durbin (D-Ill.) was deeply displeased with the stay. "With this unexplained administrative stay of the Juul denial, we are right back in a legal morass of FDA's own making," he said in a statement Wednesday. "I am deeply disappointed by FDA's ongoing failure to competently regulate the e-cigarette market."
| | | EUROPE OPEN TO BOOSTER TARGETING ORIGINAL OMICRON — The European Medicines Agency is open to using Covid-19 vaccines tailored to the first Omicron strain that circulated worldwide in late 2021, Reuters reports. Remarks Thursday by EU drug official Marco Cavaleri suggest a reasoning that's twofold — manufacturers can make vaccine recipes focused on BA.1 more quickly than boosters targeted to BA.4 and BA.5, and it could be futile to try to precisely match future formulations to currently circulating variants with a frequently evolving virus.
| | | On Thursday, former Theranos executive Ramesh "Sunny" Balwani was convicted by a federal jury on 12 fraud charges pertaining to his role at the embattled blood-testing company, The Wall Street Journal's Heather Somerville and Meghan Bobrowsky write. In The Wall Street Journal, Cara Lombardo, Dana Cimilluca and Jonathan Rockoff report that Merck aims to reach an agreement to acquire Seagen, a cancer biotech company, in the next few weeks.
| | | The Centers for Medicare and Medicaid Services published a proposed rule on Thursday outlining payment policies under the physician fee schedule for calendar year 2023. Medicare is considering classifying follow-up colonoscopies performed after a positive at-home test as a preventive service and covering the procedure for patients 45 years and older | | | | Follow us on Twitter | | | | Follow us | | | | |
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