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Senate MPs review your drug pricing plan – POLITICO

Senate MPs review your drug pricing plan – POLITICO

With help from Alice Miranda Ollstein and Megan Wilson

– The Democrats passed regulations on drug pricing of their reconciliation package to Senate lawmakers this week.

– Juul products remain on the market After the FDA remains the market’s refusal orders, it issued the company.

– FDA extends prescribing authority for Paxlovid to pharmacists, with some restrictions.

It is Friday. welcome to Prescription pulse. Are you a member of the House Energy and Commerce Committee ranking Cathy McMorris Rodgers senior legislative assistant KRISTIN FLUKEY? We want to hear from you.

Send tips and feedback to David Lim ([email protected] or @davidalim), Lauren Gardner ([email protected] or @Gardner_LM) or Katherine Ellen Foley ([email protected] or @katherineefoley).

‘BYRD BAD’ REDUX The Democrats sent the drug the pricing of their reconciliation package, which is still under negotiation, to Senate lawmakers this week to ensure the provisions can be passed by fewer than 60 votes. They also want to get this particular procedural step – where the MP is reviewing the proposed text to determine whether it complies with the Byrd rule – out of the way while talks continue about the more difficult tax, climate and Obamacare subsidies, said Hill- sources for Alice and Megan.

Both sides expect to meet the parliamentarian to discuss which pieces should be in or out when she returns from holiday next week, but the talks can last 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 have been doing at the parliamentarian’s office for several months.

2. They have already cut a provision that is most likely to be removed – a $ 35 a month ceiling on co-pays for insulin in commercial insurance plans – which lawmakers hope to pass in a separate, two-part bill.

However, both Senate assistants and industry sources are skeptical that the separate insulin package could get 10 Republican votes – and note that conservatives have openly criticized the proposal for insulin withdrawal as a state pricing. Others, they added, may be reluctant to give Biden and Democrats any kind of victory so close to the intervening periods, although some Republicans may sign the politically popular measure.

Lawmakers and spokesmen on the right and left also lament that the pocket is letting the pharmaceutical industry out of the hook for the high prices and just shifting the costs to the insurance companies and the authorities instead of lowering it. Should that bill fall apart, parts of it could end up in the reconciliation work, they said.

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Several Republicans from the Senate Finance Committee want chair Ron Wyden (D-Ore.) And ranking member Mike Crapo (R-Idaho) to hold hearings on possible drug pricing measures – such as draft insulin legislation – before being brought to the floor.

“We request that the Senate Finance Committee maintain a surcharge on this or other drug pricing legislation within the committee’s jurisdiction before it is brought to the entire 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 Wednesday.

WYDEN RELEASES INTERIM REPORT ON AVOIDANCE OF DRUG TAXOn Thursday, Wyden released a preliminary report outlining how some pharmaceutical companies avoid paying federal taxes with offshore subsidiaries.

The report focused on AbbVie, the manufacturer of the best-selling drug Humira, which the report claims paid corporation tax of only 1 percent of taxable income in 2020. According to the report, the other 99 percent of the company’s revenue came from offshore subsidies, which were probably subject to the lower the tax rates created by a Republican-backed tax law from 2017.

CALIFF, VIDAL WANTS TO DAMN PATENTING OF ‘INCREDIBLE’ GENERIC CHANGESThe 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 blog post on Wednesday. “This effort may lead to lower drug prices because drug companies will not be able to unfairly postpone generic competition based on trivial changes in a drug product.”

FDA LET Pharmacists DISTRIBUTE PAXLOVID, WITH LIMITSOn Wednesday, the FDA extended its emergency use approval for Paxlovid, so that pharmacists have limited prescribing authority for the Covid-19 drug. The move represents a victory for pharmacy groups, which have been lobbying since December for a bigger 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 Representative Buddy Carter (R-Ga.), A pharmacist.

Reservations: The FDA noted in its announcement a hope that the decision would expand access to treatment. However, the EUA change places the burden on patients to deliver enough laboratory work to their pharmacist to help them determine the qualification for the drug, and raises questions about how much broader access to Paxlovid will increase.

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Pharmacists must examine for kidney or liver problems that Paxlovid may aggravate, and patients must provide a list of all medications they are taking so that the pharmacist can identify potential drug-drug interactions – of which there are dozens.

Pharmacists also want the Biden administration to do more to ensure that they are compensated for advising patients and doctors on Covid antiviral drugs. Some have claimed to see refund rates as low as $ 1.

QUEST GETS ICATT COVID TEST CONTRACTQuest Diagnostics announced Thursday that it is joining the Center for Disease Control and Prevention’s program for increasing community access to testing, an initiative to expand access to Covid-19 testing in underserved communities.

Free testing will be offered at approximately 1,200 of the company’s patient service centers in communities that are disproportionately affected by the pandemic. Some uninsured individuals who have symptoms, have recently been exposed to someone infected with Covid-19 or have other health risks may be eligible for the tests.

LABCORP STARTS SCREENINGS FOR APEPOPPERThe first large commercial laboratory began testing monkeys for samples on Wednesday, a step that effectively doubled the United States’ 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 orthopedic virus test used to detect monkey pox in the coming days, according to the American Clinical Laboratory Association.

“We expect that eventually over the next few weeks, [the commercial labs will] each can increase to a capacity of at least 10,000 tests per week, FDA Diagnostic Director Timothy Stenzel told test developers at a virtual town hall last week. “So that takes us to about 60,000 tests per week in the United States”

FDA SUSPENSES JUULS MARKETING NECT ORDER The FDA announced this week that for the first time ever, it had withheld its marketing refusal orders for Juul vape products while conducting an additional review of the company’s marketing application, reports Katherine.

In a joint bill submitted on Wednesday, the regulatory agency stated that it does not intend to implement enforcement measures on Juul products while the stay is in place – which means that Juul vapes and pods are currently available to consumers.

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Neckline: At the end of June, the agency ordered all of Juul’s products from the market, citing concerns about toxicity data. The next day, Juul applied for an emergency stay for enforcement while appealing the decision in the American Court of Appeal for DC Circuit. Both parties have now asked the court to refrain from taking action in the case before the FDA has completed its further review.

What happened? “What I’m reading now is that the FDA is going back to re-analyzing Juul’s application based on the lawsuit,” said Desmon Jenson, a lawyer at the Public Health Law Center at the Mitchell Hamline School of Law that focuses on commercial tobacco policy. It is unlikely that the FDA will lift its marketing denial order, but the agency will ensure that it is in a position to win, given Juul’s strong position in the e-cigarette arena, he added.

At least one senator is not happy: Senate majority whip Dick Durbin (D-Ill.) Was deeply dissatisfied with his stay. “With this inexplicable administrative stay of the Juul denial, we are right back in a legal mora of the FDA’s own production,” he said in a statement Wednesday. “I am deeply disappointed by the FDA’s ongoing failure to competently regulate the e-cigarette market.”

EUROPE OPEN TO BOOSTER TARGET TO ORIGINAL OMICRONThe 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 on Thursday by EU drug official Marco Cavaleri suggest a two-pronged reasoning – manufacturers can make vaccine prescriptions focused on BA.1 faster than boosters targeted at BA.4 and BA.5, and it may be useless to try to match future formulations accurately. to currently circulating variants with a frequently evolving virus.

On Thursday, former Theranos boss Ramesh “Sunny” Balwani was convicted by a federal jury of 12 fraud charges related to his role in the difficult blood test company, write The Wall Street Journals Heather Somerville and Meghan Bobrowsky.

In The Wall Street Journal, Cara Lombardo, Dana Cimilluca and Jonathan Rockoff report that Merck aims to reach an agreement to buy Seagen, a cancer biotechnology company, in the coming weeks.

The Centers for Medicare and Medicaid Services published on Thursday a proposed rule outlining payment policies under the doctor’s fee plan for the calendar year 2023. Medicare is considering classifying follow-up colonoscopies performed after a positive home test as a preventive service and covers the procedure for patients 45 years and older

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