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Politico (9/23/2022): WHITHER CURES 2.0? — On Wednesday, during what was likely the House Energy and Commerce Committee’s last markup of the year, Rep. Diana DeGette (D-Colo.) gave an unexpected update: DeGette and retiring Rep. Fred Upton’s (R-Mich.) CURES 2.0 legislation was supposed to be on the docket this month, but majority staff pulled the bill from markup after Republicans threatened to offer “poison pill amendments.”

Axios (9/23/2022): Drug pricing law a GOP target - Some key House Republicans are calling for the repeal of Democrats' newly-passed drug pricing measure if the GOP flips control of one or both chambers of Congress next year, Axios' Peter Sullivan and Victoria Knight write.

Bloomberg (9/23/2022): Senate Nears FDA Deal to Ride on Stopgap - The Senate is close to finalizing a bipartisan deal reauthorizing FDA user fees with just days left until the existing agreement expires.

Politico (9/23/2022): RAND PAUL WEIGHING POTENTIAL COMMITTEE GAVELS — Sen. Rand Paul (R-Ky.) told POLITICO he will decide after the election whether he will push for the top Republican slot on the Senate Homeland Security and Governmental Affairs Committee or the Senate HELP Committee.

Axios (9/23/2022): Deal reached to renew FDA user fees - Senate and House health committee leaders on Thursday reached an agreement to renew programs that fund key Food and Drug Administration programs for another five years, Victoria and Peter report.

Politico (9/23/2022): FIVE MORE YEARS — The leaders of the Senate HELP Committee and the House Energy and Commerce Committee reached a deal on Thursday to include a five-year reauthorization of the FDA’s user fee programs and a few smaller policy riders on a short-term government funding bill this month, David reports. The agreement does not include overhauls of how the FDA regulates diagnostics, dietary supplements and cosmetics.

Washington Post (9/22/2022): Biotech Aims to Detect Cancer Early. But Tests Have a Long Way to Go. - Biotechnology is full of tantalizing promises, but few as appealing as this: a test that can screen for any kind of cancer early, allowing patients to start treatment early and have a better chance at surviving.

Bloomberg (9/22/2022): Democrats Slam ‘Poison Pills’ on Cures 2.0 - Partisan bickering is holding up a biomedical innovation bill in the House, the legislation’s main Democratic sponsor said.

Politico (9/22/2022): BIPARTISAN DRUG PRICING BILL — Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) plan to introduce a bill today aimed at lowering prescription drug costs.

Axios (9/22/2022): Cancer deaths fall with treatments, screening - The decline in cancer deaths has accelerated in recent years, reaching a 2.3% annual drop every year between 2016 and 2019, according to the latest American Association for Cancer Research Cancer Progress report.

Politico (9/21/2022): PROVIDERS DROP SURPRISE BILLING SUIT — But another is likely on the way. Provider groups, including the American Medical Association and the American Hospital Association, seek to drop their lawsuit against the federal government over how disputes in surprise bills are arbitrated.

Bloomberg (9/21/2022): Califf Hopeful for FDA Deal as Lapse Looms - Appropriations talks at the Capitol are in full swing this week as time is running out for lawmakers to reauthorize the Food and Drug Administration’s user fees. But the agency’s commissioner, Robert Califf, is expressing optimism.

Politico (9/21/2022): GOP EYES TELEMEDICINE EXPANSION — Rep. Kevin McCarthy is set to roll out Republicans’ “Commitment to America” agenda Friday, a spokesperson for the House minority leader told Future Pulse.

Axios (9/21/2022): Biosimilars aren't always that much cheaper - The prices of biosimilars — the generic equivalent of drugs known as biologics, which are made from living organisms — are often not much lower than their brand-name originator products when purchased through employer-sponsored insurance plans, according to a new report from the Health Care Cost Institute.

Politico (9/20/2022): SURPRISE! USER FEES TALKS CONTINUE — Negotiations between the leaders of the Senate HELP Committee and the House Energy and Commerce Committee on a package to reauthorize the FDA’s user fee programs for drugs and medical devices continued over the weekend, but no resolution was reached. Negotiations are centered on approximately 15 to 20 riders to the base reauthorization, according to five industry lobbyists and congressional aides granted anonymity to discuss the ongoing talks.

Politico (9/19/2022): AND MEDICARE PATIENTS EMBRACE TELEHEALTH — A new study published in JAMA Health Forum found Medicare patients took advantage of pandemic-era policies permitting them to see doctors who practice in other states via phone or video call, POLITICO’s Ben Leonard reports.

Bloomberg (9/19/2022): Advocates Target Pharmaceutical Middlemen - Drug pricing advocates fresh off a major win say they’re turning their attention to changes for pharmaceutical industry middlemen and to curbing high launch prices for new medicines.

Bloomberg (9/19/2022): Skyrocketing Prices Fuel Drive for Fresh Crackdown on Drug Costs - Drug pricing advocates fresh off a major win say they’re turning their attention to changes for pharmaceutical industry middlemen and to curbing high launch prices for new medicines.

Politico (9/16/2022): FDA USER FEES TALKS DRAG ON — Lawmakers are still working to hammer out a deal to reauthorize FDA user fee programs, with negotiations slated to continue into the weekend, your hosts report. Senate Republicans are pressing for a clean five-year bill, but policy riders are still in play as the clock winds down on the number of days left on the House calendar — and as the Sept. 30 fiscal year-end deadline approaches.

Bloomberg (9/16/2022): Tying FDA Fees to CR Seen as Missed Chance - Health policy advocates are wary that a push to attach FDA user fee legislation to a government funding bill will deny the agency new drug approval oversight tools and other long-sought policy changes.

Bloomberg (9/16/2022): Cancer Institute Wants $10 Billion for Fiscal 2024: The National Cancer Institute laid out a $10 billion spending plan for fiscal year 2024, marking one of its most ambitious budget proposals that calls for a more than 30% increase over last year’s request. The institute released Thursday its fiscal 2024 professional judgment budget, an annual report issued directly to Congress and the president identifying research priorities and areas of potential investment.

Bloomberg (9/15/2022): ARPA-H Pick Paves Way for Biden’s Cancer Goal: The biomedical innovation center envisioned by President Joe Biden can now move forward in building its scientific agenda, even as influential lawmakers continue to press for changes in the agency’s setup. The White House this week announced Renee Wegrzyn as the first director of the Advanced Research Projects Agency for Health. Wegrzyn is expected to assume her new role by Oct. 1, the start of fiscal 2023, the White House Office of Science and Technology Policy confirmed to Bloomberg Law.

Politico (9/14/2022): TELEHEALTH LEGISLATION PUSH — The American Medical Association, the Mayo Clinic, Google and Amazon were among the 375 groups that signed a Tuesday letter to Senate leadership urging the chamber to pass telehealth legislation this fall, Ben reports.

Bloomberg (9/14/2022): Senators Eye Stopgap as User Fees Vehicle - Senators say the only way to avoid layoffs at the FDA is to attach user fee legislation to a must-pass government funding bill.

Modern Healthcare (9/14/2022): Cleveland Clinic, Amazon join call for Senate to extend telehealth pay - A group of 375 organizations, including the Federation of American Hospitals and the American Medical Association, asked Senate leaders to pass a two-year extension of telehealth flexibilities.

Politico (9/13/2022): WAKE ME UP WHEN SEPTEMBER ENDS — Both chambers of Congress are back in action today for the first time in a month, but a deal to reauthorize the FDA’s user fee programs is still not yet hammered out despite weeks of staff-level talks.

Politico (9/13/2022): BIDEN TOUTS NEW ARPA-H DIRECTOR, CANCER MOONSHOT GOALS — Biden traveled to Boston Monday to hype his cancer moonshot initiative now that he’s named the first director of the agency he says will be integral to making his goals reality. The new Advanced Research Projects Agency for Health will be led by Renee Wegrzyn — currently at Ginkgo Bioworks but an alum of the Defense Advanced Research Projects Agency, one of the agencies ARPA-H is modeled after.

Bloomberg (9/13/2022): Biden Taps Innovation Veteran for ARPA-H - President Joe Biden announced biotech company vice president and longtime scientist Renee Wegrzyn as his choice to lead a new government agency focusing on biomedical research.

Axios (9/13/2022): Report: Sky-high markups on 340B cancer drugs - Safety net hospitals are marking up the cost of drugs they buy through the government's discount drug program by as much as 11 times the cost, according to a new report provided first to Axios by the Community Oncology Alliance (COA).

Roll Call (9/12/2022): Biden touts new drug pricing law amid cancer, biotech push - President Joe Biden on Monday hit the campaign trail to unveil new initiatives in biotechnology and a leader for a new health research agency key to his “Cancer Moonshot” initiative.

Washington Post (9/13/2022): President Biden took to the road Monday to tout his cancer moonshot, including the signing of an executive order aimed at boosting the domestic biotech industry.

Washington Post (9/12/2022): China Competition Spurs Biden Push for Domestic Biotech Subsidies - President Biden issued an executive order Monday intended to boost the domestic biotechnology industry, which encompasses everything from pharmaceutical manufacturing to plastics to innovative fuels, according to White House officials.

Axios (9/12/2022): Congress hits home stretch renewing FDA user fee programs - Congress is entering a critical week in efforts to renew the user fees that help fund the Food and Drug Administration. The question is how much the must-pass bill will become a vehicle for other policy priorities, Axios' Victoria Knight writes.

Axios (9/12/2022): 340B spending rises to $44 billion - Health providers bought $43.9 billion of outpatient drugs under the federal 340B drug pricing program in 2021, according to a new government breakdown of purchases.

Modern Healthcare (9/9/2022): Medicare fraud in telehealth stays low in pandemic’s first year, HHS study finds - There were 1,714 providers out of about 742,000 whose billing was deemed "high risk" for Medicare during the pandemic's first year.

Politico (9/8/2022): Three House Democrats have sent a letter to the Centers for Medicare and Medicaid Services, calling for the extension of audio-only telehealth coverage through Medicare - CMS recently published a proposed rule, which includes plans to cut coverage for audio-only visits.

Bloomberg (9/8/2022): Senate GOP Rejects Biden’s Covid Request - Senate Republicans will oppose President Joe Biden’s request for billions in funding to combat the ongoing Covid and monkeypox pandemics, setting up a potential fight over a must-pass government funding bill.

Bloomberg (9/8/2022): Watchdog Scrutinizes Telehealth Billing in Pandemic: The Biden administration has to strengthen its oversight of Medicare telehealth providers, in particular those suspected of improper or fraudulent billing practices, a federal watchdog agency said, after finding that 1,714 telehealth providers—who billed Medicare almost $128 million during the first year of the pandemic—posed a “high risk” to the Medicare program. Read more from Tony Pugh.

Bloomberg (9/8/2022): Revised draft guidance on pediatric clinical trials seeks to tackle the lack of information on how well drugs work in kids. The FDA unveiled draft guidance on the general clinical pharmacology considerations for pediatric drug studies. Jeannie Baumann has more.

STAT (9/8/2022): Launch prices: tackling the next drug pricing challenge - The passage of the Inflation Reduction Act brings a new era to drug pricing in the United States. After decades of being an outlier, it now joins every other developed nation in having the federal government engaged in negotiating drug pricing.

Axios (9/7/2022): Profiting through donations to patient charities - Drug manufacturers may have profited from donating to charities that help patients pay for costly medicines, Axios' Victoria Knight writes about a new Health Affairs study.

The Hill (9/7/2022): Biden to give ‘cancer moonshot’ remarks on 60th anniversary of JFK moonshot speech - President Biden will deliver remarks on his “cancer moonshot” initiative in Boston on Monday, marking the 60th anniversary of former President John F. Kennedy’s famous “moonshot” speech.

Axios (9/6/2022): Republican campaigns are silent on health care - Republicans in tight congressional races are going silent on health care, scrubbing campaign websites of anti-abortion language and in some cases distancing themselves from past criticisms of the Affordable Care Act, Axios' Victoria Knight writes.

The Hill (9/2/2022): Health Care — White House makes new push to fund health battles - Now that the pumpkin-spiced latté has returned, you can take your love of fall even further with these pumpkin-shaped Dutch ovens that Twitter has fallen in love with.

Bloomberg (9/2/2022): Proposal to Harmonize Research Protection Rules Clears Review - An FDA proposal to align its research volunteer protections with those of the HHS has cleared White House review and can be published at any time.

Bloomberg (9/1/2022): Veterans’ ‘Burn Pit’ Aid Becomes Calling Card in Midterm Races - Rep. Chris Pappas, as supporters enjoyed free ice cream at his family’s century-old New Hampshire restaurant, listed a litany of legislative successes his fellow Democrats racked up: pandemic aid, bipartisan infrastructure spending, lowering drug prices, subsidizing semiconductors and renewable energy.

Bloomberg (9/1/2022): FDA Drug Center Faces Layoff Notices If User Fee Deal Stalls (1) - FDA drug center staff will be the first to receive layoff warnings this month if the agency doesn’t quickly hear that congressional leaders are nearing an agreement to reauthorize the fees that help fund the agency, current and former officials warn.

Axios (8/31/2022): The fight over drug copays - Groups representing HIV and diabetes patients are trying to kill a Medicare rule they say leaves sick patients stuck with higher drug costs, by preventing them from applying billions of dollars in assistance against their insurance deductibles.

Axios (8/31/2022): Early arbitration issues between insurers, providers - A lot of hay has been made out of the process insurers and providers use to settle billing disputes under the surprise billing law — and it turns out that process is already causing some ... friction, Modern Healthcare reports.

Bloomberg (8/30/2022): Republicans Question Execution of Drug Bill: House Energy and Commerce Republicans said Democrats’ climate and health-care law would create price controls that will “lead to fewer cures, more expensive drugs when they launch, and make America more reliant on China’s drug development and manufacturing supply chains.”

Modern Healthcare (8/30/2022): States to give low-income patients access to top-tier cancer providers - In New York and California, new policies seek to make complex cancer care accessible to Medicaid, exchange enrollees.

Bloomberg (8/29/2022): Drug Negotiations Seen Driving Biosimilars: Medicare’s drug-price negotiations will push out more lower-cost biosimilars if Democrats’ landmark climate and health-care law changes incentives for makers of brand-name biologics, some analysts said. Drugmakers may find themselves grappling with whether to subject their products to federal negotiations or alter their patent strategies to let a biosimilar come on the market.