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Washington Post (6/10/2022): Debunking myths about cancer - Many popular beliefs are wrong and cause needless worry, sometimes prompting people to disregard prevention behaviors. They can also result in unwise treatment decisions.

Washington Post (6/10/2022): Eye-catching cancer drug trial results have researchers asking: What’s next? - After a small cancer drug study yielded the unprecedented result of 100 percent of participants entering remission, oncologists — and patients — wonder if the approach from the experimental drug trial can apply to other types of cancer.

Politico (6/10/2022): HOUSE PASSES FDA USER FEE PACKAGE — The House late Wednesday passed a legislative package to reauthorize FDA’s medical product user fee programs in a 392-28 suspension vote.

Politico (6/10/2022): SENATE TEES UP RESCHEDULED USER FEE MARKUP — After running into challenges reaching an agreement on a manager’s amendment earlier this week, the Senate HELP Committee pushed back its user fee reauthorization package markup to next Tuesday.

Bloomberg (6/9/2022): House Passes FDA Package Reauthorizing Drug, Device User Fees: The House on Wednesday passed a sweeping package to reauthorize the fees that help fund the FDA as the Senate works to pass its own version of the bipartisan legislation. Celine Castronuovo has more on the bill.

Politico (6/8/2022): BURN PIT BILL INCHES CLOSER TO LAW — The Senate voted 86-12 Tuesday to limit debate and advance a bill that would cover veterans’ care for toxic exposures from burn pits , a leap toward addressing the health problems that have plagued millions who served overseas.

Axios (6/8/2022): Exponential drug price growth - Nearly half of all drugs launched in the last two years initially cost above $150,000 a year, according to new research that's landing as Congress renews discussions about drug price controls. 

Politico (6/8/2022): INTERSTATE TELEHEALTH STATS — Virtual care increased significantly across state lines amid pandemic waivers, but it still made up a small amount of overall Medicare telehealth usage, researchers from the University of Michigan found in a study published in Health Affairs.

Modern Healthcare (6/8/2022): FTC takes aim at PBM business practices in new inquiry - The regulator is demanding information from companies such as CVS Health, UnitedHealth Group and Humana. 

Politico (6/7/2022): HOUSE MAY CONSIDER UFA BILL UNDER EXPEDITED RULE — The House appears poised to vote this week on H.R. 7667 (117) . The bill would reauthorize FDA’s medical product user fees under suspension of the rules, a speedy legislative process that would allow legislation to advance with two-thirds of the chamber present and voting. The potential procedure suggests leadership is confident members will back the measure, which won’t be open for floor amendments. 

Politico (6/7/2022): SENATE UFA PACKAGE HITS SPEED BUMP — A Senate HELP Committee markup of the chamber’s own user fee reauthorization package might slip past the initially scheduled Wednesday date after an agreement on a manager’s amendment was not reached in time, two sources close to the negotiations told POLITICO.

Politico (6/6/2022): IN DEFENSE OF ACCELERATED APPROVAL — A new analysis from the Partnership to Fight Chronic Disease says that drugs approved under the FDA’s accelerated approval program don’t drive up Medicaid spending.

Bloomberg (6/6/2022): House Press FDA User Fee Bill for Passage - The House returns from its week-long Memorial Day recess Tuesday with plans to pass a bill (H.R. 7667) to reauthorize user fees the Food and Drug Administration negotiates with regulated industries.

Politico (6/3/2022): SENATE HELP COMMITTEE TO MARK UP USER FEE BILL — The Senate HELP committee has officially scheduled a markup of the chamber’s bill to reauthorize FDA’s medical product user fees next Wednesday, June 8, beginning at 10 a.m. In addition to the user fee bill, the committee will mark up legislation aimed at improving access to mobile health care clinics.

Axios (6/3/2022): Drug price controls may have little effect on R&D - Modest drug pricing reforms aren't likely to squelch pharmaceutical innovation or jeopardize the future health of Americans, researchers from the USC-Brookings Schaeffer Initiative for Health Policy write in a new post.

Politico (6/1/2022): SENATE HELP LEADERS INTRODUCE FDA USER FEES BILL — On Friday, Senate HELP Committee members introduced the bill that would reauthorize the human medical product user fee programs for FDA.

Modern Healthcare (6/1/2022): Providers urge FTC to probe PBM practices - Providers, patients and senators want the FTC to investigate pharmacy benefit managers. Insurers and PBMs say drug companies are the problem.

Axios (6/1/2022): Americans overpay for generics - U.S. consumers overpay for generic drug prescriptions by as much as 20% and it's largely because of the industry middlemen known as pharmacy benefit managers, according to a white paper from the USC Leonard D. Schaeffer Center for Health Policy & Economics.

Politico (6/1/2022): TELEHEALTH DISCUSSION DRAFT — The top two lawmakers on the Senate finance committee unveiled a proposal to permanently remove the requirement that Medicare patients see mental health care providers in person before undergoing telehealth visits.

Politico (5/31/2022): CMS TO LOWER PREMIUMS IN 2023 — On Friday, CMS announced it will lower the premiums for doctor-administered drugs in 2023, POLITICO’s Katherine Ellen Foley reports.

Bloomberg (5/31/2022): Fast Drug Approvals Would Get Revamp in Senate Bill: The FDA would have more power to push for post-market studies of drugs cleared through its accelerated approval pathway in a Senate package unveiled Friday to reauthorize the fees that help fund the agency. The accelerated approval changes in the proposal by Sens. Patty Murray (D-Wash.) and Richard Burr (R-N.C.), chair and ranking member of the Senate Health, Education, Labor and Pensions Committee, were among the provisions added to their draft. Read more from Celine Castronuovo.

Politico (5/27/2022): BURR: FDA FORMULA RESPONSE MAY SLOW UFA PROCESS — Senate HELP ranking member Richard Burr suggested Thursday he may not be as amenable as he once was to quickly moving an FDA user fee reauthorization package through the chamber, given FDA’s answers to congressional inquiries about the agency’s response to the formula shortage.

Bloomberg (5/27/2022): Diagnostics Revamp Inches Forward in FDA User Fee Plan: A Senate proposal to overhaul the way that the FDA regulates diagnostics is raising questions over whether the agency has the resources it needs to undertake such a project. Inclusion of the VALID Act (H.R. 4128) in the Senate’s must-pass draft user fee measure marks a key step in realizing changes to how much oversight the FDA should exert over diagnostic tests. But the bill leaves a lot of text in brackets, indicating there are still major sections that have been proposed but are still up in the air as to how lawmakers will sort that out, including how to fund it. Read more from Jeannie Baumann.

Politico (5/27/2022): UFA RIDER-WATCH — Several senators introduced bills this week that could potentially hitch a ride on the user fee package. Sens. Tim Kaine (D-Va.), Susan Collins (R-Maine) and Maggie Hassan (D-N.H.) introduced the Interchangeable Biologics Clarity Act, a bill that aims to clarify exclusivity provisions for interchangeable biologics. Sens. Kaine, Hassan, Roger Marshall (R-Kan.) and Bill Cassidy (R-La.) also filed the Biologics Market Transparency Act, which would require biologic manufacturers to let FDA know when a product is coming off the market.

Politico (5/26/2022): CALIFF COMPLETES HILL OVERSIGHT ONSLAUGHT — Thursday’s hearing marked FDA Commissioner Robert Califf’s third appearance on Capitol Hill in one week to explain the FDA’s response to the baby formula crisis, Lauren writes.

Bloomberg (5/26/2022): HHS Names No. 2 for New Biomedical Research Unit: A former DARPA project manager will serve as the first senior official of Biden’s new biomedical entity, a move that marks significant strides in getting the new National Institutes of Health agency off the ground. Adam H. Russell will serve as acting deputy director of the Advanced Research Projects Agency for Health, a new unit within the NIH. Read more from Jeannie Baumann.

Politico (5/25/2022): TOP OFFICIAL TALKS TELEHEALTH — We caught up with Heather Dimeris, director of HRSA's Office for the Advancement of Telehealth, during the agency’s National Telehealth Conference last week.

Bloomberg (5/25/2022): Bill Would Bolster FTC Oversight of Drug Pricing: Pharmacy benefit managers would have to report how much money they make through fees to the Federal Trade Commission under a bill introduced Tuesday. The bipartisan measure from Sens. Maria Cantwell (D-Wash.) and Chuck Grassley (R-Iowa) also seeks to crack down on unfair pricing schemes and clawbacks of payments to pharmacies. Read more from Alicia Diaz.

Bloomberg (5/25/2022): Lawmakers Unveil Veterans’ Toxic Exposures Bill: Sens. Jon Tester (D-Mont.) and Jerry Moran (R-Kan.), the heads of the Veterans Affairs Committee, unveiled sweeping legislation behind a bipartisan agreement that would allow millions of veterans exposed to toxic substances during military deployments to access more medical care and disability benefits, Roxana Tiron reports. Senate Majority Leader Chuck Schumer (D-N.Y.) said he’ll bring the burn pit legislation to the floor in early June. Read the bill here.

Axios (5/25/2022): Washington targets prescription drug middlemen — again - Pharmacy benefit managers are back in the hot seat, facing pressure from both Congress and the Federal Trade Commission — as well as the now customary wrath of drugmakers, pharmacies, hospitals and patient groups, Axios' Caitlin Owens writes.

Modern Healthcare (5/25/2022): Insurers estimate No Surprises Act blocked 2M bills in two months - The health industry reports the surprise billing ban is protecting patients, but providers believe it's at their expense.

Axios (5/25/2022): Ban prevented 2M surprise bills so far - The federal surprise billing ban prevented 2 million potential unexpected medical bills from reaching privately insured patients early this year, Axios' Adriel Bettelheim writes from an analysis released by leading health plans Tuesday.

Politico (5/24/2022): SENATE PLANS TO FORMALLY INTRODUCE UFA BILL THIS WEEK — The leaders of the Senate HELP Committee aim to formally introduce their bill this week to reauthorize FDA’s user fee programs, a GOP Senate HELP Committee aide confirmed to POLITICO.

Politico (5/24/2022): DRUGMAKERS OFTEN REFORMULATE BLOCKBUSTER DRUGS — In a paper published Friday , researchers found that drug companies were more likely to reformulate drugs that brought in $1 billion or more than they were drugs that reached a smaller number of people or already had generic versions available. Reformulating drugs — like making extended-release or combination capsules — allows companies to keep their exclusive rights to sell them.

Bloomberg (5/24/2022): Manchin Outlines Fiscal Priorities: Sen. Joe Manchin (D-W.Va.), a key Democrat who opposed his party’s “Build Back Better” economic agenda (H.R. 5376), at a World Economic Forum panel Monday said Democrats could still roll back parts of the Republican 2017 tax cuts bill, pass drug pricing legislation, and pass an energy and climate measure as part of a reconciliation package. Manchin said opposition to the Republican tax law is a unifying force among Democrats. Read more from Jack Fitzpatrick.

Washington Post (5/24/2022): Democrats refocus attention on drug prices after Oregon primary shakeup - Oregon Rep. Kurt Schrader has long served as a reliable ally of the pharmaceutical industry inside an increasingly hostile Democratic Party.

Politico (5/20/2022): E&C COMMITTEE ADVANCES USER FEE PACKAGE TO HOUSE FLOOR — The House Energy and Commerce Committee on Wednesday advanced six bills, including its user fee and mental health packages and a bill that would establish the Advanced Research Projects Agency for Health, known as ARPA-H. 

Modern Healthcare (5/20/2022): Cancer deaths in Black people drop; still higher than others - An earlier report from the American Cancer Society found the racial gap was narrowing, mostly because of a bigger decline in cigarette smoking among Black people. 

Bloomberg (5/20/2022): Drug Firms Urged to Draft Plans to Avert Shortages: Drugmakers should create plans early on in their product’s development stages to mitigate supply disruptions and shortages, the FDA said on Thursday in draft guidance. The recommendations outline the steps sponsors of drug or biologic applications should take to develop risk management plans that could limit the impacts of quality issues. The draft guidance is part of a coordinated effort by the FDA to better prepare for future issues in pharmaceutical supply following pandemic-fueled shortages. Read more from Celine Castronuovo. 

Politico (5/20/2022): FDA: DRUGMAKERS SHOULD PREP SHORTAGE PLANS — On Thursday, FDA published draft guidance outlining recommendations for drug manufacturers developing and maintaining shortage risk-management plans.

Politico (5/19/2022): HOUSE PANEL ADVANCES PACK OF HEALTH BILLS — The House Energy and Commerce Committee advanced six health care bills Wednesday, including two that renew several mental health programs and another that would establish Biden’s proposed Advanced Research Projects Agency for Health. 

Axios (5/19/2022): Medicaid's digital health gap narrow - For decades, digital health entrepreneurs largely ignored Medicaid users based on assumptions about profit margins and usage rates, Axios' Erin Brodwin writes.

Bloomberg (5/19/2022): House Panel Advances Trio of Health Bills: The House Energy and Commerce Committee on Wednesday approved three bills targeting mental health, ARPA-H, and the user fees that help fund the FDA

Politico (5/18/2022): DRAFT OF USER FEE BILL LANDS — The leaders of the Senate HELP Committee on Tuesday released bipartisan draft legislation to reauthorize the FDA’s medical product user fees for five years and overhaul how diagnostics, dietary supplements and cosmetics are regulated, POLITICO’s David Lim, Katherine Ellen Foley and Lauren Gardner report. 

Bloomberg (5/18/2022): Proposed Cancer Office Cuts Blamed on Timing: The proposal to cut nearly $200 million from the National Cancer Institute as the White House reignites the Cancer Moonshot stems from the timing of overlapping spending plans and does not necessarily reflect the administration’s priorities, NIH’s acting director said. The administration made its funding proposal for the next fiscal year based on the only figures it had at the time, from fiscal 2021, acting Director Lawrence Tabak told a Senate panel. 

Bloomberg (5/18/2022): Lawmakers Press Biden to Put ARPA-H in Their States: Lawmakers are lobbying the White House to put a new biomedical research agency in their home states, with delegations from Texas and Massachusetts sending warring letters recently. Sens. Ed Markey (D-Mass.) and Elizabeth Warren (D-Mass.), and the state’s full House delegation, told Secretary Xavier Becerra that their state would be the ideal place to house the Advanced Research Project Agency for Health (ARPA-H).

Bloomberg (5/18/2022): Drug Dispensing Errors Get FDA Focus: Drugmakers should make sure their product labels are easy to read and prominently display dosing information to prevent dispensing errors, the FDA said in finalized guidance. The guidance, filed Tuesday in the Federal Register, aims to help makers of pharmaceutical and biologic products know what factors to think about to ensure that their labeling is “designed to promote safe dispensing, administration, and use of the product.” Celine Castronuovo has more.

Bloomberg (5/18/2022): Drugmakers Win Challenge to Drug Rebate Rule: A rule issued by the US Centers for Medicare and Medicaid Services requires drugmakers to include discounts offered directly to patients when calculating the “best price” of drugs for purposes of Medicaid’s drug rebate program exceeds the agency’s authority, a federal judge in D.C. ruled Tuesday. The challenged rule, issued in 2020 by CMS, is inconsistent with the federal Medicaid rebate law, Judge Carl J. Nichols said. Read more from Maeve Allsup. 

Politico (5/17/2022): E&C SCHEDULES FULL COMMITTEE MARKUP — The Energy and Commerce Committee will mark up major health legislation — including reauthorization of FDA’s user fee programs and the House’s mental health package — Wednesday at 10 a.m. EDT, Chair Frank Pallone (D-N.J.) announced Monday.

Bloomberg (5/17/2022): FDA to Be ‘Deeply Involved’ in ARPA-H: The FDA’s ability to advance biomedical discoveries from Biden‘s new research hub will hinge on an efficient partnership and will likely intensify an ongoing debate over accelerated approvals, the agency’s second-in-command said. Janet Woodcock’s comments on Monday offered some of the first glimpses into how the FDA sees its role as the Advanced Research Projects Agency for Health (ARPA-H), gets off the ground. Read more from Jeannie Baumann.

Politico (5/17/2022): SENATE USER FEE PACKAGE ANTICIPATED TODAY — Senate HELP Chair Patty Murray (D-Wash.) and ranking member Richard Burr (R-N.C.) plan to release a discussion draft to reauthorize FDA’s medical product user fee programs today, a GOP Senate HELP Committee aide told POLITICO. 

Politico (5/17/2022): WOODCOCK WEIGHS IN ON ARPH-A — If the proposed Advanced Research Projects Agency for Health is created, new treatment candidates would need to engage with FDA early on to help determine appropriate clinical testing design, FDA principal deputy commissioner Janet Woodcock said Monday at the Reagan Udall Foundation for the FDA’s annual public board of directors meeting.

Axios (5/16/2022): What the end of America's public health emergency could mean - The Biden administration is expected to signal this week whether it's ready to end the COVID-19 public health emergency — which would affect a host of health care policies, including vaccines for kids, Axios' Adriel Bettelheim and I write.

Politico (5/12/2022): HOUSE HEALTH PANEL ADVANCES FDA PACKAGE — On Wednesday, the House Energy and Commerce Health Subcommittee advanced legislation that would establish an Advanced Research Projects Agency for Health and reauthorize the Food and Drug Administration’s medical product user fee programs, as well as certain mental health and substance use disorder programs.

Bloomberg (5/12/2022): Medicare for All to Get Senate Look: The Senate Budget Committee today will hold hearing on Sen. Bernie Sanders’ (I-Vt.) proposal to establish a single-payer health system in the US, replace private insurance with an overarching public health insurance coverage program. Sanders, chairman of the panel, rose to national prominence in 2016 running for the Democratic presidential nomination partly on the promise to enact his Medicare for All legislation, but the political realities since then have shifted attention away from the bill, Alex Ruoff reports. 

Bloomberg (5/12/2022): Cures 2.0 to See Summer Action: The biomedical innovation legislation “Cures 2.0" is likely to come up for a vote in the House Energy and Commerce Committee in the coming weeks, the bill’s Republican architect told Bloomberg Government. Cures 2.0 is a follow-up to the 2016 landmark law 21st Century Cures (Pub. L. 114-255) by Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.). It was aimed at accelerating research and bringing innovations to patients faster. Cures 2.0 would build upon that, partly by addressing the lasting impacts of Covid-19. Read more from Alex Ruoff and Jeannie Baumann.

Bloomberg (5/12/2022): FDA’s User Fee Package Advances to Full House Committee: The House Energy and Commerce Committee’s Subcommittee on Health voted 30-0 to advance a bill (H.R. 7667) reauthorizing the user fees that help finance the FDA, including policy proposals to improve the accelerated approval pathway and remove barriers to generic drug competition. “This package is an enormous legislative undertaking,” Subcommittee Chair Anna Eshoo (D-Calif.) said, adding that the agreements will give the FDA billions of dollars over the next five years to help it recover from the pandemic. Celine Castronuovo has more.

Bloomberg (5/12/2022): Biden’s NIH Spending Plan Faces Criticism From House Panel: The White House’s proposed NIH budget faced criticism from both Democratic and Republican leaders of a House spending panel for pouring too much money into a new biomedical entity and not enough into the agency’s base budget. The House Appropriations Labor-HHS-Education Subcommittee held a hearing Wednesday on the 2023 budget request for the National Institutes of Health, whose budget would grow by about $270 million from the current $45 billion spending level, under the request. Jeannie Baumann has more.

Politico (5/11/2022): PUBLIC HEALTH EMERGENCY WATCH — HHS Secretary Xavier Becerra could soon announce whether the Covid-19 public health emergency expanding telehealth access ends in mid-July — or is extended.

Modern Healthcare (5/11/2022): AHA, AMA ask HHS for COVID-19 emergency extension - The end of the COVID-19 public health emergency declaration could be announced within days.

Bloomberg (5/11/2022): House Panel to Mark Up Health Bills: A House subcommittee Wednesday will mark up six health care bills that represent rare bipartisan agreement in areas like mental health and pharmaceuticals. The House Energy and Commerce health subcommittee will weigh bills ranging from authorization of Biden’s proposed new biomedical agency to a slew of mental health measures and a new agreement on the Food and Drug Administration’s user fee programs.

Bloomberg (5/11/2022): HHS Says Drug Discount Rule Breakers Face Fines: The Health and Human Services Department should be allowed to penalize drugmakers who violate the rules of a federal program designed to help lower-income Americans afford drugs, the HHS told the Third Circuit. HHS is appealing a lower court ruling that partially vacated enforcement letters it sent to Novo Nordisk Pharma and Sanofi-Aventis, threatening monetary penalties if the companies don’t lift limits on discounts provided to pharmacies contracting with health providers in the 340B program. Allie Reed has more.