(7/29/2022): SENATE DEMS RELEASE FY2023 FDA BUDGET
— On Thursday, Democrats on the Senate Appropriations Committee debuted all 12 of their annual spending bills to fund the government in fiscal 2023, proposing a more than 10 percent increase in nondefense spending and a nearly 9 percent boost in defense funding, POLITICO’s Jennifer Scholtes reports.
(7/29/2022): FDA Layoffs Loom, Califf Says
: FDA employees could start receiving layoff warnings by September if House and Senate leaders don’t reach a compromise to reauthorize the fees that help fund the agency by then, Commissioner Robert Califf said Thursday. Celine Castronuovo has more.
(7/29/2022): DRUGMAKERS WAGE ‘HAIL MARY’ CAMPAIGN TO SINK RECONCILIATION BILL
— For the pharmaceutical players, the newly revived budget reconciliation bill is a five-alarm fire , POLITICO’s Megan Wilson reports.
(7/29/2022): Schumer to Try Again on Burn Pits Bill
: Schumer said Thursday he’ll bring the legislation giving veterans exposed to toxic burn pits access to expanded health benefits back to the floor next week, and that he will allow Sen. Pat Toomey (R-Pa.) to bring an amendment addressing mandatory spending to the floor for debate. Read more from Diego Areas Munhoz.
(7/29/2022): FIRST IN PULSE: NEW ADS TARGET DEMS OVER DRUG PRICING
— Conservative group American Commitment is dropping seven figures to run ads in the Washington, D.C., area plus Nevada , Georgia and West Virginia in the latest effort to pressure key Democratic lawmakers to vote “no” on the reconciliation bill as the package gains momentum.
(7/29/2022): WHAT BIG PHARMA IS DOING
— Advertisements flooding the airwaves are just one tactic being used in the effort to kill the reconciliation bill. Pharmaceutical executives and lobbyists are on Capitol Hill, continuing to make the case that the drug pricing provisions would be harmful to innovation and new drug development.
(7/28/2022): House Passes Medicare Telehealth Extension
: The House passed a bill H.R. 4040 from Rep. Liz Cheney (R-Wyo.) would extend Medicare telehealth waivers through Dec. 31, 2024, regardless of whether the Covid public health emergency is lifted. Tony Pugh has more.
(7/28/2022): House passes bill extending telehealth reimbursement through 2024
- The bill would extend Medicare flexibilities established during the COVID-19 pandemic.
(7/28/2022): August Recess Start Date in the Air as Senators Await Ruling
- The Senate’s planned departure date next week is in question, as Democrats push to pass a tax, climate, and health care bill through the budget reconciliation process before leaving town until September.
(7/28/2022): Drug industry poised for rare political loss on prices
- Year after year for most of two decades, proposals to allow the government to negotiate lower prices from drug companies for Medicare recipients have wound up dead in Congress, defeated by the powerful pharmaceutical industry and its allies. Now the Washington drug lobby is on the cusp of a rare political loss.
(7/28/2022): MANCHIN-SCHUMER DEAL
— Sen. Joe Manchin (D-W.Va.) said Wednesday that he’s reached a deal with Senate Majority Leader Chuck Schumer on a party-line spending bill that includes energy and tax policy, POLITICO’s Burgess Everett reports.
(7/28/2022): TELEHEALTH BILL PASSES HOUSE
— The House passed legislation from Rep. Liz Cheney (R-Wyo.) that would extend loosened telehealth rules through the end of 2024 in a landslide vote Wednesday.
(7/27/2022): DEMS BRACE FOR PARLIAMENTARIAN RULING ON DRUG PRICING
— The Senate parliamentarian could decide as early as today whether Democrats’ drug pricing provisions can pass with fewer than 60 votes, Alice reports.
(7/27/2022): Dem drug bill targets old blockbusters
- Democrats' push to allow Medicare to negotiate prescription drug prices has been limited to older drugs without generic competition, but even so, many of the program's costliest medicines would still be eligible, Axios' Caitlin Owens writes.
(7/27/2022): TELEHEALTH VOTE TEED UP
— The House is set to vote this week on a bill by Wyoming Republican Liz Cheney that would extend through the end of 2024 the telehealth flexibilities the Trump administration granted at the pandemic’s outset.
(7/27/2022): Cancer Patients to Get Easier Path to Trials
: Patients with incurable cancers should have an easier time getting into clinical trials under new FDA guidance on developing criteria for trial eligibility. The final guidance marks the latest bid by the agency to expand the criteria for who can participate in cancer trials. Jeannie Baumann has more.
(7/26/2022): DEMS TWEAKING DRUG PRICING PLAN
— Democratic senators are adjusting language in their plan to have Medicare negotiate some drug prices after debating the reconciliation package with Republicans last week ahead of the Senate parliamentarian’s ruling on whether the plan meets budget reconciliation rules, POLITICO’s Caitlin Emma, Jennifer Scholtes, Marianne Levine and Burgess Everett report.
(7/26/2022): FDA to Enforce Generic Drug Deadlines
: Generic drugmakers risk having their product applications withdrawn by the FDA if they don’t address application deficiencies within one year of notification, according to guidance issued Friday. The FDA’s recommendations apply to abbreviated new drug applications for generic versions of approved drugs. Celine Castronuovo has more.
(7/26/2022): Sanders says Democrats’ prescription drug reform bill is ‘weak’
- Senate Budget Committee Chairman Bernie Sanders (I-Vt.) said Tuesday that the prescription drug reform proposal that Democrats plan to move under special budget reconciliation rules is “weak,” noting it covers a limited number of drugs and doesn’t substantially take effect until 2026.
(7/25/2022): Democrats rev up high-stakes final push to lower drug prices
- Senate Democrats are making a high-stakes final push to get legislation to lower prescription drug prices over the goal line.
(7/22/2022): FDA CAN CONTINUE NORMAL OPERATIONS UNTIL NOVEMBER, BURR SAYS
— The FDA has enough carryover funds from its user fee programs to maintain normal operations through the start of November, Senate HELP ranking member Richard Burr (R-N.C.) told reporters Tuesday .
(7/22/022): There’s no ‘Moonshot’ or ‘Warp Speed’ for rare diseases. There should be
- The term “rare disease” is both an apt descriptor and a misnomer. Individually, each rare disease affects a relatively small number of people. But taken together, more than 30 million Americans, and 400 million people worldwide, are affected by one of the 10,000-plus rare diseases — 95% of which have no approved treatment. More than half of those with rare diseases are children, one-third of whom won’t live to celebrate their fifth birthdays.
(7/22/2022): Biden’s Claim That the Drug-price Bill Will ‘help Fight Inflation’
- "This will not only lower the cost of prescription drugs and health care for families, it will reduce the deficit and help fight inflation."
(7/22/2022): Biden to Name First Woman to Lead National Cancer Institute
: Harvard cancer surgeon Monica M. Bertagnolli is on tap to serve as the next director of the National Cancer Institute, indicating the White House plans to install a well-known cancer physician-scientist as it shores up the next phase of the Cancer Moonshot. Bertagnolli won’t need Senateconfirmation. Jeannie Baumann has more.
(7/22/2022): FDA FUNDING HOPS ON HOUSE MINIBUS
— The House passed a six-bill spending package on Wednesday that would include $3.66 billion in fiscal 2023 discretionary funding for the FDA, POLITICO’s Jennifer Scholtes reports. Senior lawmakers are still working out a broader funding deal, making a continuing resolution extending current levels past Sept. 30 likely.
(7/22/2022): FDA USER FEE RENEWAL WOULD SAVE $1.4B
— CBO also projected on Thursday that a bill to reauthorize Food and Drug Administration user fees, S. 4348 (117) , would save almost $1.4 billion over a decade.
(7/21/2022): Senators Meet Referee on Drug Pricing, ACA
- Democrats are hoping to clear a key procedural hurdle today for their legislation to direct the government to demand lower prices from drugmakers and expand Obamacare premium subsidies. Senate Democratic and GOP staffers will argue before the chamber’s parliamentarian on whether parts of the bill could qualify for the budget reconciliation process, which allows some kinds of legislation to pass via a simple major in the Senate.
(7/21/2022): House Passes Six-Bill Funding Package
: The House passed a six-bill government funding package totaling just over $400 billion—about a fourth of discretionary funds for fiscal 2023—by a 220-207 vote. It includes a provision to block reviews of drugs by Russian pharmaceutical companies. Jack Fitzpatrick has more.
(7/20/2022): STATES JOCKEY FOR ARPA-H HEADQUARTERS
— Congress gave the green light to President Joe Biden’s idea to create a new agency to bolster “high-risk, high-reward” biomedical research when it passed legislation funding the Health and Human Services Department in March.
(7/20/2022): Powerful Senate Democrat outlines ‘plenty’ more drug pricing reforms to follow Medicare negotiation
- WASHINGTON — Democrats may be closer than ever to passing sweeping drug pricing reforms, but Sen. Ron Wyden says there’s more to do.
(7/20/2022): Democrats are full speed ahead on drug pricing bill
- It’s official. Democrats’ Manchin-ified health-care reconciliation bill is moving forward. But there are still major questions hanging over the effort. For one, the structure of a two-year extension of enhanced Affordable Care Act subsidies is still under discussion, according to multiple people familiar with the negotiations. And the drug pricing effort is set this week to go before the arbiter of the Senate’s rules — and must pass inspection before Democrats can approve the measure with a simple majority.
(7/20/2022): UNIFORM TELEHEALTH ACT HEADS TO STATES
— An influential commission agreed to propose a bill to states to coordinate state telehealth legislation and expand access to virtual care.
(7/20/2022): Senate Eyes Research Tax Break in Chips Bill
: The US Senate voted by a 64-34 margin to begin debate on legislation to provide more than $52 billion in grants and incentives for the American semiconductor industry, Daniel Flatley and Erik Wasson report. Meanwhile, a bipartisan Senate group is making a last-minute push to revive a tax break for corporate R&D in the bill. Sen. Todd Young (R-Ind.) said lawmakers are eyeing a one-year extension to a tax break for R&D costs that expired at the end of 2021, which would be a boon to drugmakers. Read more from Laura Davison and Erik Wasson.
(7/19/2022): RECONCILING WHAT DRUG PRICING MEANS FOR PHARMA
— All eyes are on the Senate this week as lawmakers battle over the piece of Democrats’ reconciliation bill that’s still standing as of now : An effort to lower some drug prices that Medicare pays.
(7/19/2022): Parliamentarian Reviewing Drug Pricing, ACA Language
: Senate Majority Leader Chuck Schumer (D-N.Y.) is moving forward on the Joe Manchin-approved package of Obamacare subsidies and drug pricing measures before the August recess, just before many Americans would receive notice that their Affordable Care Act premiums are set to skyrocket in January. The first stop is the Senate parliamentarian, who could decide this week on whether those provisions can be pushed through via a filibuster-proof budget reconciliation process. Read more from Erik Wasson and Laura Davison.
(7/18/2022): DEMOCRATS BRACE FOR DRUG-PRICING BYRD BATH AS BROADER AGENDA CRUMBLES
— Following Sen. Joe Manchin’s (D-W.Va.) blow to Democrats’ dreams for a sweeping tax-climate-health care reconciliation bill, lawmakers will fight this week over a core piece of what remains on the table: a major overhaul of how the country sets drug prices.
(7/18/2022): Next up for new vaccines: cancer and Alzheimer’s
- A vaccine is a preparation that stimulates your immune system to respond against a disease. We have grown accustomed to thinking of a vaccine as a virus (or bacteria) or part of a virus that is “defanged” or inactivated and then introduced into the body to provoke the same kind of immune response that the full-fledged virus would. This in effect “tricks” the body into responding.
(7/18/2022): Biden Pushes for Separate Drug-Price Bill
- President Joe Biden vowed to take executive action on climate change after Sen. Joe Manchin (D-W.Va.) put a sweeping tax and energy bill on hold, telling congressional Democrats to move ahead on a smaller measure to rein in drug prices and stop premium hikes for Obamacare that he would sign.
(7/18/2022): How Manchin could force Dems to swallow a skinny health bill
- Sen. Joe Manchin's insistence on a skinny reconciliation bill is infuriating Democrats but forcing them to consider the power of running on health costs and coverage, heading into the midterms, Axios’ Adriel Bettelheim writes.
(7/15/2022): BURR UNDER DEMS’ SADDLE
— Senate HELP Committee ranking member Richard Burr (R-N.C.) is done trying to negotiate a wide-ranging FDA user fee reauthorization package that includes yearslong efforts to revamp oversight of diagnostics, dietary supplements and cosmetics. The powerful Republican on Thursday introduced a spartan bill that simply reauthorizes the underlying user fee agreements for five years and strips out major riders and amendments.
(7/15/2022): Democrats' economic package may have just turned into a health-care bill
- There’s been another seismic shift in the negotiations over Democrats’ long-stalled economic package. The climate change and tax increase provisions appear out. What’s left is a health care bill — and one that’s much smaller than the once-in-a-decade remake of the system Democrats had originally envisioned.
(7/15/2022): FDA Funding in Peril as Lawmakers Diverge on User Fee Deal:
Food and Drug Administration funding is in question after a key negotiator Sen. Richard Burr (R-N.C.) Thursday proposed walking away from months of efforts to overhaul the agency’s fast-track approval system. House leaders are now urging the Senate to vote quickly on their proposal (H.R. 7667) for reauthorizing industry user fees that help fund the FDA after the Senate health committee’s ranking member proposed a stripped down version lacking several previously negotiated provisions. Read more from Celine Castronuovo and Alex Ruoff.
(7/15/2022): HOUSE PASSES BURN PIT BILL, AGAIN
— The 342-88 vote Wednesday sends the bill back to the Senate, again, after both chambers have already passed versions of the legislation that would expand Veterans Affairs coverage for millions of service members who reported cancer and respiratory illnesses after exposure to burn pits at military locations overseas.
(7/15/2022): NORTH CAROLINA VIES FOR ARPA-H
— State universities, nonprofits and industry groups are banding together to make a case for Biden’s research vision, the Advanced Research Projects Agency for Health, to be headquartered in North Carolina.
(7/14/2022): Congressionally Directed Medical Research Programs
: Background and Issues for Congress.
(7/14/2022): Manchin broaches stand-alone drug pricing bill
- Congressional Democrats see government drug price negotiations as a core piece of a reconciliation bill — but one key swing lawmaker suggested Wednesday it could wind up being an end in itself, Axios' Adriel Bettelheim writes.
(7/14/2022): Reconciliation talks so far quiet on Medicaid expansion
- Advocates are pushing to squeeze Medicaid expansion and home health funding into a potential budget reconciliation bill after Majority Leader Charles E. Schumer, D-N.Y., renewed negotiations with moderate West Virginia Democrat Joe Manchin III.
(7/14/2022): BURR ‘DOUBTFUL’ USER FEE RIDERS SURVIVE
— A crowded legislative calendar, industry lobbying and a wide gap between the House and Senate packages to reauthorize the Food and Drug Administration’s user fee programs are endangering yearslong efforts to revamp oversight of diagnostics, dietary supplements and cosmetics.
(7/13/2022): House Vote on Burn Pits Bill
: The House is slated to vote Wednesday on legislation (S. 3373) to provide health benefits to veterans exposed to toxins while serving overseas, Loren Duggan reports. The new version of the measure omits a tax provision from the original bill (H.R. 3967) that raised constitutional issues, and will be offered as a House amendment. Brittney Washington has highlights in the BGOV Bill Summary.
(7/12/2022): CBO: SENATE DEM DRUG PRICING PROPOSAL COULD SAVE BILLIONS
— The drug pricing portion of Senate Democrats’ budget reconciliation package would cut the deficit by nearly $288 billion over the next decade, the Congressional Budget Office said in an estimate released Friday . The score results in slightly fewer savings compared with the drug pricing provisions in the House-passed social spending package, H.R. 5376 (117). They were projected in November to save about $300 billion over 10 years.
(7/11/2022): House Aims to Tackle Spending Bills This Month
: The House plans to vote on a package of six appropriations bills the week of July 18, including the Agriculture-FDA and Military Construction-Veterans Affairs spending bills, according to a release. Find text of the bills here.
(7/11/2022): Democrats are racing to pass their scaled-back economic and health package
- The race to pass a long-stalled economic package this month is on. Momentum — and optimism — has picked up in recent weeks, as party leaders attempt to broker a compromise with Sen. Joe Manchin (D-W.Va.) on a package that could be brought to the floor before August recess. Several key health issues remain unresolved, though Senate Democrats recently secured agreements on efforts to lower seniors’ prescription-drug prices and improve Medicare’s financial health.
(7/11/2022): Drug Pricing Plan Faces Industry Gripes as Senate Reconvenes
- An attempt on Capitol Hill to reduce skyrocketing US drug costs may undercut its own goal by stripping pharmaceutical companies of incentives for producing blockbuster drugs and their lower-cost counterparts, industry groups and analysts warn.
(7/8/2022): ‘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.
(7/8/2022): Democrats Propose Medicare Solvency Plan
- Senate Democrats have reached a deal to extend the solvency of Medicare by closing a tax loophole frequently used by law firms and other partnerships, adding another leg to President Joe Biden’s revised economic agenda.
(7/7/2022): DEMS ATTEMPT TO REVIVE DRUG PRICING
— Much to the chagrin of the pharmaceutical industry, Senate Democratic leadership released legislative text on Wednesday detailing their updated drug pricing plans in an attempt to revive the sweeping Build Back Better reconciliation bill that fell apart last year.
(7/7/2022): Oncologists turn to telehealth for an extra layer of patient care
- Even as physicians in other sectors return to in-person visits, some health systems plan to expand remote monitoring technology and digital platforms for cancer care.
(7/7/2022): Dems revisit drug price negotiations
- Democrats are trying again to enact government price negotiations for prescription drugs, with a revised plan that would be wrapped into a broader reconciliation bill, Axios' Adriel Bettelheim writes.
(7/7/2022): Agencies Join Democrats’ Drug Price War
- Biden administration officials are committing to curbing patent practices that lead to high drug costs as Senate Democrats push ahead with a plan to lower pharmaceutical prices.
(7/7/2022): Here’s what Democrats changed in their latest drug pricing bill - WASHINGTON
— Senate Democrats have put final tweaks on their drug pricing proposal, as they race to achieve one of their signature domestic policy promises ahead of the midterm elections.
(7/6/2022): Senate Democrats Finalize Prescription Drug Pricing Bill
- Democrats finalize a prescription drug plan in a step to initiate the Senate parliamentarian review process, according to a copy obtained by Bloomberg News.
(7/6/2022): A national bidding war for ARPA-H
- An interstate bidding war has broken out for the chance to house the headquarters of a multibillion-dollar new science agency aimed at curing major diseases — before the agency's structure has even been finalized by Congress, Axios' Emma Hurt writes.
(7/6/2022): The future of telehealth reimbursement
- Many providers are advocating for CMS to permanently lift its restrictions on billing Medicare for telehealth care.
(7/6/2022): Democrats’ latest attempt at resurrecting Build Back Better, explained
- This month, Democrats are, once again, trying to resurrect parts of the Build Back Better Act after the broader package imploded last year.
(7/6/2022): Schumer moves on reconciliation
- Senate Majority Leader Chuck Schumer is getting the ball rolling on a potential Democratic reconciliation package.
(7/1/2022): USER FEE REAUTHORIZATION TIMELINE SLIPPING
— Congress will likely miss its self-imposed goal of sending a bill to reauthorize the FDA user fee programs to President Joe Biden’s desk before August, raising the specter that reduction-in-force notices will have to be sent to thousands of agency employees, people familiar with ongoing negotiations told Prescription Pulse.
(7/1/2022): Consumers will soon get access to huge amounts of health care price data
- Patients will soon have a clearer picture of what insurers and employers pay for health care thanks to a federal rule that kicks in today — if a collection of health tech companies can make the trove of data understandable.
(7/1/2022): McConnell Threatens China Bill Over Biden Drug, Climate Plan
: Senate Minority Leader Mitch McConnell (R-Ky.) said he will block bipartisan legislation (H.R. 4521) to boost US competition with China as long as Democrats pursue a go-it-alone economic package. McConnell’s threat comes as Majority Leader Chuck Schumer (D-N.Y.) and holdout Sen. Joe Manchin (D-W.Va.) are close to a framework agreement on a $1 trillion bill that includes prescription drug price cuts, Erik Wasson and Laura Davison report.
(7/1/2022): HOUSE APPROPRIATORS ADVANCE HHS BILL AFTER ABORTION FIGHT
— The House Appropriations Committee approved $242 billion legislation Thursday on a party-line vote that would fund the Department of Health and Human Services for fiscal 2023 — but without longstanding language banning the use of federal funds to cover abortions. Debate over the so-called Hyde amendment dominated the first two hours of the markup, with Republicans arguing that the provision would eventually need to be added to the bill to win enough Senate votes for HHS funding to be appropriated.