Shutdown or no shutdown? Leaders strike deal on general spending framework, but drama brews as January 19 deadline approaches
Members of Congress are back to work this week, and a Sunday announcement has Capitol Hill buzzing. Congressional leaders announced a top-line agreement on basic budget parameters, and now the two chambers can work to reconcile those differences in the underlying legislation and pass appropriations before the funding deadlines on January 19 and February 2. Most health care spending line items need to pass by the first January 19 deadline. While House Speaker Mike Johnson (R-LA), Senate Majority Leader Chuck Schumer (D-NY) and the White House touted the initial agreement, some House Republicans immediately criticized the move, calling the spending reductions too minimal. The influential House Freedom Caucus, a group of conservative Republican members, accused congressional leaders of getting creative with spending numbers, claiming the cuts in domestic spending are not as deep as reported. The agreed-upon framework does not address major issues that threaten to torpedo ongoing budget discussions. Republicans hold that any new funding for conflicts in Ukraine and Israel must be coupled with U.S. border security changes, which they contend is a primary national security issue. Without an agreement on border security, it’s unlikely Speaker Johnson will be able to keep his caucus united in the coming weeks. With the recent resignation of Rep. Bill Johnson (R-OH), the Republican majority in the House is down to just two votes, meaning any ultimate budget agreement will require support from Democratic members. If you’re looking for influential members and organizations to follow on X (formerly Twitter) and stay abreast of where things stand in House at any given moment over the next two critical weeks: Speaker Johnson (@SpeakerJohnson), conservative leader Rep. Chip Roy (R-TX) (@chiproytx), House Minority Leader Rep. Hakeem Jeffries (D-NY) (@hakeemjeffries), House Freedom Caucus (@freedomcaucus) and House Progressive Caucus (@USProgressives).
FDA approves 55 novel therapies in 2023; Second highest number of approvals in last 30 years
The FDA’s Center for Drug Evaluation and Research (CDER) approved 55 new therapies last year, a 50% increase over the previous year. Looking over the last 30 years, 2023 is second only to 2018 in terms of the highest number of therapies approved. The FDA approved 59 therapies in 2018. According to an analysis by the journal Nature, the oncology therapeutic area saw the most approvals (as has been the case in recent years). CDER approved 13 (24% of the total approvals) new cancer therapies in 2023. Neurology came in second, with 9 (16%) approvals, also in line with recent trends. Infectious diseases and hematology tied for third, with 5 (9%) each. While several headline-grabbing approvals occurred in 2023, most notably the Alzheimier’s therapy Leqembi® from Eisai/Biogen and Pfizer’s COVID antiviral Paxlovid®, several new therapies to treat rare diseases were also approved. These include therapies to treat Rett syndrome, ALS, Pompe disease and Duchenne muscular dystrophy. Seven of the new approvals were Pfizer products. For a complete list of 2023 approvals, visit the FDA 2023 Novel Drug Approvals site.
Biden Administration warns pharmaceutical companies: We can seize patents if prices are too high
Continuing to flame the political fire over drug pricing heading into the November elections, the Biden administration has opened the door to seizing the patents of some medications from drugmakers to address what they consider excessive prescription drug prices. In December, the administration unveiled a framework outlining the factors federal agencies should consider in deciding whether to use a controversial policy (also known as “march-in rights”) to take patents for drugs developed with taxpayer funds and share them with other pharmaceutical companies if the public cannot “reasonably” access the medications due to price. It’s the first time the federal government has explicitly stated that officials can now consider a medication’s price in deciding to break a patent. Experts say it’s somewhat unclear how federal agencies will use march-in rights under the new framework. However, the announcement is a clear example of how the debate over drug pricing has changed since the passage of the Inflation Reduction Act (IRA) in 2022. While some members of Congress, including Sen. Bernie Sanders (I-VT), have long advocated for federal utilization of “march-in rights” to address prescription drug prices, it was not generally considered a mainstream position, even among Democrats. The Biden Administration’s December announcement changes that dynamic. PhRMA, the biopharmaceutical company trade association, immediately criticized the Biden Administration’s framework, saying seizure of patents would “further harm patients who rely on public-private collaboration to advance new treatments and cures”. PhRMA also spotlighted a Fact Sheet that outlines how the federal government’s exercising of “march-in” rights would negatively impact the U.S. innovation ecosystem.
New Year = Many New Health Care Laws
As we kick off 2024, a plethora of new state health care laws are now in effect. Here’s a sampling of some of the more notable, as states continue to be “health policy laboratories”:
- California – Physician assistants can now perform surgical abortions without direct physician supervision
- Colorado – Health care providers can no longer perform intimate exams on patients who are sedated or unconscious (with limited exceptions)
- Connecticut – The state’s pharmacy benefit managers (PBMs) are subject to new transparency requirements, especially when dealing with 340B providers or pharmacies
- Illinois – Health care facilities must now notify the state attorney general within 30 days of a proposed merger or acquisition
- Minnesota – Similar to Illinois, any health care facility that earn annual revenue between $10M-$80M must inform the state of upcoming mergers or acquisitions
- Nebraska – Medicaid postpartum coverage is now extended from 60 days to 12 months
- Oregon – State-regulated individual and fully insured group health insurance plans must cover three primary care visits per year, per individual
- Texas – Health insurers must create and maintain a website where health care providers can verify a patient’s coverage and see potential deductibles, copays and coinsurance
Health Policy Snippets:
- The Food and Drug Administration on January 5 approved Florida’s request to import certain drugs from Canada, marking the first time a state has been authorized to buy lower-cost medications in bulk from abroad. Florida Governor Ron DeSantis, who is seeking the 2024 Republican nomination to challenge President Joe Biden, signed the legislation into law in 2019, but it had been blocked by the FDA since it was signed. Critics of such laws cite safety concerns.
- In December, the Kaiser Family Foundation (KFF) issued its annual report examining the country’s uninsured population. It found that in 2022 the number of nonelderly uninsured individuals continued to decline. The uninsured rate decreased from 10.2% in 2021 to a record low of 9.6% in 2022. The KFF Uninsured Report can be accessed here.
