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| By Lauren Gardner and David Lim |
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Rep. Andy Harris says passage is possible, but not certain, for the fiscal 2025 Agriculture-FDA spending bill. | House Appropriations Committee |
APPROPS WEEK — House and Senate appropriators return to the Capitol this week with our favorite bill on their schedules: the fiscal 2025 Agriculture-FDA spending measure. The House Appropriations Committee will vote on its bill during a marathon markup on Wednesday. The Agriculture-FDA Subcommittee approved the draft legislation last month on a party-line vote. The Senate Appropriations Committee will take up its fiscal 2025 bill on Thursday. In the House: The bill would direct $3.5 billion in federal spending to the FDA, with an additional $3.25 billion earmarked for the agency from user fees. That’s a slight drop from current funding levels of $3.52 billion in discretionary funding and $3.2 billion in user fees. Rep. Andy Harris (R-Md.), chair of the FDA spending panel, told POLITICO’s Jennifer Scholtes and Caitlin Emma in the spring that he expected the bill to “easily” pass out of subcommittee and committee and that it “might” have an easier time during floor debate than it did last year. The House’s fiscal 2025 bill has a higher monetary allocation than its fiscal 2024 proposal, which Harris suggested should help its prospects. But those will also depend on the extent to which members load up the measure with so-called poison-pill riders that provoke GOP defections. Republicans didn’t include a provision to effectively ban the mail delivery of abortion pills in the bill’s base text in a concession to swing-district members. But that doesn’t mean conservative lawmakers won’t try to add it during Wednesday’s markup. A Senate mystery: Meanwhile, the Senate committee will mark up the fiscal 2025 FDA bill shortly after it adopts allocations for all 12 spending bills, leaving everyone in suspense until Thursday about how much discretionary funding it sets aside for the agency. The chamber’s fiscal 2024 bill largely tracked with the House’s allocation for the agency, which ultimately got a slight bump once lawmakers finally reached a deal in March on that year’s spending. All this to say: A continuing resolution to fund the government is still very likely come September. IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Your morning hosts are here to remind you that, no matter what the news of the day is, we’re always available to talk about pharma policy (shorter: Please be kind to policy beat reporters!). Send news and tips to David Lim (dlim@politico.com or @davidalim) and Lauren Gardner (lgardner@politico.com or @Gardner_LM).
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| A message from 340B Health: Support the 340B PATIENTS Act The 340B PATIENTS Act eliminates harmful big pharma restrictions on 340B savings that are vital for expanding health care and support for patients and rural communities in need. By restricting 340B pharmacy partnerships, drugmakers have siphoned billions from the health care safety net solely to bolster their profits. The 340B PATIENTS Act stops this damaging behavior. We call on Congress to support this vital legislation. Learn more. |
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Drug companies seek to roll back the Inflation Reduction Act's drug price negotiation program, but they've not been successful with challenging it in the courts. | Sue Ogrocki/AP |
ANOTHER PHARMA LOSS — Boehringer Ingelheim expressed disappointment with a federal court ruling against its Inflation Reduction Act challenge in a Monday statement but didn’t say whether it plans to appeal to the Second Circuit. The U.S. District Court in Connecticut last week rejected Boehringer Ingelheim’s legal challenge to Medicare’s drug price negotiation program, dealing yet another blow to the industry’s efforts to challenge its constitutionality. “Boehringer Ingelheim shares the goal of ensuring our medicines are affordable and available to people who need them — however, we remain concerned about the detrimental and limiting effects the IRA and its ‘negotiation’ program will have on the future of innovation for the patients we serve,” it said. Eyes on the prize: Drug companies and their business allies have targeted circuit splits at the appellate level, hoping to escalate their cause to the Supreme Court, so the district-level losses aren’t the final say in the legal saga. Still, the industry has yet to notch a win in the lower courts — and those judges “are just not buying what pharma is selling,” said Zach Baron, director of the Health Policy and the Law Initiative at Georgetown’s O'Neill Institute. Judges in Connecticut, Delaware and New Jersey have “pretty squarely rejected” industry arguments that the negotiation program is unprecedented and should be considered differently from past Medicare challenges, Baron said, adding that they’ve grappled with how their decisions could affect other types of agreements the federal government makes with private businesses. And Chevron? Whether and how drug companies might capitalize on the Supreme Court’s killing of the Chevron doctrine in their IRA cases remains to be seen. While some lawsuits argue the Biden administration violated the Administrative Procedure Act by implementing the program via guidance instead of notice-and-comment rulemaking, the Justice Department didn’t invoke the precedent in its responses. U.S. District Court Judge Michael P. Shea agreed with the DOJ that BI’s argument failed because Congress explicitly asked the agency to implement the first three years of the negotiation program through guidance. “Much as BI might dislike Congress’s policy choices, it cannot seek to undo them through an APA claim,” he wrote.
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| Understand 2024’s big impacts with Pro’s extensive Campaign Races Dashboard, exclusive insights, and key coverage of federal- and state-level debates. Focus on policy. Learn more. |
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| FDA: HELP US COMBAT MISINFORMATION — Pharmaceutical and medical device companies have a role to play in combating misinformation about their products, the FDA said Monday. Draft recommendations aim to help patients and their health care providers avoid making medical decisions based on faulty information. Specifically, the agency wants companies to feel comfortable communicating online when false or inaccurate information about their products is decimated on social media. “The growing spread of rumors about science and medicine continues to put patients and consumers at risk,” FDA Commissioner Robert Califf said in a statement. “We remain steadfast in our commitment to address this public health concern and continue to support and encourage all parties in the public health ecosystem to take an active role.”
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| A message from 340B Health:   |
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ALL EYES ON BIOSECURE — House Speaker Mike Johnson said Monday he expects Congress to send a legislative package to the president’s desk by the end of the year to take tougher action against China — including a bill focused on the country’s influence over the domestic drug supply chain, POLITICO’s Doug Palmer reports. The Louisiana Republican name-checked the BIOSECURE Act, which he said would “halt federal contracts with biotech companies that are beholden to adversaries.” Attempts to get the bill offered as an amendment to the defense authorization measure last month failed, but lobbyists and analysts tracking its prospects have chalked that up to strict germaneness requirements for amendment consideration.
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FDA’S REGULATORY AGENDA — The Biden administration’s updated list of regulatory priorities it plans to act on in the coming months includes proposed rules containing requirements on pediatric study plans and importers of e-cigarettes to include FDA premarket application numbers on their packages. The list — formally known as the Spring 2024 Unified Agenda — contains 69 agency regulations. But the timelines for the numerous regulations are not binding, and the agency does not always adhere to the agenda. But several high-profile cigarette regulations are on the back burner — otherwise known as the long-term actions list. Those include an anticipated agency proposal to set limits on the amount of nicotine allowed in cigarettes and a ban on menthol-flavored cigarettes.
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| Understand 2024’s big impacts with Pro’s extensive Campaign Races Dashboard, exclusive insights, and key coverage of federal- and state-level debates. Focus on policy. Learn more. |
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GOP PLATFORM — The GOP's new party platform, authored by former President Donald Trump and his campaign, says that prescription drug costs “are out of control.” The document, adopted at a party platform committee meeting, calls for increased transparency, choice and competition in health care and expanded access to “new affordable healthcare and prescription drug options.”
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| The Washington Post spoke to five people who survived measles in their childhoods, as cases tick up amid vaccine hesitancy. A new study shows that people lost significantly more weight on Eli Lilly’s diabetes drug Mounjaro than on Novo Nordisk’s competitor Ozempic — with roughly the same side effects and dropout rates, USA Today reports.
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| A message from 340B Health: Support the 340B PATIENTS Act
340B hospitals are the backbone of the nation’s health care safety net, providing essential services to patients with low incomes and those living in rural America. 340B hospitals play a vital role in delivering 77% of Medicaid hospital care, providing 67% of the nation’s unpaid care, and offering comprehensive specialty services that otherwise might not be available. 340B helps lower health care costs and enable doctors, nurses, and pharmacists to provide expanded care for the benefit of their community—all at no cost to the taxpayer.
The 340B PATIENTS Act will end harmful drug company restrictions on 340B savings that are vital for protecting patients and communities. By restricting 340B pharmacy partnerships, big pharma has siphoned billions from the health care safety net solely to bolster its profits. The 340B PATIENTS Act stops this damaging behavior. We call on Congress to support this vital legislation. Learn more. |
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