August Congressional Recess is here (sort of), and the November mid-term elections are just 95 days away
Members of the House of Representatives are back in their home districts after passing several key pieces of legislation, including a funding resolution that will keep the government funded through December 4. Pressure is now on the Senate to act before they are scheduled to adjourn on August 7, but negotiations with Senate Democrats aren’t going well (no surprise). Some Republican senators continue to insist on passage of the Safeguard American Voter Eligibility (SAVE) Act before moving on to other items. It’s unlikely there will be consensus before August 7, setting up a hectic September congressional schedule. As of today, members are only expected to be in session 14 days in September before heading home for the month of October to campaign. Several health care programs need to be reauthorized before they expire on September 30 including discretionary funding for community health centers (CHCs), the National Health Service Corps and disease-specific research programs such as the Accelerating Access to Critical Therapies for ALS (Act for ALS). The House has acted on many of these items, but finding consensus on a broader package will be challenging. Some non-controversial health care reauthorizations will likely be considered through the Senate’s “hotline” process that brings bills the floor for passage if no member raises an objection.
Mid-term election watch: What the pundits and polls are telling us as we head toward November 3
Gridiron’s disclaimer/advice: Don’t start seriously considering mid-term election polling and prediction until after Labor Day. However, here’s a quick look at what the “experts” are saying right now.
U.S. House – Democrats need to flip just 3 seats to retake the majority. A slew of court decisions in the final days of April and early days of May shifted the 2026 congressional map slightly in the Republican Party’s favor, but given the national mood over the economy, domestic tension, the war with Iran and the fact that the controlling party historically performs poorly in mid-term elections, Democrats are still in the driver’s seat. Additionally, respected firms like Cook Political Report have been shifting many pivotal congressional seats in the favor of Democrats in the past few weeks.
U.S. Senate – Republicans currently hold 53 seats to Democrats’ 47 (including two independents), with 35 seats up in 2026 — including special elections in Florida and Ohio. Democrats need a net gain of four seats to retake control in 2027. While the math still favors the GOP holding the chamber, but several forecasters see it tightening. New fundraising data has improved Democrats’ odds, particularly in Alaska, Georgia, and New Hampshire, with slight improvement also in North Carolina and Texas. Interestingly, one independent model currently projects a 50-50 tie in the Senate, with Vice President J.D. Vance casting the deciding vote.
In recent discussions with House Republicans, the mood has improved in the last few weeks, with some expressing optimism that generic congressional ballot polling shows Republicans with an increasing chance of keeping the House. While last month’s generic ballot (where those surveyed are asked, “If the election for Congress where held today, would you vote for the Republican or Democrat?”) showed Democrats with an average of a 7 point spread, it has shrunk to around 5% in the most recent polls. For those interested in specific races, here is a Top 10 list for the U.S. House, and here is an overview of the races to watch in the U.S. Senate.
Please contact us (operations@gridironpublicaffairs.com) if you’d like to schedule an election preview presentation or a summary in November. A state election preview (focusing on state legislatures and governors’ races) will also be available in late August.
FDA works to repair relationships with rare disease community; Rare disease drug approvals lag 2025 numbers
Following Acting FDA Commissioner Kyle Diamantas’ meeting with rare disease community leaders in June, the agency has continued its efforts to open the lines of communication with July’s launch of its Rare Connections newsletter. Diamantas said the new quarterly newsletter will provide a “single, centralized communication that serves as a one-stop shop for the rare disease community to more readily have access to and be informed of FDA’s most recent activities in the rare disease space.” The inaugural issue included a summary of the FDA’s June meeting with rare disease leaders, as well as press releases, a “Rare Reflections” column penned by an agency leader, updates from the FDA’s Rare Disease Innovation Hub and a calendar of upcoming public meetings and events. You can subscribe to the Rare Connections newsletter here. While FDA officials attempt to chart a different course in a post-Makary/Prasad-led agency, many in the rare disease community remain cautiously optimistic that the new public relations efforts will ultimately result in more approvals. FDA approved 26 novel therapies in the first half of 2026, including six for orphan (rare disease) indications — among them Denali’s Avlayah, the first treatment for Hunter syndrome’s neurological complications, and Regeneron’s Otarmeni, the first gene therapy to target an underlying cause of deafness. That’s a slower pace than recent years: FDA approved just six orphan drugs in H1 2026, versus 30 for all of 2025. On a related note, a legislative commission that advises Congress on biotechnology and national security called on FDA and Congress to advance a national strategy to boost development of rare disease cures. The bipartisan National Security Commission on Emerging Biotechnology (NSCED) said last week that FDA should be open to accepting rare disease drug approvals based on non-standard study designs, including smaller trials, and Congress should clarify that developers can meet the requirement for ‘substantial evidence’ through other scientifically valid trial designs when large trials are not feasible.” The commission also says FDA’s staff levels need to be increased.
Bipartisan legislation to reduce animal testing in drug development passes House; awaits Senate action
Congress is ramping up pressure on the FDA to reduce the use of animal testing in drug development. The bipartisan FDA Modernization 3.0 Act passed the House this month. Amongst many other things, the bill would require the agency to issue an interim final rule within one year updating its regulations to allow for increased use of non-animal methods in clinical trials, including computer modeling, lab-grown human tissue and other advanced technologies. The Senate has passed similar language related to animal testing, but will need to act on the House version. Rep. Buddy Carter (R-GA), a pharmacist, said during a House E&C markup in May the bill is needed because FDA has not fully implemented the FDA Modernization Act 2.0, which Congress passed in 2022 to allow drug developers to use certain alternatives to animal testing. “Congress made its intent clear: We wanted to reduce outdated testing requirements and encourage more effective, humane, and innovative approaches to drug development,” he said during the markup. The bill’s lead Democrat is Rep. Nanette Diaz Barragan (D-CA). “Unfortunately, the Biden administration failed to fully implement that law, limiting its effectiveness and leaving too many animals still at risk,” said Carter. FDA has encouraged developers to use alternatives to animal testing and recently stated that it will substitute references to animal testing with references to “nonclinical” testing in underlying regulations. “FDA Modernization Act 3.0 closes that gap by directing the FDA to align its regulations with the law Congress already enacted. Once signed into law, this legislation will provide greater regulatory certainty, encourage broader adoption of New Approach Methodologies, and further accelerate the transition toward faster, more predictive, and more humane drug development,” Tamara Drake, director of research and regulatory policy for the Center for a Humane Economy, said in a statement. “This is the culmination of years of bipartisan work by Congress, federal agencies, scientists, patient advocates, and advocates for animals to modernize the way medicines are developed for the benefit of both people and animals.”
Health Policy Snippets
- Analysis of 2026 state legislation points to troubling trends. In 2026, more than 20 states have considered more than 30 bills to impose government price controls of pharmaceuticals. The bills ranged from establishment of government-run Prescription Drug Affordability Boards (PDABs) to linking prices paid by state-regulated health plans or consumers to either the Medicare negotiated price or the prices paid for medications in other countries (e.g. “International reference pricing”). While most of the legislation did not advance, states are the real policymaking laboratories and attention should be paid to state trends. For example, a conservative Republican in the Florida legislature introduced aggressive legislation to require foreign reference pricing consideration in state programs. The bill passed one committee, but did not advance beyond that. Undoubtedly fueled by President Trump’s support for “Most Favored Nation” foreign drug pricing policies, the move by some Republicans to advance such proposals is a trend that bears watching in 2027.
- Launch prices could be next target for drug pricing reform advocates.Consumer group Public Citizen is urging Medicare to negotiate prices for new FDA-approved drugs at or shortly after launch to stem what it says are exorbitant costs companies maintain for prescription drugs until they are selected for Inflation Reduction Act negotiation. Currently, small molecule drugs must have been on the market for seven years before they are eligible for price negotiation, and biologics for 11 years. Public Citizen argued in a July 22 Health Affairs article that despite the IRA’s mandate that CMS negotiate lower drug prices for seniors and deter drug companies from raising prices faster than the rate of inflation, launch prices are still 442% higher in the United States than in other wealthy, comparable countries. The group is calling on Congress to update the IRA to permit price negotiations for new, expensive drugs when they launch before high launch pricing gets worse. Restrictions on launch prices were not included in the first version of the IRA, despite attempts by some Senate Democrats. If Democrats take control of both the House and Senate in 2027, we fully expect new IRA expansion legislation to consider launch price language (a top concern for companies bringing new rare disease therapies to market).
