FAIRFAX, Va. (AP) — Voters in the northern Virginia suburbs of Washington will choose a replacement Tuesday for the late Democratic Rep. Gerry Connolly, who died in May after battling cancer.
Control of the U.S. House doesn't hang in the balance in the special congressional election, but it could narrow the Republican majority in the closely divided chamber as members return from the August recess.
Democrat James Walkinshaw is facing Republican Stewart Whitson. Walkinshaw is a member of the Fairfax County Board of Supervisors and previously served as Connolly’s chief of staff. Whitson is a former FBI special agent and Army veteran who oversees federal affairs for a conservative think tank. The two won their parties’ nominations in party-run primaries held in late June.
The seat is among three Democratic vacancies that have lowered the number of votes Republicans need to pass President Donald Trump’s top legislative priorities in the House, where the GOP holds a slim 219-212 majority. The vacancies may have played a decisive role in May, when the president’s big tax breaks and spending cuts bill passed the House by one vote, 215-214. A fourth House vacancy opened up in July, when Tennessee Republican Mark Green stepped down to accept a private-sector position.
Walkinshaw has held a financial advantage throughout the abbreviated campaign, with about $1.1 million raised in contributions, compared with about $225,000 for Whitson. Walkinshaw’s campaign had about $139,000 in the bank as of Aug. 20, more than double Whitson’s $57,000.
Virginia’s 11th Congressional District is located just outside Washington and includes the City of Fairfax and most of Fairfax County. Although not as deep blue as the neighboring 8th District, which includes Alexandria and Arlington, the 11th District is still reliable territory for Democratic candidates. Democratic presidential nominee Kamala Harris carried the district with 65% of the vote in 2024. Connolly received about 67% of the vote in his final reelection bid. Trump received 40% or more of the vote in only nine of the district’s 183 precincts.
Fairfax County is the dominant player in district elections. It comprised about 97% of the vote in the 2024 general election, compared with only 3% for the City of Fairfax.
Connolly was elected to nine terms and served for more than 15 years. He succeeded Republican Tom Davis, who held a version of this seat for 14 years.
The Associated Press does not make projections and will declare a winner only when it’s determined there is no scenario that would allow the trailing candidate to close the gap. If a race has not been called, the AP will continue to cover any newsworthy developments, such as candidate concessions or declarations of victory. In doing so, the AP will make clear that it has not yet declared a winner and explain why.
Virginia does not conduct automatic recounts. Candidates may request and pay for recounts if the margin between the top two candidates is 1 percentage point or less. The government will pay for the recount if the margin is less than 0.5 percentage points or the final outcome has changed. The AP may declare a winner in a race that is eligible for a recount if it can determine the lead is too large for a recount or legal challenge to change the outcome.
Here’s a look at what to expect on Tuesday:
The special election in Virginia’s 11th Congressional District will be held Tuesday. Polls close at 7 p.m. ET.
The Associated Press will provide vote results and declare a winner in the special congressional election in the 11th District. There are no other contests on the ballot, and Walkinshaw and Whitson are the only candidates listed.
Any voter registered in the 11th Congressional District may participate in the special election.
As of Sept. 1, there were nearly 568,000 registered voters in Virginia’s 11th Congressional District. Voters in Virginia do not register by party.
Turnout in the district was 52% of registered voters in the 2022 midterm election and 71% in the 2024 general election. Ballots cast before Election Day made up about 34% of total votes in 2022 and about 57% in 2024.
As of Wednesday, more than 48,000 ballots had been cast before Election Day, about 52% by mail and the rest in person at early voting locations.
In the 2024 general election, the AP first reported results from the 11th District at 7:38 p.m. ET, or 38 minutes after polls closed. Tabulation ended for the night at 12:36 a.m. ET with about 95% of total votes counted.
As of Tuesday, there will be 420 days until the 2026 midterm elections.
Follow the AP’s coverage of the 2025 election at https://apnews.com/projects/election-results-2025/.
American and Commonwealth of Virginia flags flank the door of the state's 11th Congressional District office on Capitol Hill in Washington, Sept. 2, 2025, after the seat became vacant following the death of Rep. Gerald Connolly, D-Va., on May 21. (AP Photo/Robert Yoon)
Campaign signs for the special election in Virginia's 11th Congressional District are on display outside the Fairfax County Government Center in Fairfax, Va., Aug. 15, 2025. (AP Photo/Robert Yoon)
WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, stoking worries that the plan may run afoul of legal, ethical and scientific standards long used to vet the safety and effectiveness of new medicines.
Marty Makary's program is causing new anxiety and confusion among staff already rocked by layoffs, buyouts and leadership upheavals, according to seven current or recently departed staffers. The people spoke to The Associated Press on the condition of anonymity because they were not authorized to discuss confidential agency matters.
At the highest levels of the FDA, questions remain about which officials have the legal authority to sign off on drugs cleared under the Commissioner’s National Priority Voucher program, which promises approval in as little as one month for medicines that support “U.S. national interests.”
Traditionally, approval decisions have nearly always been handled by FDA review scientists and their immediate supervisors, not the agency’s political appointees and senior leaders.
But drug reviewers say they've received little information about the new program's workings. And some staffers working on a highly anticipated anti-obesity pill were recently told they can skip certain regulatory steps to meet top officials' aggressive deadlines.
Outside experts point out that FDA drug reviews — which range from six to 10 months — are already the fastest in the world.
“The concept of doing a review in one to two months just does not have scientific precedent,” said Dr. Aaron Kesselheim, a professor at Harvard Medical School. “FDA cannot do the same detailed review that it does of a regular application in one to two months, and it doesn’t have the resources to do it.”
On Thursday Reuters reported that FDA officials have delayed the review of two drugs in the program, in part due to safety concerns, including the death of a patient taking one of the medications.
Health and Human Services spokesman Andrew Nixon said the voucher program prioritizes “gold standard scientific review” and aims to deliver “meaningful and effective treatments and cures."
The program remains popular at the White House, where pricing concessions announced by the Republican president have repeatedly been accompanied by FDA vouchers for drugmakers that agree to cut their prices.
For instance, when the White House announced that Eli Lilly and Novo Nordisk would reduce prices on their popular obesity drugs, FDA staffers had to scramble to vet new vouchers for both companies in time for Trump's news conference, according to multiple people involved in the process.
That’s sparked widespread concern that FDA drug reviews — long pegged to objective standards and procedures — have become open to political interference.
“It’s extraordinary to have such an opaque application process, one that is obviously susceptible to politicization,” said Paul Kim, a former FDA attorney who now works with pharmaceutical clients.
Many of the concerns around the program stem from the fact that it hasn't been laid out in federal rules and regulations.
The FDA already has more than a half-dozen programs intended to speed up or streamline reviews for promising drugs — all approved by Congress, with regulations written by agency staff.
In contrast, information about the voucher program is mostly confined to an agency website. Drugmakers can apply by submitting a 350-word “statement of interest.”
Increasingly, agency leaders such as Dr. Vinay Prasad, the FDA’s top medical officer and vaccine center director, have been contacting drugmakers directly about awarding vouchers. That’s created quandaries for FDA staffers on even basic questions, such as how to formally award a voucher to a company that didn’t request one.
Nixon, the HHS spokesman, said that voucher submissions are evaluated by “a senior, multidisciplinary review committee,” led by Prasad.
Questions about the legality of the program led the FDA’s then-drug director, Dr. George Tidmarsh, to decline to sign off on approvals under the pathway, according to several people with direct knowledge of the matter. Tidmarsh resigned from the agency in November after a lawsuit challenging his conduct on issues unrelated to the voucher program.
After his departure, Sara Brenner, the FDA’s principal deputy commissioner, was set to have the power to decide, but she also declined the role after looking further into the legal implications, according to the people. Currently the agency’s deputy chief medical officer, Dr. Mallika Mundkur, who works under Prasad, is taking on the responsibility.
Giving final approval to a drug carries significant legal risks, essentially certifying that the medicine meets FDA standards for safety and effectiveness. If unexpected safety problems later emerge, both the agency and individual staffers could be pulled into investigations or lawsuits.
Traditionally, approval comes from FDA drug office directors, made in consultation with a team of reviewers. Under the voucher program, approval comes through a committee vote by senior agency leaders led by Prasad, according to multiple people familiar with the process. Staff reviewers don't get a vote.
“It is a complete reversal from the normal review process, which is traditionally led by the scientists who are the ones immersed in the data,” said Kesselheim, who is a lawyer and a medical researcher.
Not everyone sees problems with the program. Dan Troy, the FDA’s top lawyer under President George W. Bush, a Republican, says federal law gives the commissioner broad discretion to reorganize the handling of drug reviews.
Still, he says, the voucher program, like many of Makary’s initiatives, may be short-lived because it isn't codified.
“If you live by the press release then you die by the press release,” Troy said. “Anything that they’re doing now could be wiped out in a moment by the next administration.”
Initially framed as a pilot program of no more than five drugs, it has expanded to 18 vouchers awarded, with more under consideration. That puts extra pressure on the agency’s drug center, where 20% of the staff has left through retirements, buyouts or resignations over the past year.
When Makary unveiled the program in October there were immediate concerns about the unprecedented power he would have in deciding which companies benefit.
Makary then said that nominations for drugs would come from career staffers. Indeed, some of the early drugs were recommended by FDA reviewers, according to two people familiar with the process. They said FDA staffers deliberately selected drugs that could be vetted quickly.
But, increasingly, selection decisions are led by Prasad or other senior officials, sometimes unbeknownst to FDA staff, according to three people. In one case, FDA reviewers learned from GlaxoSmithKline representatives that Prasad had contacted the company about a voucher.
Access to Makary is limited because he does not use a government email account to do business, according to people familiar with the matter, breaking with longstanding precedent.
Once a voucher is awarded, some drugmakers have their own interpretation of the review timeline — creating further confusion and anxiety among staff.
Two people involved in the ongoing review of Eli Lilly's anti-obesity pill said company executives initially told the FDA they expected the drug approved within two months.
The timeline alarmed FDA reviewers because it did not include the agency's standard 60-day prefiling period, when staffers check the application to ensure it isn’t missing essential information. That 60-day window has been in place for more than 30 years.
Lilly pushed for a quicker filing turnaround, demanding one week. Eventually the agency and the company agreed to a two-week period.
Nixon declined to comment on the specifics of Lilly's review but said FDA reviewers can “adjust timelines as needed.”
Staffers were pushed to keep the application moving forward, even though key pieces of data about the drug's chemistry appeared to be missing, according to one person involved in the process. When reviewers raised concerns about some of the gaps during an internal meeting, the person said, they were told by a senior official: “If the science is sound then you can overlook the regulations.”
Former reviewers and outside experts say that approach is the opposite of how FDA reviews should work: By following the regulations, staffers scientifically confirm the safety and effectiveness of drugs.
Skipping review steps could also carry risks for drugmakers if future FDA leaders decide a drug wasn’t properly vetted. Like other experts, Kesselheim says the program may not last beyond the current administration.
“They are fundamentally changing the application of the standards, but the underlying law remains what it is,” he said. “The hope is that one day we will return to these scientifically sound, legally sound principles.”
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, April 22, 2025. (AP Photo/Jose Luis Magana, File)
Dr. Marty Makary, commissioner of the Food and Drug Administration, speaks during a press briefing at the White House, Wednesday, Jan. 7, 2026, in Washington. (AP Photo/Jacquelyn Martin)
