DETROIT (AP) — Ford Motor Co. will pay a penalty of up to $165 million to the U.S. government for moving too slowly on a recall and failing to give accurate recall information.
The National Highway Traffic Safety Administration said Thursday that the civil penalty is the second-largest in its 54-year history. Only the fine Takata paid for faulty air bag inflators was higher.
The agency said Ford was too slow to recall vehicles with faulty rearview cameras, and it failed to give the agency complete information, which is required by the Federal Motor Vehicle Safety Act.
Ford agreed to a consent order with the agency that includes a payment of $65 million, and $45 million in spending to comply with the law. Another $55 million will be deferred.
“Timely and accurate recalls are critical to keeping everyone safe on our roads,” NHTSA Deputy Administrator Sophie Shulman said. “When manufacturers fail to prioritize the safety of the American public and meet their obligations under federal law, NHTSA will hold them accountable.”
Under the order, an independent third party will oversee the automaker’s recall performance obligations for at least three years, and Ford has to cooperate with the monitor.
Ford also has to review all recalls over the last three years to make sure enough vehicles have been recalled, and file new recalls if necessary.
The company also must review and change its recall decision-making process, improving the way it analyzes data to find safety defects in its vehicles. It also has to invest in technology so it can trace parts by vehicle identification numbers.
Ford says it will invest the $45 million into advanced data analytics, a new document system, and a new testing lab.
“We appreciate the opportunity to resolve this matter with NHTSA and remain committed to continuously improving safety,” Ford said in a statement.
Under the law, an automaker has to notify NHTSA by filing a defect report within five working days of finding out that a line of vehicles has a safety defect.
The problematic recall of more than 620,000 vehicles in the U.S., over 700,000 in North America, came in September of 2020 for rear-view cameras that can fail on several 2020 models, including the F-Series pickup, the top selling vehicle in the U.S.
In agency documents, NHTSA said Ford found warranty claims about the faulty cameras from February through April of 2020, and the matter was brought to a Ford committee in May of that year.
In July of 2020, NHTSA contacted Ford about complaints it had received about failing cameras, and during an August 2020, meeting with NHTSA, Ford showed data for many 2020 models with high camera failure rates.
The company did the recall on Sept. 23, 2020, and about a year later NHTSA began investigating whether the recall was done quickly enough or included enough vehicles.
In 2022 and 2024, Ford did two more recalls for the same problem, adding about 24,000 vehicles to the first camera recall.
In the consent order, NHTSA said its investigation found that Ford violated multiple parts of the law by moving too slowly to recall vehicles with faulty cameras, giving the agency inaccurate or incomplete information, and failing to turn in required quarterly reports about additional recalls.
The order said that Ford disagreed with its assertions.
For several years, high warranty and recall costs have dinged Ford's profits, but the company says it's working to fix the issues.
The penalty doesn’t end conflicts between Ford and NHTSA.
Earlier this year the agency opened an investigation into a Ford SUV recall repair that doesn’t fix gasoline leaks that can cause engine fires. Investigators wrote in an April 25 letter to Ford that they have “significant safety concerns” about a March 8 recall of nearly 43,000 Bronco Sport and Escape SUVs.
Ford said in documents that fuel injectors can crack, allowing gas or vapor to leak near hot engine parts, potentially causing fires and injuries. But the fix is to add a drain tube to send the gas away from hot surfaces and software that cuts off the fuel supply if it detects a leak.
In the letter, the agency’s Office of Defects Investigation wrote that based on its review of the recall fix, it “believes that the remedy program does not address the root cause of the issue and does not proactively call for the replacement of defective fuel injectors prior to their failure.”
Ford said that it has a strong recall process and is committed to complying with the law, but it can always improve. It said it has learned from the camera recall.
“We look forward to working with NHTSA and the independent third party to implement further enhancements,” Ford said.
FILE - The Ford logo is seen on the grill of a Ford Explorer on display at the Pittsburgh International Auto Show in Pittsburgh, on Feb. 15, 2024. (AP Photo/Gene J. Puskar, File)
WASHINGTON (AP) — Those ever-present TV drug ads showing patients hiking, biking or enjoying a day at the beach could soon have a different look: New rules require drugmakers to be clearer and more direct when explaining their medications' risks and side effects.
The U.S. Food and Drug Administration spent more than 15 years crafting the guidelines, which are designed to do away with industry practices that downplay or distract viewers from risk information.
Many companies have already adopted the rules, which become binding Nov. 20. But while regulators were drafting them, a new trend emerged: thousands of pharma influencers pushing drugs online with little oversight. A new bill in Congress would compel the FDA to more aggressively police such promotions on social media platforms.
“Some people become very attached to social media influencers and ascribe to them credibility that, in some cases, they don’t deserve,” said Tony Cox, professor emeritus of marketing at Indiana University.
Still, TV remains the industry's primary advertising format, with over $4 billion spent in the past year, led by blockbuster drugs like weight-loss treatment Wegovy, according to ispot.tv, which tracks ads.
The new rules, which cover both TV and radio, instruct drugmakers to use simple, consumer-friendly language when describing their drugs, without medical jargon, distracting visuals or audio effects. A 2007 law directed the FDA to ensure that drug risk information appears “in a clear, conspicuous and neutral manner.”
FDA has always required that ads give a balanced picture of both benefits and risks, a requirement that gave rise to those long, rapid-fire lists of side effects parodied on shows like “ Saturday Night Live.”
But in the early 2000s, researchers began showing how companies could manipulate images and audio to de-emphasize safety information. In one example, a Duke University professor found that ads for the allergy drug Nasonex, which featured a buzzing bee voiced by Antonio Banderas, distracted viewers from listening to side effect information, making it harder to remember.
Such overt tactics have largely disappeared from drug ads.
“In general, I would say the ads have gotten more complete and transparent,” says Ruth Day, director of the medical cognition lab at Duke University and author of the Nasonex study.
The new rules are “significant steps forward,” Day said, but certain requirements could also open the door to new ways of downplaying risks.
One requirement instructs companies to show on-screen text about side effects while the audio information plays. A 2011 FDA study found that combining text with audio increased recall and understanding.
But the agency leaves it to companies to decide whether to display a few keywords or a full transcript.
“You often cannot put all that on the screen and expect people to read and understand it,” Day said. “If you wanted to hide or decrease the likelihood of people remembering risk information, that could be the way to do it.”
Viewers tend to tune out long lists of warnings and other information. But experts who work with drug companies don’t expect those lists to disappear. While the guidelines describe how the information should be presented, companies still decide the content.
“If you’re a company and you’re worried about possible FDA enforcement or product liability and other litigation, all your incentives are to say more, not less,” said Torrey Cope, a food and drug lawyer who advises companies.
Experts also say the new rules will have little effect on the overall tone and appearance of ads.
“The most salient element of these ads are the visuals, and they are uniformly positive,” said Cox. “Even if the risk message is about, for instance, sudden heart failure, they’re still showing someone diving into a swimming pool.”
The new rules come as Donald Trump's advisers begin floating plans for the FDA and the pharmaceutical industry.
Robert F. Kennedy Jr., an anti-vaccine activist who has advised the president-elect, wants to eliminate TV drug ads. He and other industry critics point out that the U.S. and New Zealand are the only countries where prescription drugs can be promoted on TV.
Even so, many companies are looking beyond TV and expanding into social media. They often partner with patient influencers who post about managing their conditions, new treatments or navigating the health system.
“They’re teaching people to live a good life with their disease, but then some of them are also paid to advertise and persuade,” said Erin Willis, who studies advertising and media at the University of Colorado Boulder.
Advertising executives say companies like the format because it’s cheaper than TV and consumers generally feel influencers are more trustworthy than companies.
FDA’s requirement for truthful, balanced risk and benefit information applies to drugmakers, leaving a loophole for both influencers and telehealth companies like Hims, Ro and Teledoc, who may not have a direct financial connection to makers of the drugs they’re promoting.
The issue has attracted attention from members of Congress.
“The power of social media and the deluge of misleading promotions has meant too many young people are receiving medical advice from influencers instead of their health care professional,” Sens. Dick Durbin of Illinois and Mike Braun of Indiana wrote the FDA in a February letter.
A recently introduced bill from the senators would bring influencers and telehealth companies clearly under FDA’s jurisdiction, requiring them to disclose risk and side effect information. The bill also would require drugmakers to publicly disclose payments to influencers.
“It’s asking the FDA to take a more serious stance with this kind of marketing,” said Willis. “They know it’s happening, but they could be doing more.”
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.
This combination of images from video shows scenes from Nasonex television commercials broadcast in the U.S. in the 2000s. (AP Photo)
