The FDA is about to change! Trump officially nominates Robert Kennedy to lead the Department of Health and Human Services

On November 14th local time, President Trump, who was re-elected, posted the following message on Truth Social, a social media platform founded by his team:

"For a long time, Americans have been exploited by the industrial food complex and pharmaceutical companies, which have spread deception, misinformation, and disinformation on public health issues..." Mr. Kennedy will restore these institutions to the tradition of gold-standard scientific research, making them transparent beacons to end the epidemic of chronic diseases and make America great and healthy again!"

These remarks follow Trump's ideas since his election, intending to appoint Robert F. Kennedy Jr. to a key cabinet position - the Secretary of the Department of Health and Human Services (HHS). Previously, Trump had publicly made a commitment to "make America healthy again" and said in a campaign speech, "I want him to go crazy on health!"

Currently, Trump has indicated that he has nominated Kennedy as the HHS Secretary. Judging by Kennedy's previous statements, he will undoubtedly make sweeping changes upon taking office. If this nomination is smoothly confirmed by the Senate, then as part of HHS, the FDA is bound to undergo significant changes!

Who is Robert Kennedy?

Robert F. Kennedy Jr., aged 70, comes from the Kennedy family. He is the son of the late former Attorney General and Senator Robert Francis Kennedy, and the nephew of former President John F. Kennedy, who was assassinated in 1963.

The Kennedy family has always been supporters of the Democratic Party. However, in the 2024 U.S. presidential election, Robert F. Kennedy Jr., seeing no hope for the Democratic nomination, first ran as an independent candidate and later withdrew to support Trump.

Before this nomination was disclosed, foreign media had speculated that Kennedy would take on an important role in the healthcare sector after Trump's successful election, which caused concern among people. NBC News revealed that some FDA staff were considering resigning after learning that Kennedy might play a key role in the healthcare sector under Trump's administration.

For many years, Kennedy has supported and spread the claim that vaccines cause autism. This theory originated from a 1998 paper by British doctor Andrew Wakefield published in The Lancet, which claimed a link between the measles, mumps, and rubella (MMR) vaccine and autism in children. However, the paper was later found to have serious methodological flaws, including a small sample size, selective reporting of data, and financial conflicts of interest. As a result, the paper was eventually retracted, and Wakefield's medical license was revoked. Subsequent research by numerous scientists on the link between MMR and autism found no causal relationship, and several authoritative institutions, including the WHO, CDC, and EMA, have stated that vaccines are indeed safe.

Based on this, Ron Wyden, the Democratic chairman of the Oregon Senate Finance Committee, expressed his opposition to Trump's announcement of the nomination, stating: "Mr. Kennedy's peculiar views on basic scientific facts are disturbing."

Currently, many people have expressed opposition to this nomination, and whether it will officially take effect depends on the final confirmation by the Senate.

What changes will Robert Kennedy bring?

Before officially becoming president, Trump had indicated in his campaign speeches that he would allow Kennedy to do everything he wanted to do, giving him the freedom to "go crazy."

After Trump's formal election, Kennedy stated in an interview with journalists that his focus in the Trump administration would be, on one hand, to have regulatory agencies eliminate corruption and conflicts and return to the gold standard based on experience and evidence. On the other hand, he hoped to end the widespread prevalence of chronic diseases within two years and continue to reduce the incidence of chronic diseases. The former point is clearly aimed at the FDA. Kennedy also mentioned in the interview that he would address corruption by removing federal staff departments that he believes are not doing their jobs well—in some cases, "entire departments"—and stated that he would reduce staff in the FDA's nutrition department.

Currently, although the nomination has not been officially approved, the impact is already being felt.

On Thursday, as the nomination news was reported, the stock prices of several vaccine manufacturers fell. Among them, Moderna's stock price dropped by 6%, and Pfizer's fell by nearly 2%.

However, it is important to note that in previous interviews, Kennedy emphasized, "He has never been against vaccines." Regarding reforms in the field of vaccines, Kennedy's idea is, "If vaccines work for someone, I won't take them away. People should have choices, and these choices should be informed by the best information. Therefore, I will ensure that scientific safety research and ethics exist so that people can individually assess whether the product is beneficial for them." To further understand, he hopes to ensure that products maintain high transparency in information while meeting safety, efficacy, and ethical standards, allowing each person the right to make free choices based on their specific circumstances and needs.

Drug advertising is also part of the reform plan and has already been partially implemented. On the 14th, the Associated Press reported that the FDA issued new regulations for drug advertising, requiring pharmaceutical companies to more clearly explain the risks and side effects of prescription drugs in simple, clear, and undistracting language. It is known that this regulation will take effect on November 20, 2024. For the emerging online video promotion methods, the FDA has indicated that it will also actively supervise and manage these in the future.

Compared to the reform plans Kennedy has previously revealed, the currently announced regulations are much less forceful. Kennedy had proposed a suggestion to "ban drug advertisements on television" because he was concerned that it would affect news reporting on health issues.

Additionally, Kennedy may make some changes to the PDUFA Act. As stipulated by the PDUFA Act, pharmaceutical companies need to pay a certain fee when submitting applications to the FDA. According to previously disclosed data online, this fee exceeds three million dollars. Kennedy pointed out: "We need to end corruption. 50% of the FDA's budget does not come from taxpayers but from the pharmaceutical industry."

In terms of controlling chronic diseases such as obesity/diabetes, Kennedy hopes to allow existing health insurance to cover some "clean food" and exercise programs, and hopes that these food and exercise programs can be recommended by doctors to patients, just like those weight loss drugs.

Summary

Foreign media have pointed out that if Kennedy can successfully take on the role of HHS Secretary, he will oversee the reform of the Affordable Care Act, Medicare, and Medicaid. Although Trump is no longer seeking to completely repeal Obama's healthcare reform, whether his administration can release plans to improve the law as promised during the campaign remains to be seen.

【Editor’s note】The above content (~6300 words) is a quick translation of a Chinese article (posted on 2024-11-15) by DrugTimes team. To read the original article, please click here. All comments are warmly welcome. Many thanks!