FDA’s Top Drug Regulator George Tidmarsh Resigns Amid Misconduct Probe

Updated Nov 5, 2025 | 05:32 PM IST

SummaryFDA’s top drug regulator, George Tidmarsh, has resigned following an internal investigation into “serious concerns” about his conduct. The agency has not disclosed details of the probe, but his departure raises questions about leadership and accountability within the nation’s top drug oversight body.
george tidmarsh

Credits: Biospace

The head of the U.S. Food and Drug Administration’s drug division abruptly stepped down on Sunday after federal authorities began investigating “serious concerns” about his personal conduct, according to an agency spokesperson. Dr. George Tidmarsh, who took over the position in July, was placed on administrative leave Friday after officials in the Department of Health and Human Services’ (HHS) Office of General Counsel were alerted to the matter, said HHS press secretary Emily Hilliard in an email statement. Tidmarsh submitted his resignation two days later.

“Secretary Kennedy expects the highest level of integrity from all officials under his leadership and remains fully committed to transparency,” Hilliard said.

Top FDA Drug Regulator Resigns Amid Misconduct Probe

Tidmarsh’s resignation coincided with a lawsuit filed by a pharmaceutical company tied to one of his former business associates. The company, Aurinia Pharmaceuticals, accused him of making “false and defamatory statements” while serving in his FDA role. The lawsuit claims Tidmarsh used his federal position to pursue a “personal vendetta” against Aurinia’s board chairman, Kevin Tang. Tang had previously sat on the boards of several biotech firms where Tidmarsh held executive roles, including La Jolla Pharmaceutical, and was allegedly involved in removing him from those posts.

In September, Tidmarsh questioned the safety and effectiveness of Aurinia’s lupus medication, Lupkynis, in a LinkedIn post that he later deleted. Aurinia maintains the drug is both safe and effective, citing results from two large clinical trials and its full FDA approval in 2021.

His exit comes amid a period of significant turnover within U.S. health agencies under Health Secretary Robert F. Kennedy Jr. Earlier this year, longtime vaccine official Peter Marks was dismissed, followed by gene therapy director Nicole Verdun.

In another leadership shake-up, Dr. Vinay Prasad, head of the FDA’s vaccines and biologics division, resigned in July after facing criticism from conservative groups close to former President Donald Trump but rejoined the agency two weeks later at Kennedy’s request.

Internal Strain at the FDA

The FDA’s drug division, previously overseen by Tidmarsh, has been struggling with heavy staff losses, more than 1,000 employees have reportedly left in the past year due to layoffs or resignations. The center is the agency’s largest branch, responsible for reviewing, approving, and monitoring the safety of both prescription and over-the-counter medicines.

In September, Tidmarsh sparked widespread attention after posting publicly on LinkedIn that Aurinia’s kidney drug “had not been shown to provide a direct clinical benefit for patients.” It is highly unusual for an FDA official to single out a specific company or product on social media.

Aurinia claims that Tidmarsh’s comments caused its stock to drop by 20%, erasing more than $350 million in shareholder value. Tidmarsh later deleted the post and stated that he had shared it in a personal capacity rather than as an FDA representative.

The company’s lawsuit also alleges that Tidmarsh targeted another drug, a thyroid medication produced by American Laboratories, where Tang also serves as board chair.

Filed in U.S. District Court in Maryland, the lawsuit seeks both compensatory and punitive damages, as well as a chance to “set the record straight,” according to Aurinia Pharmaceuticals.

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Leptospirosis: US health officials flag outbreak risk after floods in Hawaii

Updated Apr 1, 2026 | 12:09 PM IST

SummaryThe Hawaii Department of Health (DOH) and the Hawaiian Humane Society (HHS) have urged residents and recovery workers to monitor for signs of leptospirosis that can affect both people and pets.
Leptospirosis: US health officials flag outbreak risk after floods in Hawaii

Credit: iStock

Health officials in the US have issued a risk of leptospirosis — a bacterial illness — in Hawaii, after the “Kona low” storm floods.

The Hawaii Department of Health (DOH) and the Hawaiian Humane Society (HHS) have urged residents and recovery workers to monitor for signs of leptospirosis that can affect both people and pets.

Leptospirosis is caused by bacteria Leptospira, which are carried in the urine of infected animals, including rats, mice, mongoose, livestock, and dogs.

The disease can spread via the urine of infected animals and can enter the human body through broken skin or through the mouth, nose, or eyes.

“Hawaii already has among the highest rates of leptospirosis in the country due to its warm, wet climate,” said HHS and DOH in a joint statement.

“Flooding events like the recent Kona low storm can dramatically increase exposure risk by spreading contaminated soil and water across a broad area,” it added.

The agency urged people to check out symptoms in pets, such as fever, decreased appetite, vomiting, diarrhea, and muscle soreness, and get medical help.

The risk of Leptospirosis outbreak is common after a storm, because the dead animals are likely to spread the bacteria. Further, flooding also forces rodents out of their burrows, leading them into homes, shelters, and debris piles where they shed bacteria more easily.

What Is Leptospirosis?

Leptospirosis is one of the most prevalent zoonotic diseases worldwide, often linked to poor sanitation and agricultural practices that involve contact with animals or contaminated water.

The bacteria can survive in contaminated water or soil for weeks to months, primarily spreading through the urine of infected animals.

Also read: With Rising Temperatures A Major Rat Infestation Is Taking Over The World- Why Is This A Health Hazard?

Humans can contract the disease through direct contact with infected urine or through contaminated food, water, or soil.

There are two main forms of leptospirosis: icteric leptospira, which presents with jaundice, and anicteric leptospira, a milder variant without jaundice. Leptospirosis can also manifest as Weil's disease, a severe complication.

What Are Symptoms Of Leptospirosis in humans?

Symptoms typically develop 2 to 30 days after exposure and can range from mild to severe. Initial signs often include

  • high-grade fever,
  • red eyes (conjunctival suffusion),
  • calf tenderness,
  • headache,
  • dry cough,
  • nausea,
  • diarrhea.
Also read: Nipah Virus: An 'Underestimated' Threat, Can Turn 'More Severe', Say Scientists

In more serious cases, the infection can lead to complications such as

  • jaundice,
  • kidney damage
  • liver damage,
  • meningitis,
  • respiratory issues,
  • hemorrhages.

Pulmonary hemorrhage — acute bleeding from the lungs — can also occur, posing life-threatening risks such as respiratory and renal failure. The illness may last from a few days to several weeks, and without treatment, recovery can take months, according to the US Centers for Disease Control and Prevention (CDC).

What Precautions Should Be Taken?

To reduce the risk of leptospirosis infection, individuals are advised to take several important precautions. According to the CDC, it is essential to avoid wading through dirty rainwater, especially during the rainy season, and to wear gumboots in such conditions.

Proper care of any injuries or cuts is crucial, and frequent handwashing, particularly after handling food or working in potentially contaminated environments, is highly recommended. Additionally, individuals should avoid contact with animals that appear sick or are known carriers of the bacteria.

Vaccination is also vital—pet owners should ensure their pets are vaccinated against leptospirosis, especially if they are frequently exposed to water or wildlife. Staying hydrated by drinking plenty of clean water and preventing water stagnation around the home can further minimize the risk of infection.

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Cicada COVID Variant: Use Masks To Avoid Transmission, Say Experts

Updated Apr 1, 2026 | 12:30 PM IST

SummaryExperts have urged people to follow COVID practices such as wearing masks in crowded areas or indoors where there is a high risk of transmission, and washing hands frequently.
Cicada COVID Variant: Use Masks To Avoid Transmission, Say Experts

Credit: Canva

The emerging COVID variant, BA 3.2, nicknamed “Cicada,” has revived memories of the COVID-19 pandemic that disrupted the world and raised fresh concerns about the possibility of severe illness.

The variant has been given the nickname “Cicada” due to its reappearance after remaining dormant or undetected for a long period, much like cicadas that emerge after years underground.

With the variant already spread to 23 nations, as of February, experts are urging people to use masks to avoid transmission.

What Is The Cicada COVID Variant?

Cicada was first identified in a respiratory sample in South Africa in November 2024.

It is a descendant of the Omicron BA.3 lineage, and is genetically distinct from the previously circulating JN.1 lineages (including LP.8.1 and XFG).

BA.3.2 comprises two major branches, BA.3.2.1 and BA.3.2.2. BA.3.2.2 also has substitutions like: K356T, A575S, R681H, and R1162P.

The World Health Organization (WHO) has designated BA.3.2 as a Variant Under Monitoring (VUM). It means the variant may not be that dangerous yet, but it may have concerning mutations.

As per the US CDC’s latest Morbidity and Mortality Weekly Report, Cicada has “70 to 75 substitutions and deletions in the gene sequence of its spike protein”.

Time To Mask Up

Dr. Sai Balasubramanian, a doctor and healthcare strategy executive, writing in Forbes, stressed the need to follow COVID practices such as masks and hand hygiene.

"Healthcare professionals recommend taking general precautions, similar to those used to prevent most viral transmission: get vaccinations when appropriate, wear masks in crowded areas or indoors where there is a high risk of transmission," he said.

He also urged “avoid individuals who have known illness or infections, wash hands frequently, and continue to stay apprised of local community guidelines and the infection spread”.

Cicada variant “is different from the (Covid-19) viruses we have been dealing with for the last two years," Prof Ravi Gupta, of Cambridge University, who advised the UK government during the pandemic, was quoted as saying by The Mirror.

Will The Cicada Variant Cause Severe Illness?

The SARS-CoV-2 virus has the potential to turn deadly in people, especially among vulnerable populations such as those with a weak immune system.

The Cicada variant is particularly concerning as it provides no immune protection to people with previous infection or even vaccination.

Yet, the World Health Organization and health experts advise that existing COVID vaccinations can help prevent severe illness and hospitalization.

"It would appear that all the protections we have from our experience with the virus and with vaccines probably offer more limited—not zero—but more limited protection against this strain," Dr. William Schaffner, professor of infectious diseases at Vanderbilt University Medical Center, was quoted as saying by Time.

Cicada Variant: Any New Symptoms?

The symptoms of Cicada aren't different from those of previous COVID variants. These include:

  • sore throat,
  • fever or chills,
  • headache,
  • cough,
  • body aches,
  • runny nose
  • nausea
  • diarrhea.

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​Tpoxx Should No Longer Be Used For Treating Mpox: European Drug Regulator

Updated Apr 1, 2026 | 12:00 AM IST

SummaryThe European Medicines Agency noted that data from four clinical studies showed that Tpoxx did not heal lesions faster, relieve pain, or help clear the virus from the body faster.
​Tpoxx Should No Longer Be Used For Treating Mpox: European Drug Regulator

Credit: Canva/ US CDC

The European Medicines Agency (EMA) has advised patients and physicians not to use the antiviral drug Tecovirimat SIGA (marketed as Tpoxx) to treat mpox disease.

The advisory from the EMA’s Committee for Human Medicines (CHMP) is based on data from four studies carried out in different regions, which showed that compared with placebo treatment with Tpoxx did not

  • heal lesions faster
  • relieve pain
  • help clear the virus from the body faster.
The EMA noted that Tpoxx was authorised for treating mpox in November 2021, based on data from an animal model of mpox infections. At the time, the virus was not circulating widely enough to conduct human studies.

“The animal data demonstrated antiviral activity and a survival benefit when treatment was started early and a reduced efficacy if treatment was initiated later after exposure to the virus,” the EMA said in an official statement.

However, the clade 2 mpox outbreaks, which began in 2022, led the World Health Organization (WHO) to declare mpox a Public Health Emergency of International Concern (PHEIC), giving the drugmaker SIGA Technologies an opportunity to conduct efficacy studies in people.

A second PHEIC was declared in 2024 over clade 1 outbreaks.

Key recommendations by the EMA include:

  • Restricting the use of Tpoxx over no benefit.
  • Due to lack of safety concerns, patients who initiated treatment with Tpoxx can continue till course ends.
  • Tpoxx can still be used as an antiviral to treat other orthopoxvirus infections, including smallpox and cowpox
  • There is currently no other drug authorized in the EU for treating mpox infections.

Tpoxx For Mpox: What Does The US CDC Say

The Centers for Disease Control and Prevention also noted that the role of Tpoxx in treating mpox "is investigational".

The federal agency called for "additional clinical trials" to explore the role of Tpoxx in treating mpox infections in patients with severe immunocompromise, including advanced HIV.

"The findings from the clinical trials suggest that most patients with monkeypox who do not have severe disease or risk factors for severe disease (e.g., severe immunocompromise) will recover with supportive care and pain management," the CDC said.

Also read: Missouri Reports 2 Cases Of Deadly Clade I Mpox, US Tally Rises To 3 In 2026

What Is Mpox?

Mpox, earlier known as monkeypox, is a rare viral disease that belongs to the orthopoxvirus genus, the same family as the more well-known smallpox virus.

Though generally less severe, mpox can still lead to serious health complications, especially in immunocompromised individuals, children, and pregnant women.

The virus is transmitted from animals to humans and can spread from person to person through direct contact with infectious sores, scabs, body fluids, respiratory droplets, or contaminated materials.

Also read: Mpox Outbreak: First Case of Severe Strain Reported in New York City

The earliest signs of mpox start within 14 days of being infected. A person may not know they have mpox and can spread the disease.

The common symptoms include:

  • fever,
  • sweating,
  • chills through the body.
  • rashes, which start as a distant rash on the face and can continue throughout the body,
  • swollen lymph nodes, migraine,
  • muscle aches,
  • fatigue,
  • weakness
  • back pain.

Mpox: Current Cases

In February, a total of 1,184 confirmed mpox cases and four deaths were reported from 46 countries, as per the WHO's latest outbreak update.

Of these cases, 58.6 percent were reported in Africa — mainly from Madagascar, the Democratic Republic of the Congo, Kenya, Burundi, and Liberia.

The WHO said all clades continue to circulate, and transmission of the virus continues mostly within sexual networks, followed by household transmission. All age-groups in some historically endemic areas are being affected.

“Unless mpox outbreaks are rapidly contained and human-to-human transmission is interrupted, there is a risk of sustained community transmission in all settings,” the WHO said.

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