Saturday, January 22, 2011

FDA-, DEA, CDC- AND NIH-RELATED NEWS

*************** CENTERS FOR DISEASE CONTROL AND PREVENTION ***************
CDC Lowers the Safe Lead Threshold for Children
In an action that has been overdue for quite some time, Centers for Disease Control and Prevention on October 28, 2021 has tightened the definition of lead poisoning, increasing the number of children with high lead levels from 200,000 to 500,000. Many experts believe that there is no safe lead level, and the action has been long time coming as the last revision of lead standard has been done in 2012. Although the CDC's internal scientists think that the standard should be revisited every four to five years, the issue has taken the back seat under Trump administration, according to the head of CDC's Center for Environmental Health, Patrick Breysse
In 1970s, the average lead concentration in the blood of children ages 1 to 5 years was 15 micrograms per deciliter. Thanks to phasing out of lead-based paints, removing the ingredient from our water system and other preventative measures, the average lead concentration in the blood has come down to 0.83 micrograms per deciliter during 2011-2016. The acceptable threshold for lead concentration in blood for children ages 1 to 5 years was set 10 MGDL in 1991. The threshold was lowered in 2012 to 5 MGDL. On October 28, 2021, it was lowered to 3.5MGDL

CDC to Revamp Focus
CDC Director Dr. Rochelle Walensky told the agency's staff on August 17, 2022 that the country's prime disease-fighting agency would change its focus and pivot more on operational efficiency, collaboration and execution strategy and less on publication. 

Dr. Walensky to Step down on June 30, 2023
CDC Director Dr. Rochelle Walensky on May 5, 2023 told the agency staff that she would step down on June 30, 2023. President Joe Biden later in the day issued a public statement, lauding the role of Dr. Walensky for her leadership to fight against "once-in-a-generation pandemic with honesty and integrity". 

Former North Carolina Health Official Named as CDC Chief
White House on June 16, 2023 named Former North Carolina Health and Human Services Secretary Dr. Mandy Cohen as the next director of Centers for Disease Control and Prevention. President Joe Biden lauded her experience of leading large government organizations, including the North Carolina state health agency from 2017 to 2021. 

One-in-Five Mothers Mistreated during Pregnancy
A mind-blowing finding made public by the Centers for Disease Control and Prevention points at  staggeringly high rate of maternal mistreatment. The Dallas Morning News reported on August 23, 2023 that almost 20% women did face mistreatment, including screaming, denial of services and other adverse situations. Many of them complained about lack of their physical privacy. The research, Vital Sign, makes the U.S. the worst among its high-income peers as far as the maternal treatment is concerned. Maternal discrimination, a broader category that includes racial and other discrimination, affects 28.9% of the pregnant women:
* Black: 40.1%
* Hispanic: 36.6%
* Indigenous: 31.4%
* White: 26%
* Asian: 22.6%
Also, the maternal mortality rate has risen in the U.S. during pandemic. In 2020, it was 23.8 deaths per 100,000 live births, but it shot up to 32.9 in 2021. In Texas, the situation is far worse, with maternal mortality rate exceeding 40 per 100,000 live births. 

Syphilis Cases Hit Record since 1950
After falling to a record low in 1998, Syphilis began to rise again. According to the STI Surveillance Report issued by the CDC on January 30, 2024, total cases of Syphilis reached 207,225, a 17% increase and highest since 1950. Infectious cases rose 9% to circa 59,000. Total cases include infectious cases, latent cases and congenital cases where pregnant mother passes the disease to her child. 

Kennedy Fires All 17 Members of ACIP
Health Secretary Robert F. Kennedy Jr. on June 9, 2025 took one of most radical steps to overhaul the vaccine advisory cadence. He fired all 17 members of the Advisory Committee on Immunization Practices, or ACIP. He pointed out conflict of interest as the key reason to replace all ACIP members. Kennedy said that he would soon name members to the ACIP. 
American Medical Association President Dr. Bruce Scott said that "today's action to remove the 17 sitting members of ACIP undermines the trust and upends the transparent process". 

Kennedy Names Eight New Members of Revamped ACIP
Two days after firing all 17 members of a key advisory panel, Health Secretary Robert F. Kennedy on June 11, 2025 named eight new members to the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. By the founding charter, ACIP should have at least eight members. Many of the new members are vaccine skeptic or vaccine benefit naysayers. 

U.S. Fertility Rate Dropping, CDC Says
The Associated Press reported on July 24, 2025 that the U.S. had experienced another year of contraction in fertility rate last year (2024), based on the data provided by the Centers for Disease Control and Prevention. The fertility rate last year stood 1.599 kids per woman, a slight drop from the 2023 figure of 1.621. The total births, though, in 2024 increased by 1%, or circa 33,000, compared to 2023, totaling 3.6 million births.
In 1960s, the U.S. fertility rate was around 3.5, but plummeted to 1.7 by 1976 after the so-called Baby Boom Era ended. It gradually rose to 2.1 in 2007, before trending down again amidst a spike in 2014.

Deadly Bacteria Rising, CDC Warns
The Centers for Disease Control and Prevention on September 23, 2025 issued an unusual warning, saying that the deadly NDM-CRE bacteria was rising and this family of bacteria was resistant to anti-biotics. NDM-CRE is part of Carbapenem-Resistant Enterobacterales, or CRE, family responsible for about 1,000 U.S. deaths annually, according to a read by a 2022 CDC report. NDM refers to an enzyme that makes the antibiotics impotent. During early days of COVID-19 spread, doctors abundantly prescribed antibiotics, assuming that it's a bacterial--not viral--infections, leading to proliferation of the spread of NDM-CRE

Major Rollback of Infant Vaccination Regime
In a major setback to the public healthcare system, a reconfigured--and now stashed in by vaccine deniers--advisory panel on December 5, 2025 voted to stop recommending Hepatitis B vaccination for all newborns. The December 5, 2025, vote by the Advisory Committee on Immunization Practices, or ACIP, is a slap and huge blow to the progress that has has been made over the years. 

CDC Drops Four Childhood Vaccines off Immunization Schedule 
It's a dark and tragic day for the American public healthcare system. On January 5, 2026, Centers for Disease Control and Prevention led by Director Jim O'Neil dealt a severe blow to the public healthcare system in the U.S. as it dropped recommendation for four childhood vaccines--Rotavirus, Influenza, Meningococcal disease and Hepatitis A--from the immunization schedule. 
The January 5, 2026, guidance came after HHS Secretary Robert Kennedy dropped recommendation for COVID-19 and Hepatitis B vaccines for children, citing debunked autism theory. 
*************** CENTERS FOR DISEASE CONTROL AND PREVENTION ***************

********************** DRUG ENFORCEMENT ADMINISTRATION *******************
Marijuana to be Reclassified a Lower-grade Controlled Substance
As part of his campaign promise, President Joe Biden pardoned many people who had been imprisoned for possession of pot. His administration on May 16, 2024 took the boldest step ever as the DOJ approved a plan to reschedule Marijuana from the Schedule I substance to Schedule III substance. The Drug Enforcement Administration will publish the reclassification rule. 

Daily Marijuana Use Surpasses Daily Drinking
In the first time since Marijuana has been made legal for medicinal or recreational purpose, the daily, or near-daily, users of the Marijuana have surpassed the daily, or near daily, drinkers, according to a research published in the journal Addiction on May 22, 2024
According to the research, 17.7 million people used daily, or near-daily, Marijuana compared to 14.7 million daily, or near-daily, drinkers in 2022. The revelation came a week after the Biden administration planned to reclassify Marijuana. 
********************** DRUG ENFORCEMENT ADMINISTRATION *******************

********************** FOOD AND DRUG ADMINISTRATION ************************
French Company Files for Permission of OTC Sales of Birth Control Pills
Adding to political and healthcare fight of the nation, a French pharma company, HRA Pharma, on July 11, 2022 filed for OTC (over-the-counter) sales of its birth control pill, Opill. HRA Pharma has acquired the drug from Pfizer in 2014, but has not marketed in the U.S. Birth control pills are widely available in the U.S. since 1960s, but normally require a doctor's prescription. Most of the birth control pills contain Progestin, which blocks sperms from entering the cervix, plus Estrogen that contributes to rare blood clots. According to the available research data, 3 to 9 women per 10,000 suffer blood clots while taking birth control pills compared to that of 1 to 5 cases per 10,000 without birth control pill. FDA will decide in the coming days whether sales of birth control pills without a prescription are safe and efficacious. In 2006, FDA has encountered similar dilemma for OTC authorization of the contraceptive Plan B. 

FDA to Ease Blood Donation Rules for Bisexual and Gay
On January 27, 2023, Food and Drug Administration announced that it would do away with a 3-month abstinence requirement for gay and bisexual men. The draft guidelines are another feather to the cap of relaxing the blood donation requirement and lowering or eliminating discrimination based on sexual orientation. U.S. had imposed lifetime ban on blood donation by gay and bisexual men in early 80s. In 2015, U.S. lifted lifetime ban, and instead, allowed one-year abstinence to qualify for blood donation. In 2020, as blood donation and blood stockpile have fallen, authorities further relaxed the requirement by dropping year-old abstinence condition and replace it by 3-month abstinence.  requirement. 

FDA Grants Emergency-use Authorization for Dual Flu-COVID At-home Test
Food and Drug Administration on February 24, 2023 granted emergency-use authorization for the first at-home test for the duo of jambalaya of flu and COVID-19. Lucira COVID-19 and Flu Test is designed to be administered in the form of a nasal swab with the results to be obtained in 30 minutes. 

FDA Approves OTC Birth Control Pill
Almost six decades after entering the market that had transformed millions of women's and girls' lives and proving their efficacy and safety, Food and Drug Administration on July 13, 2023 granted over-the-counter (OTC) sales of Opill, also called norgestrel, that had taken added significance after last summer's Supreme Court verdict to overturn Roe vs. Wade. Dublin-based pharmaceutical giant Perrigo will begin selling Opill over the counter, most likely, beginning January or February 2024. The other birth control pills, though, are to remain prescription-only for now. 

FDA Approves a Pair of Sickle Cell Therapies
Food and Drug Administration on December 8, 2023 approved two gene therapy treatments for sickle-cell disease. They have been developed by Vertex Pharmaceuticals and CRISPR Therapeutics as well as a second one by Bluebird Bio. The therapy developed by Vertex works differently than Bluebird. 
The Vertex therapy, called the Casgevy, aims to push back the body cells to fetal cell phase. It's the adult cells that have changed from the fetal format into ones with characteristics of sickle-cell disease. It's the CRISPR technique that extricates the gene from the adult cells so that the hemoglobin is produced again in the same quality and genetic format as in the birth. 
The Bluebird therapy, also called the Lyfgenia, adds copies of a modified gene to reverse the sickling process of the blood cell. The Bluebird therapy is, thus, also known as anti-sickling hemoglobin producing therapy. 

Experts Ask FDA to Retract Approval of Opioid Risk Identifier Test
The Food and Drug Administration in December 2023 has granted an accelerated approval of the AvertD test developed by SOLVD Health that identifies an elevated risk for an opioid addiction based on the patient's genetic test. The FDA and pro-approval experts argue that the test will empower a doctor with additional insight while prescribing an opioid to a patient. 
On April 4, 2024, 31 experts from genetics, addictions, ethics and psychiatry wrote separate letters to the FDA and CMS, respectively, pleading for retracting the approval for AvertD as it might lead to a false sense of security to patients who tested false negative and lead doctors to "refrain from prescribing opioids" even under a compelling scenario, especially adversely affecting the health of patients who tested false positive

FDA Approves a Nasal Spray for Food Allergy  
EpiPen is the tool of choice for millions of people in the U.S. to counter and mitigate Anaphylaxis, a severe food allergy. Food and Drug Administration on August 9, 2024 granted authorization for a needle-free alternative, a nasal spray, Neffy, designed and developed by ARS Pharmaceuticals Inc. 
********************** FOOD AND DRUG ADMINISTRATION ************************

********************** NATIONAL INSTITUTES OF HEALTH ************************
Fauchi to Retire in December 2022
Dr. Anthony Fauchi, a household name during the time of the pandemic and the face of the fight against COVID-19 as well as the vicious target of political attack by Conservatives, announced on August 22, 2022 that he would retire in December 2022 as the head of National Institute of Allergy and Infectious Diseases. He advised seven U.S. presidents on infectious diseases and public health policy during his stint in various roles in the federal government. Under President George W. Bush, Dr. Fauchi designed the PEPFAR to bring lifesaving HIV treatments to Africa. In 2008, President Bush awarded him the Presidential Medal of Freedom
********************** NATIONAL INSTITUTES OF HEALTH ************************

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