from the who-defines-serious? dept.
The FDA is proposing a new, risk-based enforcement approach to homeopathic drug products (alternative medicine):
To protect consumers who choose to use homeopathic products, this proposed new approach would update the FDA's existing policy to better address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices.
Under the law, homeopathic drug products are subject to the same requirements related to approval, adulteration and misbranding as any other drug product. However, prescription and nonprescription drug products labeled as homeopathic have been manufactured and distributed without FDA approval under the agency's enforcement policies since 1988.
"In recent years, we've seen a large uptick in products labeled as homeopathic that are being marketed for a wide array of diseases and conditions, from the common cold to cancer. In many cases, people may be placing their trust and money in therapies that may bring little to no benefit in combating serious ailments, or worse – that may cause significant and even irreparable harm because the products are poorly manufactured, or contain active ingredients that aren't adequately tested or disclosed to patients," said FDA Commissioner Scott Gottlieb, M.D. "Our approach to regulating homeopathic drugs must evolve to reflect the current complexity of the market, by taking a more risk-based approach to enforcement. We respect that some individuals want to use alternative treatments, but the FDA has a responsibility to protect the public from products that may not deliver any benefit and have the potential to cause harm."
FDA draft guidance (8 pages).
Related: Probiotics Come with Bold Health Claims, but the Science is Shaky
What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
Supplement Maker on FDA Blacklist After Deadly Bacteria Found in Water System
FDA Designates MDMA as a "Breakthrough Therapy" for PTSD; Approves Phase 3 Trials
Homeopathic "Healing Bracelet" Poisons Baby With High Levels of Lead
FDA: Love is Not an Ingredient
FDA Cracking Down on Unsubstantiated Cannabidiol Health Claims
FDA Blocks More Imports of Kratom, Warns Against Use as a Treatment for Opioid Withdrawal
Biohackers Disregard FDA Warning on DIY Gene Therapy
The "good bacteria," or probiotics, that fill the pomegranate drink are everywhere these days, in pills and powders marketed as super supplements. Probiotics are said to improve digestive and immune health. They're touted as potential treatments for conditions ranging from inflammatory bowel disease to eczema to tooth decay. Some marketing campaigns even hint that they can prevent the flu.
Scientific evidence, however, does not necessarily support those claims.
Studies in rodents and small groups of humans point to possible health benefits of consuming probiotics. But there have been only a few large human trials — in large part because Food and Drug Administration rules have dissuaded food companies and federally funded researchers from conducting the types of studies that could confirm, or refute, the proposed benefits of consuming "good" microbes.
President Trump will likely nominate Dr. Scott Gottlieb as head of the FDA. Though he is presently a resident fellow at the conservative American Enterprise Institute and a partner at a large venture capital fund, he used to be an FDA deputy commissioner known for advocating dramatic reforms in the process to approve new medical products.
According to his statements as well as comments to people familiar with his thinking on the FDA, Gottlieb intends to shoot for the rapid approval of complex generics, ushering in a wave of less expensive rivals to some of the biggest blockbusters on the market. He's also likely to spur the FDA to follow the course laid out by agency cancer czar Richard Pazdur in speeding new approvals, possibly setting up a special unit aimed at orphan drugs to hasten OKs with smaller, better designed clinical trials. Other potential reforms include the possible quick adoption of new devices that could be used to improve the kind of medtech Apple, Verily and others have been working on.
Gottlieb is viewed very favorably within the pharmaceutical industry as a regulatory reformer but not destroyer. If nominated, he will have been chosen over another high-profile name on the short list: Jim O'Neill.
The close associate of Peter Thiel, O'Neill famously suggested that drugs should be approved based on safety alone, letting consumers sort out what works. That left many fearing that Trump intended to toss out the regulatory framework for new drug approvals, raising fears that his idea of competition would allow de facto placebos to compete for market share.
Arthur T Knackerbracket has found the following story:
The Food and Drug Administration advised consumers and healthcare providers Friday to avoid all liquid products made by PharmaTech LLC of Davie, Florida after finding dangerous Burkholderia cepacia bacteria in the water system used to manufacture its products. Those products include liquid drugs and dietary supplements labeled under Rugby Laboratories, Major Pharmaceuticals, and Leader Brands.
An outbreak of B. cepacia infections affecting at least 60 people in eight states led the FDA and Centers for Disease Control and Prevention to PharmaTech. Late last year, the agencies tracked the source to more than 10 lots of PharmaTech's oral liquid docusate sodium, a stool softener. But suspicion of contamination crept to the company's other products, and this month PharmaTech issued a voluntary nationwide recall of its other liquid products, such as its liquid vitamin D drops and liquid multivitamins that are marketed for infants and children.
"B. cepacia poses a serious threat to vulnerable patients, including infants and young children who still have developing immune systems," FDA Commissioner Scott Gottlieb said in a statement. "These products were distributed nationwide to retailers, health care facilities, pharmacies and sold online—making it important that parents, patients and health care providers be made aware of the potential risk and immediately stop using these products."
-- submitted from IRC
The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to MDMA for the treatment of posttraumatic stress disorder (PTSD). MAPS and the FDA have also reached agreement under the Special Protocol Assessment Process (SPA) for the design of two upcoming Phase 3 trials (MAPP1 and MAPP2) of MDMA-assisted psychotherapy for patients with severe PTSD.
MDMA-assisted psychotherapy is a novel treatment package that combines psychotherapeutic techniques with three administrations of MDMA as a pharmacological adjunct. By granting Breakthrough Therapy Designation, the FDA has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD.
The first Phase 3 trial (MAPP1), "A Randomized, Double-Blind, Placebo-Controlled, Multi-Site Phase 3 Study of the Efficacy and Safety of Manualized MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder," will begin enrolling subjects in Spring 2018, after the completion of an open-label lead-in training study at Phase 3 sites starting this fall.
[...] The Phase 3 trials will assess the efficacy and safety of MDMA-assisted psychotherapy in 200-300 participants with PTSD, aged 18 and older, at sites in the U.S., Canada, and Israel. Participants will be randomized to receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy over a 12-week treatment period, along with 12 associated 90-minute non-drug preparatory and integration sessions. The primary endpoint will be the Clinician Administered PTSD Scale (CAPS-5), as assessed by a blinded pool of independent raters.
In MAPS' completed Phase 2 trials with 107 participants, 61% no longer qualified for PTSD after three sessions of MDMA-assisted psychotherapy two months following treatment. At the 12-month follow-up, 68% no longer had PTSD. All Phase 2 participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years.
Since 2012, FDA has designated close to 200 drugs as breakthrough therapies, a status that indicates there's preliminary evidence that an intervention offers a substantial improvement over other options for a serious health condition. The agency aims to help develop and review these treatments faster than other candidate drugs.
Ars Technica is reporting on a story where the CDC report that a Homeopathic “healing bracelet” caused lead poisoning in a infant girl
[...] during a routine health screening. Healthcare workers found that the baby was anemic and had a blood lead level of 41 micrograms per deciliter (μg/dL). While no level of lead is known to be safe, the CDC recommends health interventions when a child’s blood lead level reaches 5 μg/dL.
[...] The authorities subsequently homed in on the bracelet, a homemade “homeopathic magnetic hematite healing bracelet.” The baby’s parents said they bought it from an artisan at a local fair and gave it to the baby to wear and mouth to ease teething pain. Small spacer beads on the bracelet (shown) tested positive for lead at a level of 17,000 parts-per-million. The Consumer Product Commission in 2010 set the allowable limit of lead in products intended for children at 100 parts-per-million.
The authors of the report—Drs. Patricia Garcia and Jennifer Haile, lead treatment specialists at Connecticut Children’s Medical Center—noted that the bracelet had no warnings or branding. They added that they couldn’t get the fair’s vendor information and were unable to track down the bracelet’s maker.
Also at Live Science
The U.S. Food and Drug Administration on Tuesday released a warning letter to Nashoba Brook Bakery, reprimanding the West Concord, Massachusetts-based baker and wholesaler about the ingredients it lists in its granola.
One, in particular.
"Your Nashoba Granola label lists ingredient 'Love,'" the agency wrote in the Sept. 22 letter. "'Love' is not a common or usual name of an ingredient, and is considered to be intervening material because it is not part of the common or usual name of the ingredient."
Nashoba Chief Executive Officer John Gates said the FDA's take on love as an ingredient "just felt so George Orwell."
Ars Technica additionally reports that was not all that the FDA found:
During a recent bakery inspection, FDA agents discovered: dirt and filth caked onto ceiling vents and sprinklers directly above ready-to-eat foods; parts of the floor and ceiling that were missing for some reason; equipment, including bowls and cooling racks, that wasn't cleaned or maintained; and counters, shelves, and food production surfaces that were coated with an unknown residue.
Insects also proved worrisome. At one point, an FDA inspector noticed a one-inch-long, unidentified crawling insect directly underneath a batch of pastries. Last, the FDA reported that employees weren't following proper hygiene practices. One baker repeatedly dipped a blue bracelet into raw dough while mixing it.
For your reading pleasure, here is the warning letter.
The FDA has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. In this case, the illegally sold products allegedly contain cannabidiol (CBD), a component of the marijuana plant that is not FDA approved in any drug product for any indication. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas, and topical lotions and creams. The companies receiving warning letters distributed the products with unsubstantiated claims regarding preventing, reversing or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. Some of the products were also marketed as an alternative or additional treatment for Alzheimer's and other serious diseases.
Related: U.S. Federal Cannabis Prohibition Remains Intact
"Hollyweed" and More Cannabis Stories
According to Gallup, American Support for Cannabis Legalization is at an All-Time High
Study Finds That More Frequent Use of Cannabis is Associated With Having More Sex
The FDA has issued a public health advisory warning of deaths related to kratom (Mitragyna speciosa) and warning against using it to treat opioid withdrawal symptoms. The DEA attempted to temporarily regulate kratom as a schedule I drug in 2016, but stopped short of doing so after a public backlash. From FDA Commissioner Scott Gottlieb's statement on the advisory:
It's very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms. The FDA is devoted to expanding the development and use of medical therapy to assist in the treatment of opioid use disorder. However, an important part of our commitment to this effort means making sure patients have access to treatments that are proven to be safe and effective. There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product's dangers, potential side effects or interactions with other drugs.
There's clear data on the increasing harms associated with kratom. Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year. The FDA is aware of reports of 36 deaths associated with the use of kratom-containing products. There have been reports of kratom being laced with other opioids like hydrocodone. The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms.
Given all these considerations, we must ask ourselves whether the use of kratom – for recreation, pain or other reasons – could expand the opioid epidemic. Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits.
Despite a warning from the federal government about do-it-yourself gene therapy, two companies say they'll continue offering DNA-altering materials to the public.
The companies, The Odin and Ascendance Biomedical, both recently posted videos online of people self-administering DNA molecules their labs had produced.
Following wide distribution of the videos, the U.S. Food and Drug Administration last week issued a harshly worded statement cautioning consumers against DIY gene-therapy kits and calling their sale illegal. "The sale of these products is against the law. FDA is concerned about the safety risks involved," the agency said.
Does the Executive Branch want the market to decide, or not?