About pharma
FDA approves first ALS drug in 5 years after pleas from patients “The newly approved therapy, which will be sold under the brand name Relyvrio, is designed to slow the disease by protecting nerve cells in the brain and spinal cord destroyed by ALS — amyotrophic lateral sclerosis.”
FDA blasts Chinese drug ingredients outfit for subpar impurity testing and poor equipment hygiene The FDA has scolded Zhejiang Tianyu Pharmaceutical in the wake of an inspection at the company’s plant in the Chinese province of Zhejiang between Feb. 28 and March 4, 2022. In FDA’s warning letter, dated Aug. 17, the regulator laid out a laundry list of complaints tied to lapses in Tianyu’s active pharmaceutical ingredient (API) production, which the company failed to amply address in its response to an earlier Form 483.
Making matters worse, the FDA raised similar concerns more than three years back. Now, it’s urging Tianyu to summon outside help to get its manufacturing operations in order.
Up top, the FDA critiqued Tianyu’s investigation into impurities found in an unnamed drug ingredient.”
Recall most APIs come from China and India.
SK Capital buys generics producer Apotex, troubled since the murder of founder Barry Sherman “Private investment firm SK Capital has bought the Toronto-based, family-owned company. Terms of the sale for Canada’s largest producer of generic drugs were not disclosed. In 2019, when the company hired a financial advisor to review its options, Apotex was said to be worth up to $3 billion.”
The 340B Drama Continues “The American Hospital Association and others brought suit against HHS for its 2018 outpatient drugs reimbursement policy for 340B hospitals. Prior to 2018, CMS paid all hospitals (i.e., 340B hospitals and non-340B hospitals) Average Sale Price (ASP) + 6% for outpatient drugs. In 2018, the Trump administration reduced the reimbursement rate to 340B hospitals to ASP – 22.5% to account for the average minimum 340B discount these hospitals receive from manufacturers. The Supreme Court found these cuts to be illegal because, under the statute’s plain language, CMS must conduct a survey of acquisition costs prior to establishing varying payment amounts among hospitals. There is, however, still an open question as to remedy, which the Supreme Court did not address.”
About the public’s health
White House reveals $8B in private sector spending to fight hunger with focus on nutrition and chronic illness “The White House announced today more than $8 billion in commitments to the "food is medicine" movement linking nutrition and chronic illness.
The announcement coincided with the White House Conference on Hunger, Nutrition, and Health, held for the first time in more than 50 years. After a call to action this summer, over 100 private and public sector contributors offered funds and services to catalyze healthcare delivery in addressing health equity.
Of the committed funds, $2.5 billion will be invested in startup companies addressing food and nutrition insecurity, and $4 billion will be directed toward initiatives improving access to nutritious food and philanthropy promoting healthy choices and increasing physical activity.”
The FDA announces a new definition of what’s ‘healthy’ “The Food and Drug Administration announced new rules Wednesday for nutrition labels that can go on the front of food packages to indicate that they are ‘healthy.’
Under the proposal, manufacturers can label their products ‘healthy’ if they contain a meaningful amount of food from at least one of the food groups or subgroups (such as fruit, vegetable or dairy) recommended by the dietary guidelines. They must also adhere to specific limits for certain nutrients, such as saturated fat, sodium and added sugars. For example, a cereal would need to contain three-quarters of an ounce of whole grains and no more than 1 gram of saturated fat, 230 milligrams of sodium and 2.5 grams of added sugars per serving for a food manufacturer to use the word ‘healthy’ on the label.
The labels are aimed at helping consumers more easily navigate nutrition labels and make better choices at the grocery store. The proposed rule would align the definition of the “healthy” claim with current nutrition science, the updated Nutrition Facts label and the current Dietary Guidelines for Americans, the FDA said.”
USPSTF Advises to Keep Screening for Syphilis as Cases Soar “Nonpregnant teens and adults who have ever been sexually active and are at increased risk for syphilis should still be screened for the sexually transmitted infection, the U.S. Preventive Services Task Force (USPSTF) said on Tuesday.
The final recommendations garnered an "A" grade, and are firmly in line with the draft guidance posted earlier this year and the Task Force's 2016 recommendation on the matter, according to Carol Mangione, MD, MSPH, of the University of California Los Angeles, and other members of the USPSTF. (Pregnant women should continue to follow separate recommendations for syphilis screening most recently released in 2018.)”
About healthcare IT
CHIME Leads Request for HHS to Delay Information Blocking Deadline “The College of Healthcare Information Management Executives (CHIME) and nine other healthcare industry groups have called on HHS to postpone the approaching information blocking compliance deadline, which is set to go into effect on October 6, 2022.
The Cures Act Final Rule, commonly known as the Information Blocking Final Rule, published by ONC in May of 2020, was passed to prevent information blocking practices by providers, health IT developers, health information exchanges (HIEs), and health information networks.
When the Cures Act Final Rule was published, the scope of electronic health information (EHI) was limited to the United States Core Data for Interoperability (USCDI) version 1, which includes information such as clinical notes.
Anticipating an October 6, 2022, start date, the definition of EHI will expand well beyond the current USCDI version 1, and stakeholders will be expected to share all EHI. Notably, EHI will now include unstructured data.”
Your Clinical Decision Support Software: Is It a Medical Device? If you are currently or, in the future, may be involved in IT healthcare applications this FDA document is a must-read.
About health technology
Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes “In this 13-week, randomized trial involving adults and children with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction than standard care in the glycated hemoglobin level.”