KFF HEALTH NEWS – The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency’s initial feedback or requirements for more data. These communications are not usually made public.
Reuters: US FDA Publishes 200 Complete Response Letters From Archive In Transparency Drive
Typically, the FDA sends the letters, or CRLs, to drugmakers whose treatments are not approved, detailing reasons and whether additional data is required, but companies have historically exercised discretion on what information from the CRL is shared with investors.
The letters published on Thursday were issued in response to applications the FDA had received between 2020 and 2024, the agency said, adding it was in the process of sharing additional letters. (Satija, 7/10)
Bloomberg: FDA Offers To Trade Faster Drug Reviews For Lower US Prices
Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other countries, an unusual proposition from the regulator that’s long avoided contentious pricing debates.
The comments, made in an interview on Bloomberg Television’s Wall Street Week with David Westin, offer insight into an idea floated to help the administration achieve one of President Donald Trump’s main health-care goals: ensuring foreign countries aren’t getting a better deal on drugs. Trump demanded that Americans get similar or lower prices as consumers in other countries in an executive order signed in May. (Cohrs Zhang and Hornblower, 7/11)
CIDRAP: FDA Approves Moderna COVID Vaccine For Kids Under 12 At Higher Risk
Vaccine maker Moderna announced today that the US Food and Drug Administration (FDA) has granted full approval of its Spikevax (mRNA-1273) COVID vaccine for children 6 months to 11 years old. But, because federal officials in May restricted its recommendations for COVID-19 vaccines to adults 65 and older and to people of all ages who are at increased risk for severe disease, Spikevax will be available only to kids in that age range who are at higher risk. (Wappes, 7/10)
Stat: FDA Rejects Capricor’s Duchenne Cell Therapy
The Food and Drug Administration rejected a marketing application from Capricor Therapeutics for a cell therapy to treat Duchenne muscular dystrophy, the company said Friday. In its letter to Capricor, the FDA said the company’s application “does not meet the statutory requirement for substantial evidence of effectiveness” and requested additional clinical data, the company said. (Feuerstein, 7/11)
In other administration news —
The Department of Health and Human Services has rescinded a policy from 1998 that gave undocumented immigrants access to certain federal health benefits, such as Head Start and mental health programs. Issued by President Bill Clinton, the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 was passed into law and deemed a major welfare reform. (Tong, 7/10)
The NIH plans to cap how much researchers can pay to have NIH-funded work published in major journals, the agency announced this week. The exact amount of that cap, however, has yet to be determined. In an email to MedPage Today, the agency said the “specific reasonable cost allowance is still under consideration,” but it’s expected to be set by October at the start of the 2026 fiscal year. (Fiore, 7/10)
California is one of the most affordable states for buying health insurance through marketplaces established by the Affordable Care Act, commonly referred to as “Obamacare,” according to a new analysis. …
That’s among the best rates in the United States.California ranked 42nd out of 50 in the company’s “States Where People Spend the Most and Least on Health Insurance” report, which took the average cost of a “silver” tier health insurance plan in each state and compared it to the median household income. Vermont ranked 1st, with about 20% of a household’s income going to health insurance. (Byik, 7/10)
This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
