The Food and Drug Administration is proposing a system for approving customized drugs and medical treatments for patients with rare or hard-to-treat diseases. The pathway laid out Monday is aimed to approving one-of-a-kind therapies, including those using emerging gene-editing technology. It's a shift long sought by patients, advocates and researchers focused on rare diseases, which often do not fit within the pharmaceutical industry's business model. For many rare diseases, drug companies have had little financial incentive to develop new treatments. The FDA proposal, if finalized, would codify a path for drugmakers and researchers to study and commercialize treatments without conducting large, expensive clinical trials.
Gov. Gavin Newsom says California will begin selling affordable insulin under its own label on Jan. 1, nearly three years after he first announced a partnership to sell state-branded generic drugs at lower prices. But California won't be the only state making lower-cost insulin available. The nonprofit Civica says Thursday it will also distribute its economical diabetes medication to pharmacies nationwide. Starting in the new year, insulin pens will be available in California under the CalRx label for $11 per pen, or a maximum of $55 for a five-pack.
Prices are falling for the popular obesity treatments Wegovy and Zepbound, but steady access to the drugs remains challenging. Reduced monthly costs for uninsured patients still amount to around $500. That can put the drugs out of reach for many. Coverage also continues to shift or restrict how patients get prescriptions. Doctors say the patchy coverage and costs force them to get creative in treating patients. But there's hope that prices for the injectable drugs may fall more in the future, especially once pill versions enter the market.
Erin Fox has tracked drug shortages for more than 20 years, and she sees no easy solutions for what has become a record run. The University of Utah Drug Information Service says total active shortages hit an all-time high of 323 earlier this year. That's up 85% from a 10-year low of 174, at the end of 2017. There have been 48 new shortages recorded through March. Fox is associate chief pharmacy officer at University of Utah Health. She sees some positive news developing, thanks to growing interest from Congress in the subject.
