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Trending News Today: FDA Warns Supplement Makers, Plans for Tougher Regulations

Top news of the day across the health care landscape.
 
Published Online: Feb 12,2019
AJPB Staff
Catalyst Pharmaceuticals announced that it anticipates its rare disease drug Firdapse to cost more than $300,000 per year, including rebates to insurers and other discounts, Reuters reported. According to the article, Firdapse, which is used to treat a rare neuromuscular disorder called Lambert-Eaton Myasthenic Syndrome, was previously available to patients for free from Jacobus Pharmaceuticals through the FDA’s “compassionate use” program. Catalyst won FDA approval in November to sell the drug at a list price of $375,000 per year, the article reported.

FDA Commissioner Scott Gottlieb, MD, said the FDA is planning to launch policy changes aimed to strengthen regulations for the dietary supplement industry, The Washington Post reported. According to the article, Dr Gottlieb said the changes could lead to the most important regulatory modernization since the enactment of the 1994 Dietary Supplement Health and Education Act. Additionally, the FDA recently sent 12 warning letters and 5 advisory letters to companies selling dozens of products that contain unapproved drugs or making illegal claims for treating Alzheimer disease or other serious conditions, the article reported.

A recent study found that physicians are twice as likely to prescribe opioids to residents of predominantly white neighborhoods than residents of neighborhoods with a high proportion of minorities, The Los Angeles Times reported. According to the article, the study examined prescribing practices across all of California’s ZIP codes between 2011 and 2015. Overall, the researchers found that in each of the 5 years studied, approximately 24% of Californians left a physician’s office at least once with a prescription for an opioid narcotic, the article reported.