FDA Advisers Agree Premature Birth Drug Makena Should Be Withdrawn
The Food and Drug Administration has been making an effort to withdraw the controversial drug, Stat notes, and now a panel of expert advisers has voted to support that goal. Separately, Pittsburgh-based insurer Highmark chose to cover prescription digital mental health therapies.
Stat:
FDA Panel Votes That Premature Birth Drug Should Be Withdrawn
After an extraordinary three-day hearing, an expert panel of advisers to the U.S. Food and Drug Administration voted on Wednesday to uphold an effort by the regulator to withdraw a controversial drug for preventing premature births. (Silverman, 10/19)
AP:
FDA Panel Backs Removal Of Unproven Pregnancy Drug
FDA Commissioner Dr. Robert Califf is expected to make a final decision on withdrawing the drug in the next several months. If he follows the panel’s advice, it would be the first time the FDA has formally pulled a drug that it initially approved based on promising early data. (Perrone, 10/19)
Axios:
Controversy Over Preterm Birth Drug Reflects Broader Issues With FDA Approval Process
A Food and Drug Administration advisory panel's recommendation to pull an early birth drug from the market is only the latest controversy surrounding a popular program aimed at getting promising new treatments to patients faster. (Owens, 10/20)
In other pharmaceutical industry news —
Stat:
Large Insurer Decides To Cover Prescription Digital Therapies
A large commercial insurer’s decision to cover a controversial class of software-based treatments for psychiatric and other conditions could prove to be a landmark moment in the development of these so-called prescription digital therapeutics, which until now had been unable to secure coverage from insurers skeptical that the new technologies are as effective as their makers claim. (Aguilar, 10/19)
Roll Call:
As Hepatitis C Proliferates, States Lift Barriers To Treatment
While national efforts to eliminate hepatitis C have faced setbacks because of increased drug use, the impact of COVID-19 and insurance complications, there’s a bright spot: Some states are now making it easier for patients to treat the disease. (Raman, 10/19)
