An analysis digs into whether the FDA really is approving drugs faster under Commissioner Scott Gottlieb, MD; a clinical trial for a Parkinson's disease drug halts enrollment after 5 deaths; and California fines Anthem $5 million for poor response to consumer complaints.
Speed of Drug Approvals Under Gottlieb
The FDA has been trumpeting the faster rate of drug approvals under Commissioner Scott Gottlieb, MD, but the process may not be any faster than before. An analysis by STAT
of the difference between the approval date of drugs and the PDUFA date has found that the FDA is right in line with previous years. On average, drugs in 2017 are getting approved 30 days ahead of schedule, but the analysis found that some notable exceptions are distorting that timeline. The median approval time for “rank and file” drugs is 8 days early, which lines up with the 7 days under Robert Califf, MD, and is actually slower than the 2 weeks ahead of the PDUFA that the FDA had under Margaret Hamburg, MD, in 2014.
Parkinson’s Clinical Trial Halts Enrollment
After reporting 5 deaths, a trial of a Parkinson’s disease drug stopped enrollment of new patients. Acorda Therapeutics said that 7 patients developed sepsis, and 4 of the fatal cases were tied to a condition in which white blood cells aren’t present to fight infections, reported The Wall Street Journal
. The company is going to monitor blood-cell counts for patients in the phase 3 trial. The drug, tozadenant, is supposed to improve motor function in patients with Parkinson’s disease. Acorda acquired the drug when it bought a Finland-based company in 2016.
California Fines Anthem Blue Cross $5 Million
Anthem Blue Cross is being fined for its poor response to consumer grievances. California’s Department of Managed Health Care has criticized the insurer for failing to resolve grievances in a timely manner and not following the law regarding consumer complaints, according to California Healthline
. The state is fining the company $5 million, which is just the latest in fines the company has had to pay—since 2002, California has fined Anthem more than $6 million for violations related to consumer grievances.