New diabetes drugs should face more stringent safety checks which could cost the pharmaceutical industry millions but protect patients from unforeseen heart risks, a US government panel has recommended.
FDA advisors voted 14 to two in favour of all new diabetes drugs undergoing more in-depth studies to ensure they do not increase risks of heart problems.
The call from diabetes experts, cardiologists and statisticians comes less than a year after the FDA was criticised for its handling of heart risks connected with a widely used GlaxoSmithKline pill. The drug was approved in 1999 but the FDA failed add a warning about potential heart risks until last November.
The majority of the panel said drug companies could begin safety testing before they submit drugs to the FDA, and finish the studies after the drugs are on the market.
The testing would take an estimated five to seven years to complete, and likely cost tens of millions of dollars.
“If you wait this amount of time for testing you’re going to be preventing certain drugs from getting out there that may be better than what we already have,” said Dr. Eric Felner, a paediatric specialist at Emory University School of Medicine, and one of the dissenting voices on the panel.
The FDA is not required to follow the panel’s advice, though it often does.
Takeda Pharmaceuticals’ Glustin, GlaxoSmithKline’s Avandia, and Eli Lilly and Amylin Pharmaceutical’s Byetta currently dominate the US market.
Copyright PA Business 2008