FDA To Reconsider The Diabetes Drug Standard For Safety And Effectiveness
The Food And Drug Administration officials are likely to have a meeting to discuss the proper regulations for the diabetes medicines. They are likely to make the rules and regulations tougher. They reconsider the Government regulations after they were criticized last year for their handling of heart risks connected with a widely used GlaxoSmithKline pill. During the two day meeting the FDA has decided to discuss the issue with diabetes experts, cardiologists and statisticians. If FDA adopts such a standard, companies like GlaxoSmithKline, Merck & Co. Inc. and Takeda Pharmaceuticals could be forced to conduct expensive, multi-year studies previously not required of diabetes medicines.
It can be recalled that an analysis of GlaxoSmithKline’s Avandia showed it increased heart attack risk, despite lowering blood sugar. After conducting its own research, FDA concluded the drugs’ heart risks were unclear and asked Glaxo to study the issue. Results from that trial are expected within 2014. FDA will ask its panel of outside experts whether heart safety studies should be mandatory for new diabetes drugs and those already on the market.
Other than GlaxoSmithKline’s, the FDA has approved Vytorin, made by Merck and Schering-Plough. But a recent study has shown that Vytorin was no more effective at limiting plaque buildup than a low-cost generic drug.
FDA is under pressure from some lawmakers to demand more thorough data on drugs before approving them. Sen. Charles Grassley, R-Iowa, asked the Government Accountability Office earlier this year to investigate FDA’s approval of Avandia and Vytorin.
Source: CNNMoney.com
Filed under Diabetes, Diabetes Drug
