FDA Cracking Down on Drug Risks after Avandia
Recent and bitter debates over the diabetes drug Avandia and other controversial drug products appear to be getting the attention of regulators. Industry insiders say that the Food and Drug Administration is increasing its scrutiny of product risks, particularly those caused by diabetes drugs.
The FDA imposed severe restrictions on Glaxo’s Avandia drug in September, following three years of debate over the drug’s link to heart risks. The agency’s actions benefited competitor Novo, a Danish drug maker that won approval for its diabetes drug Victoza earlier this year after a long period of review.
Medical devices are also under intense scrutiny because of problems with orthopedic devices. FDA commissioner Margaret Hamburg says that the agency is promoting investments in better scientific tools so they will be better equipped to quickly recognize and respond to safety problems.