Recently, a string of meningitis infections plagued parts of the U.S. after tainted vials of a steroid were distributed to medical facilities.
The official tally of the outbreak: 438 people infected, 32 killed.
The vials originated at an American compounding company that hospital pharmacists in the U.S. say are not sufficiently regulated by the Food and Drug Administration.
FDA commissioner Margaret Hamburg this week formally requested from Congress greater federal power to inspect compounding companies and test their medicines. She asked for powers to inspect the companies’ records, test their drugs and require large-scale operations to register with the agency.
Legislators (as well as lobbyists working on behalf of compounders) expressed skepticism, saying that current laws are sufficient for the agency to oversee such companies. Understandably, they also questioned why the agency couldn’t prevent the outbreak.
Obviously, the parties are talking past each other: the FDA is saying it couldn’t have prevented an outbreak without more oversight; Congress and the compounders are saying it could (and should) have.
Regulation: insufficient to stop outbreaks, or too much of a burden on business? And is there a technological solution to slow infection rates? We wonder.
Hospital Pharmacists Want Better Oversight of Drug Compounders [Bloomberg]
