While we're watching the FDA for yeas or nays on new drugs, pharmacists are dispensing hundreds of meds the FDA has never evaluated. Surprising, eh? Well, it surprised the Associated Press, too, when it sifted through Medicaid records and found that the government program spent more than $200 million over the past four years on non-FDA-approved drugs. And along the way, the AP found that dozens of people have died while taking those very meds.
Millions of private patients are taking these unapproved drugs, too. So are Medicare patients, even though the program specifies that unapproved drugs must not be used. In most cases, docs and pharmacists don't even know the drugs don't have the FDA stamp.
A huge legal loophole allows these drugs--which are all older medications--to still be sold. So does lax oversight by the FDA; the agency has no master list of unapproved drugs and no mechanism for sniffing these drugs out. Neither does Medicaid, which continues to pay for these drugs over and over again. Even Medicare, which has tried to purge these unapproved meds from its formulary, hasn't completed the job.
Apparently, it's a problem Congress will have to tackle. "Over the years, [these drugs] have become fully entrenched in the system," Patti Manolakis, a Charlotte, N.C., pharmacist who has studied the issue told the AP. Only a few unapproved drugs are truly essential and should remain on the market, she added.
- read the AP story