FDA Promises Tougher Stance on Unapproved Drugs
But Crackdown Could Take Years, and Will be Limited to Riskiest DrugsSep 27, 2007 | Parker Waichman LLP
More than forty years after a legal loophole allowed thousands of unapproved drugs to stay on the market, the Food & Drug Administration (FDA) is finally taking steps to crack down. But with even the FDA conceding that it cannot be certain of how many unapproved medications are on the market, it could be years before consumers are completely protected from this threat.
A recent investigation by cable network CNN revealed that the FDA estimates that around 2% of the prescription drugs now on the market never went through the agency’s approval process. Many are familiar drugs, like Phenobarbital, an anti-seizure medication, and most are listed in the Physicians Desk Reference. But many others are defective drugs that have been allowed to stay on the market because the law requiring FDA approval for prescription medications wasn’t in place until 1962. The FDA never took steps to insure that these older medications went through the approval process. And while it’s illegal to sell unapproved drugs, many companies’ that make these medications took the FDA’s lack of action as a sign of approval.
What’s worse, according to CNN, is that the FDA’s own system has made it nearly impossible for doctors and patients to ascertain if a drug has been approved. When a pharmaceutical company submits a drug for approval, the FDA gives the medication a 10 digit code called the National Drug Code, which is used to track drugs during the approval process. In the instance of older unapproved drugs, the FDA gave the medications the code back in 1962, but the drug makers never actually went through with the approval. Unfortunately, pharmacies also use the number when ordering a drug, and most doctors and pharmacists assume that the presence of a National Drug Code means that a medication has received FDA approval.
Last year, the FDA finally decided to tackle the problem of unapproved drugs. Recently, it managed to get unapproved versions of the antihistamine carbinoxamine off the market. That drug had been blamed for the deaths of dozens of children.
Now the FDA is preparing a new drug safety initiative, part of which will include tougher scrutiny of unapproved drugs. The agency is also considering waiting to assign National Drug Codes until after medications have been approved. But because the FDA has limited resources, it says it can only target the riskiest unapproved medications. And it took months to get unapproved carbinoxamine drugs off the market, so the status quo won’t change very quickly.
For this reason, some consumer advocates have called on the FDA to release a list of unapproved medications, so at least patients, pharmacists and doctors have a way to determine if a drug has been approved. But so far the agency has refused to do this. The FDA won’t even say how many people have been injured or killed by unsafe unapproved drugs, or which unapproved medications have the most serious safety issues. So for now at least, there is very little that patients or doctors can do to protect against unapproved drugs.