The FDA, Government and Unapproved Drugs

One more story on the lack of communication between data bases here. If queries were ran and matches were determined, this would certainly help keep a lid on some of this, but as we all know the FDA is working hard to play catch up in the technology department after years of almost no growth in that area and it takes a while to get the appropriate business intelligence software in place to track some of this activity. You can find a listing here of the unapproved drugs and other relative information from the FDA.

Not only is Medicare and Medicaid paying for the drugs, also private insurers, so when it comes down to legal action with a drug with potential dangers and side effects, well this leaves the door wide open. Perhaps down the road all medications will be required to provide a stamp with a certification that they have been approved by the FDA, could help, as those without approval would be missing the stamp and easily identified. As our government is so busy in certifying products such as electronic medical records, why not here where the consequences stand to be much greater in the case of failure. Once technology enters the picture in a bigger way, it will help to identify some of the medications and drugs that are out there without approval, in the meantime we probably have not heard the last of this issue. This is outside the realm of clinical trial drugs in studies and pertains to products on the shelves of pharmacies today. BD

FDA officials say they tell Medicaid and Medicare when the agency moves to ban an unapproved drug, so the programs can stop paying. "The situation is complicated by the fact that Medicaid and Medicare have a different regulatory regime than FDA does," said FDA compliance lawyer Michael Levy. "There are products that we may consider to be illegally marketed that could be legally reimbursed under their law." The FDA began its latest crackdown on unapproved drugs two years ago and has taken action against nine types of medications and dozens of companies. Typically, the agency orders manufacturers to stop making and shipping drugs, and it also has seized millions of dollars' worth of medications. But federal law does not provide fines for selling unapproved drugs, and criminal prosecutions are rare.

The Associated Press: AP IMPACT: Govt pays for deadly, unapproved drugs