As many as 72 million prescriptions each year are written for drugs that never received approval from the US Food and Drug Administration (FDA), costing US taxpayers, by way of the Medicaid program, more than $200 million since 2004, according to recent analysis by the Associated Press (AP).  When the FDA was chartered with drug review and approval in 1962, it failed to review the drugs in use at the time, as legislation directed, focusing instead on new drugs, and it failed to implement a master list of drugs earning approval.  The unapproved drugs prescribed today are said to have been ‘grandfathered’ into acceptance at that time.

In an alarming number of cases, the doctors prescribing them and the pharmacies filling those prescriptions do not know they are working with drugs never proven safe or effective.  About 100 such drugs are thought to be in frequent use, many of which are linked to adverse side effects that include death of the patient.  The FDA suggests there are thousands more unapproved drugs in less frequent use.

Most of the drugs in question are meant for relief from colds or pain and FDA officials say they inform both the Medicaid and Medicare programs when a drug is banned so payments can stop but they cannot supply a comprehensive list of approved drugs the healthcare providers can use in a system of checks and balances.  It is important to note these drugs are as likely to be prescribed for the 46 million uninsured Americans and those enrolled in private healthcare programs as they are for those enrolled in the two government-backed healthcare programs.

Medicaid officials say they are allowed to cover the cost of unapproved drugs until given specific orders otherwise by the FDA.  Medicare is not allowed to pay for unapproved medications and, over time, has purged hundreds of unapproved drugs from its coverage list although the agency continues to discover more unapproved drugs within the system.

Saying the situation is “complicated,” Michael Levy, a compliance lawyer for the FDA, cites these differing regulations in the Medicaid and Medicare programs as a factor in the problem.  Although the FDA can issue orders to stop manufacture and shipping of unapproved drugs, there are no federally established fines for selling unapproved drugs and drug companies doing so are rarely prosecuted.

Levy further states he is skeptical of any grandfathered drugs sold today.  One criterion for grandfathering is that chemical formulations must have remained identical to pre-1962 formulations, a situation suggested as unlikely.

Some unapproved drugs in common use today include:

• Colchicine, for gout, was banned this past February after 23 people died and others suffered organ failure.  A subsequent investigation revealed a very narrow margin of safety, making overdosing too easy.
• Hydrocodone, officially classified as a powerful narcotic, has never been proven safe or effective for children under the age of 6 although, until a recent ban, it was marketed to children as young as 2.
• Carbinoxamine-based allergy and cold medications marketed to children were banned in 2006 after 21 children no older than 2 died from them.
• Carbofed, a cold/flu drug, garnered Medicaid payments of $7.3 million from 2004 to 2007.
• Hylira, an ointment for dry skin, earned $146,000 in Medicaid payments during that same time period.
• Andehist, a decongestant, earned payments of $4.8 million.\
• ICAR Prenatal vitamins earned $900,000.

Sen. Charles Grassley, R-Iowa, says the system is failing taxpayers and consumers alike and has called for an in-depth investigation by the US Health and Human Services Department.  Describing the situation as a “house of mirrors” backed by “bureaucrats (who) don’t want to make a decision,” he is investigating the possibility of initiating legislation that will require public notification when a medicine fails to meet approval.