Tue, Nov 25, 2008 (2:04 a.m.)

A common assumption is that prescription drugs carried by pharmacies have all been federally approved.

An Associated Press investigation, however, challenged the assumption and came away with this surprising result: 2 percent of all prescriptions in this country, or about 72 million a year, are for drugs that have no approval from the Food and Drug Administration.

Medicare, the federal health insurance program for senior citizens, does not knowingly cover unapproved drugs and has purged hundreds of them from its coverage lists, the AP reported.

But Medicaid, which covers low-income people, has no such policy. And prescriptions for unapproved drugs are often written by doctors and filled by pharmacists for private patients without them realizing the drugs’ true status.

Why this problem exists is rooted in the date — 1962 — that Congress ordered the FDA to review all medications, AP reporters found. They learned that many drug manufacturers claimed at the time that Congress’ order applied only to new drugs.

Although the FDA did not agree with that position, it has never compiled a master list of all approved drugs. This has left thousands of drugs whose ingredients have not changed over the past 46 years unapproved and still on the market.

The FDA acknowledges that unapproved drugs present a public health hazard.

Our view is that Medicaid officials should follow the lead of Medicare and begin purging unapproved drugs from their coverage lists. Additionally, Congress should give the FDA a date by which it must either have reviewed the unapproved drugs or banned them from the marketplace.