Personal Injury Law

Medicaid Pays Millions For Unapproved Drugs

By Chrissie Cole

The government is paying out millions for unapproved drugs that were never reviewed for safety and effectiveness but are still covered under Medicaid, according to analysis by the Associated Press.

Taxpayers have paid more than $200 million since 2004 for unapproved drugs. These drugs pose a public health concern and many have been linked to several of deaths. 2008 data is not yet available, but unapproved drugs are still being sold.

The medications span back decades, before the agency strengthened its drug review process in the early 1960s. The Food and Drug Administration (FDA) is trying to remove these drugs from the market, but conflicting federal laws allow Medicaid to continue paying for them.

The AP used FDA databases and agency guidelines to determine if drugs were unapproved. Of the unapproved drugs, most were for common conditions such as colds and pain. The agency says there may be thousands of such drugs still on the market.

While Medicaid officials recognize the problem, they say they need assistance from Congress to begin fixing it. The FDA has yet to create a master list of unapproved drugs and Medicaid – the biggest purchaser – keeps paying the bill.

“It’s a serious problem and something we need to examine closely so it can be fixed,” said Herb Kuhn, Medicaid chief. “It raises several questions, not only in terms of safety, but the effectiveness of the program to ensure beneficiaries are getting the right services.”

The HHS inspector general has been asked to investigate by Sen. Charles Grassley, R-Iowa.

The agency estimates that unapproved drugs account for 2 percent of the 72 million prescriptions filled each year in U.S. pharmacies. They are also covered by private insurance plans.

The root of the problem stems back years in time, tangled in layers of legalese.

Among drugs identified by the AP’s research were Carbofed, for colds and flu; Hylira, an ointment for dry skin and Andehist, a decongestant. Data shows Medicaid paid $7.3 million for Carbofed from 2004-2007, $146,000 for Hylira and $4.8 million for Andeshist.

In 1962, Congress ordered the FDA to begin reviewing all drugs for their effectiveness. Thousands of medications on the market were also supposed to be reviewed, but several drug manufacturers claimed their drugs were “grandfathered in” under earlier laws, which means they don’t need FDA approval.

E-Ferol, a powerful vitamin E injection, was the center of a safety scandal in the 1980s after it was linked to serious adverse reactions in more than 100 premature babies, 40 of whom died.

In response, the FDA started a program to detect drugs that had never been scientifically reviewed. Yet, still, some drugs escape review.

The medications are often ineffective. In some cases, the FDA says, they caused patients to become sicker, and in some cases caused death. For example, earlier this year the FDA banned colchicine an injectable gout drug, after 23 reports of death. The unapproved drug was found to have a narrow margin of safety and patients could easily receive a toxic dose leading to serious adverse effects including organ failure.

Fixing the problem is made difficult by confusing – and often conflicting – laws, regulations and responsibilities that relate to different government agencies.

For instance, Medicaid is allowed to pay unapproved drugs until the FDA orders the drug off the market, which can take many years.

In contrast, Medicare, the health care program for elderly people does not cover unapproved drugs. They have removed hundreds of drugs from its list of coverage but continually find others.

The FDA banned unapproved cough medicines that contain hydrocodone, a strong narcotic, last year. Some listed directions for medicating children as young as two-years-old, although no hydrocodone cough products have been shown to be safe and effective for children under six.

In 2006, the FDA received 21 reports of children under two dying after taking unapproved cold and allergy medications. #

Full post as published by InjuryBoard on November 25, 2008 (boomark / email).