Fw: Medicaid pay's for Risky drugs never reviewed...

[Guest guest]

From: Darin <darin_bryant@...>

Subject: Medicaid pay's for Risky drugs never reviewed...

Medicaidforhbot@..., @...

Date: Monday, November 24, 2008, 9:49 AM

They can kill us with Drugs that are never reviewed but they can't pay for HBOT

that is proven to work. What's up with this........

 

 

 

 

 

WASHINGTON – The government is paying millions for risky medications that have

never been reviewed for safety and effectiveness but are still covered under

Medicaid, an Associated Press analysis of federal data has found.

Taxpayers have shelled out at least $200 million since 2004 for such drugs. Yet

the Food and Drug Administration says unapproved prescription drugs are a public

health problem, and some unapproved medications have been linked to dozens of

deaths.

Millions of private patients are taking them as well, and their availability may

create a false sense of security.

The AP analysis found that Medicaid, which serves low-income people, paid nearly

$198 million from 2004 to 2007 for more than 100 unapproved drugs. Data for 2008

were not available but unapproved drugs still are being sold. The AP checked the

medications against FDA databases, using agency guidelines to determine if they

were unapproved. The FDA says there may be thousands of such drugs on the

market.

The medications are mainly for common conditions like colds and pain. They date

back decades, before the FDA tightened its review of drugs in the early 1960s.

The FDA says it is trying to squeeze them from the market, but conflicting

federal laws allow the Medicaid health program for low-income people to pay for

them.

Medicaid officials acknowledge the problem, but say they need help from Congress

to fix it. The FDA and Medicaid are part of the Health and Human Services

Department, but the FDA has yet to compile a master list of unapproved drugs,

and Medicaid — which may be the biggest purchaser — keeps paying.

" I think this is something we ought to look at very hard, and we ought to fix

it, " said Medicaid chief Herb Kuhn. " It raises a whole set of questions, not

only in terms of safety, but in the efficiency of the program — to make sure we

are getting the right set of services for beneficiaries. "

At a time when families, businesses and government are struggling with health

care costs and 46 million people are uninsured, payments for questionable

medications amount to an unplugged leak in the system.

Sen. Grassley, R-Iowa, has asked the HHS inspector general to

investigate.

That unapproved prescription drugs can be sold in the United States surprises

even doctors and pharmacists. But the FDA estimates they account for 2 percent

of all prescriptions filled by U.S. pharmacies, about 72 million scripts a year.

Private insurance plans also cover them.

The roots of the problem go back in time, tangled in layers of legalese.

It wasn't until 1962 that Congress ordered the FDA to review all new medications

for effectiveness. Thousands of drugs already on the market were also supposed

to be evaluated. But some manufacturers claimed their medications were

grandfathered under earlier laws, and even under the 1962 bill.

Then, in the early 1980s, a safety scandal erupted over one of those

medications. E-Ferol, a high potency vitamin E injection, was linked to serious

reactions in some 100 premature babies, 40 of whom died.

In response, the FDA started a program to weed out drugs it had never reviewed

scientifically. Yet some medications continued to escape scrutiny.

Sometimes, the medications do not help patients. In other cases, the FDA says,

they have made people sicker, maybe even killed them. This year, for example,

the FDA banned injectable versions of a gout drug called colchicine after

receiving reports of 23 deaths. Investigators found the unapproved drug had a

very narrow margin of safety, and patients easily could receive a toxic dose

leading to complications such as organ failure.

Critics say the FDA's case-by-case enforcement approach is not working.

" The FDA does not appear to have a systematic mechanism to report these drugs

out, " said Jon Glaudemans, senior vice president of Avalere Health, a health

care industry information company, " and there doesn't seem to be a systematic

process by which health insurance programs can validate their status. And

everyone is pointing the finger at someone else as to why we can't get there. "

In most cases, doctors, pharmacists and patients are not aware the drugs are

unapproved.

" Over the years, they have become fully entrenched in the system, " said Patti

Manolakis, a Charlotte, N.C., pharmacist who has studied the issue. Only a few

unapproved drugs are truly essential and should remain on the market, she added.

Tackling the problem is made harder by confusing — and sometimes conflicting —

laws, regulations and responsibilities that pertain to different government

agencies.

Medicaid officials said their program, which serves the poor and disabled, is

allowed to pay for unapproved drugs until the FDA orders a specific medication

off the market. But that can take years.

Compare that with Medicare, the health care program for older people.

Medicare's prescription program is not supposed to cover unapproved drugs.

Medicare has purged hundreds of such medications from its coverage lists, but it

continues to find others.

It might be easier to sort things out if the FDA compiled a master list of

unapproved drugs, but the agency hasn't done so. FDA officials say that would be

difficult because many manufacturers do not list unapproved products with the

agency. Yet, the AP found many that were listed — a possible starting point for

a list.

Among the drugs the AP's research identified were Carbofed, for colds and flu;

Hylira, a dry skin ointment; Andehist, a decongestant, and ICAR Prenatal, a

vitamin tablet. Medicaid data show the program paid $7.3 million for Carbofed

products from 2004 to 2007; $146,000 for Hylira; $4.8 million for Andehist

products, and $900,000 for ICAR.

Grassley said the system is failing taxpayers and consumers.

" The problem I see is bureaucrats don't want to make a decision, " Grassley said.

" There is no reason why this should be such a house of mirrors when so much

public money is being spent. " Grassley is considering introducing legislation to

ensure that consumers are told when a medication is unapproved..

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

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 call for fines for selling unapproved drugs, and criminal

prosecutions are rare.

Some manufacturers of unapproved drugs say their products predate FDA regulation

and are " grandfathered in. "

" These are drugs that don't require an FDA approval, " said Bill s, chief

financial officer of Hi-Tech Pharmacal in Amityville, N.Y. " These are products

with active ingredients that have been on the market for a long time.. " The

company is moving away from older products, s said, and its new market

offerings are FDA-approved.

Levy said the FDA is skeptical that any drugs now being sold are entitled to

" grandfather " status. To qualify, they would have to be identical to medications

sold decades ago in formulation and other important aspects.

The agency is targeting drugs linked to fraud, ones that do not work and, above

all, those with safety risks. While the crackdown has helped, it does not appear

to have solved the problem.

The gout drug banned by the FDA this February is not the only recent case

involving safety problems.

Last year, the FDA banned unapproved cough medicines containing hydrocodone, a

potent narcotic. Some had directions for medicating children as young as age 2,

although no hydrocodone cough products have been shown to be safe and effective

for children under 6.

In a 2006 case, the agency received 21 reports of children younger than 2 who

died after taking unapproved cold and allergy medications containing

carbinoxamine, an allergy drug that also acts as a powerful sedative. Regulators

banned all products that contained carbinoxamine in combination with other cold

medicines.

" We as Americans have a belief that all the prescription drugs that are

available to us have been reviewed and approved by the FDA, " said Manolakis, the

pharmacist. " I think the presence of these drugs shows we have a false sense of

security. "