FDA To Allow Off-Label Rx Marketing

Agency Gives Pharmaceutical Companies Leave To Promote Their Drugs For Unapproved Uses To Doctors

(AP)  Food and Drug Administration officials have finalized guidelines that make it easier for pharmaceutical companies to use medical journal articles to promote drugs for unapproved uses.

The final guidelines, which have been criticized by some lawmakers as too lenient, allow companies to distribute articles about their products to doctors - even when they involve uses that have not been federally approved.

The FDA document, posted online Monday, comes just days before the Bush administration turns over power to President-elect Obama's government. On the campaign trail, Obama criticized pharmaceutical industry efforts to court physicians.

For their part, companies like Pfizer Inc. and Eli Lilly said the guidelines merely reauthorize a longstanding policy that benefits doctors and patients.

"Physicians need timely access to the latest medical information to keep abreast of the best practices in patient care," said Alan Bennett, an attorney representing the pharmaceutical industry.

Companies are not allowed to advertise products for "off-label" uses, or those that have not been cleared by the FDA as safe and effective. However, FDA has allowed company salespeople to distribute articles about such uses if they are published in a peer-reviewed medical journal.

The law permitting that practice expired in September 2006, and drugmakers have been lobbying the agency to renew it ever since.

The reliability of medical journal articles came into question earlier this year when drugmaker Merck & Co. Inc. was accused of ghostwriting several articles about its painkiller Vioxx, which was withdrawn from the market in 2004 for safety reasons.

Reports published in the Journal of the American Medical Association alleged that Merck paid academics to take credit for articles which were actually written by the company. Merck denied the allegations, calling them false and misleading.

FDA said the new guidelines are designed to discourage ghostwriting. Specifically, they recommend companies disclose any financial relationships with article authors and specify authors' affiliations.

Overall, though, FDA remains supportive of distributing articles about experimental uses of drugs and medical devices.

"The public health may be advanced by healthcare professionals' receipt of medical journal articles ... on unapproved new uses," the agency states. Such uses may even "constitute a medically recognized standard of care," according to the agency.

Lawmakers including Rep. Henry Waxman, D-Calif., have criticized FDA's guidance, saying it represents a step backward in enforcement standards for the pharmaceutical industry.

Under the expired law, companies had to submit reprints of articles to the FDA before sending them to doctors. That way, the article's accuracy could be verified. Under the new proposal, drug companies don't have to submit articles to the FDA.

Waxman and other Democrats have said the change makes it easier for drugmakers to promote potentially risky medical practices.

[solarrays247-2009]

"Waxman and other Democrats have said the change makes it easier for drugmakers to promote potentially risky medical practices."

Yet, the FDA screamed bloody murder about the safety of prescription formulations when our elderly citizens crossed the border into Canada to purchase their medications at affordable prices!

Will the madness ever end? Doubt it. Not as long as there is greed. One unbelievable mess after another!

[alphaa10000]

Over eight years of the Bush term, the FDA proved itself a corrupt, ineffectual rest home for Bush political appointees.

The agency''s formerly respectable reputation was squandered by Bush patronage politics-- the kind that put Michael Brown in charge of FEMA before Katrina struck.

And now this-- the Bush FDA''s parting gift to its real masters, the American pharmaceutical industry.

Allowing "off-label" use is the effective equivalent of telling doctors and their patients, "You are on your own-- we''re not going to get involved."

Proponents of creative clinical experimentation with certain drugs may be overjoyed, until they realize they venture into uncharted territory for which nobody wants to accept responsibility-- least of all the drug companies. All they want is the money.

[greeneyes222]

The FDA is a total disgrace. What happened to their mandate to protect the citizens?

[sly_64]

How about a label on certain drugs stating "You can get a DUI while taking this medication."

[scotch41-2009]

What will they do next?

[photolex]

The new FDA guidance only allows companies to market off-label uses with specific restrictions. Doctors have ALWAYS been able to prescribe off-label uses. If you don''t trust your doctor to have your best interests in mind, don''t go!

[lochlan-2009]

Food and Drug Administration officials have finalized guidelines that make it easier for pharmaceutical companies to use medical journal articles to promote drugs for unapproved uses."

And the article yesterday was wondering why people refuse to let their children get vaccinated with these poisons for profit. It seems quite apparent, the inability of the FDA to protect the people from the abuses of the profit motivated, at the cost of whom evers health, pharmaceutical companies. True, there are things that doctors can do with this that previously they would get arrested for, that tends toward the better good for their patients. But in the majority, and I mean significant majority, this is going to be abused, and we all know it. But it''s done, the poison is in the river now. Buyer beware. Your government has failed to protect you from the greedy and corrupt AGAIN.

[lochlan-2009]

Notice how this is being conveniently timed for the release of unprecidented amounts of cash to the medical lobby, from Congress.

Our government is being run by the mob. I have no doubt anymore.

[getoffmine1]

once again, profit is more important then people. Isn''t this a great capitalist system?

[cariboubarbi]

Once again the Bush administration gives corporations free reign with no regard whatsoever for public safety.

Worst President in U.S. history.

[impeach___w]

This will be good for the drug biz at first but bad for consumers.
I have no issue with off label use but I do for advetising it.
This should open up some big time lawsuits as people die or are injured from a drug they saw advertised on TV or elsewhere and was prescribed for something it was never tested to treat.

[tincup356]

The FDA is the most corrupt arm of the federal government...when they accept lobby dollars in congress from the drug companies...it always means there is something very rotten going on to scam billions of dollars from citizens....Do not think for a second just because something has the blessing of the FDA that it is safe.....far from the truth....instead it means someone was bribed big bucks so someone else could make a million times more than that. How else would approval been given to Aspartame to be used in food and drugs....after it was made originally for chemical warfare?....go ask Donald Rumsfeld....he was responsible in that dirty deed......so next time you open a diet coke ...don is killing you.

[harbinger19]

It benefits doctors and drug companies who, from Prevacid to nightmare products like Zyoprexa--get their patients hooked and in need of more meds. The FDA should be torn apart and all lackeys--fired. As for using drugs for uses not approved of--what is the point of a watch dog agency, if the drug companies can market products without testing or safety? Anybody remember Lilly just had to settle a 1.4 BILLION dollar suit for off marketing and now people are dying due to their off marketing? If this had already been in place, they would not even have gotten in trouble.

The FDA is now blatantly irresponsible.

[harbinger19]

The public health may be advanced by healthcare professionals' receipt of medical journal articles ... on unapproved new uses," the agency states. Such uses may even "constitute a medically recognized standard of care," according to the agency."

*********--the public has now become guinea pigs--to test out theories...So,, If the new uses and patients are harmed--can they sue the mf FDA?