The extensive review this week by a panel assembled by the Food and Drug Administration of the diabetes drug Avandia highlights the critical importance of government regulation and oversight of the drug industry.
Questions have been raised about the safety of Avandia since 2007, and a process to assess these risks versus patient benefits was undertaken by the objective professionals at FDA. But one important question underscores all such inquiry: What happens when the drug safety cop is taken off the beat?
Even though our system of pharmaceutical review and approval is regarded as the most effective in the world, there exists an incredible -- and potentially deadly -- loophole: unapproved drugs.
Recent news stories regarding the recall of 1,500 lots of Johnson & Johnson's children's and infants' Tylenol, Motrin, Zyrtec and Benadryl due to bacterial contamination, and the subsequent suspension of the their manufacture, reinforce the importance of the US Food and Drug Administration's (FDA) regulatory oversight over drug products--even years after they have been approved for sale. But due in large part to grandfather provisions going back 50 years, unapproved drugs - those that have been marketed prior to the establishment of today's FDA - are actively promoted, prescribed and taken by millions of patients in the U.S. These drugs escape FDA scrutiny otherwise imposed for all approved prescription and over-the-counter medications.
Most alarming is the fact that unapproved drugs account for nearly 72 million prescriptions per year. Unapproved drugs lack the specific quality controls of an FDA-approved drug, including manufacturing oversight that ensures the appropriate amount of active drug in each tablet, the purity of ingredients and consistency from dose-to-dose. And perhaps equally troubling is the fact that - unlike every other medication available for human consumption in the United States - unapproved drugs are not required to be accompanied by dosing information supported by human clinical studies.
The consequences of this approval gap can be tragic. Hundreds of deaths have been linked to the more than 500 unapproved drugs that FDA eventually banned. Yet to this day dozens of unapproved drugs are marketed under the regulatory radar. As recently as this past March, FDA took action against manufacturers of unapproved sublingual nitroglycerin tablets for treating certain heart conditions. FDA stated that it had seen "significant quality and efficacy problems" with unapproved nitroglycerin products and, as a result, recalled them from the market. Meanwhile, an FDA approved version had been available for years right alongside the unapproved, unregulated, and we now know, unsafe versions.
And the front-line gatekeepers of the nation's prescription drug delivery system--America's pharmacists--are themselves largely unaware of this dual standard for safety among the products on their shelves. A 2006 nationwide study of 500 pharmacists found that 91% of them incorrectly assumed that all of the products they dispense are FDA-approved.
They should be approved, of course. That's why in June of 2006, when I was head of the FDA's Center for Drug Evaluation and Research, we launched an initiative to finally address unapproved drugs. The Agency issued a Compliance Policy Guide (CPG) to review the safety and efficacy of unapproved drugs that continue to be available, in an attempt to bring these products into the modern world of drug safety with clinical, regulatory and manufacturing oversight.
Certain medications that have never undergone FDA evaluation should continue to be available for patients--when no substitute exists--so long as there are no known safety concerns. Many patients simply have no alternative treatment. But as soon as an approved version becomes available, FDA needs to act immediately and enforce its policies by withdrawing all unapproved formulations from the market. Regulatory oversight alerted us all to the risks associated with certain products manufactured by J&J. If no one is watching, how can we be sure it will never happen again?
The problem goes well beyond the Internet. In his article (Close the FDA Approval Gap), Galson reports a key fact: that “unapproved drugs account for nearly 72 million prescriptions per year.” This illustrates the fact that the dispensing of unapproved prescription drugs is not merely an occasional oversight.
Galson, who played a key role in the 2006 launch of the FDA’s “Unapproved Drugs Initiative”, which is meant to better protect American patients from unapproved drugs, correctly states that the “FDA needs to act immediately and enforce its policies by withdrawing all unapproved formulations from the market” as soon as approved versions become available if this problem is to be fixed.
Galson has the right idea. It is likewise important to note that this problem cannot be solved without leadership from the FDA. Patient advocates, pharmacists and pharmacies alike should welcome a renewed commitment from the FDA to educate patients and pharmacists about unapproved drugs, and to enforce the nation’s drug safety laws accordingly.
Pure greed on the part of our corporations sanctioned by our FDA. FDA is not our friend!
harm it might be causing.
When a patient buys and consumes a drug, is he saying that he knows it might kill him but it might not and therefore he accepts any consequence effected by that drug? Does that make any sense?
Not convinced? visit the official fda.gov website and read why red yeast rice (a simple, inexpensive grain that is the source of lovastatin) is now illegal and Mevacor (whose active ingredient is lovastatin) is now available exclusively via prescription - here it is in black and white from the FDA's site:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108962.htm
FDA, CDC: think MMS and its relationships to Big Oil.
http://c4jrme.110mb.com/
The History, Science and Politics Affecting Patients Disabled by M.E. around The Globe.
This is the only way to end the corporate corruption.
I would go for 20 years, but Dylan's suggestion of 7 years over 2 is an improvement to end corruption in regulatory agencies.
What are we paying so much for.
Good service?
didn't Pelosi say we have to pass it to find out?
According to the NEJM, the price of an old unapproved medication for gout, colchicine, went up a hundred-fold when an "approved" version was given the blessing by the FDA, although no studies were needed to verify the safety or efficacy of the old line medication. The same applies to quinine, which is now also priced a hundred times its price now that it has been reviewed for safety and efficacy. This is a new trick that the FDA, bought and owned by Big Pharma, has learned. Required new testing for old line pharmaceutical remedies, and then manufacturing monopolies charge for the "new, approved" version, which used to cost pennies, several dollars per pill, is the latest scheme that drug companies use to maximize profits..
Dear colleague:
As you probably know, the practice of what you describe is known as "off-label prescribing". When in the course of his practice, a physician observes that an approved drug has collateral actions, the doctor can still prescribe the drug for that use, even though that is not the indication for which it was developed. Minoxidil, as you probably know, was initially developed to treat hypertension but soon it was seen that it also stimulated hair growth [eventually, after the due trials were conducted it gained, FDA approval for that use and now it is sold as a lotion OTC]. Off label prescribing of a drug is not illegal as long as the dose prescribed is not toxic. Off label marketing, in contrast, is illegal because as you say, is not based on rigurous clinical trials but on mere observations made by physicians in their practice.
http://frozenjustice.blogspot.com/2009/09/parmaceutical-industry-engineered-our.html
http://frozenjustice.blogspot.com/2009/09/president-obama-dont-back-away-from.html