This weekend the Associated Press (AP) wrote a story FDA Faulted over unapproved uses of medications about a draft of a yet to be released report from the Government Accounting Offices (this is the investigation watchdog group for congress) on the FDA oversight of off label advertising. The draft report is not complementary of the FDA citing that it takes an average of seven months for a company get cited for off label promotion and another four months for the companies to fix the problem and come in to compliance with the FDA.
So what is the extent of the “problem” From 2003-2007, the FDA issued 42 notices of possible violations, (this amounts to little over 8 violations per year) given the thousands of drugs and possible scenarios, this is a very small number. When they are cited this usually prompted the drug maker to drop its promotional claims.
Senator Grassley is quoted in the article:
The situation has raised concerns for Sen. Charles Grassley of Iowa, who fears that federal programs such as Medicare and Medicaid are paying billions for medications used for questionable purposes while bulking up the bottom line for pharmaceutical companies. Indeed, a 2006 study suggested that more than 20 percent of prescriptions written in the United States are for off-label use.
Un cited sources “2006 study” are not the same as real research, many of the off label uses of medications are following peer reviewed studies that show patients benefit from their use. I would not want to tell the patient dying of cancer that “because the FDA has not approved this medication that would save your life, we can’t give it to you.” We need to take a hard look at which is more important “saving lives and better quality of life for our patients or saving taxpayers dollars, and those are not necessarily the same goal.
The cases included a drug approved for breast cancer and rectal cancer that also was being promoted for treatment of gastric, cervical, uterine, ovarian, renal, bladder, thyroid and liver cancers. Cancer is one of those questionable area’s for off label promotion, in that most agents work on multiple tumor types and if data is available that shows that lives can be saved by a new treatment it can take years for the FDA to give approval and in the mean time precious lives can be lost.
An additional 11 cases involving off-label promotions wound up in the hands of the Justice Department during the same period. Last year, for example, Bristol-Myers Squibb Co. agreed to pay the government more than $500 million to settle claims involving a series of alleged infractions, including promoting the drug Abilify — approved to treat schizophrenia and bipolar disorder — for treatment of dementia-related psychosis and for use in treating children.
This shows that the system may be working better than the reports stated; companies who pay $500 million dollar settlements spend a lot of resources to make sure they don’t make the same mistakes twice. In addition other companies take notice and change their practices to avoid fines as well.
As is often the case in an election year, the GAO is more than happy to write reports that shed a unfavorable light on the administration especially if the president is from a different party than the party that controls congress.
It wouldn’t hurt the FDA to increase the size of DDMAC, the office at the FDA that reviews advertising but with more and more drugs going off patent that may not be a long term necessity.
Senator Grassley’s chief concern is that Government takes too long to issue citations on off label promotion. These are not traffic tickets, many of the citations can fall into “grey areas”, because of the complexity of labeling, and the fact that false claims equal huge fines, the FDA is entitled to taking their time to ensure they have all the facts correct, prior to moving towards citation (I admit seven months is too long, but perhaps three months is reasonable, but as is much with these types of reports the real number is probably closer to three months than seven)
Until we have evidence that there is actual patient harm or that the activity is actually happening, a slow and steady process might not be such a bad thing.
When the GAO does get around to finalizing their draft “report” we will make it available here.
AP Story: FDA Faulted over unapproved uses of medications
MSNBC Reprint: Little monitoring for 'off-label' drug marketing