Drugmakers haven't made progress in starting studies that they promised to conduct after their products were approved by U.S. regulators, according to newly released FDA data. The agency determined that 1,044, or 62 percent, of incomplete studies for drugs and biotechs had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn't begun,
Bloomberg News reports.To receive FDA approval, drugmakers often agree to perform additional studies of safety, dosing and other matters after meds come to market. The research is usually voluntary, and lawmakers have repeatedly complained it isn't completed. President Bush signed legislation in September that allows the FDA to require certain post-approval studies.
Meanwhile, some research has been pending for years. Of the 1,044 studies that hadn't begun, drugmakers committed before Oct. 1, 2004, to undertake 444 of them. The stats show 271 studies, or 16 percent, were on or ahead of schedule, and 242, or 14 percent, had been submitted for FDA review or terminated before completion. The FDA described 125 studies as "delayed.'' The FDA report didn't identify specific companies or the number of drugs covered by the studies. Drugmakers sometimes agree to complete multiple studies for a single product.
Not all of the uninitiated studies are considered late by the FDA. Many don't have deadlines imposed by regulators. The FDA is considering how to "integrate'' its new power to require studies with commitments that have been made by drugmakers, agency spokeswoman Susan Cruzan wrote Bloomberg. The FDA will work to ensure that studies previously promised "are completed in a timely manner."
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Those of us in the diabetic community who cannot tolerate rDNA insulin have been waiting 26 years for Lilly to complete the required Phase IV study, an FDA approval-requirement. Remember these rDNA insulin manufacturers want Congress and the FDA to prohibit generic manufacturing--because the generic manufacturers cannot prove 'what's in the vial.' I contend that Lilly has yet to prove 'what's in the vial.' The patented processes used to create this small-molecule (51 amino acid) biologic could be easily researched to PROVE (or disprove) bioequivalency since naturally-occuring hormones are still available for comparison.
The FDA could pull the med if the study is not done by the drug company, yet they have never done this. The drug company is reluctant to do such a trial for fear of a concern arising from such a study, possibly related to the safety of the approved med.
Lilly's Prozac comes to mind. Who in their right mind would pull prozac!,.. no one, abrupt withdrawl would be deadly.
Surprise, surprise, surprise - as Gomer would say. I work in big pharma and the level of accountability they hold employees to is very strict, but my experience has been that the same rules and level of accountability do not apply to the corporation and execs in general. Unfortunately, it is the patient, so 'protected' by pharma that suffers.
I think this is really an FDA story and, in contrast to yesterday's re: Dingell, an issue that money will _not_ fix.
FDAAA gave the agency a range of potential sanctions aside from pulling a drug (which they had before) for incomplete studies. But the futzing appears not to have changed. I assume "integrate" its new powers means figuring out how to move them from Nevernever Land to something vaguely actual.
I have no doubt that some companies drag their heels on post-marketing studies. However, some trials are delayed or never happen because of the difficulty in recruiting patients. One drug I was involved with got approved by FDA with the caveat that the company had to conduct a large study of high-dose usage in pediatrics. Trouble was, very few children actually required high doses of the drug, it was impossible to identify them prospectively, doctors had an excellent alternative treatment to high-dose use (combining two separate meds, in this case)and parents refused to choose high-dose when presented with multiple treatment options. After several years of continuous recruitment efforts, there simply weren't enough patients available. Some post-marketing studies simply involve difficult or very small patient groups, such as those with kidney or liver disfunction. Hopefully, FDA's public list of industry "violators" will somehow differentiate those who won't meet their regulatory obligations from those who can't.
Tom - Appreciate the point. Surely, if FDA has the will to do anything at all in this regard, they will be selective - _very_ selective.
In the past, they've made much the same kind of points that you do here to explain why a number of these studies don't happen.
When you are the victim of a post-marketing study (a consumer), when the drug is not performing as intended, you report to the FDA, via MedWatch, and get the following letter.
In my experience, the words May and Might mean 'not gonna happen'.
Thanks for the automated form letter though, I feel all better now.
(one... two... shoot, I lost count. one... two...)
~~~~~~~~~~~~~~~~~~~~~~~~
Dear Reporter:
Thank you for submitting your report to MedWatch, The FDA Safety Information and Adverse Event Reporting Program.
This acknowledgement confirms that your report was received. Reports are added to a postmarketing safety database with similar reports and reviewed by the FDA’s postmarketing safety staff. Voluntary reports are essential for ensuring the continued safety of FDA-regulated products. One or two well-documented case reports may provide an early signal of unexpected problems and lead to additional evaluation. This may result in FDA regulatory actions that improve the safety of the products used in patient care each day.
You might be contacted by an FDA staff member if additional information on your report is needed.
Again, thank you for taking the time to submit your report.
Sincerely yours,
MedWatch
Tom, your point about difficulty in recruiting patients is very important. I've experienced similar difficulties.
to Just a Thought--you're not going to get any feedback. Alterts, when they are issued, are posted on the FDA MedWatch web site, communicated electronically to health care providers who have signed up for e-Alerts, and to Partners (mostly health care provider associations) and to health and medical media.
Thank you, Bob
I'd be cool with that. How long do you suppose it takes to put out a notice?
Hi, Just A Thought,
I'll see if I can get a time estimate for you. If it's a slight labeling change I imagine it doesn't take that long. (That's the form the majority of Alerts take.) Following entry of your MedWatch report into the data base, a case series analysis is usually performed. They aren't really that useful in establishing causality but may give hypotheses that can be explored in epidemiology studies (clinical studies, patient registries, prospective cohort studies). Clincal studies, as you know, require time and involvement of the manufacturer. Cohort studies from third-party data bases are easier to do, all things considered.
I realize I'm not answering your question adequately but the specific nature of the serious adverse event and its association with the drug will drive what the FDA requires and its time frame. Drugs associated with death and permanent disability will likely cause the FDA to move much faster.
Regardless, I'll get back to you tomorrow with what I can find.
I would appreciate that, Bob. It sounds like you're saying that the simpler the problem the less time it takes for an alert to be sent out. Makes sense. It's easier.
Alternately, a larger problem, based on the time required for possible additional testing and investigation, leaves no alert for a longer period of time, while the public continues to suffer ill effects. That seems more than a little worrysome and backwards.
When any danger is reported you would think some pretty rapid reaction would come about. After all, if the FDA (and whatever pharmaceutical company is involved) is not going to respond quickly to adverse post-marketing reports, then post-marketing studies seem nothing more than marketing at the cost of the public's well-being.
I'm just trying to understand and I do thank you for trying to find the answer.
"Just a Thought"
My intentions were good but I don't think I can get back to you today. Apologies. I won't forget to post what I find.
The post marketing reports of drug side effects by the MHRA (UK regulator) is deeply flawed and inadequate, I presume the FDA system is just as bad if not worse...
Just because you report a side effect or an adverse reaction, doesn't mean the regulators actually give a damn..
There are many drugs which have caused life threatening reactions in recent years and they remain on the market...
Avandia, Paxil, Zyprexa to name but a few...
It is not in the regulators interest to pull drugs even if they are killers... They stall for as long as they can and even then the drugs are rarely pulled...
I'm thinking there is no answer to be had concerning a time table. Maybe if a Senator's child is on an offending drug...