Lawmakers Blast FDA Rule For Label Changes
7 CommentsBy Ed Silverman // January 24th, 2008 // 11:23 am
A group of influential House and Senate Democratic leaders yesterday complained about an FDA proposal to tighten rules for allowing drugmakers to make changes on their product labeling. In a letter to FDA commish Andy von Eschenbach, they wrote that the proposed FDA rule would set a new standard leading to fewer warnings by drugmakers, longer agency reviews and delays in communicating problems to consumers.
“We are concerned that the intent of this proposal is to protect companies in the pharmaceutical and device industry from being held liable for marketing products they know are unsafe. Such a policy change comes at the expense of consumers and violates the mission of the FDA,” they wrote. “It is apparently designed to bolster the argument by companies defending against lawsuits that the regulations precluded them from adding contraindications, warnings, precautions and adverse reactions in the absence of FDA approval.”
Indeed, plaintiffs’ attorneys argue that if a drugmaker can update labeling at its own discretion, the drugmaker is responsible for warning consumers about new safety info. So the FDA’s stricter proposal is a welcome step for pharma, because product-liability lawsuits regularly charge this or that drugmaker with failing to do enough to warn consumers about some side effect issue.
This is where preemption comes in. Pharma has been arguing that FDA labeling should trump state court judges and juries because the agency’s actions are the final word on safety and effectiveness, which is found in the labeling. And if drugmakers have less latitude to make changes, they can use FDA regs as a defense. Not surprisingly, trial lawyers last week blasted the FDA rule change. Preemption, by the way, will be heard by the US Supreme Court in a case involving Wyeth’s Phenergan.
The letter was signed by John Dingell, who chairs the House Energy and Commerce Committee; Henry Waxman, who chairs the House Committee on Oversight and Government Reform; Ted Kennedy, who chairs the Senate Health, Education, Labor and Pensions Committee; Pat Leahy, who chairs the Senate Judiciary Committee, and four others.
Justice in Michigan
No one will be surprised to see me weigh in.
The latest FDA “rule change” is about as naked a power grab as it gets, and perfectly timed to support, no only preemption in general, but the three preemption cases the Supreme Court will hear this term. You’d have to be paranoid _not_ to see the connection!
But Congressional condemnation is not enough. A bill needs to be passed that explicitly says that it is the intent of Congress that FDA compliance complements, but does not fully preempt, state tort liability. That has been the situation for one hundred years (except in my own state).
Congress had a chance to do this as part of FDAAA but they balked to get the bill through. Perhaps that was necessary. But tomorrow is another day.
We’ll see if it is also a different Congress.
Jack2
Here’s my understanding (and correct me if I’m wrong)…
A patient or HCP can report an AE to the company or the FDA’s medwatch number. The company must report the AEs to the FDA. The FDA does not need to (and often does not) report AEs it receives directly from a patient or HCP to the company. So doesn’t the FDA have the only complete picture of reported AEs?
Shouldn’t that leave the FDA in charge of regulating the safety information?
ol cranky
Jack2:
The company actually has a broader and deeper understanding (a more complete picture) of safety information about their product as they have data for reported AEs that may show a trend related to safety and/or data from ongoing studies that aren’t reported to the FDA. An HCP (including pharmacist) is supposed to report any AE that is considered to be possibly, probably or definitely related to the product(s) via MedWatch. You run into a couple of problems with this: #1 HCPs don’t utilize the MedWatch reporting system as they should (i.e., if an AE is listed in the PI or is considered a class effect they don’t bother reporting it even though this information is really key for accurate post-market surveillance), they tend to limit reporting to significant events that they are really sure is related to the product; #2 events considered to be odd may not be reported because they don’t see a direct causal relationship even when the event resolves after discontinuation (few docs rechallenge); #3 if the event doesn’t appear to be serious or severe, they tend not to report things they think are nuisance events. Even in clinical trials, I’ve had to fight with investigators to get them to report AEs that they assume aren’t related to study drug or are related to the disease under study or a co-morbidity (they are supposed to report all AEs in studies regardless of relationship to study drug), so you can imagine how hard it is to get them to submit a MedWatch report or even notice events unless they’re so bad and unexpected in a regular clinical setting.
Sorrowful
Relying on the FDA is like having the fox watch the henhouse. They are under tremendous pressure from Pharma not to mess in Pharm affairs and thousands die because the FDA doesn´t take action or acts too late. States SHOULD be added to the mis, to do the job that so often the FDA fails to do. Face it, the FDA as it is currently structured, is a failure
Justice in Michigan
Jack2 - What you say is true as far as it goes. But here is a very small sampling of some of what has come out in civil liability that goes beyond purview of FDA, or is only in their limited purview, but relevant in civil liability.
- Company sends Medwatch reports but, knowing the limits of ODS resources, camouflages the more serious and less known AEs (that it knows about) behind other AEs that are headlined in reports. Thus, there is “compliance” in letter, but the opposite in intent = essentially leaving FDA to find needle in haystack, what Jerry Avorn of Harvard calls “passive-aggressive compliance.” (There is much delay in reporting also that FDA could - theoretically - take sanctions over, but, in practice, never does.
- Company does its own internal studies which suggest potential problem but does not report results to FDA, or cuts short the study as soon as it “looks like trouble.” This may be harder under FDAAA, but probably not impossible.
- Company reports full data set to FDA but publishes only part of it. CLASS study as published in JAMA is the classic example - the last six months not included. FDA has the data, but not docs (full data set required a FOIA to get). And, of course, FDA has no control over editorial policies of journals.
Of the CLASS episode, FDA’s Bob Temple said, “The hype [caused by published study] probably has more impact than our labelling dos.” Meaning, docs went by what they read in JAMA. Question becomes: Should a company be accountable if it can be shown it _deliberately_ misled HCPs via JAMA even though it reported accurately to FDA?
- Company intimidates researchers, or bribes them, in order to influence research done or not done (I am personally aware of some bribery instances). We hear about the high profile cases, not the ones beyond that. This, of course, is entirely outside the purview of FDA. Ought it be considered a relevant part of a company’s _potential_ accountability for what is, and is not known, about its product? (We’re not talking “vigorous scientific debate” here, we’re talking c-notes in briefcases).
This is a very small sample of some of the issues that arise in civil liability that are essentially not covered by FDA regulation, or covered only partially. A good summary of the impact of this sort of behavior on what we learn about drug safety - that we would never have learned from FDA alone - is in a Commentary by Kesselheim and Avorn that was in JAMA in Jan. 2007. Sorry I don’t have the exact reference in front of me, but the title was something like “The Role of Litigation in Drug Safety.”
billyclyde
“[The FDA is] under tremendous pressure from Pharma not to mess with Pharma affairs.” Indeed, what might become of the future job prospects of our friends at FDA if they do mess with Pharma affairs? Maybe our good friend Daniel Troy could shed some light on the subject.
Justice in Michigan
That reference above is from JAMA, Jan. 17, 2007, “The Role of Litigation in Defining Drug Risks.” Kesselheim and Avorn take a strong position against FDA preemption. Based on the cases they discuss (mainly Vioxx, Baycol, Rezulin, Propulsid, Paxil, Bextra, and a few others), they conclude: “In each instance,the litigation process revealed new data on the incidence of adverse events, enabled reassessments of drug risks through better evaluation of data, and influenced corporate and regulatory behavior.”
Just two weeks ago, there NEJM published an even stronger editorial against FDA preemption in the Jan. 3, 2008 issue. They described the current cases before the Supremes as having “momentous” consequences for patients’ rights and companies accountability. Read the editorial. “Momentous” means cataclysmic.
When the two major medical journals go out of their way to defend what trial lawyers do against FDA preemption, you know you have a “momentous” issue indeed.