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Critics Say FDA Drug-safety Oversight Needs To Be More Independent

Big Pharma Tells IOM Panel, However, No Major Changes Are Needed

In the January 12, 2006 edition of the New England Journal of Medicine (NEJM), an article by Wayne A. Ray and C. Michael Stein calls for Congress to establish more independence and authority as concerns FDA drug-safety oversight so as to better protect patient from the risks of serious prescription drug side effects. Ray is a professor of Preventive Medicine at Vanderbilt University, and Stein is associate professor of Medicine and Pharmacology at Vanderbilt. 

In their NEJM article, "Reform of Drug Regulation — Beyond an Independent Drug-Safety Board"  (subscription required),  Wayne Ray and Michael Stein assert that the FDA should have independent offices for (1) the approval of a new prescription drug for sale and (2) the monitoring of that drug’s safety profile after approval.  The authors also suggest that a new FDA office — the Center for Drug Information — should be created to provide doctors with emerging information about drug risks, and promptly issue drug-safety warnings when necessary.  From the NEJM article:

We thus propose a reformed regulatory authority with three distinct functions (Table 2): new-drug approval, post-marketing studies, and drug information. We envision three independent but cooperative centers within a unified agency, although other administrative structures are possible. The new centers would be funded by a tax on pharmaceutical sales. For the reforms to work, the centers must be provided with adequate statutory authority, sufficient funding, and protection from inappropriate political pressure.

In addition, on January 17, 2006 Wayne Ray presented these points to an Institute of Medicine (IOM) panel, which was asked by the FDA to evaluate the agency’s drug-safety oversight and recommend changes.  The FDA requested this IOM evaluation last year after the agency was criticized for being slow to act as regards the Vioxx debacle as well as safety problems with some other prescription drugs. 

In advance of his IOM testimony, in an interview with Kerry Young, of Bloomberg News, Wayne Ray pointed out that patients are largely unaware of how little authority the FDA has to update prescribing information given to doctors on drugs.

A recent example of this situation is how two drug companies effectively delayed for a year having to put the "black-box" warning on Elidel and Protopic about increased cancer risks that the FDA wanted placed on the package insert, or label, of those skin ointments.

On the other side of things, according to a January 19, 2006 article by Lisa Richwine, of Reuters, representatives of the drug companies told the IOM panel that while there may be room for some improvement, there is no need for any major change at the FDA.

  • "Drug safety in the U.S. definitely needs improvement. It needs a careful, focused treatment, but I would argue not radical exploratory surgery," said Geoffrey Levitt, chief counsel for regulatory and research at Wyeth.
  • "We think that moving oversight of safety to another federal agency seems extreme and could significantly stall incremental progress," said James Nickas, senior director of development at Genentech Inc.

This IOM panel regarding drug-safety oversight in the U.S. is scheduled to release a report in mid-2006 with any recommendations it has for changes at the FDA.

(Posted by: Tom Lamb)

2 responses to “Critics Say FDA Drug-safety Oversight Needs To Be More Independent”

  1. Dan Abshear Avatar
    Dan Abshear

    The FDA and Its Damaging Lack of Citizen Protection
    The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States. However, their focus seems to have changed the past few decades, as they appear to have formed a pathological alliance with the pharmaceutical industry. An example is the large amounts of money the industry gives the FDA for various reasons- amounts so large that this accounts, according to some, for about half of the FDA’s income, upon information and belief. An example of funds received is due to the prescription drug user fee act, which began in 1992. Basically, the drug industry has been authorized and required to pay the FDA for faster approval of their pending medications. Results of this relationship between the drug industry and the FDA, one could posit, could be a contributing factor the progressive and recent approval of unsafe drugs and lack of regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform. Yet the FDA continues to validate what has been posited through their support from the drug industry, in ways that seem reciprocal, and as a consequence, have possibly neglected the health of the public as best as they should.
    The presumed intimacy between these two organizations does in fact seem to continue to worsen. For example, and recently, a new proposal by the FDA has been introduced that would allow the pharmaceutical industry’s drug sales reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry with their approval to possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative, and this is rather delusional, to say the least.
    A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and more pharmaceutical companies are being penalized for this behavior in the past in the form of monetary settlements with the Department of Justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, and rarely admit guilt as part of such settlements.
    This FDA protocol described and proposed is called, “Good Reprint Practices”, would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug reps, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the meds involved in such trials, such as by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol. These facts can be validated and have been discovered by others, so it appears the FDA did not take this into consideration.
    Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability for most drug representatives to analyze the unique statistical data regarding this issue with accuracy and meaning is unlikely, for the most part, I surmise. Remember that most drug reps have no medical or clinical training in any objective way, and, in my experience, have no interest in such training. So this seems to further complicate the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to embellish statements to prescribers for their own benefit in regards to their promoted meds. So, our previous safety association, the FDA, appears to be evolving into a possibly harmful association by suggesting such practices as this with deliberate intent and reckless disregard for public health, so it seems. Yet this situation of the FDA proposal mentioned appears to be of most benefit for the drug companies. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, most likely. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens are no longer the concern of the FDA, one could conclude.
    However, there is freedom of speech, but in the amendment may be restrictions in regards to public health, as speech should be accurate and objective. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the drug reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval. Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that one could argue are in fact somewhat covert and tacit. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves, which could be the case now with the FDA. And the health of the public is that interests what I believe we as citizens demand, and should be enforced than it appears to be presently.
    “As far as we can discern, the sole purpose of existence is to kindle a light in the darkness of being.”
    —- Carl Jung
    Dan Abshear

    Reply
  2. Tom Lamb Avatar
    Tom Lamb

    I appreciate you sharing your essay about the various problems with our FDA.
    Perhaps other readers would like to comment on the points you raised or related issues.
    I hope you keep reading — and contributing to — Drug Injury Watch.
    Tom Lamb

    Reply

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