2005N-0394 FDAs Communication of Drug Safety Information; Public Hearing
FDA Comment Number : EC9
Submitter : Mr. david fuller Date & Time: 12/09/2005 11:12:26
Organization : Fluoroquinolone Toxicity Research Foundation
Category : Individual Consumer
Issue Areas/Comments
GENERAL
GENERAL
One of the questions being asked is "...Do these tools provide the right kind and amount of risk and other information that health care professionals need to make informed decisions about whether to prescribe drug products, and that the public needs to make informed decisions about whether to use those products...?"

The answer is a resounding NO!

Navigating the CDER's webpages is a nightmare. Little if any information of value can be found there without possessing extensive computer research skills. Rarely, if ever, do health care professionals utilized the information found there. These tools UTTERLY FAIL to provide the right kind and amount of risk and other information that health care professionals need to make informed
decisions about whether to prescribe drug products. Links are available to the package inserts but unless you possess a degree in pharmacology this information is useless.

The basic information that the public needs to make informed decisions about whether to use those products is buried in archaic and draconian text, always followed by the words "RARE" when discussing serious adverse reactions, and hidden within the package inserts amongst page after page of useless informatin.

The CDER's patient-focused communication tools provide NO useful information for the average patient or physician let alone people with low health literacy (or computer) skills. The major weakness is the fact that there is NO plain English caveats for the serious adverse reactions one may encounter when researching a particular drug. Medical "legalese", or archiac latin is untilized in the place of plain everyday disease states one may encounter. The patient information sheets fail miserably in this regard as rarely if ever does one find the so called "rare" adverse events listed giving one the false impression that the drug being researched is "safe and without substantial risk". In the entire year of 2005 we find 12 notifications regarding problems with prescription drugs. What is required to correct this situation is a simple to use list of prescription drugs, what they are to be used for, and a FULL AND COMPLETE listing of the possible side effects, whether they are to be considered "rare" or otherwise, together with a link to the Med Watch Program (which list less than 4% of the actual adverse reactions encountered by the patient). Without this BASIC information it is impossible for a patient to enter into a risk/benefit discussion with his or her physician. From personal experience I have found that the average physician has LITTLE TO NO KNOWLEDGE concerning the possible side effects of the medication they are prescribing. For example fluoroquinolones have been associated with spontaneous tendon rupture and irreversible peripherial neuropathy since the mid eighties. Yet the physician states that such reactions are NOT POSSIBLE with the fluoroquinolones. Such information should be readily available on the CDER's webpages but it is not. In the Fall of 2004 the FDA added additional warnings regarding such reactions to ALL the fluoroquinolones yet this information was never provided to the treating physician via Warning Letters, (Dear Doctor Lettrs) or Advisories, and as such the physician continues to deny any such association to this day. Such information is readily available to the CDER but rarely, if ever, is it made readily available to the physician or the patient.

In summary it has been my experience that navigating the CDER webpages is a challenge even to a computer literate person such as myself and is
all but impossible to those who lack such skills. Broken links, dead end pages, tons of useless and outdated information, basically the same bueracratic nonsense one finds when dealing with the CDER and FDA by other means. A lot of useless information with little to no substance rather than a straight forward guide to the medications and their associated risk and approved uses.