Earlier in the week, there was a story about how the FDA has failed to follow through on post-approval studies of drugs required through what’s called “conditional approval.”

Condition approval means that the FDA is saying, OK, you can market it but do more studies. Often companies don’t complete these studies. Often, according to reports this week,  the FDA doesn’t come behind and ask why and fine them if the companies fail to do these studies. Some companies are years overdue on specific medications.

In the meantime, the drugs continue to be sold, physicians are without valuable information they need about them and patients may or may not get the most effective treatment.

However, that is about what is not known that doctors need to know.

This full, free text article discusses what is known about medications, information which never reaches physicians because of the labeling system for drugs. The information is there. It simply is not passed on.

This article also notes that a fix is in the works but the FDA has to agree to it and implement it.

A different kind of label would give doctors much more information, information lying around unused. An example would be if reviewers had uncertainties and what those were.

Doctors need this information to help you. When you are at an appointment, and your doctor starts going on and on about this drug, what is known and what is not known, this is why they do that.

They know they don’t have all of the information they should have about benefits, harms and question marks about medications.

It should not be this way. Your taxpayer dollars should be used more wisely than this. Your bodies should benefit from drugs about which you and your doctor know as much as you possibly can.

New England Journal of Medicine

“The 2009 federal stimulus package included $1.1 billion to support comparative-effectiveness research about medical treatments. No money has been allocated — and relatively little would be needed — to disseminate existing but practically inaccessible information about the benefits and harms of prescription drugs. Much critical information that the Food and Drug Administration (FDA) has at the time of approval may fail to make its way into the drug label and relevant journal articles. (Emphasis added)

“The most direct way that the FDA communicates the prescribing information that clinicians need is through the drug label. Labels, the package inserts that come with medications, are reprinted in the Physicians’ Desk Reference and excerpted in electronic references. To ensure that labels do not exaggerate benefits or play down harms, Congress might have required that the FDA or another disinterested party write them. But it did not. Drug labels are written by drug companies, then negotiated and approved by the FDA. (Emphasis added)

O FDA Has Recognized Drug Label Problems

…”To its credit, the FDA has recognized problems with drug labels. In 2006, it revised the label design, adding a “highlights” section to emphasize the drug’s indications and warnings. It also issued guidance about reporting trial results in the label, emphasizing the importance of effectiveness data. Yet the data presentations for the approval studies referred to in the labels for Lunesta and Rozerem, which were updated in 2009 and 2008, respectively, are substantively unchanged.

O Standardized, Executive Summary of Drug Reviews Would Be Substantial Improvement…Attention Is Needed to Reviewers’ Uncertainties About Drug and Whether Approval Was Conditional, Based on Post-Approval Studies

“The FDA has not issued new guidance about its drug-review documents. A standardized executive summary of the reviews would be a substantial improvement. These summaries should include data tables of the main results of the phase 3 trials, highlight reviewers’ uncertainties, and note whether approval was conditional on a post-approval study. (Emphasis added)

:Toward this goal, we conducted a pilot test, funded by the Robert Wood Johnson Foundation’s Pioneer Portfolio, in which FDA reviewers created “Prescription Drug Facts Boxes,”⁵ featuring a data table of benefits and harms. Recently, the FDA’s Risk Advisory Committee recommended that the FDA adopt these boxes as the standard for their communications. FDA leadership is deciding whether and how to use the boxes in reviews, labels, or both.”

O Much Drug Information Is There…But Lost Between FDA and Clinicians

“Whatever approach the agency adopts, it needs a better way of communicating drug information to clinicians. We don’t need to wait for new comparative-effectiveness results in order to improve practice. We need to better disseminate what is already known.” (Emphasis added)

Citation: (10.1056/NEJMp0907708) was published on October 21, 2009, at NEJM.org.