Congress Should Give FDA Authority to Impose New Labeling Language on Approved Drugs Without Needing Big Pharma’s Permission

When Health and Human Services (HHS) Secretary Michael Leavitt was announcing the new Drug Safety Oversight Board (DSOB), he admitted that the FDA was trying to address continuing criticism concerning the agency’s handling of drug safety issues related to currently marketed medications: "The public has spoken, and they want more oversights and openness," said Leavitt. "They want to know what we know, and what we do with the information, and why we do it."

Thus far FDA Commissioner Lester Crawford has rejected suggestions that its Office of Drug Safety should be made an independent entity, and instead is proceeding with the Drug Safety Oversight Board (DSOB) plan of action.  Under that plan, the DSOB is supposed to operate on two levels. First, the DSOB will consider the broad regulatory issues, such as what the FDA’s drug-safety policies should be, e.g., how to balance risks and benefits.  Second, the DSOB will examine safety issues about specific prescription drugs already approved by the FDA, and attempt to resolve internal conflicts within the FDA about a particular drug-safety issue.

Looking beyond the FDA’s public relations efforts in support of the DSOB plan of action, one must be concerned that the powers of the DSOB will be limited. A prime example is that although the FDA has promised that all DSOB drug-safety conclusions will be made public on a new Web site, the DSOB panel can only issue advisories. That is, the DSOB panel will not be able to force any FDA-approved drug off the market nor order changes in a pharmaceutical company’s sales practices regarding a specific drug.

This limitation of the DSOB’s power as concerns possibly unsafe drugs already on the market part is part of the reason that some top FDA officials do not believe the DSOB plan of action, by itself, is sufficient.  Given the current emphasis on how the FDA deals with the potential dangers of currently marketed drugs, those top FDA officials also want expanded legal authority from Congress.  On March 1, 2005 Sandra Kweder, deputy director of the FDA’s Office of New Drugs, asked Congress for authority to impose new labeling language on approved drugs when the agency learns of problems related to a drug’s safe use. As it stands at present, although the FDA can dictate label language as a condition of approving a drug for marketing, once the marketing approval has been given by the FDA, "we don’t have the authority to tell a company, ‘This is how your label has to look,’" Kweder testified.

In more depth, presently — unless the Health and Human Services (HHS) Secretary declares that a prescription drug’s current labeling creates an "imminent hazard", or the FDA moves to take the drug off the market entirely, i.e., a drug recall, extreme situations, both — all the FDA can do is "negotiate" with a pharmaceutical company over changes to the package insert label of a possibly unsafe drug being used by thousands of patients, daily. 

One needs to look no further than Vioxx (rofecoxib) for an illustration of this problem.  As the FDA’s Kweder testified before Congress in March 2005, safety-related label change negotiations for Vioxx took 14 months because Merck rejected the FDA’s suggestions and, in turn, agency officials rejected Merck’s proposals.

Let’s hope lawmakers take heed of this request for more FDA authority, so that the FDA can get back to being the regulator as opposed to just another stakeholder who must grovel with the drug companies over warning label changes that would protect patients.

(Posted by: Tom Lamb)