The FDA Law Blog reported this morning on an October 7 response by the Food & Drug Administration (FDA) to a state senator in New Jersey who had written the agency seeking its opinion on a bill that would “require pharmacists to dispense epilepsy drugs from the same manufacturer as previously dispensed for certain patients, unless otherwise prescribed.” Senator Joseph Vitale’s concerns with the effect on epileptics of switching from branded to generic drugs, or among different generics, have been echoed by physicians, epilepsy patient advocates, and scholarly researchers. While FDA didn’t offer any direct thoughts on the bill, the letter was written in such a haughty and dismissive tone that the agency’s opinion came through loud and clear: butt out, there is no problem, we know what we are doing here in Washington.
The letter pointedly reminded Sen. Vitale that FDA “has many years of experience in the review, approval and monitoring of generic drugs.” It helpfully recites for him a passage from the preface to the “Orange Book” summarizing FDA’s screening process. FDA then proceeds to lecture care providers that among other things,
It is not necessary for the health care provider to approach any one therapeutic class of drug products differently from any other class, when there has been a determination of therapeutic equivalence by FDA . . .
Finally, FDA attempts to both acknowledge that some have complained about anti-epileptic drug (AED) switching and deny the existence of a problem. Even though “anecdotal evidence” of quality problems “can not be dismissed lightly,” FDA “has not seen any scientific evidence” of a problem with “this group of products or any other class of generic drug products.” FDA has “sought to conduct further study,” but such pursuit of “further scientific evidence” is not because of “doubt within the agency,” but because “patients may lose confidence in their prescribed medication.”
Seeking to conduct further study is not the same as actually studying something. Either FDA felt it didn’t owe this state senator any information about impending studies, or nothing in fact is pending. In denying the existence of any problems with any generic drugs and stressing that there is no doubt at the agency, FDA seems to betray its extreme sensitivity to scrutiny of its generic drug approvals. FDA’s own senior leadership has called the Office of Generic Drugs on the carpet for public concern over generic quality, and the agency has been strongly challenged recently over its sudden alterations of bioequivalence criteria for generic versions of complex medicines including extended-release products and locally acting drugs.
The bureaucratic hubris FDA exhibits on bioequivalence is irresponsible and unhealthy, given the dire potential consequences of breakthrough seizures if a generic AED is ineffective, or if a copycat locally acting anti-bacterial medicine fails to stop an infection. FDA certainly doesn’t feel accountable for any of this to a state senator who represents epilepsy sufferers. Nor is the agency in any hurry to be accountable to Congress on concerns over epilepsy drugs – FDA is almost two months overdue with a report federal elected officials sought on generic AED bioequivalence standards, as The FDA Law Blog noted. Is there any doubt what FDA will say in that report?