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Bipartisan call for GAO to investigate FDA's use of inappropriate studies for drug approvals

In a nutshell, U.S. Reps. Edward Markey (D-MA), John Dingell (D-MI), Henry Waxman (D-CA), Bart Stupak (D-MI) of the House Energy and Commerce Committee, and Senate Finance Committee Chairman Charles Grassley (R-IA) have requested that the Government Accountability Office (GAO) investigate FDA's reliance on non-inferiority studies, with particular reference to antimicrobial drugs.

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TheCongressmen areproposing the GAO crawl way up FDA's butt for this investigation, which apparently was spurred by Congressional committee hearings into the FDA approval of Sanofi-Aventis' antibiotic Ketek (see, for instance, this article on lawyersandsettlements.com). The list of requested inquiries includes:

1. In the past 10 years, a list of all of those products approved by FDA Office of Antimicrobial Products that established effectiveness on the basis of non-inferiority studies. For each product:

a. The indication for which the product was approved; whether this indication is or is not serious and life threatening (pursuant to the FDA's definition contained in 21 CFR 312.81);

b. The sponsor of the NDA;

c. The date on which the product was approved;

d. The name(s) of the active control drug(s) or comparator(s);

e. Whether the comparator was approved in the U.S.;

f. The margin used in the trial;

g. The treatment difference between the active control and the test drug and the associated confidence intervals;

h. Any groups or subgroup analyses included in labeling;

i. Whether the active control drug used to establish non-inferiority for each medication was itself approved on the basis of a placebo study or other superiority trial, or if it too was approved on the basis of non-inferiority;

j. A copy of the explanation contained in the applicants analysis of the study for why the results of the non-inferiority trials could be believed to assure the effectiveness of the drug (as required by 21 CFR 314. l26(b)(2)(iv)) and, if the required explanation was not included in the analysis of the study, an explanation as to why it was not included; and

k. A copy of any analysis(es) by FDA staff relevant to whether the non-inferiority trial or trials we're adequate to establish the effectiveness of the new drug.

The Congressmen also asked for information relating to FDAidentification ofand guards against "biocreep." [Biocreep is described by FDA as the selection of successively less effective comparator agents, which individually fit a statistical confidence interval relative to the product to which it was compared. This process, over time, may result in the presumed equivalence of statistically and clinically inequivalent products.]

They also wanted to know the results of an internal FDA conference on non-inferiority held last year and whether FDAs acceptance of non-inferiority trials to establish drug effectiveness adheres to the principles for such trials that the agency has set forth (e.g. in ICH E9).

Wow. I can't recall aCongressional request for a GAO investigation that is intended to second-guess and micromanage FDA's scientific processes as much as this one. It begs the question of motivating forces at work: Is this just political grand-standing or is it more indicative of genuine overseer skepticism of FDA's sincerity and effectiveness? Given the political season, I suspect the former is at least as operative as the latter.

Which is not to say that Markey et al's concerns are not worthy of public discussion. They are. Non-inferiority studies are subject to big-time biases and inaccurate conclusions if not planned and scrutinized carefully. The documents linked above attest to FDA's awareness of these challenges, so what is the scientific basis for this investigation request? Is this a fishing expedition, or does this group of Congressmen already have evidence (perhaps from an insider) that FDA has shirked it's scientific responsibilities?

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Posted in Dentistry Post Date 01/31/2016


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