29 November 2013

Pharma Regulation

Two US articles relevant to the Australian pharma regulation regime.

'The Money Blind: How to Stop Industry Bias in Biomedical Science, Without Violating the First Amendment' by Christopher T Robertson in (2011) 37 American Journal of Law and Medicine 358 argues that
The pharmaceutical and medical device industries use billions of dollars to support the biomedical science that physicians, regulators, and patients use to make healthcare decisions—the decisions that drive an increasingly large portion of the American economy. Compelling evidence suggests that this industry money buys favorable results, biasing the outcomes of scientific research. Current efforts to manage the problem, including disclosure mandates and peer reviews, are ineffective. A blinding mechanism, operating through an intermediary such as the National Institutes of Health, could instead be developed to allow industry support of science without allowing undue influence. If the editors of biomedical journals fail to mandate that industry funders utilize such a solution, the federal government has several regulatory levers available, including conditioning federal funding and direct regulation, both of which could be done without violating the First Amendment. 
Robertson's  'When Truth Cannot Be Presumed: The Regulation of Drug Promotion Under an Expanding First Amendment' in (2014) 94 Boston University Law Review argues that
 The Food, Drug, and Cosmetic Act (“FDCA”) requires that, prior to marketing a drug, the manufacturer must prove that it is safe and effective for the manufacturer’s intended uses, as shown on the proposed label. Nonetheless, physicians may prescribe drugs for other “off‐label” uses, and often do so, such that a large portion of U.S. healthcare spending is consumed by such unproven uses. Still, manufacturers have not been allowed to promote the unproven uses in advertisements or sales pitches. 
This regime is now precarious due to an onslaught of scholarly critiques, a series of Supreme Court decisions that enlarge the First Amendment, and a landmark Court of Appeals decision holding that the First Amendment precludes the Food and Drug Administration (“FDA”) from regulating off‐label promotional claims. These critiques strike at the very core of the FDCA, calling into doubt the constitutionality of the entire premarket approval regime, as a prior restraint on speech. 
This Essay makes three critical contributions, and offers a constructive approach to the regulation of drug promotion. First, this Essay reveals how the notion that “truthful” promotional claims enjoy First Amendment protection has been central to these scholarly and judicial critiques. However, those critiques have simply presumed the predicate of truthfulness – that the drugs are safe and effective for the newly intended uses, and further presumed that the FDA is acting paternalistically to protect the public from acting upon the truth. Second, this Essay clarifies that the truth is unknown, and this ignorance is itself the motivation for regulation. The FDCA incentivizes drugmakers to invest in producing that missing knowledge. Third, this Essay highlights the way courts currently use the Daubert doctrine to regulate scientific speech presented in their own courtrooms, noting that it is a prior restraint on speech that has received virtually no First Amendment scrutiny. 
Going forward, in FDCA enforcement actions, courts should defer to the FDA’s premarket approval process as the test for the truth of promotional claims, and thus their status under the First Amendment. Accordingly, courts should remain in epistemic equipoise until the drugmaker proves safety and efficacy. Nonetheless, if the courts refuse to defer to the coordinate branches in that established expert regulatory process, the courts should put the burden upon the drugmaker to prove its claims true in court. Even under this fallback position, drugmakers will remain incentivized to produce the epistemic basis to support their claims of safety and efficacy. Thus the FDCA can have a secure place even within an enlarged conception of the First Amendment.