FDLI symposium: special topics

Special Topics
FDA Regulation of Genomic Testing and the First Amendment
Barbara Evans, Professor, University of Houston Law Center
 
Of companies in clinical sequencing industry: 10 of 68 do
sequencing only; 21 of 68 annotation and interpretation only. That is speech
only. [Or it’s professional advice and not even protected by Central Hudson, as
Robert Post would say.] Question of FDA scope: when there’s bundling of
interpretation with device/test, FDA jurisdiction is easy, but what if it’s
unbundled and people are merely talking? 
 
Shouldn’t have unintended consequences drive unbundling or
drive it offshore.  Regulator’s task:
protect consumers without causing these effects.
 
Bad consequences aren’t enough to justify speech regulation:
test results that lead people to make stupid medical decisions have to be
regulated by regulating medical decisions, not information.  Could require doctor for interpretation;
could put warnings/disclaimer on interpretation; develop FDA-recognized list of
which claims are proven/legitimate. 
 
State Action in Food and Controlled Substances Regulation
and the Benefits of Friction Between Regulatory Authorities
Diana R. H. Winters, Associate Professor, Indiana University
School of Law
 
Regulatory flexibility can be vertical or horizontal. Can be
productive to fill gaps, address what’s seen as misguided federal policy.  E.g., humane treatment of animal laws in Cal.,
two of which have been invalidated and are on appeal; Vt. GMO labeling law;
concerted AG action to remove allegedly fraudulently labeled dietary
supplements from shelves.  Cal. just past
a law on animal antibiotics—stricter than federal; not yet challenged.  Movement to decriminalize and regulate
marijuana—also brings fed/state interaction into sharp relief.  Challenged & invalidated: ban on sale of
foie gras.  Egg/chicken treatment law now
under challenge as preempted by Egg Inspection Act & as violating dormant
commerce clause.  That case was thrown
out for lack of standing by challenger states; on appeal.  We should enjoy and celebrate the mess as it
fills gaps and spurs national debates.
 
A First Amendment Exception for Flexible FDA Regulation
Sally Wang, Principal, DocFlight
Market arms race: inefficient to keep spending advertising
to keep in the game; costs get passed to payors and consumers.  A lot of blockbusters going off patent: there
should be shrinkage but there is almost doubling of marketing spend.  Regulatory void left by FDA has been filled
to some extent by DOJ actions—over $13 billion in fines for fraudulent
marketing. Less regulation is not beneficial for industry.  Selling drugs is different from selling TVs.  Can use gov’t granted IP rights/monopoly
privileges as a way to continue regulation. 
IP rights for drugs are closely intertwined w/regulatory process.  Analogy to FCC’s rights because it grants
spectrum to broadcasts.
 
Discussant:
Patricia Zettler, Associate Professor, Georgia State
University, College of Law
Genomic testing is high interest in Silicon Valley, with concerns
about FDA regulations stifling innovation. 
Appealing to distinguish between speech about the genomic test itself
and speech about what the test reveals (meaning of particular results).
 
Choice of regulators: if the fed gov’t is not regulating,
states can regulate medical practice. We have seen docs v. Glocks case in
Florida, abortion restrictions—it’s not infeasible that states might regulate.
Who do we want doing the regulating? 
(Though as with abortion, she points out, guns may be special and
therefore not a precedent.)
 
Winters persuasively argues that state-federal friction can
be beneficial for food and perhaps controlled substances. But how far does this
extend? Many examples are from Cal. & NY, which because of size and
politics may be more persuasive to this group than other states’ policy
choices.  Can Vt. be as persuasive on the
national stage?  Also, is this an actual
benefit if GMO status really isn’t that important?
 
Wang’s paper: analogy to FCC and Nat’l Endowment for Arts
may be different—obscenity/profanity restrictions v. info on drugs—some claim
the info is very valuable for the public health. I worry that courts wouldn’t
extend the rationale they’ve used for FCC/NEA to that speech.  Also, consider other areas, such as genomic
testing—how far can this extend into other areas where FDA faces First
Amendment challenges not so tied to regulatory exclusivity? Maybe the answer is
that authorization to market is a gov’t benefit in itself, but wants to know
more.
 
Winters: California does tend to drive national policy.  Humane treatment as related to human health:
connections b/t factory farming and health, as opposed to standalone concerns
about morality—may get more of a patchwork. But we’ll see industry and private
actors (like McDonald’s) moving to creating a uniformity not mandated by
federal law.  We’ll see convergence/informal
agreements.
 
Wang: Art v. IP is an interesting point.  Even profanity could have a benefit, but the
gov’t can still regulate it because of its structural position conferring a
benefit. Step outside of assumptions and think about it from IP perspective.
 
Moderator: Joseph Page, Professor, Georgetown University Law
Center: Consider state right to try laws: statutes giving people with
life-threatening diseases access to drugs w/o full FDA approval.  In order for them to be successful, the fed
gov’t has to stay its hand, as w/marijuana. 
Otherwise all you have is expressive libertarianism: symbolic laws that
make another point. It’s one thing for states to fill in the gaps; it’s another
for states to encourage violation of federal law.
 
Winters: it fits in the theme b/c it’s a conversation, but
agrees it’s different.
 
Zettler: FDA does allow compassionate use, so you could
comply with both treatment regs and right to try laws, though the laws are
intended to circumvent FDA rules.  But
not as direct a conflict.
 
Winters: Controlled Substances Act has mostly been enforced
by states; states are refusing to take action, but historically they were the
ones who locked people up for drugs.  So
that’s another difference.
 
Q: gov’t property allocation doesn’t mean there are no 1A
rights.
 
Wang: there has to be a relationship to the gov’t program.
It’s not a direct mapping, but a looser analogy.

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