Healthy Skepticism Library item: 1993

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Adams C.
Firms Pressure FDA to Relax Rules on Commercial Speech
The Wall Street Journal 2002 Sep 17
http://online.wsj.com/article/SB1032211864319468275.html?mod=googlewsj

Full text:

The food and drug industries are pushing
federal regulators to loosen longstanding restrictions
on promoting their products, setting themselves up for
a bruising clash with congressional critics who think
such a move would endanger consumers.
At stake is the way the Food and Drug Administration
handles a wide array of advertising and marketing
issues, including how pharmaceuticals makers peddle
their wares to doctors, how food producers label their
products and how medical-device makers inform the
investing community about potential new products.
Because the FDA regulates products accounting for 22%
of U.S. consumer spending, its restrictions on these
“commercial speech” issues can have an immense impact
both on consumer and producer behavior.

Responding to the FDA’s offer to review its rules and
its solicitation of public input, the industry is
pushing for both wholesale and tiny changes. Pfizer
Inc. wants the FDA to ditch a rule that requires
manufacturers to prominently place the generic name
for a drug alongside its branded name in
advertisements. Such “old, paternalistic traditions”
simply “cannot withstand First Amendment scrutiny”
today, Pfizer said in comments recently filed to the
agency. The New York company also wants the FDA to
drop its requirement that drug makers list possible
side effects in reams of fine print in magazine ads.
Regulatory lawyers are unsure how long the FDA review
will last, but are certain some rules will go. “Am I a
good predictor of which ones? Absolutely not,” says
Peter Barton Hutt, a former FDA chief counsel now
working on behalf of a grocery-manufacturers group and
a venture-capital association. “But the important
thing is, all of the FDA’s policies are being put
under scrutiny.”
In May, the FDA , spurred by a string of adverse court
decisions on commercial-speech issues, asked for
public comment on its current rules. The agency wanted
to know if its rules advanced public health or whether
“alternative approaches” would be better. Industry
groups and companies jumped at the chance, as did the
American Civil Liberties Union, which urged a “less
restrictive” approach. Comments were due last Friday.
Those pushing a rules retreat are encouraged that the
person leading the review is Daniel Troy, the FDA’s
chief counsel. Before leaving his law practice to join
the Bush administration, he was known for taking on
the FDA over marketing and promotion issues.
“Some of the people at the FDA place a higher regard
on First Amendment rights than perhaps others did in
the past,” says Richard Samp of the Washington Legal
Foundation, a free-market advocacy group that worked
with Mr. Troy to sue the FDA over some rules in the
late 1990s. Mr. Troy also was involved in challenging
agency efforts to restrict tobacco ads.
But influential Democratic lawmakers and others, such
as the advocacy group Public Citizen, assert that FDA
rules are vital to the public health. The American
Medical Association cautions that “the FDA should not
be deterred” in regulating what medical-products
makers say about their goods.
Congressional critics are especially opposed to any
relaxation of the rules governing “off-label” drug
promotions — that is, plugging medicines for uses
other than the specific ones for which they were
approved. The FDA approves most drugs for specific
uses, although doctors can prescribe them for other
uses. Companies, however, aren’t allowed to advertise
such off-label uses.
“The First Amendment shouldn’t force us to return to a
time the public health would be endangered — where
manufacturers can profit by giving misinformation or
deceptive information, and where it could be years
before any product could be taken off the market,”
says Rep. Henry Waxman, a California Democrat.
Mr. Waxman and eight other Democrats, including
Massachusetts Sen. Edward Kennedy, chairman of the
Senate health committee, warned in a letter to the FDA
that “Americans could lose their lives” if the agency
rules are eased. The lawmakers were especially
incensed that changes were being weighed without a
permanent commissioner in place; the FDA’s current
leader, Lester Crawford, is serving as interim
commissioner and thus isn’t subject to Senate
confirmation.
On the Republican side, House Energy and Commerce
Committee Chairman W.J. “Billy” Tauzin of Louisiana,
acknowledges the FDA’s watchdog role but says that
role needs to be carefully considered. “I think that
if a product is legal, we ought to be able to talk
about it publicly without government restricting our
conversation,” he says.
The FDA essentially has two jobs: to determine whether
products are safe and effective, and to ensure they
are marketed responsibly. The agency’s speech-related
rules have evolved in recent decades, as the FDA seeks
to meet Supreme Court tests for restrictions on
commercial speech. The high court has held that false
or misleading commercial speech can be banned. As for
truthful commercial speech, the court has said it can
be limited if the government can show the restrictions
are necessary for the public good and aren’t more
onerous than necessary.
But even as the FDA has made some changes, the
industry has remained dissatisfied. The Pharmaceutical
Research and Manufacturers of America, the drug
industry’s main trade group, wants looser rules on
what information drug makers can hand out detailing
off-label uses of approved drugs.
For example, if a researcher publishes a paper — even
in the totally independent and prestigious New England
Journal of Medicine — that analyzes an off-label use
of a drug, sales representatives used to be prohibited
from handing a reprint of the article to doctors. Such
an act was seen by regulators as promoting the
unapproved use. The FDA has backed away from that
stance recently because of a court setback, but hasn’t
given companies the green light to widely disseminate
such literature, the industry says.
“To this day, the ground rules remain unclear,” says
Matthew Van Hook, PhRMA’s deputy general counsel.
Drug makers, as well as the National Venture Capital
Association, which funds biotechnology start-ups, say
the FDA’s policy essentially takes neutral, truthful
information and applies a double standard: An
independent researcher can freely hand out such a
reprint, while the maker of the drug can’t.
Companies also are pressing the FDA to ease up on its
regulation of news releases that highlight research
results. PhRMA says the FDA has cited companies for
improperly describing “encouraging preliminary
studies” for drugs. The trade group argues that
approach “impermissibly burdens speech.”
Pfizer, in its comments, also criticizes the FDA
division that reviews drug ads. Senior corporate
counsel Arnold Friede says some letters admonishing
companies for their ad content go too far. “You could
make the case that many of them are based on
subjective interpretations of an ad that consumers
might not share.”
Mr. Friede says Pfizer would like to have some sort of
“neutral arbitrator” that would listen to drug-company
appeals. FDA defenders say tough enforcement of the
rules is necessary to protect consumers from the
sometimes exaggerated claims of pharmaceuticals
makers.