|
 The meeting, announced last month by FDA chief counsel Elizabeth
Dickinson, comes as a bill known as 21st Century Cures, designed to
speed new drugs to market, is moving through Congress. Language in
the bill is adding pressure on the agency to relax its guidelines.
Efforts by drug companies to change the rules gained steam after a
2012 decision from the Second Circuit Court of Appeals, which
overturned the conviction of Alfred Caronia, a sales representative
for Orphan Medical, which was later acquired by Jazz Pharmaceuticals
Inc. After Caronia was caught talking to physicians about various
off-label uses of the narcolepsy drug Xyrem, the court said the
First Amendment protected truthful and non-misleading off-label
speech.
Under current rules, physicians are allowed to prescribe medicines
off-label for whatever condition they want. But drug companies are
not allowed to promote them for uses that have not been approved by
the FDA.
Pharmaceutical companies are citing the Caronia and similar rulings
to pressure the FDA to let them talk more freely about off-label
use.
"If you're a community physician it's hard to stay current," said
Coleen Klasmeier, a partner at Sidley Austin LLP, which petitioned
the on behalf of a coalition of pharmaceutical companies to
"adequately justify and appropriately tailor its regulatory regime"
in light of Caronia and similar rulings.
The coalition, known as the Medical Information Working Group,
includes Pfizer Inc, Sanofi, Novartis AG, Johnson & Johnson, Eli
Lilly and Co and GlaxoSmithKline Plc, among others.
At stake are billions of dollars in potential sales if manufacturers
can persuade physicians to use their products for unapproved uses
and a potentially significant weakening of the FDA's regulatory
authority.
Karen Riley, an FDA spokeswoman, said the agency decided to hold a
public meeting "because of the wide range of views held by different
stakeholders and the importance of the underlying public health
issues."
OFF-LABEL PROMOTION
Drug companies have a long history of breaching the off-label rules.
Over the past decade 17 companies paid more than $16 billion in
settlements for off-label promotion, according to the American
Medical Association, including Pfizer, GlaxoSmithKline and Eli
Lilly.
In September, Shire Plc agreed to pay $56.5 million to settle
charges it overstated the benefits of its attention deficit disorder
drug Adderall XR and claimed, with little evidence, that it would
prevent criminal behavior, traffic accidents and sexually
transmitted disease.
"At my own medical center we have banned pharmaceutical reps from
coming because we don't think they are a good source of
information," said Dr. Rita Redberg, professor of medicine at the
University of California, San Francisco, and editor of the medical
journal JAMA Internal Medicine. "You don't ask the barber if you
need a haircut."
Off-label use already accounts for 10 percent to 20 percent of
prescribing, with that figure rising in oncology and pediatric rare
diseases, according to the AMA, which said it "supports the
important need for physicians to have access to accurate and
unbiased information about off-label uses of drugs and devices,
while ensuring that manufacturer-sponsored promotions remain under
FDA regulation."
REPUTABLE JOURNALS
The FDA does allow companies to provide doctors with data from
well-controlled clinical trials from reputable medical journals and
reference texts (but not from early clinical trials or letters to
editors) and they can talk about off-label use at medical
conferences. They can also respond to unsolicited questions from
physicians as long as the responses do not tout the benefits of a
product without disclosing its risks.
Companies want to be able to discuss data that does not come from
randomized clinical trials. They also want to be able to provide
economic analyses to insurance companies showing why a drug should
be covered.
"Let's say a drug is very expensive and very effective and doesn't
have many side effects," Klasmeier said. "If you're a health plan
and you are trying to decide whether to pay for the drug you want to
know how it stacks up against others."
[to top of second column] |
Industry pressure has "forced the FDA to think harder about this
topic," said Peter Pitts, a former FDA associate commissioner for
external relations, who is now president of the Center for Medicine
in the Public Interest, a think-tank that receives funding from drug
companies.
In response to petitions from the coalition, the FDA noted that its
regulatory framework was developed "in response to public health
tragedies" but said it "recognized the evolving legal landscape in
the area of the First Amendment" and promised to review its
policies.
It has proposed adding clinical practice guidelines to the list of
material companies can circulate. These are often developed by
professional associations and may include treatment and dosing
regimens that differ from what is on a drug's label.
It has also proposed allowing companies to distribute medical
literature showing a product's side effects to be less than
described in the label. Comments from the public in response to the
proposal were overwhelmingly opposed, according to documents
obtained and made public by the consumer watchdog Public Citizen.
TRUTHFUL BUT NOT MEANINGFUL
Those moves have not been enough to appease the industry. Yet public
health advocates fear that if the FDA yields further, companies may
be able to circulate data which is truthful under the Caronia
definition without being meaningful for patient health.
A 2012 study showed that up to 75 percent of published pre-clinical
trial results could not be reproduced in subsequent trials. An
earlier one showed that when scientists attempted to corroborate 34
claims from frequently cited published trials they were unable to do
so 41 percent of the time.
"People do not realize that the consequences of this new ideological
approach to the First Amendment will be measured in lives," Dr.
Joshua Sharfstein, a former principal deputy commissioner at the FDA
who is now associate dean at Johns Hopkins Bloomberg School of
Public Health.
For example, doctors prescribed schizophrenia and bipolar disorder
drugs for years to control behavior in elderly patients with
dementia. Studies later showed they increased the rate of death in
the elderly.
Premarin and Prempro, drugs to treat symptoms of menopause, were
prescribed extensively to women for years on the assumption they
would prevent increased coronary disease. The hypothesis was
supported by some data but not by randomized, controlled clinical
trials. When the drugs were eventually analyzed in a large
government-sponsored trial they were found to increase the risk of
stroke and heart attack.
If companies can market drugs for off-label uses there will be no
incentive for them to conduct the clinical trials needed to show the
products work and are safe, critics say.
"If off-label marketing is allowed then drugs will come to be used
for a wide variety of conditions for which there has not been
developed evidence of safety and efficacy," said Dr. Steven Nissen,
chairman of cardiovascular medicine at the Cleveland Clinic. "You
take away those checks and balances and it's the wild, wild west."
(This version of the story was refiled to capitalize "First
Amendment" in paragraph 1)
(Reporting by Toni Clarke in Washington. Editing by Michele
Gershberg and John Pickering.)
[© 2015 Thomson Reuters. All rights
reserved.] Copyright 2015 Reuters. All rights reserved. This material may not be published,
broadcast, rewritten or redistributed.
 |
