Contact Your Financial Adviser Money Making MC
1 December
2016
 |
Drug industry (The Total Investment & Insurance
Solutions)
This week, Congress is taking back up a
sweeping bill introduced last year that would expand medical research funding
while also loosening the regulations for approving new drugs and medical devices.
While the legislation has undergone revisions, it still includes many of the
deregulatory provisions that have drawn criticism from some consumer safety
advocates. Back in October 2015, we detailed the bill's origins and the massive
lobbying push by the drug and device industry supporting it.
This might seem to be a rough political patch
for the pharmaceutical and medical device industries. The exponential price increases of
several drugs have
brought scrutiny to the overall rise in drug costs and have prompted several
2016 candidates, most notably Hillary Clinton, to vow action to rein
in the industry. Meanwhile, thousands of complaints are pouring into the Food and Drug
Administration about a contraceptive implant made by Bayer.
In Congress, however, things are looking
better for the manufacturers. Legislation is advancing that would speed up the
FDA's approval process for medications and medical devices, offering a rare
example of how major initiatives can get traction even in today's gridlocked
Washington.
The industry has mounted a major lobbying and
public relations push for the 21st Century Cures Act. The bill, in turn, has garnered an
unusually broad range of support, ranging from Republican lawmakers and
conservative think tanks to the White House, patient advocacy groups, Democrats
and nonprofit organizations that are typically leery of deregulatory efforts by
industry. One reason: Lawmakers softened up the usual opponents of looser rules
with a big carrot — billions of dollars in new federal medical research funding
for the National Institutes of Health. After years of austerity, that money is
awfully difficult to turn down.
But the enthusiasts have left a small band of
critics warning that bipartisan consensus does not necessarily affirm the
bill's worth. Far from showing that Washington can still get big things done,
they say, it shows how a lobby can blow past skeptics if the pot of resources
is sweet enough. They maintain that the bill, which easily passed the House in
July and has a counterpart soon to be introduced in the Senate, hasn't received
the scrutiny that such sweeping legislation deserves. The Total Investment & Insurance Solutions
"Expanding NIH funding in a substantive
amount is a grand and wonderful thing," said Susan Wood, a former
assistant FDA commissioner for women's health who is now a professor at George
Washington University. "But the price of that expansion should not be the
gutting of the FDA." The Total
Investment & Insurance Solutions
Wood's criticism is echoed by other former
FDA officials including David Kessler, who was appointed commissioner by
President George H.W. Bush, as well as by two Harvard medical school professors
who argued in a leading journal that the bill "could lead to the approval
of drugs and devices that are less safe or effective than existing criteria
would permit."
For their part, the bill's proponents say it
would spur innovation, particularly when it comes to finding cures for rare
diseases — of the 10,000 or so known diseases, 7,000 are considered rare and
treatments exist for only 500. Francis Collins, director of the NIH and a
leading champion of the bill, says it now takes "around 14 years and $2
billion or more" to
develop a new drug and notes that all but five percent of drugs fail during
development.
If the legislation passes the Senate and is
signed by President Obama, the FDA would be encouraged to develop faster routes
to the approval of new products. Under the current system, most new drugs and
devices must pass through multiple levels of clinical trials that can take
years to conclude. One alternative would be to make more frequent use of so-called
"biomarkers" that gauge physical responses to a drug rather than
waiting for the final results from a patient trial. The Total Investment & Insurance Solutions
To increase the incentive for drug makers to
seek cures for rare diseases, the bill also would grant an extra period of exclusive marketing rights to a
company if an
existing drug were approved to treat a rare disease after having been
previously approved for a different disease.
"The 21st Century Cures legislation is
viewed very positively by both political parties and the public at large,"
said Michael Castle, a former House Republican from Delaware who is the vice
chairman of Research America, an organization that lobbies for biomedical
research funding. "If you get down to a list of substantive legislation
that has actually a chance of passage now, something like 21st Century Cures is
very high on that list."
The legislation is responding, in part, to the demand from many patients'
groups for medical breakthroughs. "It doesn't mean you give
the industry free rein, but are you really protecting the public if you're
preventing real cures from getting to them?" said Brian Baird, a former
Democratic congressman from Washington state who supports the bill.
The bill's critics have argued that the FDA
has already greatly streamlined its approval processes. A recent analysis by Forbes found that so far this year the FDA
has rejected only three never-before marketed drugs, and approved 25, an
approval rate of 89 percent, up from 66 percent just seven years ago.
"We're the fastest regulatory agency in the world," said Gregg
Gonsalves, a prominent HIV activist now working as a research scholar at Yale
Law School. "Pharma would just be very pleased to do less work for more
gain."
Stephen Ostroff, now the FDA's interim
commissioner, has said the agency initially had concerns about the House bill,
but that officials were reassured by revisions. The version that passed would
only encourage the agency to use the alternate approval methods, rather than
require them. Still, critics note that the FDA would get only $550 million to
administer the new approval processes, far less than it says it needs to do so properly.
The legislation has its roots in a
longstanding push by conservative groups to liberate drug and device
development from red tape. "Now, I don't want to get your hopes up, but
Phase Three, maybe we'll take out FDA," said Newt Gingrich during the
Republican Revolution of 1994, when he also called the agency the nation's
"leading job killer." More recently, the deregulatory crusade against
the FDA has been led by conservative think tanks such as the Goldwater
Institute and Manhattan Institute, which launched its "Project FDA" to reform the agency so that it
provides a "more predictable, transparent, and efficient pathway" for
new medications and devices. The Total
Investment & Insurance Solutions
The cause was taken up in Congress over the
last couple years by House Energy and Commerce Committee Chairman Fred Upton, a
Michigan Republican who will be giving up his gavel to term limits next year
and is, his colleagues say, eager for a major legislative capstone before he
leaves. Upton has received major backing from the drug and device industries—in
the last election cycle, they contributed about $370,000 to him and his associated political
action committee, according to the Center for Responsive
Politics, more than all but two other business sectors. The Total Investment & Insurance Solutions
Besides campaign contributions, the industry
has invested in lobbying. The Pharmaceutical Research and Manufacturing
Association, which represents drug makers, increased its quarterly lobbying
from $3.96 million to $5.44 million as Upton prepared to release the
legislation early this year. The Advanced Medical Technology Association, which
represents device makers, increased its quarterly lobbying spending from
$550,000 to $740,000 in the same period. Drug and device makers themselves also
increased their lobbying expenditures, the records show.
But the key for the legislation's proponents
has been to earn support beyond Republicans and the industry. Early on, Upton
enlisted help in crafting the bill from Rep. Diana DeGette, a Colorado
Democrat, for whom the legislation was a chance to make a mark on the Energy
and Commerce committee, and Rep. Gene Green, a Texas Democrat whose physician
daughter took great interest in aspects of the bill. The Total Investment & Insurance Solutions
Then many other Democrats, including New
Jersey's Frank Pallone, the ranking member on Energy and Commerce, lined up
behind the legislation when Republicans in June added nearly $9 billion in new
support for the NIH over the next five years. The agency has seen its funding
essentially flat-line for more than a decade at about $30 billion per year.
Pallone did manage to scale back many of the "marketing exclusivity"
provisions.
The NIH money also brought the bill support
from patient advocacy organizations, from the American Cancer Society to smaller groups seeking cures
for rare diseases, which the bill's proponents say would benefit
particularly from the deregulatory reforms.
"I don't see this as a pro-industry
bill," said Ellen Sigal, the founder and chairwoman of the Friends of
Cancer Research. "It's a bill for innovation and research at basic
levels." She added: "It's hard, frankly, not to support it. There are
very few people who are not supporting it."
The promised NIH money also brought on board
major universities, which carry out about $15 billion of all NIH-funded
research. "It was the investment in NIH that led everyone to get behind
it," said Atul Grover, chief public policy officer at the Association of
American Medical Colleges. "As soon as we talked about innovation, people
said, look, you can try to grease the skids on the approval process, but if
we're not investing as a nation in research, then this other stuff is not going
to make much difference. You have to invest in cures to get them."
The list of entities lobbying on the bill now
runs to about 1,800 quarterly entries in the Senate's lobbying database, with more than 1,100 lobbyists
registered as working on it, which is staggering even by the
standards of Washington. And what has been so beneficial for the legislation is
that the vast majority of those entities are not companies or trade
associations, which are motivated by bottom-line demands, but patient groups
and universities, which have a far more neutral sheen. The Total Investment & Insurance Solutions
"Members of Congress who wouldn't be responsive
to pharma's lobbying did respond to universities' lobbying or to patients'
lobbying," said Diana Zuckerman, president of the National Center for
Health Research, an advocacy group that has spoken out against the legislation.
"It was a perfect storm of lobbying." The Total Investment & Insurance Solutions
In fact, there is considerable overlap
between the sets of advocates. Drug and device makers have long provided
financial support to many patient and disease groups—some of the money that
those groups are spending in pushing for the legislation is also coming from
industry coffers. Similarly, many academic researchers whose institutions are
lobbying for the legislation in Washington have received consulting and
speaking fees from the industry.
The lobbying has also gotten a big boost from Michael Milken,
the former junk-bond king who took up the cause of medical research after
surviving prostate cancer. Milken has been hosting events in Lake Tahoe, New
York, and elsewhere to bring members of Congress together with researchers,
patient advocates and industry executives who support the bill.
Meanwhile, an array of the bill's promoters,
including industry representatives, patient groups and scientific associations,
are monitoring the legislation's progress in weekly conference calls and
monthly meetings at the office of the American Association of Medical Colleges,
regular contacts that the association says it has been hosting for years to
push for funding.
The overlap was on display recently at the
annual luncheon for one of the nonprofit groups backing the bill, Research
America. At the Newseum in Washington, dozens of industry officials, patient
advocates and academic researchers mingled with the event's sponsors, which
included the drug companies Astellas, Shire, Janssen, Celgene and Gilead, as
well as AdvaMed, the device lobby. Various panel discussions ranged widely
across the challenges facing medical research, but throughout the event there
was a steady drumbeat urging those in attendance to keep pushing Congress to
pass 21st Century Cures.
"We want them to hear us in the
Capitol," said Research America director Mary Woolley as she kicked off
the event. "Decisions made just a few blocks from here this fall will be
consequential." (Research America itself receives support from the
industry to help cover its costs, which includes Woolley's roughly $500,000 in
annual compensation.)
She was followed by Jeffrey Bloss, Astellas'
senior vice president for medical affairs, who hailed the "groundswell of
support" and "massive effort" for the bill. "We need to
count on your impassioned advocacy for these changes," he said.
In an interview afterward, Woolley hailed the
coalition behind the legislation. "It's a very broad consensus—as broad as
you can have," she said. "It's patient groups, it's physicians, it's
industry, it's the academic community, it's everybody. It's a goal America can
embrace. This is legislation that can make everybody look good." The Total Investment & Insurance
Solutions
And she dismissed the notion that concerns
about the bill's impact on drug safety were being cast aside. "Industry
are people too, and they're patients too," she said. "The idea that
industry is just in this to peddle toxic drugs to sick people is absurd."
She added, "You'd have to think that people from industry and their
families are exempt from disease. It's preposterous. Mistakes hurt everybody." The Total Investment & Insurance
Solutions
Also buttressing the coalition are experts
and organizations that in the past have sometimes cautioned against FDA
deregulation. One of the bill's strongest early proponents was the Bipartisan
Policy Center, which in January announced a one-year initiative to overhaul the FDA led by former
Senate majority leader Bill Frist, the Tennessee Republican and physician.
The bill has also gotten vocal backing from
the center-left Brookings Institution, whose director of health care policy,
Mark McClellan, served as FDA commissioner under George W. Bush. "None of
[the bill's reforms] is replacing or modifying the FDA's standards that it
needs to be confident that a drug is safe before approval," he said.
"It's just modifying the evidence that can be brought to bear in making
that decision." McClellan said his support for the bill had zero
connection to the funding Brookings receives from drug and device companies,
which includes between $500,000 and $999,000 from Genentech and between
$100,000 and $249,000 from Amgen. "Those are gifts to the overall
institution and they are a small fraction of support to the institution,"
he said. The Total Investment &
Insurance Solutions
The bill has even gotten support from Pew
Charitable Trusts, which has in the past taken the lead in advocating for drug
safety. More recently, though, it has taken up the cause of developing antibiotics
to combat dangerous infections, and the legislation includes
language to speed the development of new antibiotics. Allan Coukell, Pew's
director of health programs, says the organization has endorsed only that
portion of the bill, along with a section on prescription painkiller abuse.
"I have to limit myself to talking about the provisions we're working
on," he said. But in promoting those sections of the bill, Pew has also
not issued public criticisms of other sections of the bill, to the dismay of
some of its usual allies.
"The most difficult thing for the
consumer-protection groups has been seeing these seemingly nonpartisan groups
sweeping in and embracing the bill as if it's good for science when everything
shows it has the opposite effect," said Vijay Das, a health care advocate
with the watchdog group Public Citizen.
The Total Investment & Insurance Solutions
The legislation passed the House by a
lopsided 344—77 vote in July. All eyes are now on Lamar Alexander, the
Tennessee Republican who chairs the Senate Health, Education, Labor and
Pensions Committee, which is expected to release its own version of the bill
soon. Alexander has also spoken out for the need to speed up drug approvals—he
co-authored a Bipartisan Policy Center report calling for an FDA overhaul—which
leaves it likely that the deregulatory language in the Senate version will
mirror that in the House. What remains to be seen is
whether the Senate will match the House in mandating additional billions for
the NIH, an approach that would break from the Senate's traditional
appropriations process.
Meanwhile, the White House has also expressed support for
the legislation, while suggesting some changes, lauding it as a
rare example of bipartisan action and a breakthrough against GOP-led budget
austerity. The Total Investment &
Insurance Solutions
But David Ross, a former deputy director of
drug evaluation at the FDA who now oversees HIV, hepatitis and public health
pathogen treatment for the Veterans Administration, still questioned the bill's
underlying justification — that it would result in a higher number of effective
drugs getting to market much faster. The
Total Investment & Insurance Solutions
"We definitely need more effective
drugs, but just calling something effective doesn't make it so," Ross
said. "It's a little like gluing some feathers together and calling it a
duck. Most drugs that go into studies don't make it not because the FDA is too
strict, but because they don't just work."The Total Investment & Insurance Solutions
No comments:
Post a Comment