Brown-Schumer Bill to legalize generic biologics
zuzu
market. Silly me for assuming open competition as the default state
in the medical industry. There's been advertisements (propaganda) on
the radio (in Pennsylvania, at least) virtually every commercial break
by the pharmaceutical industry asking people to tell their
representatives to vote against this Brown-Schumer bill (for sake of
"jobs", "high cost of research", and other spurious economic
arguments).
Normally I'll be the first to dismiss the entire "absurdity and
insanity of politics", but tissue cultures and bioprocessing for
production of biologics are easily within domain of DIYbio and DIY H+
transhumanism / extropianism. Legal generics are a major step to
popularly opening up availability of both knowledge and equipment
towards those goals.
(I fully expect someone to be yielding and isolating significant
quantities of PT-141 in their home laboratory within 10 years from
now.)
http://en.wikipedia.org/wiki/Biologic
Biologics include a wide range of medicinal products such as vaccines,
blood and blood components, allergenics, somatic cells, gene therapy,
tissues, and recombinant therapeutic proteins created by biological
processes (as opposed to chemically).
http://www.rollcall.com/issues/54_145/vested/35823-1.html
Biologics Battle Over Billions of Dollars
Fight Fueled by FTC Report That Says 12-Year Exclusivity Unnecessary
By Kate Ackley
Roll Call Staff
June 15, 2009, 12 a.m.
Lobbyists who want Congress to approve a swift pathway to generic
versions of biotech drugs say the Federal Trade Commission last week
handed their side a boost just as Congress wades into the health care
reform debate.
But biotech brand companies, which have billions of dollars at stake,
stepped up their own lobbying efforts, calling the FTC report flawed
and working to give their side momentum on Capitol Hill.
“This study is an enormous game-changer,” said Mark Merritt, president
of the Pharmacy Care Management Association, which supports a bill by
House Energy and Commerce Chairman Henry Waxman (D-Calif.) that would
give brand-name companies five years of market exclusivity for their
biotech drugs before generics enterprises could market their versions.
Brand-name companies argue they need at least a dozen years of market
exclusivity in order to make it worth their bottom lines to keep
producing the products.
The FTC report stated that such a lengthy period of exclusivity was unnecessary.
The Senate Health, Education, Labor and Pensions Committee, which last
week unveiled its health care reform bill, left out the details when
it comes to biologics. Lobbyists for both sides say this week, when
the committee is expected to mark up its bill, Senators will determine
the length of exclusivity.
But on the House side, a competing bill to Waxman’s — one sponsored by
Reps. Anna Eshoo (D-Calif.), Jay Inslee (D-Wash.) and Joe Barton
(R-Texas) and generally supported by the brand industry — is adding
co-sponsors.
“It blows apart this mythology that you need all these extra years of
exclusivity to protect innovation,” added Merritt, whose group is part
of the Coalition for a Competitive Pharmaceutical Marketplace. “This
gives hope that there can be real biologics legislation that can
provide real savings that can finance broader health reform.”
Biotech drugs, or biologics, are some of the costliest therapies on
the market. They include such products as Genentech’s Herceptin, a
cancer treatment, and Amgen’s Enbrel, which is used to treat
rheumatoid arthritis. Biologics are almost never taken in pill form
but are injected. And brand makers say they cannot be replicated
exactly.
The debate is so contentious that even the terms are politically
loaded. Brand makers use the terms biosimilars or follow-on biologics;
Merritt’s side calls them biogenerics.
Tom DiLenge, general counsel for the Biotechnology Industry
Organization, says his group is in favor of creating a pathway but
needs a 12-year exclusivity. Otherwise, he said, “there would be much
less incentive to engage in all of that work, if a competitor can
free-ride on your work” immediately.
The brand-name side also says that the amount of money a quicker path
to generics could save is not nearly as much as Merritt and his allies
claim. David Beier, senior vice president of global government and
corporate affairs for Enbrel’s maker Amgen, said that the most recent
Office of Management and Budget report says the savings to the federal
government would be about $6 billion over 10 years.
“People who claim that somehow there’s going to be a massive amount of
savings, that just doesn’t work as a matter of mathematics,” Beier
said.
But according to a draft letter from the Coalition for a Competitive
Pharmaceutical Marketplace, “Growth in spending on biologics continues
to outpace that of traditional pharmaceuticals, creating an
ever-increasing multi-billion dollar savings opportunity for these
life-saving products.”
The letter is expected to go to the Hill today, and its signers
include consumer groups, unions and employers. The letter urges
passage of the Waxman bill and a similar version in the Senate (S.
726) backed by Sens. Charles Schumer (D-N.Y.) and Sherrod Brown
(D-Ohio).
A brand pharmaceutical industry source said the HELP Committee is
considering three possible scenarios, including one that would give
brand biotech drugs closer to 12 years of exclusivity and one that
would provide far fewer years. (HELP Chairman Edward Kennedy [D-Mass.]
sponsored a bill two years ago that provided 12 years of exclusivity.)
“Frankly, it’s in flux,” said this brand industry source. “There is
some language that was circulated that troubles our industry quite a
bit.”
Regardless of the number that comes out of the markup, the brands
won’t stop there.
“The markup is only the first step,” this brand industry source said.
“I don’t see it as being the end of the debate.”
Senate Introduces Bipartisan Bill on Biosimilars
Apr 2, 2009
By: Patricia Van Arnum
EPT--The Electronic Newsletter Of Pharmaceutical Technology
The US Senate introduced a bipartisan bill (S. 726) on Mar. 26, 2009,
which establishes a regulatory pathway for approval of biosimilars.
The bill, “Promoting Innovation and Access to Life-Saving Medicine
Act'” was introduced by Senators Charles Schumer (D-NY), Sherrod Brown
(D-OH), Susan Collins (R-ME), Mel Martinez (R-FL), and co-sponsored by
other Senators. Last month, the House also introduced a bipartisan
bill (HR 1427) for establishing a regulatory route for biosimilars.
A key provision in the Senate bill is to establish five years of
market exclusivity for a biologic product from the time the brand-name
drug was approved. The bill also establishes a procedure for
resolution of patent disputes before a biosimilar is approved and
establishes penalties for failure to litigate patents in a timely
fashion.
“It’s past time we created a way for generic versions of these
expensive drugs to come to market,” said Schumer in a press release.
“We have a bipartisan plan that we know consumers will support and we
believe the President will, too. The savings reaped from this will be
a down payment on healthcare reform,”
The Biotechnology Industry Organization (BIO), the trade association
representing biotechnology companies, was critical of the proposed
legislation as it is with the House measure. “While well-intentioned,
the bill introduced today by Senators Schumer, Brown, Collins, and
Martinez follows its companion bill in the House (HR 1427, ‘The
Promoting Innovation and Access to Life-Saving Medicine Act’) through
the looking glass to a world of biosimilars that would jeopardize
patient safety and undermine future medical breakthroughs,” said BIO
President and CEO Jim Greenwood in a Mar. 26 BIO press release.
BIO disagrees with the time period allowed for exclusivity for
brand-name biologics under the bill, the use of certain language that
it says would discourage FDA from conducting certain clinical trials
for a biosimilar, and information-disclosure requirements by biologics
manufacturers.
“The bill unfairly tilts the playing field toward biosimilars
manufacturers,” said Greenwood in the Mar. 26 press release. “This
legislation provides for less data exclusivity than traditional
pharmaceutical drugs currently receive under the Hatch-Waxman regime
even though every credible study on this issue has found that
biologics will need greater data exclusivity than traditional drugs to
ensure future medical breakthroughs,” he said. “Additionally,
innovators would be required under the bill introduced today to share
detailed information about every applicable patent to biosimilar
manufacturers, making it easier for the biosimilar company to bypass
valid patents. Innovators, on the other hand, would have no ability
to receive relevant information from the biosimilar manufacturer about
the molecules, ingredients, and processes they use to create the
biosimilar.”
Instead, BIO endorses another biosimilar bill, HR 1548, “The Pathway
to Biosimilars Act.” That bill was introduced in March 2009 by
Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA), and Joe Barton
(R-TX). “The Eshoo-Inslee-Barton bill establishes parity with the
outcomes of the Hatch-Waxman regime developed for traditional
pharmaceuticals, balancing the need to increase access, lower costs,
ensure drug safety and promote continued biomedical breakthroughs,”
said Greenwood in a Mar. 17, 2009 BIO press release. “At the same
time, the bill recognizes the fundamental differences between
biologics and traditional pharmaceuticals.”
With regard to the Senate bill, Sens. Schumer and Collins said they
are looking forward to moving forward with negotiations on the
proposed biosimilar legislation as Congress considers broader health
reform. In particular, they mentioned working with Sen. Edward Kennedy
(D-MA), chairman of the Senate Committee on Health, Education, Labor
and Pensions, to develop a pathway based on their legislation. In
2007, Kennedy was critical of a bipartisan group of senators that
reached a compromise on generic biologics, according to the Senate
press release. Several aspects of current Senate bill include measures
from that compromise, including providing FDA full discretion to
determine what studies are necessary to establish that a biogeneric is
as safe and effective as the original product, said the Senate
release.
http://blog.cleveland.com/openers/2009/03/sen_brown_floats_bill_to_allow.html
Sen. Brown floats bill to allow generic versions of biologic drugs
Posted by Sabrina Eaton/Plain Dealer Washington Bureau March 26, 2009 17:33PM
Categories: Sherrod Brown
Rule change could save seniors hundreds of dollars on prescriptions
Washington — Sen. Sherrod Brown joined a bipartisan crowd of U.S.
senators today to announce a legislative compromise that would pave
the way for the Food and Drug Administration to allow generic versions
of biologic drugs that are produced from living cell cultures instead
of chemicals.
The senators said the FDA currently lacks the authority to approve
generic forms of those drugs. The legislation Brown introduced with
Sens. Charles Schumer (D-NY), Debbie Stabenow (D-MI), Susan Collins
(R-ME), David Vitter (R-LA) and Mel Martinez (R-FL) would set up an
FDA approval procedure. A bipartisan House of Representatives'
counterpart of the bill has been introduced by Democrat Henry Waxman
of California and Republican Nathan Deal of Georgia.
"We have seen what competition in the marketplace means," said Brown.
"Generic drugs can save consumers hundreds of dollars a year . There's
simply no reason we can't introduce the same kind of competition into
a segment of the health care market where there hasn't been that kind
of competition."
Biologic drugs are often prohibitively expensive. For example the
drug, Avonex, which treats multiple sclerosis, costs $20,000 yearly,
even though its patent expired in 2003. Avastin, for colorectal
cancer, costs $43,000 per course of treatment. Enbrel, which treats
rheumatoid arthritis, can cost up to $25,000 per year. Allowing
generic competition would bring down the drugs' price, the senators
said, and save billions of dollars yearly for federal programs like
Medicare and Medicaid.
The legislation is endorsed by groups, including the trade association
for the nation's pharmacy benefit managers -- the Pharmaceutical Care
Management Association -- whose president declared it would "increase
access to life-saving medications, save billions and ensure continued
innovation for new groundbreaking biologics."
It's one of those rare "win-wins" supported by consumers, "budget
hawks," business, labor and policymakers on both sides of the aisle,
the group's president, Mark Merritt, said in a press release.
The drug industry trade group Pharmaceutical Research and
Manufacturers of America was less enthused. They issued a statement
opposing the legislation on the grounds that the FDA procedures it
outlines "are not sufficient to ensure patient safety." The group also
dislikes that the bill would allow competition from generics after
brand name drugs have been exclusively sold for five years, instead of
14 years, as the industry would prefer.
"Developing biologic cures is a complex and difficult undertaking,"
PhRMA Senior Vice President Ken Johnson said. "Congress needs to
approach any changes in this arena carefully to safeguard the future
development of life-saving and life-enhancing therapies."
Although similar legislation has been floated in previous Congresses,
Brown predicts it will pass this time because it now has bipartisan
support and is a priority of the current president.
"Competition brings prices down and causes more innovation," said Brown.
Bob Keyes
There's a big difference between 5 years and 14 years (referring to 'brand-name' exclusivity. Maybe there's some room for compromise? I don't want to get too political on this forum, because it's not the place for it. I do want to see something closer to 5 years than 14, but worry that such a huge change in time spans is going to make the 5 year bill fail.