[Ip-health] Key democrats back BIO industry against consumers to delay generic medicines

[Judit Rius Sanjuan]

Key democrats back BIO industry against consumers to delay generic
medicines (biosimilars)
By James Love
Director, Knowledge Ecology International
Posted: July 16, 2009 01:03 PM

Source: http://www.huffingtonpost.com/james-love/key-democrats-back-bio-in_b_235877.html

Congress is considering a long overdue reform in the way the FDA
regulates medicines that are classified as "biologic products." For
medicines classified as pharmaceuticals, the FDA created a system for
allowing new drugs on the market if they were "bioequivalent" to a
drug that had already been approved. This is the mechanism used to
make it easier for generic medicines to enter the market, and drive
prices down through competition.

Like pharmaceutical drugs, biologic products are used in the
prevention, treatment, or cure of diseases. Examples of biologic
products include Zostavax , the herpes zoster (shingles) vaccine,
erythropoietin (EPO), a therapeutic agent used in the treatment of
anemia resulting from chronic kidney disease, or Herceptin/
trastuzumab, a treatment for breast cancer.

Unlike for pharmaceutical drugs, there is no easy way to get FDA
approval for a generic biologic product (called biosimilars). Congress
is considering an FDA reform to fix this. But the reform is being
derailed by an effort by BIO, the trade association for the
biotechnology industry, to create a long period before generics can
enter the market. BIO is asking Congress to approve 12 to 14.5 year
legal monopoly on a biologic product, that has nothing to do with the
patent status of the product. Given the way that many biologic
products are used, a monopoly of up to 14.5 years will discourage
entry by generic producers.

Representative Henry Waxman has tried to keep the monopoly at 5 years
-- the same minimum monopoly that exists now for pharmaceutical drugs,
and the Obama White House has drawn the line at 7 years. But BIO now
has Howard Dean pushing for the longer monopoly (See his recent op ed
in the Hill), as well as Joe Trippi, and a number of key Democratic in
Congress, including Senator Edward Kennedy, and Representatives John
Conyers and Anna Eshoo.

The Senate Help Committee recently rejected an effort by Senators
Brown, Sanders, Harkin, Bingaman, and Merkley to limit the monopoly to
7 years. Senator Kennedy and many other liberals on the Senate Help
Committee backed the BIO 12-14.5 year monopoly position.

In the House, the evil proposal is HR 1548, sponsored by
Representative Anna Eshoo and more than 130 co-sponsors, including
several democrats, such as John Conyers, the Chairman of the Judiciary
Committee. A Tuesday Judiciary subcommittee hearing on "Biologics and
Biosimilars: Balancing Incentives for Innovation," was loaded up with
5 industry lobbyists/experts, and one consumer group.

BIO has enlisted endorsements from several industry funded "patient
groups", but consumer groups not funded by drug companies, such as
AARP, PIRG, Essential Action, UAEM, KEI, are opposing the longer
monopoly.

The US generics association GPhA has also.

In June the Federal Trade Commission unanimously approved a report
that found a 14 year-period excessive and unnecessary to induce
further biomedical innovation . (Bio's rebuttal is here).

Our letter to Congress on the issue follows:

     Congress should reject the 12-14.5 year monopoly for biologic
products provided for in HR 1548

     KEI* opposes H.R.1548, the bill to "establish a pathway for the
licensure of biosimilar biological products," on the grounds that the
period of the monopoly is excessive, and not subject to safeguards
that would protect consumers.

     HR 1548 conditions market entry for biosimilar products on a 12
to 14.5 year period of legal monopoly for products that is independent
of the patent status of products. The putative rationale is to reward
investments in new products. However, there is no requirement that the
monopoly bear any relationship to the investments in particular
products, pricing, or the cumulative revenues generated by the
product. The period of exclusivity can extend 9 years beyond that
currently exists for pharmaceutical drugs, and presents considerable
risks to the public as consumers, taxpayers, employers and subjects of
medical experimentation.

     The alternative approach supported by Representative Waxman and
the White House of providing a 5 to 7 year monopoly is also excessive,
but certainly preferred to an approach that provides a 14.5 year
monopoly.

     KEI agrees with Essential Action and others that believe a bill
based upon exclusive rights to rely upon safety and efficacy of
products is itself fundamentally flawed, for several reasons,
including the fact that it provides economic incentives for
unnecessary and unethical clinical testing of products on human
subjects. KEI encourages members of Congress to reflect on the
provisions of the Declaration of Helsinki on the ethical principles
for medical research involving human subjects, including but not
limited to Articles 20 and 21, and to consider if other approaches are
more appropriate, including those that allow biosimiliars to enter
into agreements to share the risk adjusted costs of clinical trials./1/

     Congress should reject the 12-14.5 year approach provided for in
HR 1548.

     In any case, the grant of a monopoly should not be without limits
or safeguards to protect consumers and taxpayers. Any bill that grants
a legal monopoly from competition should also include provisions that
allow the monopoly to be eliminated if products are priced
excessively, or if other factors merit a review of the monopoly
status. The bill should also require that companies disclose actual
R&D costs, prices and revenues for products, and that that the federal
government should have the opportunity to review the provision
periodically to determine if the term of the monopoly is excessive, or
if there is a need for additional safeguards to protect the public, or
if new approaches, such as cost sharing, are more appropriate in the
context of a policy to advance health interests.

     Knowledge Ecology International
     FMI: Judit Rius judit.rius@keionline.org (1.202.332.2670)
     James Love james.love@keionline.org (1.202.361.3040)

     *Knowledge Ecology International (KEI) is a non-profit
organization that focuses on issues about innovation and access to
knowledge goods, including new medical inventions.

     /1/. See: Judit Rius Sanjuan- James Love - Robert Weissman,
PROTECTION OF PHARMACEUTICAL TEST DATA: A POLICY PROPOSAL, 21 November
2006

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