[Ip-health] Senate panel backs 12 year data exclusivity for biologics

[Sarah Rimmington]

Late last night the Senate Health committee voted 16 to 7 last night in
favor of a proposal for 12-years of data exclusivity for brand-name
biologics that was offered by Sens. Mike Enzi (R), Orrin Hatch (R)and
Kay Hagan (D-NC). This proposal was backed by the brand-name industry
and opposed by consumer groups.  I believe but am unsure that the data
exclusivity proposal is identical to what was offered in the
Kennedy/Clinton/Hatch bill (S. 1695) passed in the committee in the
110th Congress, but the text has not yet been made available so details
are unclear. The approval pathway is said to be almost identical to what
was in S. 1695 as well.   The Enzi, Hatch and Hagan proposal also added
a four year filing moratorium for generic applications (from the date of
FDA approval).  The exclusivity period in the bill will apply to all
biologics passed under the Public Health Services Act starting from
their date of FDA approval.

By a 5 to 17 vote the committee rejected an alternate measure backed by
consumer groups that was proposed by Sen. Sherrod Brown, D-Ohio.  This
proposal would have started with a seven-year exclusivity period, with a
limited amount of additional years possible for innovations that require
additional clinical trials, and no filing moratorium on generic
applications.

The proposal was added to the current health care reform bill that the
Senate Health committee is close to finalizing. Senator Dodd believes
the markup of the bill (which has yet to be officially introduced) can
be finalized today or tomorrow.   The bill will then be passed to the
Senate Finance Committee, who will work on the bill and officially
introduce the final version.  The full senate will have a chance to vote
on the bill after these processes are finished.  It is currently
believed there will be a chance to alter the biologics provisions by
floor amendment,  if efforts to do so do not succeed in the Finance
committee.

In the meantime, the House Committee on Energy and Commerce (including
its health subcommittee) has not yet finalized its version of the bill,
which will probably be added to its health care reform proposal as
well.  The details of the process by which the issue will be resolved in
the house is currently unclear.

Initially the two competing house bills were being considered separately
from the health care reform act, but there is a large group of
representatives pushing an industry proposal for a minimum of 12  years
of data exclusivity [led by Representative Anna Eshoo (D-CA)] which have
requested that biogenerics issue be folded into the house health care
reform bill.  In light of the activities in the senate, and in light of
the fact the Rep Eshoo likely has the votes to force the incorporation
into the broader health bill,  it is all but certain that this will happen.

Energy and Commerce Chairman Henry Waxman is backing a competing bill
that offers a base of 5 years of data exclusivity.  The White House has
indicated it supports a "generous compromise" of 7 years base period of
exclusivity.   The industry-backed Eshoo proposal (H.R. 1548) has strong
support in the house so far (131 co-sponsors).  Now is the time to build
more support for consumer-friendly Waxman biogenerics proposal (H.R.
1427) in the house while the bill remains in committee.

For press coverage of the Senate proposal passage last night, see:
Reuters: http://www.reuters.com/article/politicsNews/idUSTRE56D0GR20090714
AP:
http://www.google.com/hostednews/ap/article/ALeqM5hB08iJTJM3MjbTjO2sm4MV6EaimgD99E09N01
Wall Street Journal:
http://online.wsj.com/article/BT-CO-20090713-715441.html
PharmaTimes: http://www.pharmatimes.com/WorldNews/article.aspx?id=16218


--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: +1 (202) 387-8030
Cell: +1 (202) 422-2687
www.essentialaction.org/access/