By
Donald Zuhn --
BIO CEO Asks President to
Focus on Unresolved Issues in Health Care Debate
Writing
for True/Slant earlier this month,
Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood provided
his organization's take on recent efforts by President Obama to re-write the biosimilars provisions of the House and Senate
health care bills ("Health Care Reform Negotiations: Focus on Unresolved
Issues"). A little more than two weeks ago, President
Obama informed Congressional Democratic leaders, including Rep. Anna Eshoo
(D-CA), of his continued opposition to a 12-year data exclusivity period in a
meeting at the White House. Noting
that the "clock was ticking away" on health care reform, Mr.
Greenwood (at right) wondered why the President and some members of Congress, like Rep. Henry
Waxman (D-CA), would focus
on the long resolved data exclusivity provisions of the House and Senate bills
rather than "on some of the 20+ areas where the House and Senate bills
don't line up -- employer mandates, a public option, taxes, to name a few."
Contending
that biosimilars provisions represent a "legislative solution . . . that
would encourage life-saving biomedical research while expanding access to
powerful biologics," Mr. Greenwood also asserted that the proposed
legislation would "preserve[] existing U.S. jobs and maintain[] the
biotechnology sector's ability to create high-wage, high-value jobs." Despite the fact that the biosimilars
provision "happens to be one of the few provisions that is almost
identical in both the House and Senate versions of the health care reform
bill," and that the provision received bipartisan support in both the Senate Health,
Education, Labor and Pensions (HELP) Committee (by a 16-7 vote) and House
Energy and Commerce Committee (by a 47-11 vote), the President has pressed for
a shorter data exclusivity period.
In
his brief article, Mr. Greenwood notes that "[t]he biosimilars provision is the
result of a careful compromise overwhelmingly approved months ago in each
Chamber," and that "[i]n addition to receiving support in both
Chambers and by both parties, the biosimilars provision is supported by
universities, patient groups, venture capitalists and economic development
groups." The BIO CEO
concludes by stating that "[i]t's time for Rep. Waxman and the White House
to take on the tough issues that are weighing down the health care reform
debate -- not reopen one of the few issues that has long been resolved."
38 Patients Groups and
Research Universities Back 12-Year Data Exclusivity Period
Earlier
this month, the Gazette.Net reported
that despite the election of Republican Scott Brown to the Massachusetts Senate
seat once occupied by Ted Kennedy, a number of legislators have been pushing
for the passage of the proposed biosimilars regulatory pathway that was
approved in both the Senate and House health care reform bills ("BioWatch:
Federal biosimilar regulation gathers support"). In two separate letters, one to Senate
Majority Leader Harry Reid (D-NV) from eight Senate Democrats and another to
House Speaker Nancy Pelosi (D-CA) and Majority Leader Steny Hoyer (D-MD) from
45 members of the House, legislators continue to support a biosimilars
regulatory pathway providing a 12-year data exclusivity period.
In
addition to the letters above, and a letter from six Governors also supporting
the 12-year period (see "Governors
Write President in Support of 12-Year Data Exclusivity Period"),
Sen. Reid and Speaker Pelosi also recently received a similar letter from 38
organizations, including groups representing surgeons plus advocacy groups such
as Easter Seals, the Parkinson's Disease Foundation and the Muscular Dystrophy
Association. (Patent Docs has not had an opportunity to review the above letter, but would gladly post a copy if any of
our readers can provide one.)
NATF Says Patient Safety
Should Be Top Priority When Crafting Biosimilar Regulatory Pathway
In
an advertisement appearing in the Eastern edition of The Wall Street Journal on January 27, the North American
Thrombosis Forum (NATF) states that "patient safety must be the top
priority and must be ensured prior to making [biosimilar] drugs available to
the U.S. public." The ad
notes that both the House and Senate health care bills would provide for the creation
of a biosimilars regulatory pathway in the U.S., and contends that "[t]he
potential of [biologic medicines] to reduce costs is why we believe follow-on
biologics are a critical component for meaningful heathcare reform." While acknowledging that "healthcare
reform legislation is a massive undertaking with many competing
interests," the ad warns that "when compared to a fight over billions
of dollars, threats to patient safety from follow-on biologics may be easily
overlooked."
The
ad proposes several changes to the biosimilars provisions of the House and
Senate health care bills in order to better address patient safety. First, the ad contends that "it is
critical that this piece of healthcare reform requires well-designed and
properly conducted clinical trials demonstrating safety and efficacy of
biosimilars." The ad also
contends that the "potency and biological effects of the biosimilar and
approved product must be equivalent," and therefore, the FDA must
"set out clear criteria to demonstrate whether biosimilars can be
substituted for approved products (interchangeability), and biosimialrs
themselves must be excluded as reference products." Finally, the ad states that
"long-term safety must be established and rigorously monitored in patients
treated with biosimilars."
According
to the ad, the NATF is a nonprofit advocacy group of scientists, clinicians,
and patients focusing on the unmet needs and issues related to thrombosis and
cardiovascular diseases.
Representing NATF on the ad are Dr. Craig Kessler, Professor of Medicine
and Pathology at the Georgetown University Medical Center, and Dr. Craig
Jackson, Associate Professor of Internal Medicine and the Washington University
School of Medicine.
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