By
Donald Zuhn --
On
Tuesday, ten Governors sent a letter to Congressional leaders expressing
their support for Congress' efforts to pass legislation that would create a
follow-on biologics regulatory pathway.
Noting that "[t]his critically important issue has a direct
economic impact on our states, our nation's public health, our economic
success, and our global leadership in biomedical research," the Governors
stated that "the balance struck in the Senate Health, Education, Labor and
Pensions Committee on 12 years of data exclusivity for biologics represents a
critical element needed to ensure appropriate incentives for continued
biomedical innovation." In
July, the Senate Health, Education, Labor and Pensions (HELP) Committee approved
an amendment providing a 12-year data exclusivity period for biologic drug
makers (see "Senators
Champion 12-Year Data Exclusivity in Senate"). The Governors also noted that the House
Energy and Commerce Committee had voiced its "overwhelming" support
for a 12-year data exclusivity period (see
"House Committee Approves Health Care Reform Bill Calling for 12-Year
Exclusivity Period").
In
their letter, the Governors assert that "[i]nnovator companies must be
provided with at least 12 years of non-patent data exclusivity to allow for
recovery of their original investment and to ensure licensing payments to our
research institutions." The
Governors also contend that "[i]n order to assure these companies continue
to make investments in medical progress and take the risks necessary to bring
these important products to patients, innovators should be provided with
appropriate incentives, including data exclusivity and protections for their
patents."
The
letter, which was sent by Governors Deval Patrick of
Massachusetts, M. Jodi Rell of Connecticut, Bill Ritter, Jr. of Colorado, John
Markell of Delaware, Martin O'Malley of Maryland, Beverly Perdue of North
Carolina, Theodore Kulongoski of Oregon, Donald Carcieri of Rhode Island, Luis
Fortuño of Puerto Rico, and Christine Gregoire of Washington (Governors
Patrick, Ritter, Markell, O'Malley, Perdue, Kulongoski, and Gregoire are
Democrats, and Governors Rell, Carcieri, and Fortuño are Republicans -- Gov.
Fortuño is also a member of the New Progressive Party of Puerto Rico), was addressed
to Speaker of the House Nancy Pelosi (D-CA), House minority leader John Boehner
(R-OH), Senate majority leader Harry Reid (D-NV), and Senate minority leader
Mitch McConnell (R-KY).
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