[Ip-health] More exclusive incentives for bioterrorism

[Kevin Outterson]

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Snips from the BioDefense Funding Report, June 6, 2006:ADVOCATES ARGUE
BIODEFENSE BILL MAY JEOPARDIZE ORPHAN DRUG DEVELOPMENT
Patient advocates argue that a provision in pending legislation
granting extended market exclusivity for drugs used to address potential
bioterrorism threats could undercut current law, is unnecessary and must
be removed. But the sponsor, Sen. Richard Burr (R-N.C.), responds that
the move is necessary.   Burr is proposing to amend the Orphan Drug Act
of 1983 (ODA) to grant its authority for extended market exclusivity to
drugs used to combat bioterrorism. The provision would also expand the
term of market exclusivity to 10 years from the current seven-year
period. Providing drugmakers with this protection from competition is
meant to be an incentive for them to produce countermeasures,
antibiotics and anti-infectives used to fight bioterrorism.   Burr has
been reworking his bill to broaden the federal government's authority to
address potential bioterrorism and pandemic flu threats since last
October, following severe criticism from various stakeholders that
undermined the legislation's support. But the National Organization for
Rare Disorders (NORD) says that the move leaves ODA vulnerable to
harmful amendments and is unnecessary. "Every time you open up a piece
of legislation, you open it up to abuse," Diane Dorman, NORD's vice
president for public policy, said....   Makers of biodefense products
also do not need this incentive because they "can anticipate a
commercially viable market," NORD said in a May 23 letter to Burr and
Senate Health, Education, Labor and Pensions (HELP) Chairman Sen. Mike
Enzi (R-Wyo.). The HELP committee has jurisdiction over HHS and the
biodefense issue. The letter is available at:
http://www.rarediseases.org/pdf/SenEnziBARDA052306.pdf.....