[Ip-health] Generic biologics bill in danger - 12 year period of data exclusivity raises concerns

[Mike Palmedo]

Generic Biologic Bill Support Crumbling

Anna Edney
Congress Daily
July 19, 2007

     The fragile support for a Senate bill that would allow the FDA to
approve generic versions of biologic drugs is deteriorating at the same
time House lawmakers are trying to persuade leaders not to allow for
such a provision in an FDA bill.

     Generic and brand pharmaceutical industry lobbyists say generic
companies and supporters might threaten to pull their support for the
bill if a provision they say would give brand companies continuous
monopoly rights is not changed.

     Senate Health, Education, Labor and Pensions Chairman Kennedy,
ranking member Michael Enzi, R-Wyo., and Sens. Hillary Rodham Clinton,
D-N.Y., and Orrin Hatch, R-Utah, negotiated the generic biologics bill
the committee marked up last month.

     A sticking point with the negotiators was how long to give brand
companies exclusive rights to sell their drug free of generic competition.

     The senators settled on 12 years, a number most believe cannot
change without crumbling the entire deal.

     The Generic Pharmaceutical Association raised the concern after the
markup that brand biologic drugs would be allowed to also receive 12
years of exclusivity for any changes made to a drug, such as FDA
approval to treat a new disease or a new form of administration, further
delaying generic competition.

     Congressional and industry sources said brand and generic
stakeholders met with staff over the weekend, but an agreement cannot be
reached on what at first was thought to be a technical fix.

     The latest issue has been addressed at the staff level and has not
yet reached lawmakers, though generic supporters are trying to move up
the ranks with their concerns.

     Generic companies want lawmakers to lower the exclusivity number
and add on years for beneficial changes, similar to the way traditional
chemical drugs are handled.

     Chemical drugs get five years of exclusivity, while three years are
added on if changes are made to improve the drug.

     "We're not looking for an additional 12 years," said Sandi Dennis,
deputy general counsel for healthcare regulatory affairs at the
Biotechnology Industry Organization. "We do think that it is important
to have incentives for the development of significant new uses of
biotechnology products."

     BIO does not support lowering the original exclusivity period,
though, to make room for the additional years.

     "Twelve years is a good, reasonable compromise and we're sticking
with it," Enzi spokesman Michael Mahaffey said.

     Without a consensus, Kennedy's intention to insert the generic
biologic bill into an omnibus FDA bill set for conference might be in
jeopardy.

     In the House, Rep. Anna Eshoo, D-Calif., led a bipartisan group of
11 House Energy and Commerce Committee members in writing committee and
Health Subcommittee leaders about not including a generic biologics
provision in the FDA bill, which reauthorizes agency programs and
overhauls drug safety at FDA.

     "We believe the establishment of a pathway for approval of
biosimilars (generic biologics) is appropriate for Congress to consider,
but only after consideration of the views of all stakeholders and full
deliberation, hearings and markup by the appropriate committees," states
the Wednesday letter.

     The House Energy and Commerce Committee has not considered generic
biologic legislation. BIO also believes generic biologic legislation
should be considered separate of the omnibus FDA bill.

     Energy and Commerce Health Subcommittee Chairman Frank Pallone,
D-N.J., was not optimistic about the chances of the House allowing
inclusion of a generic biologic provision in the FDA bill in conference.

     Pallone said House members have not reached a consensus on generic
biologics and one would be tough to reach before they hope to conference.

     The FDA bill must be passed by the end of the month to prevent the
agency from sending out layoff notices to employees.

--
Mike Palmedo
Research Coordinator
Program on Information Justice and Intellectual Property
American University, Washington College of Law
4910 Massachutsetts Ave., NW Washington, DC 20016
T - 202-274-4442 | F 202-274-0659
mpalmedo@wcl.american.edu