By
Donald Zuhn --
On
Sunday night, the House of Representatives voted by a narrow 219-212 margin to
agree to the version of the Patient Protection and Affordable Care Act (H.R.
3590)
that the Senate passed on December 24, 2009 (see "Follow-on Biologics News Briefs - No. 11"). Less than an hour later, the House
added 135 pages of amendments
to the Senate bill by a 220-211 vote.
Those amendments will now go to the Senate for approval.
As
we reported in December, the Senate bill contains a section providing for an
approval pathway for biosimilar biological products. This portion of the bill would preclude a biosimilar
application from being approved "until the date that is 12 years after the
date on which the reference product was first licensed," as well as offer
an additional 6 months of exclusivity for the use of reference products
"in the pediatric population."
We also noted in January that an effort by Sen. Herb Kohl (D-WI) to add a
pay-for-delay provision to the Senate health care bill had failed (see "Consumer
Groups Ask Congress to Add Pay-for-Delay Provision to Health Care Bill"). The provision, which was based on a
bill (S. 369) Sen. Kohl introduced in February 2009, would have prohibited payments
from brand name to generic drug manufacturers with the purpose to prevent or
delay the entry of competition from generic drugs.
The
additional House amendments that were passed yesterday leave the biosimilars
portion of the Senate bill untouched, but do not add the pay-for-delay ban that
President Obama was seeking as recently as last month. The President had included a ban of pay-for-delay
settlements among 34 key improvements in his health care
proposal released prior to the Bipartisan Meeting on Health Reform (see "President's Health Care Plan
Includes Pay-for-Delay Ban and Biosimilar Regulatory Pathway").
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