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").