New Life for Old Antibiotics – Senate Passes Bill Creating New Exclusivity Provisions; House Passage is Expected Very Soon

September 26, 2008

Yesterday, the U.S. Senate passed S. 3560, the “QI Program Supplemental Funding Act of 2008.”  Section 4 of the bill would amend the FDC Act to add new subsection 505(v) – “Antibiotic Drugs Submitted Before November 21, 1997” – to create Hatch-Waxman benefits for so-called “old” antibiotics.  “Old” antibiotics are antibiotic active ingredients (and derivatives of such ingredients) included in an application submitted to FDA for review prior to November 21, 1997, the date of enactment of the FDA Modernization Act (“FDAMA”).  The 1984 Hatch-Waxman Amendments excluded antibiotic drugs, which were then approved under FDC Act § 507, from the Act’s patent and non-patent market exclusivity provisions (except for the availability of a patent term extension).

FDAMA repealed FDC Act § 507 and required all NDAs for antibiotic drugs to be submitted under FDC Act § 505.  FDAMA included a transition provision declaring that an antibiotic application approved under § 507 before the enactment of FDAMA would be considered to be an application submitted, filed, and approved under FDC Act § 505. 

Congress created an exception to this transition provision.  FDAMA § 125(d)(2) exempts certain applications for antibiotic drugs from those provisions of § 505 that provide patent listing, patent certification, and market exclusivity.  Specifically, FDAMA § 125(d)(2) exempts an antibiotic application from Hatch-Waxman benefits when “the drug that is the subject of the application contains an antibiotic drug and the antibiotic drug was the subject of an application” received by FDA under § 507 of the FDC Act before the enactment of FDAMA (i.e., November 21, 1997). 

Thus, applications for antibiotic drugs received by FDA prior to November 21, 1997, and applications submitted to FDA subsequent to November 21, 1997 for drugs that contain an antibiotic drug that was the subject of an application received by FDA prior to November 21, 1997 are within the FDAMA § 125(d)(2) exemption and are not currently eligible for Hatch-Waxman benefits.  Applications for antibiotic drugs not subject to the FDAMA § 125(d)(2) exemption – so-called “new” antibiotics – are eligible for Hatch-Waxman benefits.  A 1998 FDA guidance document explains the effects of FDAMA § 125 in greater detail.  On January 24, 2000, FDA published proposed regulations in the Federal Register that include a list of “old,” pre-FDAMA antibiotic drugs not subject to Hatch-Waxman benefits.  FDA has not yet promulgated final regulations.  In addition to the specific chemical substances listed, the list also includes “‘any derivative’ of any such [listed] substance, such as a salt or ester of the [listed] substance.”

S. 3560, if passed by the U.S. House of Representatives (as widely anticipated) and signed into law, would effectively undo FDAMA § 125.  Under the bill, for those antibiotic drugs approved before November 21, 1997, a sponsor can obtain 3-year exclusivity for a new condition of use.  For those antibiotic drugs submitted before November 21, 1997, but not approved, a sponsor may elect to be eligible for 3-year exclusivity, 5-year exclusivity, or a patent term extension (provided the applicable legal and regulatory requirements are met).  The bill would also make the Hatch-Waxman Amendments fully applicable to those antibiotic drugs subject to new FDC Act § 505(v).  Finally, the bill includes three “transition provisions.”   Those provisions: (1) require antibiotic drug NDA sponsors to submit to FDA for Orange Book listing information on applicable patents within 60 days of enactment of S. 3560; (2) require FDA to list those patents in the Orange Book not later than 90 days after the enactment of S. 3560; and (3) create “fist applicant” status (for 180-day exclusivity purposes) for each ANDA applicant that not later than 120 dates after enactment of S. 3560 amends a pending application to contain a Paragraph IV certification to a newly listed antibiotic drug patent.  A summary of the bill is available here. 

Section 4 of S. 3560 is not new.  It was included in the Staff Agreement version of the FDA Amendments Act (§ 1111), but due to cost concerns was removed immediately before passage of the bill in the House of Representatives.  Also, earlier this year, there was a failed attempt to add the provision to the Animal Drug User Fee Amendments of 2008 as part of a technical corrections package.

By Kurt R. Karst 


Categories: Hatch-Waxman