The hammer for generic firms - forfeiture of 180-day exclusivity - was absent from the "pay for delay" amendment added to the health care reform bill in the House Energy and Commerce Committee July 31.

The reverse settlements amendment, proposed by Rep. Bobby Rush, D-Ill., and adopted by voice vote, was otherwise the Protecting Consumer Access to Generic Drugs Act, H.R. 1706, that was reported out by his Subcommittee on Commerce, Trade and Consumer Protection on June 3 (Also see "Reverse Settlement Bill Clears House Subcommittee With GAO Report Attached" - Pink Sheet, 8 June, 2009.).

The forfeiture provisions are within the jurisdiction of the Judiciary Committee and could be considered non-germane to the health reform legislation. Concern about such a ruling prompted Rep. Anna Eshoo, D-Calif, to remove declaratory judgment provisions from here biosimilars legislation ([A#20090722]). Her stripped down amendment was also adopted during mark-up (see Also see "Follow-On Biologics: Defeat For Waxman, Win For Health Reform" - Pink Sheet, 31 July, 2009. ).

Rush's original language on forfeiture would have required generic firms to give up 180-day exclusivity if they fail to market their drug within 75 days of a declaratory judgment dismissal for lack of subject matter jurisdiction, or of filing of a covenant that the patent owner will not sue for patent infringement.

The only other change from H.R. 1706, which would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, tightens language on what the ANDA filer may not do.

Where H.R. 1706 prohibited reverse settlements in which the ANDA filer "agrees not to" research, develop, manufacture, market, or sell the drug that is being manufactured under the ANDA, the Commerce Committee amendment further mandates that the ANDA filer not agree to limit those activities.

The amendment includes a provision offered by Rep. George Radanovich, R-Calif, during the subcommittee mark-up that a Government Accountability Office report will keep tabs on whether the amendment results in earlier or delayed entry of generics to the market.

-Lauren Smith (lauren.smith@elsevier.com )

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