Myriad Amendments to Senate Health Care Reform Bill Aimed at Generic Drugs

By Kurt R. Karst –      

Although much discussion has been devoted over the past few days to Sen. Byron Dorgan’s (D-ND) proposed amendment (SA 2793) to the Senate Health Care Reform Bill that would let U.S. pharmacies and drug wholesalers import FDA-approved drugs from certain countries, and FDA’s letter expressing concern about the amendment, several amendments affecting generic drug manufacturers have also been proposed.

Sen. Herb Kohl (D-WI) filed an amendment (SA 2862) concerning so-called “pay-for-delay” settlements.  The amendment is almost identical to the substitute amendment to S. 369, the Preserve Access to Affordable Generics Act, that was passed out of the Senate Judiciary Committee earlier this year.  As we previously reported, the Kohl amendment would amend the Federal Trade Commission Act to permit the Federal Trace Commission (“FTC”) to “initiate a proceeding to enforce the provisions of [new Sec. 28] against the parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug product.”  Such agreements, if challenged, would be presumptively anticompetitive and unlawful unless it can be demonstrated “by clear and convincing evidence that the procompetitive benefits of the agreement outweigh the anticompetitive effects of the agreement.” 

And while we are on the topic of pay-for-delay settlements, FTC Commissioner J. Thomas Rosch recently gave a speech at the World Generic Medicine Congress providing his thoughts on how competition law can best protect consumer welfare in the pharmaceutical context.  In addition to settlement agreements, Commissioner Rosch also discussed follow-on biologics and authorized generics, which, as discussed below, have also been the subject of recent amendments to the Senate Health Care Reform Bill.

Sen. Jay Rockefeller (D-WV) filed an amendment (SA 2952) that would  prohibit the marketing of authorized generics during a generic applicant’s 180-day exclusivity period.  The amendment is almost identical to legislation Sen. Rockefeller introduced earlier this year.  A similar version of the bill was introduced in the House of Representatives by Rep. Jo Ann Emerson (R-MO) (see our previous post here). 

Sen. Sherrod Brown (D-OH) filed an amendment (SA 2895) concerning biosimilars that would cut the proposed 12-year exclusivity period for an innovator product short if the innovator’s product is a blockbuster drug; that is, a biologic for which “the Secretary determines that the gross sales in the United States of the reference product equals or exceeds $3,500,000,000.”  A similar blockbuster proposal with respect to the availability of pediatric exclusivity was considered and rejected during consideration of the 2007 FDA Amendments Act, which, among other things, amended and reauthorized the Best Pharmaceuticals for Children Act.  FDA Week (subscription required) has reported that another amendment concerning biosimilars from Sen. Bernie Sanders (I-VT) is in the works that could also affect the availability of the proposed 12-year exclusivity period for innovator products. 

Finally, Sen. Jeanne Shaheen (D-NH) filed an amendment (SA 2961) that would add her so-called “Generic Loophole Bill” to the Senate bill.  As we previously reported, S. 1778, the Access to Affordable Medicines Act, would amend the FDC Act’s ANDA provisions at § 505(j) to permit FDA to approve a generic drug notwithstanding “last minute [labeling] changes” to the reference listed drug labeling hat could otherwise delay ANDA approval. 

The Drug Price Competition Act of 2009, which was introduced earlier this year by Sen. Bill Nelson (D-FL), and in the house by Rep. Alcee Hastings (D-FL), does not yet appear to be the subject of an amendment to the Senate Health Care Reform Bill.  As we previously reported (here and here), the bill would amend the definition of “first applicant” at FDC Act § 505(j)(5)(B)(iv)(II)(bb) with respect to 180-day exclusivity eligibility so that certain subsequent ANDA applicants could trigger and be eligible for exclusivity.  Rep. Hastings initially proposed his bill as an amendment to the House Health Care Reform Bill, but then withdrew it from consideration.