Bristol-Myers Squibb expects the pediatric exclusivity reauthorization bill to be signed into law by the end of the month.

"It now appears fairly clear that Congress will pass a pediatric extension bill that will include a legislative amendment that purports to give FDA discretion to approve generic Glucophage ," Bristol CEO Peter Dolan told analysts during a Dec. 13 conference call to provide new earnings projections for 2002.

"Assuming the President signs the pediatric bill into law later this month, and we assume he will, the FDA would have to decide whether and when to approve multiple generic competitors," Dolan said.

Bristol would have to seek an injunction to stop FDA from approving generics of Glucophage, Dolan added.

Discussion of post-enactment strategies is a concession of defeat for Bristol in its attempts to extend exclusivity for the diabetes treatment by blocking passage of the legislation.

Section 11 of the bill would permit marketing of metformin generics that do not carry the pediatric labeling information of Glucophage. After House and Senate staffers negotiated a consensus version of the bill, the Senate passed S 1789 Dec. 11. The House is expected to vote on the measure as early as Dec. 18.

Dolan's carefully phrased remarks suggest that the company intends to press its case before FDA and in court.

"If the FDA were to approve generic competition despite a clear legal position which was confirmed by independent legal scholars, then only an injunction would prevent generic competition from immediately entering the market," Dolan said.

Bristol argues that section 11 would effect a taking of the company's intellectual property under the Fifth Amendment.

While some members of Congress expressed concerns about section 11 and the potential for costly litigation, the Senate passed S 1789 by unanimous consent. The House will likely consider the motion under a similar procedure this week.

In one change to the final bill from its original House and Senate drafts, generic drugs whose Waxman/Hatch exclusivity expires during the innovator's pediatric exclusivity period would receive an exclusivity extension equal to the number of days of the overlap.

The previous House and Senate versions would have provided a six-month extension regardless of the duration of the overlap.

The change means that generic companies could still face concerns about the timing of exclusivity-triggering events that could preclude them from using their entire 180 days.

The issue of generic and pediatric exclusivity overlap first arose with Barr's fluoxetine. Barr successfully challenged a patent on Lilly's Prozac , but could not immediately launch its generic because a shorter- running patent was still in effect.

Had a final order invalidating Lilly's longer-running patent been issued before the expiration of its pediatric exclusivity, Barr's exclusivity might have been triggered and started to run before the company could launch its generic (¹ Also see "Barr Fluoxetine Will Have Two Months Exclusivity Under "Worst Case"" - Pink Sheet, 12 March, 2001., p. 3).

The original versions of the bill would have allowed generic companies in similar circumstances to receive a full 180 days even if it were triggered before the beginning of a brand's pediatric exclusivity.

That section 10 language, which would have essentially postponed the generic exclusivity trigger date under some circumstances, could have been seen as a broader reopening of Waxman/Hatch mechanisms rather than a simple fix of pediatric-related concerns.

Sen. Orrin Hatch (R-Utah) raised concerns over the interaction of generic and pediatric exclusivities in a Dec. 6 letter to Sen. Edward Kennedy (D-Mass.). Consecutive, rather than concurrent, exclusivities "should be explicitly recognized as the law and policy even for already-approved generic drug products because all successful Paragraph IV applicants should be treated equally and receive the full 180 days - no more, no less - of marketing exclusivity," he said.

In a related change from original bill language, the consensus version omits a paragraph which would have stressed that "under no circumstances" should section 10 be interpreted to enable a drug to be marketed "to the exclusion of a subsequent applicant" for more than 180 days.

The consensus version also omits a subsection which specified that, in cases where FDA asks the National Institutes of Health to perform pediatric studies for a drug whose sponsor has declined to do so, that research "shall be considered to be an activity conducted for the purpose of development and submission of information to the [HHS] Secretary under this act." The original Senate bill contained this language.

The final version of the bill would also create a "Pediatric Pharmacology Advisory Committee" to oversee the design of clinical trials and identify research priorities in pediatric pharmacology.

FDA has an informal "freeze" from HHS on forming new full-fledged advisory committees (² Also see "FDA Cardiotoxicity Group Paper To Suggest Use Of Troponins As Biomarkers" - Pink Sheet, 19 November, 2001., p. 9).

The Senate bill proposed creating a "Pediatric Advisory Committee" to discuss research issues and resolve disputes between sponsors and the FDA on labeling changes.

The consensus bill retains the House language that charges the existing Anti-Infective Drugs/Pediatric Advisory Subcommittee with resolving labeling disputes.

The advisory role of the Oncologic Drugs/Pediatric Advisory Subcommittee is outlined under the bill. The subcommittee would include up to 11 voting members from the membership of the Pediatric Pharmacology and Oncologic Drugs Advisory Committees.

Two House amendments are preserved in S 1789. The bill would create a toll-free number maintained by FDA for the reporting of adverse events associated with the pediatric use of a drug, as suggested by Rep. Bart Stupak (R-Mich.). Pharmacy groups objected to the inclusion of such a hotline on bottle labels (³ Also see "Roche Accutane Prescriber Registry Added To Pregnancy Prevention Program" - Pink Sheet, 5 November, 2001., p. 5).

The bill also includes House langauge introduced by Rep. Diana DeGette (D-Colo.) that would direct the General Accounting Office to study how well children of racial and ethnic minorities are represented in pediatric trials and whether diseases that disproportionately strike minority children are appropriately studied.

Glucophage Generics Coming Soon, Bristol Says; Exclusivity Bill Clears Senate

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