Barr plans to launch its generic version of Bristol-Myers Squibb's Glucophage (metformin) by early February, CEO Bruce Downey said Jan. 10.

"We were very active in the efforts to defeat Bristol-Myers Squibb's attempts to have this product sort of grandfathered for another three or four years," Downey told analysts at the JP Morgan H&Q conference in San Francisco. "We look forward to launching [metformin] later this month or early in February."

President Bush signed "The Best Pharmaceuticals for Children Act" Jan. 4. The bill includes language intended to resolve Bristol's claim that generic versions of metformin cannot be approved until its three-year Waxman/Hatch exclusivity for Glucophage pediatric labeling expires.

Bristol filed a citizen petition Dec. 26 arguing that appropriate pediatric labeling for metformin generics should be the subject of a public hearing (¹ Also see "Bristol Glucophage Petition Seeks FDA Hearing Before ANDA Approval" - Pink Sheet, 7 January, 2002., p. 3).

FDA is evaluating Bristol's petition and said it has not set a deadline to complete its review. The agency indicated that Barr's estimate of approval in the next four weeks may be optimistic.

The Generic Pharmaceutical Association is planning to respond to Bristol's petition in the next week. Teva said it expects to submit a response within two weeks.

Barr said it does not believe the citizen petition will further delay generic approval and does not plan to submit a response. The company expects to hear from FDA soon on generic metformin labeling.

Watson submitted a response to Bristol's petition Jan. 10, prepared by the D.C. law firm Hyman, Phelps & McNamara. Bristol "is resorting to bogus procedural arguments in a desperate attempt to prevent generic competition," Watson declared.

"Nothing in the BPCA says that FDA is required to adopt regulations or new regulatory procedures to approve ANDAs that omit pediatric labeling," Watson declares. "Even if Congress had expressly required FDA to promulgate implementing regulations, there is nothing in the BPCA nor any authority provided by BMS, that would prevent FDA from regulating from the statute until any regulations were finalized."

Watson notes that FDA was directed to issue implementing regs for the 1984 Waxman/Hatch Act within one year. The regs were not finalized until 1992, but the agency nevertheless approved ANDAs as directed by the law.

FDA does not need new procedures to implement Sec. 11, Watson says. "FDA makes decisions about ANDAs and the content of labeling for generic drugs every day. That is what the Office of Generic Drugs does."

Finally, Watson suggests a procedural technicality: under FDA's rules for citizen petitions, petitioners are required to suggest "the exact wording...of the proposed regulation" sought in a filing. Bristol did not include proposed regulations in its petition.

"One might expect that BMS, with its extensive knowledge of metformin, would have been able, for example, to propose...suggested labeling for metformin generics," Watson declared. "BMS did not do so because its real concern is delaying generic competition."

Approval of a second round of buspirone generics has also been delayed by Bristol's pediatric labeling change to BuSpar . However, other issues raised by Bristol may further delay approval of those products.

FDA has granted Barr's request for restoration of full 180-day exclusivity for generic Prozac under the pediatric exclusivity law. The company's exclusivity for 20 mg fluoxetine capsules will expire Jan. 29 instead of Jan. 23.

In a Jan. 8 letter, the agency says "that Sec. 10 of the Best Pharmaceuticals for Children Act extends Barr's current generic exclusivity period by the amount of the 'overlap' between Barr's 180-day exclusivity and Lilly's pediatric exclusivity."

Barr's 180 days began July 27 following a favorable district court decision on appeal of Lilly's patent challenge. Lilly's pediatric exclusivity did not expire until Aug. 2 (² Also see "The end of an era?" - Pink Sheet, 6 August, 2001., p. 23).

Another piece of housekeeping associated with the new law is the repeal of the user fee exemption for pediatric supplements. FDA notified industry on its web site that fees are now required for pediatric supplements, unless they are otherwise eligible for waivers.

Barr Expects Metformin Launch By Early February; Pediatric Bill Signed

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