NAPM seeks to keep antibiotics out of Waxman/Hatch exclusivity procedures if Sec. 507 is repealed.

NAPM HOPES TO KEEP ANTIBIOTICS OUTSIDE WAXMAN/HATCH EXCLUSIVITY provisions, David Weeda of the Washington, D.C. law firm Olsson, Frank & Weeda told the National Association of Pharmaceutical Manufacturers annual meeting Jan. 31 in Naples, Fla. Legislation to repeal the separate regulation of antibiotics under FD&C Act Sec. 507 is expected to be reintroduced this year, Weeda noted. NAPM wants to ensure that such a repeal does not overturn the exemption of antibiotics from the Waxman/Hatch amendments.

By repealing section 507, "you subject antibiotics to the Waxman/Hatch exclusivity provisions...which do not apply to antibiotics today," Weeda said. "We've raised this issue with FDA....We have not received a written confirmation on this but we think in our heart of hearts FDA agrees that shouldn't apply." A bill to repeal Sec. 507 was introduced in 1996 by Rep. Waxman on behalf of FDA ("The Pink Sheet" June 24, 1996, T&G-6).

Brand name manufacturers will presumably try to have Waxman/Hatch exclusivity extended to antibiotics, either through repeal of Sec. 507 or a planned reconsideration of the Waxman/Hatch compromise by Sen. Hatch (R-Utah).

The D.C. law firm Fox, Bennett & Turner weighed in on the current relationship of Waxman/Hatch procedures to antibiotics in a recent citizen's petition. The firm asks that FDA "stop conducting therapeutic equivalence evaluations for, and assigning therapeutic equivalence codes to, antibiotic drugs approved pursuant to Sec. 507." The Jan. 24 petition asks that, at minimum, FDA provide interested persons with notice and an opportunity to comment on FDA's equivalence evaluations of antibiotics prior to publication.

Because the Waxman/Hatch Act exempts antibiotics, sponsors cannot claim marketing exclusivity upon approval regardless of patent status and cannot receive labeling exclusivity for new indications or formulations as they can for other drugs, the petition notes. "As a result of this disparity, antibiotic drugs have been disadvantaged in many respects," the petition states.

"By `facilitating substitution' of antibiotics," the petition claims, "the agency has administratively erected a barrier to new antibiotic development." The publication of antibiotic ratings "was designed to, and successfully achieves, generic substitution of antibiotics." The petition continues: "Given the existence of other disincentives impeding antibiotic research, the agency's disparate treatment of antibiotic drugs...further tips the balance in favor of pursuing innovative drug discovery in other therapeutic areas."

The statements made in the petition are similar to remarks by a Bristol-Myers Squibb Research Institute exec in 1995 suggesting that extension of patent exclusivity for novel antibiotics could encourage R&D in the area ("The Pink Sheet" May 22, 1995, p. 6). Rockefeller University researcher Joshua Lederberg, PhD, made similar claims at an American Medical Association press conference in 1996 ("The Pink Sheet" Jan. 29, 1996, T&G-4).

Weeda said NAPM will also work on adding generic drugs to the list of covered drugs in the federal employee's health benefits program. "It will just further strengthen the government's use of generic drugs if there's a specific reference in that law," Weeda said. The association is also hoping to become involved in international discussions about changes to the so-called "Bolar" amendment allowing research on still-patented drugs to speed generic development.