HUMAN GROWTH HORMONE (hGH) APPLICATION REVIEWS

HUMAN GROWTH HORMONE (hGH) APPLICATION REVIEWS are proceeding at FDA for followup products to Genentech's Protropin and Lilly's Humatrope, the agency told Senators Kennedy (D-Mass.) and Hatch (R-Utah) in a Jan. 25 letter (see related story above). Noting that Kennedy and Hatch had asked that pending hGH application reviews be completed by June of this year, FDA reported "the review of those applications is ongoing, and we expect that much of the review work will have been completed by June 1989." The senators had asked FDA to complete its review by June so that any changes in orphan exclusivity provisions could be taken advantage of by the pending hGH products. Lilly's Humatrope has about five years of exclusive marketing rights remaining for its recombinant human growth hormone product. FDA included one proviso in its assurance of a continuing review of the pending hGH applications. The agency noted the exception "of those areas where evolving technology may result in different production methods." Genentech recently defended its pricing and marketing practices for Protropin in a Jan. 17 letter to the National Commission on Orphan Diseases. Noting that the average annual cost of Protropin is $ 12,000, the letter states that the price of Protropin, since its market introduction at "25% less than the price of the two pituitary-derived products that it replaced," has not changed.