Leaders seek new strategies to strengthen generic industry

Drug Store News, August 18, 1997 by Ken Rankin

The most celebrated, and controversial, of these petitions was filed by Wyeth-Ayerst in an effort to block FDA approval of generic competition for the company's Premarin (conjugated estrogen) product.

Although Premarin has been off patent for more than a generation, difficulties in synthesizing the complex combination of estrogens in the drug have kept lower-cost generic versions off pharmacy shelves. As a result, Wyeth-Ayerst has enjoyed a period of market exclusivity that has lasted decades beyond Premarin's patent protection.

Scientists at Duramed believed they had finally solved the puzzle two years ago, and filed an Abbreviated New Drug Application seeking FDA approval to market a generic equivalent.

Before the FDA could rule on that application, however, Wyeth-Ayerst challenged the approval through a citizens petition that raised questions about whether the synthetic conjugated estrogen developed for generic distribution contained all of the active ingredients in the original product.

An FDA advisory panel was unable to resolve the controversy, and, after chewing over the issue for more than a year, the FDA rejected the application.

Generic drug industry leaders responded to the FDA's ruling with outrage and frustration, calling the FDA's refusal to approve a generic form of Premarin a "politically motivated decision." GPIA chairman Marvin Samson said, "There is no supportable scientific data to justify the FDA's position."

But, even as they chastised the agency publicly, generic drug industry leaders spent much of the past year working to build congressional support for higher levels of funding for the FDA's activities. At a minimum, the industry is hoping to squeeze out at least $1 million in additional funds to finance an expansion of the FDA's Office of Generic Drugs and speed the approval of new generic medicines. While the agency's final budget had not cleared Congress at press time, the version passed by the House Appropriations Committee last month does contain the extra OGD funding.

State challenges

The generic drug industry also faced a series of challenges at the state level this year, including an aggressive lobbying campaign by DuPont Merck to secure legislation limiting generic substitution for so-called narrow therapeutic index drugs, such as Coumadin.

Although opposition from both the generic drug industry and retail pharmacy groups killed prospects for Narrow Therapeutic Index bills in several states, lawmakers in Virginia, North Carolina and Texas enacted legislation placing restrictions on the right of pharmacists to dispense generic substitutes for narrow therapeutic index products.

A potentially even more serious problem for generic pharmaceutical manufacturers involves proposals by branded drug makers to seek legislative revisions in the 1984 Waxman-Hatch Act, the landmark federal law credited with streamlining the approval process for generic medicines. One possible change that worries industry leaders would enable manufacturers of brand name drugs to secure more favorable patent term extensions to offset the period of patent life lost during the FDA approval process. A change in the formula for calculating such patent restorations could delay the introduction of competing generics by several months or even years.