Follow-on biologics legislation without a long period of data exclusivity for the original drug would significantly hinder future innovation, according to one economist.
Meanwhile, legislators' insistence that incentives for innovation be balanced with generics' promise of affordability means that a regulatory pathway for the drugs could remain uncharted in 2009.
Data exclusivity for follow-on biologics is the “period of time after [a biologic drug's] approval before a follow-on biologic can enter the market with an abbreviated filing” that relies on the original drug's safety and efficacy data, said Henry G. Grabowski, Ph.D., at a recent audioconference sponsored by Avalere Health LLC, a health care consultancy.
Because a “typical” new biologic drug might cost up to $1.2 billion in research and development, the “data exclusivity [period] acts as an insurance policy to ensure that there is adequate incentive” to produce the drugs in the first place, said Dr. Grabowski, a professor of economics and director of the program in pharmaceuticals and health economics at Duke University in Durham, N.C.
Ann Witt, a health care adviser to Rep. Henry Waxman (D-Calif.), who cosponsored the 1984 generic drugs legislation, disagreed with Dr. Grabowski's assessment. “Many of the arguments we heard here today were also made in 1984 by the then-manufacturers of small molecule drugs, who insisted that innovation would come to an end” with the advent of generics, she pointed out. Since then, “I have never heard anyone claim that that bill reduced innovation in the pharmaceutical industry,” she said.
The Food and Drug Administration's stance seems to side with Dr. Grabowski and the drugmakers. A Sept. 18, 2008, letter from the FDA's then-chief scientist, Dr. Frank M. Torti, states: “The Agency believes that sponsors that develop innovative biotechnology products should be eligible for a significant period of market and/or data exclusivity, independent from any patent protections that might be applicable to the product, to ensure continued innovation.”
Dr. Torti has since taken over as the FDA's acting commissioner.
The letter was addressed to the chairman of the House Subcommittee on Health, Rep. Frank Pallone Jr. (D-N.J.). The subcommittee is a division of the House Committee on Energy and Commerce, of which Rep. Waxman was recently appointed chairman. Ms. Witt said that legislation supporting a follow-on biologics pathway would be a high priority for the committee in 2009.