Last week, the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) released dueling statements about the proposal to establish an approval pathway for follow-on biologics that the Senate Committee on Health, Education, Labor, and Pensions (HELP) is considering. Are the two antagonists advancing the debate?
Not exactly. BIO restated familiar concerns that the proposal would provide insufficient protection to innovators and hamper the quest for cures. GPhA countered by citing the Federal Trade Commission’s (FTC) finding that long exclusivity periods are not needed to spur innovation. GPhA added that FTC provides “extremely robust intellectual-property protection” that, they imply, eliminates the need for market exclusivity, although GPhA did not explain why this was the case.
BIO noted that the proposal before the HELP committee provides nine years of base data exclusivity “only to a new ‘major’ substance” and grants no exclusivity to a product that is “similar to a previously approved product.” This language seems intended to prevent evergreening. Surprisingly, GPhA did not mention this language approvingly (or even at all) in its statement.
Though BIO and GPhA have not introduced new arguments to the debate, GPhA gives the impression of being more flexible. Although generic-drug companies prefer a five-year term of exclusivity, as the Hatch–Waxman bill would establish, GPhA accepts the seven-year period that the president supports as a helpful compromise. BIO’s most recent public statement gives no indication that the organization is willing to accept anything less than the long exclusivity period it has always demanded. In this regard, GPhA might be winning the public-relations battle.