Representatives Anna G. Eshoo (D, CA), Jan Inslee (D,WA), and Joe Barton (R,TX) have sent a letter to the FDA, explaining the "legislative intent" of the data exclusivity provisions of the bill.
Their letter states that P.L.111-148 does not provide a market exclusivity period. Instead, the bill provides 12 years of data exclusivity. The differences between these two types of exclusivity are "significant and critical," because the intent of these legislators was to "prohibit[] the FDA from allowing another manufacturer to rely on the data of an innovator to support approval of another product." The law was not intended to "prohibit or prevent another manufacturer from developing its own data to justify FDA approval of a similar of competitive product." This interpretation would encourage biologic drug competitors (presumably using the innovator's FDA submission as a roadmap) to submit their own data in support of an independent biologic license application (BLA) pursuant to Sec. 351 of the Public Health Service Act.
The letter also emphasizes that the bill prohibits "evergreening" by innovators, specifically that "no product, under any circumstances, can be granted 'bonus' years of data exclusivity for mere improvements on a product." New products, termed "next generation" by the letter's signatories, are not within the definition of evergreening -- such a new product (having "significant changes in safety, purity or potency") is considered a "new biologic [that] will receive its own 12-year period of data exclusivity" (emphasis in original). However the letter positively asserts that while its authors "care deeply about patient access to biologics," they "also care about the advancement of science and our ability to treat the most complex diseases." Thus, they warn that "[a]ny proposal to limit the definition of a 'new' product, and thus one which is entitled to its own period of data exclusivity has the potential to stifle innovation and negatively impact patient care," which they oppose.
